Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha Datta Meghe institute of Medical Sciences (DU), Nagpur

“EVALUATION OF THE EFFECTIVENESS AND IMPACT OF TOBACCO DE-ADDICTION TOOL IN THE CONTEXT OF PRESENT ANTI-TOBACCO CAMPAIGNS”

Thesis submitted for the degree of Doctor of Philosophy (Oral Medicine & Radiology) Faculty of Dentistry

By Dr. Stuti Sharad Bhargava

Research Supervisor Dr. Rahul R. Bhowate Professor & HOD, Department of Oral Medicine & Radiology

Department of Oral Medicine & Radiology Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha

2017

Declaration by the Candidate

I hereby declare that the thesis entitled “Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti tobacco campaigns” is a bonafide and genuine research work carried out by me under the guidance of Professor and Head, Department of Oral Medicine and Radiology , Dr. Rahul R. Bhowate.

I hereby solemnly affirm that the contents of this thesis have not been submitted earlier in candidature for any degree elsewhere. The university is permitted to have its legal rights for its subsequent uses.

Date:

Place: Sawangi (Meghe), Wardha

Dr. Stuti S. Bhargava, Ph.D. Scholar, Department of Oral Medicine and Radiology Sharad Pawar Dental College and Hospital Sawangi (Meghe),Wardha

Department Of Oral Medicine & Radiology Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha

Certificate

This is to certify that the work embodied in the thesis for the degree of Doctor of Philosophy (in Oral Medicine and Radiology) of Datta Meghe Institute of Medical Sciences (Deemed University), Nagpur, entitled “Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti tobacco campaigns” , was undertaken by Dr. Stuti Sharad Bhargava and was carried out in the department of , Oral Medicine and Radiology , VSPM DCRC Nagpur , under my guidance and direct supervision to my satisfaction.

This thesis fulfils the basic ordinance governing the submission of thesis laid down by Datta Meghe Institute of Medical Sciences University. Nagpur.

Date:

Place: Sawangi (Meghe), Wardha

Dr. Rahul R. Bhowate, Professor and Head, Department of Oral Medicine & Radiology Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha.

Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha Datta Meghe institute of Medical Sciences (DU), Nagpur

This is to certify that the work entitled “Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti tobacco campaigns”, for the degree of Doctor of Philosophy (Oral Medicine and Radiology) of Datta Meghe Institute of Medical Sciences (Deemed University), Nagpur, 2015-2017 is undertaken by Dr.Stuti Bhargava , Assistant Professor , OMR, VSPM DCRC .

We have great pleasure in forwarding this thesis to Datta Meghe Institute of Medical Sciences (Deemed University), Nagpur.

Date:

Dr. Rahul R. Bhowate, Dr. A.J. Pakhan Professor and Head, Dean, Dept of Oral Medicine & Radiology SPDC Wardha

Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha

Acknowledgements

In the name of God, Most Gracious, Most Merciful

It gives me immense pleasure to express my sincere thanks and deep sense of gratitude to my honorable guide and supervisor, Dr. Rahul R. Bhowate, Professor and Head, Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Hospital Sawangi (Meghe), Wardha. His constant liberal support, encouragement, critical appraisal , unlimited patience and vast wisdom have all been a profound source of inspiration in realization of this endeavor. I’m thankful to him for instilling in me the qualities of a good researcher. He has been a source of knowledge and for learning innumerable new things in the realm of my fraternity. I will always remain indebted to him.

Though not in any lesser measure, I am indebted to Dr. Minal Chaudhary, Professor, Department of Oral Pathology, Dean Examination Cell and Chairman PhD Cell and Dr. A. J. Pakhan, Dean SPDC for their valuable ideas and advice. Their continuous encouragement has contributed to a great extent in the completion of this task.

I am also grateful to Dr. Usha Radke, Dean and Dr. S.R Shenoi, Vice Dean, and Dr. Mukta B. Motwani, Professor and HOD, OMR; VSPM DCRC for supporting me throughout the duration of my PhD work and encouraging my work.

A special thanks to Dr.Dhananjay Raje PhD, Charted statistician for extending his valuable support in analyzing the results of this study and Dr. Sushil Naik , Lecturer Prosthodontics VSPM DCRC for his help with the translations.

At the risk of sounding more of a fan than a pupil; I am very grateful for the immensely useful discussions with Dr.Ved Prakash Mishra sir, Chief Advisor DMIMS DU. Sir truly embodies Author Conan Doyle’s fabled “Art of Deduction”

His analysis and troubleshooting have been awe inspiring and every interaction with him has been a very informative learning session. I hope to to have more learning opportunities with sir.

Speaking of awe inspiring appreciation, I will also like to put in my words of admiration for Dr. Minal Chaudhary, Dr. Mukta Motwani and Dr. USha Radke madam. In times when women with voices may still be considered as vices, the three of them lead by example in living a balanced life; perfectly handling all personal and professional responsibilities. I am fortunate to belong to a profession which is so accommodative of women’s progress and I hope to follow the footsteps of my peers and inspirational seniors and make a meaningful contribution to the world around me.

I am also thankful to Dr. S. Digwekar , Dr. Lohe , Dr. Dangore , Dr.Panchbhai , Dr.Mhod , Dept of OMR , SPDC ;Dr.Karemore , Dr.Chaudhary , Dr.Golhar and Dr. Mohite , Department of OMR VSPM DCRC , Dr. Langekar Dr.Kulkarni , Dr.Chandak SKDS DCH for their cooperation and support during the course of this project.

My sincere gratitude to all well-wishers and participants in this project , who all are too many to name but I sincerely acknowledge their cooperation, support and time given to this project. My special thanks to my extended family and friends for their love, affection, consistent encouragement and blessings in countless ways.

Words cease to be the medium to extend my profound sense of gratitude to my parents who are the wind beneath my wings. They have stood by me through thick and thin and everything in between with their unconditional love, affection and allowed me not just to dream but also to fulfill my dreams. Being blessed with limited means and seemingly more challenges; my parents instilled in me the jest to keep on growing as a person and a professional under all circumstances. They have blessed me with two most important gifts; that of higher education which I believe is an equally important privilege and asset in today’s times and the ability to differentiate between right and wrong which is the core of the humane existence

I dedicate this enterprise to them for being the pillar of strength for all my endeavors.

Most importantly, I would forever be grateful to the almighty God without whose abundant blessings, this accomplishment would have been just an ideal dream.

I humbly pay my utmost reverence to all those who have directly or indirectly helped me in my study and through a very crucial period of my life.

Dr. Stuti Bhargava Index

Sr. TITLE PAGE No. NO.

A. ABBREVIATIONS

1. INTRODUCTION 1

2. AIMS & OBJECTIVES 8

3. HYPOTHESIS 9

SECTION I : 4. KNOWLEDGE, ATTITUDE & PRACTICES OF TOBACCO 11 USERS & EFFECT OF ANTI-TOBACCO MEASURES

4.1 REVIEW OF LITERATURE a. Tobacco Use in India b. Anti Tobacco Measures :FCTC measures c. Tobacco Cessation Measures in India d. Ban on tobacco use in public e. Health warning labels f. Tobacco advertising, Promotion & Sponsorship g. Mass Media Intervention h. Price and Taxation i. Understanding the socio demographic co relates of tobacco use

4.2 MATERIAL AND METHODS 49

4.3 RESULTS 57

4.4 DISSCUSION 130

4.5 CONCLUSION 153

SR TITLE PAGE NO. NO. SECTION II: 169 TOBACCO CESSATION COUNSELLING 5. 5.1 REVIEW OF LITERATURE a. Interventions promoting tobacco cessation b. Role of Dentists in tobacco cessation counselling c. Assisting the tobacco users to quit 5.2 MATERIAL AND METHODS 189 5.3 RESULTS 196 5.4 DISSCUSION 217 5.5 CONCLUSION 235 6. SCOPE, LIMITATIONS & IMPLICATIONS 239 7. POSSIBLE CONTRIBUTIONS & TRANSLATORY 246 COMPONENT 8. REFERENCES 248 9. ANNEXURES i. Kuppuswamy’s Socio-Economic Status Scale 2014 i ii. Consent form ii iii. Interview Questionnaire iii iv. Intervention follow up record Sheet vi v. Tobacco Cessation Information Leaflet (Self –help) xi vi. Tobacco Cessation counselling Manual (i) 10. Master sheets 11. Publications

Section - I List of Tables

Sr. Title Page No. No. 1. Distribution of Age 75 2 a. Distribution of Gender 75 2 b. Distribution of participants according to gender in different age 75 groups 3a. Distribution of participants according to Educational 76 Qualification 3b. Distribution of Education Qualification according to Gender 76 4. Distribution of participants according to Occupation 76 5. Distribution of participants according to Income 77 6. Distribution of participants according to Accommodation 77 7. Distribution of participants according to Socioeconomic Status 77 8. Awareness of tobacco hazards during the initiation period 78 9. Awareness of different type of tobacco products & preparations 78 10. Awareness about tobacco hazards at the time of the interview 78 11. Awareness of health hazards from tobacco preparations 78 12. Awareness about the harmful effect of tobacco on various organs 79 13. Awareness of tobacco cessation advertising campaigns 79 14. Medium of information 79 15. NRT awareness 79 16 Reason for starting consumption of tobacco products 80 17 Reasons for continuation of tobacco use 80 18 Feelings after tobacco consumption 80 19 Feelings in absence of tobacco consumption 81 20 Details noticed from tobacco cessation infomercials 81 21 Reactions to tobacco cessation infomercials 81 22 Willingness to quit tobacco 81 23 Aids opted for tobacco cessation 82 24 Access to tobacco products despite ban 82 25 Inputs for improving the tobacco cessation campaign 82 26 Age of onset of tobacco consumption 82 27 Duration of tobacco use 83 28 Frequency of tobacco use (per day) 83 29 Gender wise distribution of participants according to 83 tobacco products used 30 Usage of same tobacco products from the time of habit initiation 84 31 Habit alteration 84 32 Sources of obtaining tobacco products 84 33 Time of tobacco consumption after waking up 84 34 Company during tobacco use 84 35 Tobacco consumption in presence of non-tobacco users in the 85 family 36 Tobacco consumption in presence of children and younger 85 family members 37 Activity during tobacco consumption 85 38 Place of tobacco consumption 85 39 Social circles knowledge of participant’s habit 85 40 Prior tobacco cessation attempts 86 41 Duration of prior cessation attempt 86 42 Reasons for relapse 86 43 Distribution of participant’s according to type of tobacco 87 product used 44 SES and choice of tobacco product 87 44b SES and choice of tobacco product 88 45 Distribution according to smoking / SLT product use 88 46 Association between SES & choice of smoking or SLT product 88 use 47 Age and SLT or smoking tobacco product use 88 48 Association of gender and use of SLT or smoking tobacco 89 49 Education level & type of tobacco product used 89 50 Occupation & type of tobacco product used 89 51 Tobacco use & accommodation 89 52 Alterations in tobacco consumption 90 53 Sources of obtaining tobacco & prior tobacco cessation attempts 90 54 Tobacco availability and restarting the habit 90 55 Awareness of tobacco hazards & willingness to quit the habit 90 56 Prior cessation attempts & willingness to quit the habit 91 57 Willingness to quit tobacco and knowledge of habit among peer 91 group 58 Continued habit and willingness to quit 91 59 Age and preference of cessation aids 91 60 Continued habit & cessation aids 92 61 Gender and aids opted for tobacco cessation 92 62 Response to infomercials and willingness to quit the habit 92 63 SES status & response to tobacco cessation infomercials 92 64 Age and reaction to tobacco cessation infomercials 93 65 Age and reaction to tobacco cessation infomercials 93 66 Gender and inputs for improving tobacco cessation measures 94 67 Occupation and inputs for improving tobacco cessation measures 94 68 SES and inputs for improving tobacco cessation measures 95 69 Oral Lesions 95

Section - I List of Graphs

Sr. Title Page No. No. 1. Distribution of Age 98 2 a. Distribution of Gender 98 2 b. Distribution of participants according to gender in different age 99 groups 3. Distribution of participants according to Educational 99 Qualification 4. Distribution of participants according to Occupation 100 5. Distribution of participants according to Income 100 6. Distribution of participants according to Accommodation 101 7. Distribution of participants according to Socioeconomic Status 101 8. Awareness of tobacco hazards during the initiation period 102 9. Awareness of different type of tobacco products & preparations 102 10. Awareness about tobacco hazards at the time of the interview 102 11. Awareness of health hazards from tobacco preparations 103 12. Awareness about the harmful effect of tobacco on various organs 103 13. Awareness of tobacco cessation advertising campaigns 104 14. Medium of information 104 15. NRT awareness 104 16 Reason for starting consumption of tobacco products 105 17 Reasons for continuation of tobacco use 105 18 Feelings after tobacco consumption 106 19 Feelings in absence of tobacco consumption 106 20 Details noticed from tobacco cessation infomercials 107 21 Reactions to tobacco cessation infomercials 107 22 Willingness to quit tobacco 108 23 Aids opted for tobacco cessation 108 24 Access to tobacco products despite ban 109 25 Inputs for improving the tobacco cessation campaign 109 26 Age of onset of tobacco consumption 110 27 Duration of tobacco use 110 28 Frequency of tobacco use (per day) 111 29 Gender wise distribution of participants according to tobacco 111 products used 30 Usage of same tobacco products from the time of habit initiation 112 31 Habit alteration 112 32 Sources of obtaining tobacco products 113 33 Time of tobacco consumption after waking up 113 34 Company during tobacco use 114 35 Tobacco consumption in presence of non-tobacco users in the 114 family 36 Tobacco consumption in presence of children and younger 115 family members 37 Activity during tobacco consumption 115 38 Place of tobacco consumption 116 39 Social circles knowledge of participant’s habit 116 40 Prior tobacco cessation attempts 117 41 Duration of prior cessation attempt 117 42 Reasons for relapse 118 43 Distribution of participant’s according to type of tobacco 118 product used 44 SES and choice of tobacco product 119 45 Distribution according to smoking / SLT product use 119 46 Association between SES & choice of smoking or SLT product 120 use 47 Age and SLT or smoking tobacco product use 120 48 Association of gender and use of SLT or smoking tobacco 121 49 Education level & type of tobacco product used 121 50 Occupation & type of tobacco product used 122 51 Tobacco use & accommodation 122 52 Alterations in tobacco consumption 123 53 Sources of obtaining tobacco & prior tobacco cessation attempts 123 54 Tobacco availability and restarting the habit 124 55 Awareness of tobacco hazards & willingness to quit the habit 124 56 Prior cessation attempts & willingness to quit the habit 125 57 Willingness to quit tobacco and knowledge of habit among peer 125 group 58 Continued habit and willingness to quit 126 59 Age and preference of cessation aids 126 60 Continued habit & cessation aids 127 61 Gender and aids opted for tobacco cessation 127 62 Response to infomercials and willingness to quit the habit 128 63 SES status & response to tobacco cessation infomercials 128 64 Age and reaction to tobacco cessation infomercials 129 66 Gender and inputs for improving tobacco cessation measures 129 68 SES and inputs for improving tobacco cessation measures 130 69 Oral Lesions 130

List of Tables & Figures SECTION - I

Figures

Sr. Title Page No. No. 4.1 Indian Tobacco Scenario 15 4.2 Tobacco Control Measures in India, as highlighted in the TCP 22 survey: 4.3 Conceptual framework for evaluation of anti-tobacco public 42 communication campaigns

Tables

4.1 M POWER Measures 19

4.2 Tobacco advertising, promotion, and sponsorship ban policies in India 21 4.3 Designated Smoking areas 23

Section - II List of Tables

Sr. Title Page No. No. 1. Age Distribution 204 2. Gender Distribution 204 3. Socio economic status 204 4. Distribution of tobacco products used 204 5. Previous tobacco cessation attempts 205 6. Compliance with different tobacco cessation modalities 205 7a. Habit Cessation according to interventional modality 205 7b. Habit Cessation according to interventional modality 205 8. Reduction in amount of tobacco consumption 206 9a. Relapse to the original tobacco habit 206 9b. Relapse to the original tobacco habit 206 10 a. Withdrawal Symptoms 206 10b Withdrawal Symptoms (At 3months) 207 10c Withdrawal Symptoms 207 11 Cravings 207 12 Association between intervention and type of product 208 13 Final status of habit according to interventional modality 208 14 Final outcome of behavioural interventional 208

Section - II List of Graphs

Sr. Title Page No. No. 1. Age Distribution 209 2. Gender Distribution 209 3. Socio economic status 210 4. Distribution of tobacco products used 210 5. Previous tobacco cessation attempts 210 6. Compliance with different tobacco cessation modalities 211 7a. Habit Cessation according to interventional modality 211 7b. Habit Cessation according to interventional modality 212 8. Reduction in amount of tobacco consumption 212 9a. Relapse to the original tobacco habit 213 9b. Relapse to the original tobacco habit 213 10 a. Withdrawal Symptoms 214 10b Withdrawal Symptoms (At 3months) 214 10c Withdrawal Symptoms 214 11 Cravings 215 12 Association between intervention and type of product 215 13 Final status of habit according to interventional modality 216

List of Tables & Figures SECTION - II

Figures

Sr. Title Page No. No.

5.1 Difficult Journey of Quitting 170

Tables

5.1 The 5 A model

5.2 Recommendations to enhance motivation to quit tobacco:

the ‘‘5 Rs’’

List of Photo Plates

Sr. Title No.

1. Tobacco Plant , Tobacco leaves & Nicotine Molecule

2. Tobacco preparations – Smoking Forms

3. Tobacco preparations – Smokeless / Chew / Spit Forms

4. Health Risks from Tobacco

5. Popular anti-tobacco measures

6. Tobacco Cessation Intervention

7. The Great Indian Tobacco Menu

List of Publications

Sr.No. Title

1. Bhargava S.S , Bhowate R.R. Assessing impact of anti tobacco mass media campaigns. Saudi J. Oral. Dent. Res. 2017 ; 2(1) : 27-30 .

2. Bhargava S. Need of Oral Pre Cancer Awareness Initiatives in India. The Open Dentistry Journal 2016 ; 10 : 417-419 .

LIST OF ABBREVIATIONS

Sr. no ABBREVIATION FULL FORM

1. SES Socioeconomic Status

2. SLT Smokeless Tobacco

3. WHO World Health Organisation

4. FCTC Framework Convention on Tobacco Control

5. TCP Tobacco Control Program

6. TCC Tobacco Cessation Counselling

7. TUC Tobacco Use Cessation

8. SHS Second hand smoke

9. COTPA Cigarette and other tobacco products act

10. M.P. Madhya Pradesh

11. NRT Nicotine Replacement Therapy

12. GATS Global Adult Tobacco Survey

13. OR Odds Ratio

14. CI Confidence Interval

15. FTND Fagerstrom Test for Nicotine Dependence

16. M POWER Monitor Tobacco use & Prevention Policies

17. AMI Acute Myocardial Infarction

Introduction

Introduction

Tobacco is an agricultural product processed from the leaves of plants in the genus Nicotiana. Nicotiana tobaccum is the main source of tobacco worldwide though most of tobacco in Northern India and Afghanistan comes from Nicotiana rustica.1 Earlier form of tobacco were limited to chewing tobacco leaves or smoking tobacco . Today several products made up of or containing tobacco are legally available for human consumption. Tobacco has psychoactive properties and is proven to be harmful to human health. After harvesting and curing, tobacco leaves are manufactured into consumable products, which may be used for chewing, snuffing or smoking. Smokeless preparations like kharra, jarada, gutkha, nass etc., are used for chewing, snuffing and local application. While smoking of tobacco is in the form of cigarettes, cigars, hookah, chillum, bidis, etc.

1 Introduction

Tobacco plant carries in its leaves an alkaloid called nicotine, which is responsible not only for several pathophysiological changes in the body but also develops tolerance to its own action with repeated use. In short tobacco consumption causes development of psychological dependence amongst users.2

Tobacco use as an addiction:

“Giving up smoking is easy, I know because I have done it thousands of times.” - Mark Twain

Tobacco contains nicotine and dependency upon nicotine is true chemical addiction, captivating the same brain dopamine reward pathways as alcoholism, cocaine or heroin addiction. The 1988 US Surgeon General‘s report states that nicotine is as addictive as heroin and cocaine 9, 12. This landmark conclusion represents the culmination from viewing smoking as a bad habit to seeing it as a behavioural form of habituation and ultimately, a formal addiction 1. The ICD–10 criteria for addiction consider ‗the nicotine‘ in tobacco smoke as addictive (World Health Organization, 1992). These criteria include compulsive use, tolerance, development of withdrawal symptoms and tendency to relapse after stopping. Furthermore, nicotine in tobacco smoke activates brain reward areas in a way comparable to that of other addictive drugs 13.

Studies suggest that the alpha-4 beta-2 nicotine acetylcholine receptor subtype is the main receptor that mediates nicotine dependence. Nicotine acts on these receptors to facilitate release of neurotransmitters such as dopamine, nor epinephrine, serotonin, acetylcholine, glutamate and beta endorphins. These neurotransmitters cause pleasure and mood modulation. A person consuming tobacco may experience a range of positive emotions courtesy of nicotine which stimulates release of dopamine. Once the nicotine level in the blood falls the brain generates a crave and the tobacco user is tempted to consume tobacco again causing the repeated release of dopamine and other neurotransmitters. Repeated exposure to nicotine develops neuro-adaptation of the receptors, resulting in tolerance to many of the effects of nicotine.2 Once the addiction is established it cannot be eliminated or cured but only arrested and regardless of how

2 Introduction long one has remained nicotine free, it is possible that only one hit of nicotine will create a high degree of probability of a full relapse. Withdrawal symptoms appear on stoppage of tobacco use, which are characterized by irritability, anxiety, increased eating and dysphoria, among others.2

In a nutshell tobacco causes its user to experience a range of positive emotions due to psychoactive properties of nicotine and causes development of addiction. Tobacco use causes no intoxication and thus no behavioral disturbances, no damage to others in the society except to its user and it is legally available despite its evident adverse effects.

Most common ways of tobacco consumption are in the forms of smoking, chewing, snuffing or dipping tobacco. Not only tobacco proper but other products used in combination for preparing various products eg. lime, beetle nut etc. are also potentially harmful to human health. Effects of tobacco use on the public health (both general and oral) are alarming. In Asian countries tobacco use is widespread and disturbingly increasing among men, women and youth. Once started, quitting tobacco is rare and can cause numerous adverse health effects ranging from mild to life- threatening.

Among the very first official records of public declarations of adverse health effects of tobacco is the June 12, 1957, US Surgeon General Leroy E. Burney public statement that evidence pointed to a casual relationship between smoking and lung cancer.156. Tobacco has been used in India for centuries with around 275 million tobacco users consuming various forms of tobacco products at present. Tobacco consumption accounts for nearly half of all cancers among males and a quarter of all cancers among females, also tobacco is a major cause of heart and lung diseases.4 The damaging and harmful effects of tobacco usage on oral health are now well- recognized as it is the primary risk factor for oral cancer, periodontal diseases and numerous systemic diseases.3 According to the WHO Global Report on ‗Tobacco Attributable Mortality 2012‘, 4% of all deaths (for age‘s ≥30) in India are attributed to tobacco. Tobacco usage in any form is the second major etiological factor responsible for death and nearly 1 out of 10 deaths worldwide is due to tobacco. By 2030, tobacco is expected to rise to become the forerunner amongst the causes of death worldwide.

3 Introduction

Every 6.5 seconds one tobacco user dies from a tobacco related disease somewhere in the world (WHO 2003). It is assumed to account for more than 10 million deaths per year by 2030, 40% of which will be from developing countries (W H O, 2005).5

The damaging and harmful effects of tobacco usage on oral health are now well- recognized as it is the primary risk factor for oral cancer, periodontal diseases and numerous systemic diseases. Tobacco affects the diagnosis and therapy in clinical practice as it alters the immune system, interferes with medication efficacy and increases the risk of medical crisis, so tobacco users become vulnerable to a wide range of debilitating diseases.

Smoking is a major risk factor for at least 20 diseases, including coronary and peripheral vascular disease, chronic bronchitis and at least 80% of lung cancers 145. Blood coagulates in smokers more easily than in non-smokers, fibrinogen levels are higher and platelets are more likely to aggregate. These effects all contribute to thromboembolic diseases. Although nicotine itself is not carcinogenic, tobacco smoke contains over 200 other compounds that are potential carcinogens and smoking itself is the greatest single risk factor for lung cancer. Cigarette smoking significantly contributes to several other nasopharyngeal and upper gastrointestinal carcinomas 146.

One of the alarming after effects of tobacco consumption is ―Oral Cancer‖, which is emerging as highly prevalent and common type of malignant condition in developing countries of Indian subcontinent. Oral cancer not only accounts for significant mortality, but is also responsible for extensive disfigurement, loss of function, behavioural changes, financial and social hardship. Tobacco addiction and related disorders causes approximately 1.5 million deaths annually and more users will fall prey to this destructive addiction if users are not persuaded to quit the habit. Prevention, of oral cancer and many other tobacco use associated disorders, if possible involves identification of population at risk on the basis of their habit and recognition and management of established lesions. Of equal if not greater importance is the need to educate patients regarding these risk factors.

4 Introduction

In recognition of the importance of tobacco cessation in health care, the World Health Organization (WHO) highlighted May 31 every year as "World No Tobacco Day".5

The prevention and control of adverse health effects associated with tobacco consumption is an emerging issue of public health significance. Public communication campaigns are widely relied upon to create awareness, disperse knowledge and improve understanding of an issue among the populace. Contemporary public health programs emphasize on such approach for health promotion and disease prevention. 6 These programs attempt to influence and improve individual and societal behaviour and contribute to a positive change. However the evidence from literature indicates that many of these campaigns and community-based programs have only made a modest impact.

Compared to many countries around the world, India has been proactive in introducing tobacco control legislations. Anti-tobacco campaigns promoting tobacco de-addiction and highlighting ill effects of tobacco use have been ongoing for quite some time now, especially in central Indian cities where a higher percentage of tobacco use is documented. These campaigns have been creating awareness amongst the masses however international reports suggest that these campaigns are not delivering the desired results in terms of dissuading tobacco use and encouraging de- addiction 2. According to the report by the International Tobacco Control Project (ITCP) 4, despite having signed up to a global treaty on tobacco control and having numerous anti-tobacco and smoke-free laws and campaigns promoting awareness amongst the masses, India is failing to implement these effectively, leaving its people vulnerable to tobacco addiction and resulting diseases. The report stated that, while India has been a regional leader in enacting tobacco control legislation over the past 10 years, the laws are poorly enforced; poor implementations of regulations and relatively cheaper cost of tobacco are the hindrances in the successful execution of anti-tobacco legislations. Also community-based prevention programs have shown only limited success. The hurdles in the desired success of such measures include methodological challenges, erroneous evaluation of public perceptions, incomplete information, not reaching the targeted vulnerable population, concurrent secular trends and smaller-than-expected effect sizes, limitations of the interventions

5 Introduction suggested and limitations of theories used. Implementation and outcomes of such campaigns should be regularly monitored to ensure their effectiveness. Vigilant scrutinizing of these campaigns will ascertain a meaningful and effectual contribution to a specific public health outcome.6

The tobacco epidemic in India requires urgent attention. 4 For a tobacco user psychological dependence along with lack of proper information regarding how give up the habit are the biggest challenges in tobacco cessation process. The impact of proper de-addiction counselling as a part of the anti-tobacco measures taken is under- explored. An effective cessation campaign along with a effective protocol for counselling and guiding the users about the de-addiction process will help in reducing the number of tobacco users. Considering the immensity of the problem, a greater involvement of health care professionals is required in tobacco control measures such as prevention, cessation and reduction of exposure to second-hand smoke. Training health care professionals and students about these issues can have a profound impact on public health.

Saud M, Madhu B, Srinath K M and Ashok N C et al (2014)7, studied physician‘s practices and perspectives regarding tobacco cessation in a teaching hospital in Mysore City, Karnataka. Almost 95% of physicians said that they ask patients about their smoking status and 94% advise them to quit smoking, but only 50% assist the patient to quit smoking and only 28% arrange follow-up visits. Thus a regular assistance is not provided to help patients quit, even though 98% of the physicians believed that helping patients to quit was a part of their role. Only 18% of the physicians said that Undergraduate Medical Education and Post Graduate Medical Education prepared them very well to participate in smoking cessation activities. Comprehensive, flexible tobacco education curriculum guides may help faculty overcome barriers to incorporate tobacco education in dental school programs. Russell (1986)8, observed habits amongst smokers and noticed the persistent nature of nicotine use; 48% of smokers in a UK study were unable to abstain from smoking for any period in excess of 1 week. Cravings were reported in 44% of smokers following attempts to stop.

6 Introduction

Stolerman and Jarvis (1995)9 reported that over 50%of smokers said they wished to give up but only 13% thought they were likely to succeed. Only about2% of smokers quit per year without professional advice or help.

It is important to educate the public about the risks associated with tobacco addiction so that those with unhealthy habits can modify their lifestyles and prevent any of the possible health problems. Recognition of relevant impediments in successful implementation of anti-tobacco measures is essential to bring about reformative changes in such programs. An understanding of the perception of the masses regarding the current anti-tobacco campaigns and their reasons for non -compliance with these measures will assist in the designing of interventions aimed at reducing and ceasing the tobacco consumption. This will also help health authorities to implement effective programs to prevent oral cancer. Preventive measures are required to control probable new tobacco users and so are the avenues for tobacco cessation guidance to help existing users quit their habit. Counselling and guided de-addiction programs by doctors, mainly oral health care professionals can become the core of such programs.

Tobacco use causes development of psychological dependence; its cessation requires repeated and regular assistance in the form of counselling and a step by step approach to de-addiction. Such assistance can be provided to patients by attending doctors and dentists.

Therefore the study ―Evaluation of the effectiveness and impact of tobacco de- addiction tool in the context of present anti-tobacco campaigns” was designed and conducted. This study was carried out to have a broader understanding of tobacco use behaviours, perception of current measures by the user population to determine the impact of such measures and effect of one on one cessation facilities provided by doctors‘ specially oral health care workers.

7 Aims & Objectives

Aims & Objectives

AIM:

1. To assess the effect of current anti-tobacco measures on tobacco users from Central India and to evaluate the effectiveness of guided Tobacco Cessation Counselling (TCC).

OBJECTIVES: 1. To assess the knowledge, attitude and practices of tobacco users and their responses towards current anti-tobacco measures.

2. To study whether on going anti-tobacco measures increased the awareness level amongst the population about the hazards of tobacco consumption and encouraged tobacco cessation.

3. To develop a tobacco cessation counselling manual (to be used by clinicians- dentists, physicians , ENT specialists, oncologists and nurses ) for assisting tobacco users in habit cessation.

4. To evaluate the effectiveness of tobacco cessation manual.

SECTIONS:

I: Objectives 1 & 2 - Knowledge, Attitude and Practices of tobacco users and effect of anti-tobacco measures on tobacco use habit.

II: Objective 3 & 4 - Effectiveness of tobacco cessation counselling.

8 Hypothesis

Hypothesis

RESEARCH QUESTION: 1. Whether the current anti-tobacco measures encourage tobacco use cessation and can the tobacco cessation interventions (as per the Indian context) provided by the dentists further help in bringing tobacco control measures to fruition?

RESEARCH HYPOTHESIS:

1. The effectiveness and success of current anti-tobacco measures and campaigns, in dissuading the tobacco use is somewhat modest.

2. Current anti-tobacco programs/ measures do not provide the tobacco users with information, guidance or assistance about tobacco use cessation, withdrawal symptoms or suggestions to overcome these.

9 Hypothesis

3. Tobacco users are unwilling for discontinuation of tobacco consumption habit due to fractional awareness about tobacco hazards, under the influence of misinformation about tobacco use along with unawareness of the methods, means and process of tobacco use cessation.

4. Step by step guidance and assistance in form of counselling for tobacco cessation if provided by clinicians, mainly dentists, will help, encourage and support the tobacco users to give up their habit.

NULL HYPOTHESIS:

1. The effectiveness and success of current anti-tobacco measures and campaigns, in dissuading the tobacco use is adequate.

2. Current anti-tobacco programs are giving the tobacco users information, guidance or assistance about tobacco use cessation, withdrawal symptoms and suggestions to overcome these.

3. Tobacco users are aware of the methods, means and process of tobacco use cessation.

4. Step by step guidance and assistance in form of counselling for tobacco cessation if provided by clinicians, mainly dentists, will not help, encourage or support the tobacco users to give up their habit.

ALTERNATE HYPOTHESIS:

1. The effectiveness and success of current anti-tobacco measures and campaigns, in dissuading the tobacco use may be adequate.

2. Current anti-tobacco programs may be providing the tobacco users information, guidance or assistance about tobacco use cessation, withdrawal symptoms and suggestions to overcome these.

3. Tobacco users may be aware of the methods, means and process of tobacco use cessation.

4. Step by step guidance and assistance in form of counselling for tobacco cessation if provided by clinicians, mainly dentists, may help, encourage or support the tobacco users to give up their habit.

10 Review of Literature

4. SECTION I

KNOWLEDGE, ATTITUDE & PRACTICES OF TOBACCO USERS & EFFECTS OF ‘ANTI-TOBACCO’ MEASURES ON TOBACCO USE HABIT

11 Review of Literature

4.1 Review of Literature

“Tobacco habit appears to be the Hydra of our Modern society” - Kenneth JR

The Tobacco epidemic poses a growing threat to health, economy and environmental stability worldwide. Tobacco use is the major preventable cause of premature death and disease, currently leading to over 5 million deaths globally each year.10 Tobacco products are considered to be health hazard due to (a) nicotine which causes addiction; attributable to its psychoactive properties and (b) many potentially carcinogenic substances which are incorporated in various tobacco preparations. More than 4,000 different chemicals have been found in tobacco and tobacco smoke and about 60 of these chemicals are known to cause cancer (carcinogens). Over time, a person becomes physically and emotionally addicted and dependent on nicotine and is thus inadvertently subjects oneself to repeated exposure via repeated consumption and also to accompanying carcinogens. Almost 30% of the Indian population older than age 15 uses some form of tobacco. Men use both smoked and smokeless tobacco (SLT) however smoking form is preferred more. Women are more likely to use smokeless (chewed) tobacco. 11 Smoking or chewing tobacco can seriously affect general, as well as oral health. It has been predicted by the WHO that more than 500 million people alive today will be killed by tobacco by 2030 as the consumption of tobacco will be the single leading cause of death. 18, 22 a. Tobacco Use in India:

During ―Mogul” period consumption of tobacco was considered as an entertainment in India, but now it is one of the major health burdens for civilised society and contributor to many serious diseases. Tobacco consumption is widely considered as leading cause of preventable morbidity and mortality.20 It has been estimated that there are 1.1 billion tobacco users worldwide and approximately 20 % of them live in India. 18 The highest incidence of oral cancers in the world is reported from India due to high prevalence of consumption of tobacco in chewable forms, 20 and due to easy availability of various smoking and smokeless tobacco products. 24 Approximately 8,00,000 deaths occur in India due to tobacco use .19,23 Data from the National Health Survey 2005–2006 shows that 57% of Indian men and 11% of women are tobacco

12 Review of Literature consumers and that an estimated 55,000 children are initiated into tobacco use every day. 24 Following studies highlights various facets of the tobacco use among Indian population;

162

Tobacco Control and Human Rights: In 2001, the National Human Rights Commission (NHRC) of India considered the issues related to tobacco control from the perspective of human rights. The commission concluded that the following rights of an individual are violated due to lack of tobacco control mechanisms in India, mainly: i. Right to clean air: A non-smoker is forced to inhale tobacco smoke in public areas. ii. Rights of children: Rights of born and unborn children are violated when they are exposed to tobacco smoke (active and passive) in the home or public areas. They are the most vulnerable and worst affected. iii. Right to information: Both the smoker and non-smoker are not provided with adequate information about the harmful effects of tobacco products and in fact, are bombarded with misinformation about tobacco products through advertisements/events/celebrity and role model - linked promotion. iv. Right to education: Both the smoker and non-smoker are not adequately educated about the drastic ill- effects of tobacco on their personal and public health. v. Right to redressal: Both the smoker/non-smoker does not have any redressal mechanism for the injuries/ill-effects suffered by them due to tobacco

13 Review of Literature products. vi. Right to tobacco cessation programme/ activities (as part of right to health): The smoker and his/her family have a right to have access to various cessation strategies. Although there are some rights of the smoker which may be violated by regulatory measures intended for tobacco control but these have to be superseded in the interest of public health and human rights of the larger community. Based on this assessment, the National Human Rights Commission (NHRC) recommended that: i. A comprehensive national tobacco policy should be evolved at the highest level, in consultation with all the stakeholders in public health. ii. A multi sectorial national-level nodal agency should be established for tobacco control with strong representation from the legal, medical and scientific communities. The right of people to access correct information related to the effects of tobacco consumption must be promoted through programmes of information, education and communication. Such programmes should be adequately supported through dedicated resource allocation. Assistance for smoking cessation should be integrated into the health care services. iii. Maintenance of health and environment, as their degradation adversely affects the life of citizens. In the light of the above, the Supreme Court held that public smoking of tobacco, whether in the form of cigarettes, cigars, bidis or otherwise, is illegal and unconstitutional .164

The International Tobacco Control Policy Evaluation Project TCP India Project Report 2013 4 states that; among individuals aged > 15 years tobacco use ranged from 23% to 47%. Prevalence of tobacco use was much higher among males than females, ranging from 34% to 59%. Among females, prevalence ranged from 9% to 32%. In general, prevalence of tobacco use was higher among low-income & less-educated adults than among high-income and more highly educated adults. SLT was the most common form of tobacco product used; at least 2 of 5 adults used SLT. Khaini was the most used SLT product except plain chewing tobacco was used more in Madhya Pradesh (MP). SLT use only was highest in Maharashtra (84%). Cigarettes were the most common smoked product (Maharashtra -67%), whereas bidis were the most common smoked tobacco product in MP (72%). Less than 1/4 of adult tobacco users used mixed (both smoked and SLT) tobacco products. Tobacco users‘ regret of habit is an important indicator of societal norms about tobacco use and a predictor of future

14 Review of Literature quitting behaviour. Majority of smokers (63% - 81%) and SLT users (64% - 87%) expressed regret for starting to use tobacco. More than half of tobacco users perceived that Indian society disapproves of the use of smoked and smokeless tobacco.

Dongre AR, Deshmukh PR, Murali N et al (2008)133, studied the pattern of tobacco use among rural adolescents (15-19 years) to find out reasons for use and non use of tobacco. 68.3% boys and 12.4% girls had consumed tobacco products in last 30 days. Out of boys who consumed tobacco, 79.2% consumed kharra, 46.4% gutkha, 51.2% consumed it due to peer pressure, 35.2% as they felt better and 5 % consumed ease abdominal complaints and dental problem. Among girls, 72% used dry snuff for teeth cleaning, 32% and 20% consumed tobacco in the form of gutkha and tobacco & lime respectively. The reasons for non use of tobacco among girls were fear of cancer (59%), poor oral health (37.9%). For boys it was fear of cancer (58.6%), poor oral health (44.8%) and fear of getting addiction (29.3%).

Kumar R, Alka S, Khushwah MA et al (2010) 18, determined the prevalence of tobacco use among the college students of Delhi University. 3800 questionnaires were distributed and 2599 (68.4%) complete responses were returned [1635 males (62.9%) and 964 (37.1%) females]. 23.5% males and 3.9% females were tobacco users. 257 (60.9%) students started tobacco use at the age of 16-20 years. Cigarette (97.6%) was most commonly used. 69.7% used tobacco for fun and pleasure and 23.2% due to peer pressure. 58.5% of tobacco users were low spenders i.e. expenditure on tobacco was not more than Rs. 20 / day. 47.6% of tobacco users made previous quitting attempt and 54% tobacco users were willing to quit now. Family history of tobacco use was present in 57.1% of tobacco users and 37.5% of non-tobacco users. 97.4% students were aware about the hazards and 95.4% were also aware the benefits of quitting.

Raval TS, Maudgal S, More N (2010)19, interviewed a cross section of marginalized children, from the lower SES of rural and urban regions of the states of Maharashtra and Assam who were vulnerable to tobacco usage. > 1700 children were checked for precancerous lesions and 1004 were surveyed for tobacco habits and awareness. The percentage of tobacco users in urban Mumbai (4.8%) was quite low compared with Assam (76%) and 74.6% of the children were aware that tobacco use

15 Review of Literature was harmful to health. The average age of initiation was 9 years. Out of the 1004 children surveyed, 253 were tobacco users and 79% were males. Of the 1700 children screened, 23.5% presented with precancerous oral lesions.

Kumar A, Sinha S , Kumar S, et al (2013)25 , conducted a questionnaire based cross sectional study in a Jharkhand village, to assess prevalence , knowledge, attitude and practice of SLT use. SLT in the form of gul (powdered pyrolysed tobacco), khaini (tobacco-lime mixtures), gutkha (industrially manufactured tobacco ) and quid (fresh betel leaf, lime, catechu, and tobacco) was assessed. The prevalence of SLT use in males was 76.41% and in females were 63.70%. The study shows that khaini was the commonest form of SLT used followed by gutkha which was the 2nd most commonly used tobacco except business and service class where betel quid was more common.

Bhimarasetty DM, Sreegiri S, Gopi S, et al (2013)26, assessed the perceptions of young smokers about smoking and their felt needs for tobacco control. An observational cross-sectional study was conducted among smokers in the age group of 15 -25 yrs in Visakhapatnam. 250 males were interviewed at randomly selected cigarette selling shops. 41.2% started smoking before or at 18 yrs of age. Mean age at initiation was 19 yrs +/-2.34 years. The commonest reason for initiation of smoking was for relaxation (43%). Other reasons were ‗for style‘ (28%), for fun (24%) and influence of friends / peers (23.6%). 74.4% were willing to quit smoking and nearly 70% had made one or more attempts to quit. The leading motive to quit smoking was for better health. 71% and 55 % were willing to join smoking cessation programs. 83.2% knew that smoking can cause cancer, only 24.8% and 7% knew of effects on respiratory system and cardiovascular system. More than 70 % of the subjects were of opinion that ‗ban on smoking in public places‘ and ‗ban on sale around educational institutions‘ were to be strictly implemented. Among the various anti-tobacco measures, the study population perceived that the most effective measure would be ―teaching the harmful effects of smoking in schools‖ .

Desai V, Gill RK, Sharma R (2012) 27, collected information about tobacco use from 552 patients from Jaipur dental college. In the age group < 20 years, 109 males and 62

16 Review of Literature females gave history of tobacco use and between 21 to 50 years; 164 males and 146 females i.e. 51.6 % used tobacco. High incidence of SLT use was seen in especially among adolescents. 51.1 % of tobacco users were aware of its harmful effects.

World heart federation (2012) 28, a report entitled, “Cardiovascular harms from tobacco use and second hand smoke‖, was commissioned by the World Heart Federation and written by the International Tobacco Control Project (ITC Project) , in collaboration with the tobacco free initiative of WHO ; was presented at Congress of cardiology Dubai. It stated that 1/3rd of Indian smokers are unaware that smoking causes heart disease around 1/2 the smokers are unaware that smoking can cause stroke. In India many people are at high risk for heart attack that too at a relatively early age. Risks of CVD are far more present and immediate than of known fatal effects of tobacco use and second hand smoke. Knowledge of cardio vascular risks of tobacco use will help smokers take quitting seriously and increase compliance with anti tobacco policies.

Tomar SL (2001) 101, stated that cigarette smoking remains the leading preventable cause of premature mortality. Tobacco use also is responsible for 75 % of deaths resulting from oral and pharyngeal cancer, more than 1/2 of the cases of periodontitis and numerous other oral health effects. b. Anti Tobacco Measures:

In 2003 WHO released FCTC protocol with the objective to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke by providing a framework for tobacco control measures to be implemented by the parties at the national, regional and international levels in order to reduce continually and substantially the prevalence of tobacco use and exposure to tobacco smoke.163

“Every person should be informed of the health consequences, addictive nature and mortal threat posed by tobacco consumption and exposure to tobacco smoke.’’ 42

--- First guiding principle WHO’s Framework Convention on Tobacco Control (FCTC) states as its (Article 4.1) 42

17 Review of Literature

Tobacco cessation is necessary to reduce morbidity and mortality related with tobacco use. A multipronged approach is required which combines effective interventions aimed at reduction of tobacco-related disorders by control of use at the point of initiation. For causes such as tobacco cessation, public communication campaigns are widely used and relied upon to improve awareness, disseminate knowledge and understanding of the issue among the population. Contemporary public health programs emphasize on a community-based approach to health promotion and disease prevention.4 Such programs attempt to influence and improve individual and societal behaviour and contribute to a positive change. The evidence from literature indicates, however, that many community-based programs have had only modest impact with the notable exception some programs eg. HIV prevention programs.6 Chief reasons for poor performance of community-based prevention programs arise due to poor calculation of methodological challenges, evaluation of perceptions, concurrent secular trends and smaller than-expected effect sizes, limitations of the interventions suggested and limitations of theories used. The effectiveness of HIV programs appears to be related in part to extensive formative research and an emphasis on changing social norms. 6

Tobacco cessations measures are required at individual, community, state and national levels to reduce the prevalence of tobacco use in all forms and exposure to tobacco smoke. Effective tobacco cessation measures comprising of mass media campaigns, taxations, bans, anti-tobacco legislations, use restrictions, policies stressing upon awareness of tobacco use hazards; all designed to discourage potential new users and encourage current users for cessation attempts should be adopted. Additionally availability of cessation avenues, self help guidelines, leaflets, brochures, continuing patient education materials regarding tobacco cessation can also prove substantial effect to the cause.10 Government tobacco control policies promoted by the Framework Convention on Tobacco Control (FCTC), these policies are known as M POWER measures.

18 Review of Literature

Table 4.1: MPOWER Measures 52:

Sr. MPOWER Measure Description NO. 1. Monitor tobacco use Surveillance of the prevalence , determinants and and prevention policy impacts of tobacco use and measuring the effects of tobacco control interventions (FCTC Article 20) 2. Protect people Reduce second hand smoke exposure through from tobacco smoke comprehensive smoke free legislation in public spaces, including all indoor workplaces (FCTC Article 8) 3. Offer help to quit Cessation support through advice from health care tobacco use providers, telephone quit lines and easily accessible or low cost medication (FCTC Article 14) 4. Warn about dangers of Warning on tobacco packing and anti tobacco media tobacco campaigns to promote awareness on health consequences of smoking (FCTC Article 11 & 12) 5. Enforce bans on Bans on direct (TV, Ads ) and indirect marketing tobacco advertising (industry sponsored) of tobacco products (FCTC and sponsorship Article 6) 6. Raise taxes on tobacco Increasing prices of tobacco products by taxation (FCTC Article 6)

c. Tobacco Cessation Measures in India:

The present tobacco cessation measures in practice in India can be shortlisted as smoke free regulations at public places and work places, health warning labels on regularized tobacco products, education, communication, public awareness campaigns and ban on some forms of tobacco preparations, tobacco advertising, promotion and sponsorship. These measures were designed with an overall goal to contribute as community-based interventions in improvement of public health. Assessment of the impact of these measures on general population is required; to evaluate the changes brought about, by both the process and outcomes of such health promotion efforts. Compared to developed countries, the rates of smokers who want to quit and who actually try to quit are low in developing countries; therefore, it is even more urgent for governments in countries like India to provide assistance to smokers to help them quit.4

Brief overview of anti–tobacco Legislations in India: India‘s anti-tobacco legislation, first passed at the national level in 1975, was largely limited to health

19 Review of Literature warnings and proved to be inefficient. The ‗Cigarettes and Other Tobacco Products Bill, 2003‘ represented an advance in tobacco control. It included demand reduction measures like outlawing smoking in public places, forbidding sale of tobacco to minors, requiring more prominent health warning labels, and banning advertising at sports and cultural events. India, as a signatory to FCTC, is actively involved in combating the menace of tobacco with renewed fervour. 160

The International Tobacco Control Policy Evaluation Project TCP India Project Report 2013 4, details that the WHO Framework Convention on Tobacco Control (FCTC) is a legally binding treaty that calls upon ratifying countries to implement evidence-based measures to reduce tobacco use and exposure to second-hand smoke. India ratified the FCTC on February 5, 2004, thereby committing to implement a range of effective tobacco control measures as set out by the treaty. Although detrimental effects of tobacco use on health are well established, still 35 % of the Indian population and 31.4% of the Maharashtra population uses tobacco. In 2003, India enacted the Cigarette and Other Tobacco Products Act (COTPA, 2003), one of the most comprehensive and powerful anti-tobacco laws in the world at that time. Over the years, India has demonstrated leadership in selected areas of tobacco control - in 2009 India became the first country to implement warnings on smokeless tobacco product packages. In 2011, India implemented the world‘s strongest restrictions on the display and use of tobacco products in films. The Maharashtra Government has introduced several tobacco control measures such as implementation of Control of Tobacco Products Act and ban on all forms of flavoured tobacco in 2013 to protect the health of its citizens and advance implementation of the FCTC. Some notable restrictions:  2004 - Prohibition of sale of tobacco products to minors and complete ban on advertising of tobacco products in the media.  2008 - Ban on smoking in public places and restrictions in restaurants  2009 - Implementation of pictorial warnings on all types of tobacco products and prohibition of sale of tobacco products near educational institutions.  2011 - Legislation was passed banning the use of plastic packaging for chewing tobacco and pan masala products.

20 Review of Literature

In 2005, the state of Goa was the first to enact a total ban on the consumption, sale and storage of gutkha. By January 2013, 17 states and 4 Union Territories (MP, Kerala, Bihar, Rajasthan, Maharashtra, Jharkhand, Chhattisgarh, Haryana, Punjab, Delhi, Gujarat, Mizoram, Himachal Pradesh, Chandigarh, Odisha, Andhra Pradesh, UP, Sikkim, Uttarakhand, Dadara and Nagar Haveli, Daman and Diu) have passed and enacted legislation that completely bans the manufacture, sale and use of gutkha. In addition to gutkha, Maharashtra has also banned the sale of paan masala products. In 2016 cigarette packaging were made to have mandatory 85 % graphic warnings.

Table 4.2: Tobacco advertising, promotion, and sponsorship ban policies in India Sr. Description Ban in Aligns No. Place with FCTC 1. Advertising on domestic TV, films, and radio Yes Yes 2. Advertising in domestic print media (e.g., newspapers, Yes Yes^ magazines) 3. Outdoor advertising (e.g., billboards, posters) Yes No 4. Point of sale advertising No No 5. Tobacco product displays at point of sale Partial* No 6. Advertisements in or on tobacco packages No No 7. Tobacco industry sponsorship of national/international Partial** No events or activities 8. Offer or supply of tobacco products free of charge Yes Yes 9. Promotional discounts, gifts or prizes Yes Yes 10. Competitions linked to tobacco products or companies Yes Yes 11. Foods, candies, toys, and objects resembling tobacco No *** No products 12. Brand stretching/sharing Yes Yes^ 13. Vending machines Yes Yes 14. Sale of tobacco products to and by minors Yes Yes 15. Unpaid tobacco product placement in entertainment media Yes *** Yes 16. Advertising on domestic TV, films, and radio Yes Yes 17. Domestic and international internet tobacco product sales No No 18. Disclosure by tobacco industry to government on Not No TAPS activities Required 19. Health warnings on permitted forms of advertisements (i.e., Required Yes point of sale; films and TV programs in which tobacco products are displayed

^ While the law technically meets the FCTC Article 13 Guidelines, violations are common

21 Review of Literature

* A 2011 amendment prohibits tobacco products only from being ―displayed in a manner that enables easy access of tobacco products to persons below the age of 18 years‖ ** The law only bans funding by the tobacco industry that is used to promote tobacco products. All other types of funding or sponsorship are allowed. *** Toys and candy that resemble tobacco products may be included in the general ban on tobacco promotion in COTPA, but the current definitions of ―tobacco advertising and promotion‖ make this unclear. **** The display and use of tobacco products in films is prohibited. For films depicting tobacco products or their use which were produced prior to the law, an anti-tobacco health warning must be shown at the beginning and middle of the film and the display of brands or close-up images of tobacco products or packages must be masked or blurred. Impact of Current anti tobacco measures on Indian population, the TCP survey: Conducted between 2010 and 2011 at Mumbai, Indore, Patna and ; face-to- face interviews were conducted with approximately 8000 tobacco users and 2400 non-users from 4 cities and surrounding rural districts. The TCP project detailed the tobacco use behaviour and perceptions of the general population and concluded that compliance with many of the laws remains weak In India. 4\

Fig: 4. 2 Tobacco Control Measures in India, as highlighted in the TCP survey:

Ban on tobacco use in public places: In 2008 National smoke-free law was initiated which prohibited smoking in all public places and workplaces (including bars and restaurants), except for designated smoking areas in airports, larger hotels and restaurants. But only 18% of smokers from MP and 35% from Maharashtra reported of being aware about the smoke-free laws. 4

22 Review of Literature

Table 4.3: Designated Smoking Areas:-

Designated Smoking Areas 4:

Designated smoking areas are allowed at airports, hotels with at least 30 rooms & restaurants with at least 30 seats. These are separately ventilated smoking rooms that: 1. Are physically separated and surrounded by full height walls on all sides 2. Have an entrance with a closed door 3. Have an air flow system 4. Have negative air pressure

Restriction on Indoor Smoking: The vast majority of smokers who worked indoors reported that smoking is not allowed in any indoor areas at their workplaces; however, 60% to 67% of smokers and 40% to 54% of smokeless only users reported that they had seen people smoking indoors. There was strong support for a comprehensive workplace smoking ban among respondents. There was a lack of compliance with indoor smoking bans in hospitality venues, particularly in bars however a strong public support for smoke-free restaurants was noticed. Smoking inside public transportation was noticed by more than 1/3rdof tobacco participants from MP and it was lowest among respondents in Maharashtra. There was almost unanimous support for a ban on smoking inside public transportation vehicles. Smokers were less likely to have voluntary bans on smoking inside the home. Maharashtra had the highest percentage of non-users (90%), smokeless only users (87%) and smokers (45%) who did not allow smoking in their homes. There was evidence of a lack of awareness of the harms of second-hand smoke to children among smokers. Only about 1/3 rd of smokers were concerned that their own smoking in the home would harm their children‘s health. Stronger compliance with smoke free laws in workplaces and on public transportation was evidenced in Maharashtra compared to the 3 other states. 4

Mandatory health warning labels: The TCP India Survey evaluated India‘s pictorial labels requirement on tobacco packages. The warnings included 2 images; drawing of diseased lung and an x-ray image of a lung, for smoked tobacco products and one image - a drawing of a scorpion for smokeless tobacco products, covering 40% of the front exterior display area. All labels included the message ―Tobacco causes cancer‖. The labels on smoked tobacco products also included the message ―Smoking kills‖, while the smokeless packs carried the message ―Tobacco kills‖. The percentage of

23 Review of Literature tobacco users who noticed warning labels ―often‖ or ―whenever they smoked / used tobacco‖ was highest in Maharashtra (75% of smokers and 77% of smokeless users) and lowest in MP (28% of smokers and 27% of smokeless users). However, less than 50% of users read or looked closely at the warning labels on packages of their respective products. The pictorial warning labels have not been effective in encouraging tobacco users to quit. Despite the limited effectiveness of pictorial labels, tobacco product packages are a prominent source of information. More than ¾thof smokers and 2/3rd of smokeless users were aware that smoking can lead to lung, throat and mouth cancers, gum disease and heart disease. However, knowledge of other health effects was lower. More than half were aware that smoking causes tuberculosis, heart disease and lung cancer in non-smokers, asthma in children, strokes and impotence. The majority of tobacco users still wanted more health information on warning labels.

Tobacco advertising, Promotion and Sponsorship (TAPS): Although India has implemented bans and restrictions on TAPS, the legislation is not comprehensive and as a result, the public continues to be exposed to the marketing of tobacco products. Exposure to tobacco advertising was highest in Maharashtra, where more than half of smokers (55%), smokeless users (50%) and non-users (55%) noticed advertising and pictures of tobacco use ―often‖ or ―once in a while‖ in the last 6 months. Tobacco users and non-users strongly supported a comprehensive ban on tobacco advertising. Brand stretching was prominent in MP despite the ban under COTPA 2003 regulations. At least 1/3rd of smokers (39%), smokeless only users (33%), and non- users (35%) in this state noticed clothing or items with a tobacco brand name or logo. Exposure to tobacco use in the entertainment media prior to India‘s strong legislation banning tobacco use on television and in movies was high as almost 1/2 of all respondents stated that they ―often‖ noticed people using tobacco in entertainment media. This high visibility is of concern as existing research has consistently shown that exposure to smoking in the movies is associated with the uptake of smoking among youth.

Education, Communication and Public awareness: Television was the most common primary source of anti-tobacco information followed by tobacco packages.

24 Review of Literature

Public transportation vehicles or stations were also a prominent source of anti-tobacco information, while bars were the least common. Anti-tobacco information in India has not had a large impact in making tobacco use less socially acceptable or encouraging quitting. Only 1% of smokers and 3% of smokeless only users said that anti-tobacco advertising has made tobacco use less socially acceptable. 10% to 27% of smokers and 8% to 25% of smokeless only users said that anti-tobacco advertising has made them ―more likely‖ to quit using tobacco ; emphasizing the importance of strengthening health warnings. Article 11 of the FCTC highlight media campaigns as a cost-effective strategy for educating the public on the harms of tobacco use , promotion of quitting and for encouraging youth not to start smoking.

Price and Taxation: Current prices of tobacco products in India are highly affordable and are not a motivation for quitting. Given that strong price and taxation policies have consistently been shown to be the most effective tobacco control measure, it is urgent for India to increase price and taxation across all tobacco products. Evidence shows that this will not only increase cessation, but will also increase government taxation revenue.

In India, tobacco taxes vary by product type and characteristics (e.g., length, filter), producer characteristics (e.g., small vs. large bidi producers) and by state. At the time of the TCP survey, tobacco taxes in India fell far below the World Bank recommendation of 66% to 80% of the retail price. Approximately 38% of the retail price of cigarettes and 9% of the retail price of bidis was the tax component, while smokeless tobacco products are often sold without any tax component in the retail price. In addition to the complex tax structure and low taxes on certain tobacco products, the Indian tobacco tax system does not adjust for inflation, so all tobacco products have become increasingly affordable over the past decade. The average price per stick for bidis (0.20 - 0.50 Rs. per bidi) was significantly lower than the average price per stick for cigarettes (2.60 - 3.30 Rs per cigarette). Tobacco users were not concerned about how much they spend on tobacco products – 44% to 76% of exclusive cigarette smokers, 48% to 82% of exclusive bidi smokers, and 63% to 83% of smokeless only users said that they ―never‖ thought about the amount of money they spent on their respective tobacco. Similarly, less than 1/4th of all current

25 Review of Literature cigarette smokers, bidi smokers and SLT users said that the money they spent on their respective tobacco products is diverted from other essential household expenditures. The price of tobacco products was not a deterrent to quitting - price was identified as one of the least important reasons that led smokers and SLT users to think about quitting. A report on the Economics of Tobacco and Tobacco Taxation in India (2010) found that raising the tax on cigarettes to `3691 per 1000 sticks would increase the tax to 78% of the retail price, avert 3.4 million premature deaths and generate `146.3 billion in tax revenue. Raising the bidi tax to `98 per 1000 sticks would increase the tax to 40% of the retail price, avert 15.5 million premature deaths and raise `36.9 billion in new tax revenues.14

Willingness to quit: Tobacco users of both smoking and SLT variety had a low degree of readiness to quit which indicates that current tobacco control policies are not providing strong motivation for tobacco users to think about quitting. The price of smoked or smokeless tobacco products and restrictions on using tobacco at work were cited by less than half of tobacco users as important reasons to think about quitting.

Cessation Advice: Number of tobacco users who received advice to quit from doctors or health professionals are encouraging, ranging from 52% in Madhya Pradesh to just over 1/3rd in Maharashtra (34%). The vast majority (59% to 85%) who received this advice said it made them think about quitting.

The TCP India Wave 1 Survey findings concluded with evidence that India needs to strengthen tobacco policies to reduce the morbidity and mortality caused by widespread tobacco use in India. The current measures are insufficient in encouraging the tobacco users for habit cessation.

Impact of anti-tobacco measures- Communicating the health effects of smoking remains a primary goal of tobacco control policy. 44 Public health and community based interventions have been hampered by lack of a comprehensive evaluation programs reviewing performances and effectiveness of such programs. Multi level interventions incorporating policy, environmental and individual components should be evaluated to review their setting, goals and purpose. One such proposed model of

26 Review of Literature evaluation is RE – AIM that assesses 5 dimensions of public health interventions: Reach, Efficacy, Adoption, Implementation and Maintenance. 34 Following studies evaluate the commonly implemented anti- tobacco policies. d. Ban on tobacco use in public:

Smoking bans in public places have been shown to have an impact on individual smoking habits. It served a motivator for smokers to reduce in smoking, reduced hospital admission due to resulting disorders but its impact as an effective motivator to quit smoking remains to be seen. Ban on public SLT use are not so efficiently implemented yet.

Meyers DG, Neuberger JS, He J (2009) 29, performed a systematic review and a meta-analysis to determine the association between public smoking bans and risk for hospital admission for acute myocardial infarction (AMI).Background second hand smoke (SHS) is associated with a 30% increase in risk of AMI, which might be reduced by prohibiting smoking in work and public places. Incidence rates of AMI per 100,000 person-years before and after implementation of the smoking bans and incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were calculated. The overall effect of the smoking bans were estimated. AMI risk decreased by 17% overall with the greatest effect among younger individuals and non-smokers. The IRR incrementally decreased 26% for each year of observation after ban implementation. It was concluded that smoking bans in public places and workplaces are significantly associated with a reduction in AMI incidence, particularly if enforced over several years.

Samet JM (2006) 30, Bartecchi and colleagues 31 describe a reduction in hospitalizations for AMI in Pueblo, Colo, after the implementation of a city-wide smoking ordinance. The ordinance strictly prohibited smoking in all workplaces, including bars and restaurants and in all public buildings. Similar consequences of a public smoking ban were noticed in Helena, Montana32, the law was in force for 6 months before a challenge led to a court order suspending it. Admissions for AMI declined by 40% during the 6 months of the ban and then rose after it was lifted.

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Wilson LM, Tang EA, Chander G (2012) 33, systematically reviewed the independent effects of tobacco control policies on smoking behaviour. 84 studies published after 1989 that assessed the effects of intervention on smoking prevalence, initiation, cessation or price participation were included. The effect on smoking prevalence was high for increasing tobacco prices and moderate for smoking bans in public places anti tobacco mass media campaigns. Limited evidence was available to quantify the effects of health warning labels and bans on advertising and sponsorship.

Ohmi H, Okizaki T and Meadows M et al (2013) 39 , 5 years after declaration of a total ban on smoking a cross sectional study was conducted among the faculty and students of the Nayoro City University Japan, the policy‘s impact on smokers was investigated along with the smoking characteristics of all students, teachers and office workers. The survey was conducted through an anonymous, self-administered and multiple-choice questionnaire. The recovery rate was 62.1%. Among respondents, smoking prevalence was 17.9% in teachers and office workers and 4.0 % in students. Among all smokers, 46.4% did not abstain from smoking while at the university and they indicated their smoking areas were ―on the streets next to the campus‖ and 29.6% reduced the number of cigarettes smoked per day as a result of the smoking ban. None of the ex-smokers replied that their principal motivation for quitting smoking was the smoking ban. It was concluded that ban on smoking served a motivator for smokers to reduce in smoking, but not serve as an effective motivator to quit smoking.

Radke PW, Schunkert H (2006) 40, The Italian Government banned smoking in all indoor public places, including cafes, restaurants and bars since January 2005. The authors evaluated whether the introduction of the public smoking ban resulted in change of hospital admissions for AMI and described a s reduction of 11 % in admissions for AMI in patients. There was 8.9% decline in cigarette sales, 7.6% reduction in cigarette consumption, 90% reduction in nicotine vapour phase concentration in pubs and discos, suggesting that the smoking ban in Italy did reduce overall smoking.

28 Review of Literature

Stallings-Smith S, Zeka A, Goodman P, et al (2013) 53, assessed the effect of national workplace smoking in the Republic of Ireland. 215,878 non-trauma deaths in the Irish population, ages > 35 years were reviewed from January 1, 2000, to December 31, 2007, with a post-ban follow-up of 3.75 years. Following ban implementation, an immediate 13% decrease in all-cause mortality, a 26% reduction in ischemic heart disease (IHD), a 32% reduction in stroke and a 38% reduction in chronic obstructive pulmonary disease (COPD) mortality was observed. Estimates indicated that 3,726 smoking-related deaths were likely prevented post-ban. Mortality decreases were primarily due to reductions in passive smoking. The national Irish smoking ban was associated with immediate reductions in early mortality.

Aroral M, Madhu R (2012) 55 , report that India is the 2nd largest producer and 3rd largest consumer of tobacco and the users of SLT are more than double than that of smokers. SLT use is an imminent public health problem, which is contributing to high disease burden in India. It is a ―unique‖ tobacco product due to its availability in myriad varieties, easy access and affordability especially for adolescents. It has been studied to be a gateway product and facilitates initiation. Currently, the Food Safety and Standards Authority of India (FSSAI) has prohibited the use of tobacco and nicotine in any food products; yet, the implementation of a permanent ban on SLT is still pending. The authors state that multiple legislations have failed to effectively control or regulate SLT in India and regionally; thus, there is need to strengthen SLT control efforts as ―no ordinary product.‖ e. Health warning labels:

Health warnings on cigarette packages are among the most widespread policy initiatives implemented to educate smokers about health risks of tobacco use worldwide and Government of India has also introduced this policy along with similar guidelines for regulated smokeless tobacco products since 2009. In 2016 it was made mandatory for 85% graphic pictorial warning on cigarette packaging; the effectiveness of this measure will be evident in near future. The extent to which smokers understand the magnitude of these health risks has a strong influence on their smoking behaviour.45-47 Smokers who perceive greater health risk from smoking are

29 Review of Literature more likely to attempt quitting and quit successfully.42 The health risks of smoking are also the most common motivation to quit cited by current and former smokers, as well as the best predictor of long-term abstinence among reasons for quitting. Recent research indicates that graphic warning labels on cigarette packages can increase cessation behavior among smokers. Smokers who noticed the warnings were significantly more likely to endorse health risks, including lung cancer and heart disease. Smokers living in countries with government mandated warnings reported greater health knowledge.42

Hammond D, Parkinson C (2009) 36, conducted a study with adult smokers (n = 312) and non-smokers (n = 291) in Ontario, Canada. Participants viewed cigarette packages that differed along a single attribute and completed ratings of perceived taste, tar delivery and health risk. Respondents were significantly more likely to rate packages with the terms ‗light‘, ‗mild‘, ‗smooth‘ and ‗silver‘ as having a smoother taste, delivering less tar and lower health risk compared with ‗regular‘ and ‗full flavor‘ brands. Respondents also rated packages with lighter colors and a picture of a filter as significantly more likely to taste smooth, deliver less tar and lower risk. Smokers were significantly more likely than non smokers to perceive brands as having a lower health risk, while smokers of light and mild cigarettes were significantly more likely than other smokers to perceive brands as smoother and reducing risk. Perceptions of taste were significantly associated with perceptions of tar level and risk. The finding suggested that current regulations have failed to remove misleading information from tobacco packaging.

37 Borland R, Wilson N, Fong GT et al (2009) examined the impact of health warnings on smokers by comparing the short-term impact of new graphic (2006) Australian warnings with: (i) earlier (2003) UK larger text-based warnings (ii) and Canadian graphic warnings (late 2000); and also to understand warning wear-out. They concluded that warning size increases warning effectiveness and graphic warnings may be superior to text-based warnings. While there is partial wear-out in the initial impact associated with all warnings, stronger warnings tend to sustain their effects for longer. These findings support arguments for governments to exceed minimum FCTC requirements on warnings.

30 Review of Literature

Wade B, Merrill RM, Lindsay GB, (2010) 41, measured the Russian population‘s acceptance and preference of graphic (picture + text) tobacco warning labels. Data was collected from 1778 in a cross-sectional survey conducted through in person household interviews with respondents aged more than 14 years. Participants rated the strength of 13 cigarette warning labels according to their effectiveness to deter from smoking. Smoking status and the population‘s acceptance of similar warning labels was also measured. Approximately 87% of all respondents favored requirement for manufacturers to place graphic warning labels on cigarette packs, while 80% of current smokers wanted their government to enact such enforcement and that to best deter from smoking, future cigarette warning labels should be as graphic as possible.

Hammond D, Fong GT , McNeill A, et al (2006), 42 studied the national samples of adult smokers from the USA, UK, Canada and Australia; from the International Tobacco Control Four Country Survey (ITC-4) to examine variations in smokers‘ knowledge about tobacco risks and the impact of package warnings. A telephone survey was conducted with 9058 adult smokers from the following countries: USA (n = 2138), UK (n = 2401), CAN (n = 2214) and AUS (n = 2305). Respondents were asked whether they believed smoking caused heart disease, stroke, impotence, lung cancer in smokers and lung cancer in non-smokers and whether about the presence of following chemicals in cigarette smoke: cyanide, arsenic and carbon monoxide. Smokers in the 4 countries exhibited significant gaps in their knowledge of the risks of smoking. Labelling policies differed between countries and smokers living in countries with government mandated warnings reported greater health knowledge. Warnings that are graphic, larger and more comprehensive in content are more effective in communicating the health risks of smoking.

Hitchman SC, Mons U, Nagelhout GE et al (2011) 43, examines the effectiveness of the text health warnings among daily cigarette smokers International Tobacco Control Policy Evaluation Project surveys in France (2007), Germany (2007), the Netherlands (2008) and the UK (2006). The European Commission requires tobacco products in European Union to display standardized text health warnings. Impact tended to be highest in countries with more comprehensive tobacco control programs. Across all countries, scores were significantly higher among low-income smokers.

31 Review of Literature

Hammond D (2011), 54 94 relevant articles prior to January 2011 were screened (72 quantitative studies, 16 qualitative studies, 5 studies with both qualitative and qualitative components, 1 review). The evidence indicated that the impact of health warnings depended upon their size and design; obscure text-only warnings had little impact, prominent health warnings on the face of packages served as a source of health information for smokers and non-smokers and increased health knowledge and perceptions of risk and promoted smoking cessation. Comprehensive warnings were effective among youth and helped to prevent smoking initiation. Pictorial health warnings that elicited strong emotional reactions were more effective.

Munzo MA et al (2013) , evaluated the emotional impact of tobacco warning images proposed by the European commission by conducting a cross sectional study with 597 health male and female volunteers divided in to 4 groups according to smoking status as non smokers, one time smoker , occasional smokers and heavy smokers. Majority of the tobacco warning images, 83 % were unpleasant space however 17 % were rated as pleasant. Findings suggested that the capability of European tobacco warning images to prompt negative attitudes to reduce tobacco consumption might not extend to general population but only to certain groups.

Chang et al (2011) 61, evaluated the impact of Taiwan‘s graphic cigarette warning labels and smoke-free law on awareness of the health hazards of smoking and thoughts of quitting smoking. Prevalence of thinking about the health hazards of smoking among smokers increased from 50.6% to 79.6% post-law, while among non- smokers it increased from 68.8 to 94.1%. Smokers who reported thinking of quitting rose from 30.2% to 51.7% post-law. The implementation of a smoke-free law in combination with graphic cigarette warning labels has been effective in increasing thoughts about the health hazards of smoking and quitting smoking. f. Tobacco advertising, Promotion and Sponsorship (TAPS):

The rise in consumption of tobacco products among youth is a public health concern in India. Several studies have shown that movies, celebrity culture and advertisements promoting tobacco products influence decisions and behavior of youth towards smoking and have been instrumental in initiation of the tobacco habit as result of

32 Review of Literature experimentation , adventure or imitating celebrity culture . The depiction of cigarette smoking is pervasive in movies, occurring in three-quarters or more of contemporary box-office hits. Identifiable cigarette brands appear in about 1/3rd of movies.71 Consumer studies show that young people who smoke are more likely to appreciate and to be aware of tobacco advertising, sponsorship and merchandising 38. Current voluntary regulations designed to protect young people from smoking have limited success and that statutory regulations are required. 38 i. Role of media in promotion and initiation of tobacco use habit:

Sardana M, Goel S and Gupta M et al , (2015) 62 , analyzed the data of youth (15- 24 years) from to ascertain which method of TAPS was more influential for initiating tobacco use in youth in India. Out of 13,383 youths surveyed, 1,982 (14.7%) used SLT and 860 (6.38%) used smoke forms. Study revealed that promotional activities mainly through cinemas and providing free samples of tobacco products were most influential means of initiating consumption of tobacco among youth and other activities including watching advertisements, promotional activities like coupons and sales on the price of tobacco products stressing on the need of stronger legislative measures should to curb promotional advertisements in cinemas and distribution of free samples.

Mashwar M (2016) 64, stated that teenagers are resorting to smoking and drinking after being influenced by visuals of celebrities in the mass media and internet. The research on "Influence of mass media on teenagers' diet and health-related behavior, in which 517 teenagers were surveyed 15 % of boys smoked cigarettes or consumed alcohol on more than one occasion to imitate media visuals involving film stars and celebrities. These visuals include from movies, television and the internet.

Yoo W (2016), 63 examined the effect of celebrity smoking on college students' perceptions of smoking-related health risks and smoking intentions. The data were collected using a web-based survey of 219 UG students. It was found that the influence of negative exemplars of celebrity smoking varied according to smoking status. Smokers who read smoking news with negative exemplars of celebrity smoking were more likely than smokers who read the same news absent any exemplar

33 Review of Literature to report higher levels of perceptions of smoking-related health risks and lower levels of smoking intentions. However, these patterns were not found in never-smokers. Exemplification theory enhanced by the celebrity element may be effectively applied as a strategy to change health behavior in college students.

Sargent JD et al (2001) 65, A cross sectional survey of 4919 schoolchildren (9•15 years) and assessment of occurrence of smoking in 601 films was made to test the hypothesis that greater exposure to smoking in films is associated with trying smoking among adolescents The films contained a median of 5 (range 1•12) occurrences of smoking. The typical adolescent had seen 17 of 50 films listed. The prevalence of ever trying smoking increased with higher categories of exposure: 4.9% among students who saw 0•50 occurrences of smoking, 13.7% for 51•100 occurrences, 22.1% for 101- 150, and 31.3% for > 150. The association remained significant after adjustment for age, sex, school performance, school, parents' education, smoking by friend, sibling or parent and receptivity to tobacco promotions. There was a strong, direct and independent association between seeing tobacco use in films and trying cigarettes, a finding that supports the hypothesis that smoking in films has a role in the initiation of smoking in adolescents.

Distefan JM, Pierce JP and Gilpin EA (2004) 66, studied whether adolescents whose favorite movie stars smoke on-screen are at increased risk of tobacco use, adolescent never smokers were interviewed and nominated their favorite stars. One third of never smokers nominated a star who smoked on-screen, which independently predicted later smoking risk (odds ratio [OR] = 1.36; 95% confidence interval [CI] = 1.02, 1.82). The effect was strong among girls (OR= 1.86; 95% CI= 1.26, 2.73). Among boys, there was no independent effect after control for receptivity to tobacco industry promotions.

Public health efforts to reduce adolescent smoking must confront smoking in films as a tobacco marketing strategy.

Song AV, Ling PM, Neilands TB et al (2007) 67, assessed whether smoking in the movies was associated with smoking in young adults. A national web-enabled cross- sectional survey of 1528 young adults, aged 18–25, was performed. Exposure to

34 Review of Literature smoking in the movies predicted current smoking. Effect on established smoking was mediated by two factors related to smoking in the movies: positive expectations about smoking and exposure to friends and relatives who smoked with positive expectations accounting for about 2/3rd of the effect. The association between smoking in the movies and young adult smoking behavior exhibited a dose–response relationship; the more a young adult was exposed to smoking in the movies, the more likely he or she would have smoked in the past 30 days or have become an established smoker.

Harakeh Z, Engels RCME, Kathleen Vohs K et al (2010), 68 examined whether smoking portrayal in movies or antismoking advertisements affect smoking intensity among young adults. 84 smokers were randomly assigned using a 2 (no-smoking versus smoking portrayal in the movie) by 3 (2 prosocial ads, 2 antismoking ads or 1of each) factorial design. Participants viewed a 60-minute movie with 2 commercial breaks and afterwards completed a questionnaire. Smoking during the session was allowed and observed. Exposure to the movie with smoking had no effect on smoking intensity. Those who viewed two antismoking ads had significantly lower smoking intensity compared with those who viewed two prosocial ads. There was no interaction between movie smoking and antismoking ads. Baseline CO (carbon monoxide) level had the largest effect on smoking intensity. These findings provide further evidence to support antismoking ads placed with movies because of their possible effect on young adult smoking behavior.

Dalton MA, Sargent JD, Beach ML et al (2003) 69, undertook a prospective study to ascertain whether exposure to smoking in movies predicts smoking initiation. 3547 adolescents aged 10–14 years, who reported that they had never tried smoking were exposed to smoking in movies. Exposure was estimated for individual respondents on the basis of the number of smoking occurrences viewed in samples of 50 movies. 2603 (73%) students were re contacted 13–26 months later for a follow-up interview to determine whether they had initiated smoking. 10% (n=259) of students initiated smoking during the follow-up period. In the highest quartile of exposure to movie smoking, 17% (107) of students had initiated smoking, compared with only 3% (22) in the lowest quartile. The effect of exposure to movie smoking was stronger in adolescents with non-smoking parents than in those whose parent smoked. In this

35 Review of Literature cohort, 52·2% (30·0–67·3) of smoking initiation can be attributed to exposure to smoking in movies. Providing strong evidence that viewing smoking in movies promotes smoking initiation among adolescents.

McCool JP, Cameron LD, Petrie KJ (2001) 70, conducted a qualitative study to explore how adolescents interpret and decode smoking imagery in movies. Same- gender groups of 12- and 13-year-old students were interviewed at their schools.

Participants discussed their recollections of and responses to portrayals of smoking in recently viewed films, as well as their perceptions of smoking in general. Students perceived that smoking in film is both highly prevalent and recognisable and they regarded on-screen-smoking imagery as an accurate reflection of reality. Adolescents in this study were predominantly nonchalant towards the inclusion of smoking images in film and they perceived an unrealistically high prevalence of smoking amongst peers and adults. Their non chalant response is linked with the perception that smoking is normal and prevalent and with the broad understanding of the constructed nature of media imagery. Smoking imagery in film may play a critical role in reinforcing cultural interpretations of tobacco use, such as its role as a means of stress relief, development of self-image and as a marker of adult independence.

Thus it is seen that favourable portrayals of smoking in the media have been cited as potential motivators of the initiation of smoking among adolescents. In order to curb this menace various restrictions have been imposed on tobacco consumption. ii. Restriction on Tobacco Advertising, Promotion and Sponsorship::

Tobacco use among youth is a major public health problem around the world. Every day, some 80,000-100,000 young people around the world become addicted to tobacco. If current trends continue, 250 million of today‘s children will die from tobacco-related diseases. Most people start smoking before the age of 18, and almost a quarter of these smokers began smoking before the age of 10.73,75

Tobacco advertising has been dominated by 3 themes: providing satisfaction (taste, freshness, mildness, etc.), assuaging anxieties about the dangers of smoking and creating associations between smoking and desirable outcomes (independence, social

36 Review of Literature success, sexual attraction, thinness, etc.). Targeting men, women, youth and young adults, specific racial and ethnic populations, religious groups, the working class and gay and lesbian populations—has been strategically important to the tobacco industry. Evidence demonstrates a direct relationship between tobacco advertising, promotion and increased tobacco use.71

Tobacco companies try to attract a new generation of tobacco users. The industry constantly loses customers because many current smokers quit or die from related diseases. As a result, tobacco companies develop massive marketing campaigns to entice youth to become long-term users , encourage smokers to smoke more and decrease smokers‘ motivation to quit 72, 73 .

Strategies used by the tobacco industry to target youth: 73

Tobacco companies‘ use carefully calculated marketing strategies to reach vulnerable populations:

 Advertising heavily at retail outlets near schools and playgrounds using large ads.

 Sponsoring schools, school programs or special school events.

 Placing cigarette ads at eye-level.

 Advertising in popular youth-oriented magazines.

 Sponsoring sports with a large youth fan base, such as soccer and cricket.

 Advertising using large billboards depicting glamorized images of tobacco use.

 Placing tobacco products in prominent movies for the youth audience.

Despite evidenced harm to the human health, the tobacco industry continues to thrive because of huge financial gains. For example in England, Smoking annually costs the National Health Service (NHS) £1500 million with around 1000 admissions every day for smoking related illnesses 12, however, the UK treasury earns £8 billion in tax on tobacco sold in the UK alone, in addition to the enormous revenue from overseas markets 148 making the profit from tobacco substantially larger than the expenses incurred.

37 Review of Literature

Voluntary regulations are not effective as the tobacco industry often fails to comply and partial bans have little to no effect on tobacco consumption. A comprehensive ban on tobacco advertising, promotion and sponsorship is one of the most effective policy measures to reduce youth tobacco use.

Article 13 of the FCTC requires parties to enact a comprehensive ban on tobacco advertising, promotion and sponsorship. As such, countries must implement comprehensive bans as a part of their tobacco control strategy.75

Jiloha RC (2012)58, India ratified the WHO's FCTC in February 2004 and enacted the legislation, ―Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act 2003‖ which specifically called for an end to direct and indirect form of tobacco advertisements. Under its Section 7, the Act stipulates depiction of pictorial health warnings on all tobacco products. Since the enactment of the legislation, the tobacco companies are prohibited from any kind of advertisement. However, studies show that the instances of smoking in movies have increased significantly to 89% and the brand placement also increased nearly three folds after the implementation of the Act. The association of tobacco with glamour and style has also been established. 75 % percent of movies have showed the lead character smoking tobacco. The instances of females consuming tobacco in movies have also increased, pointing toward a specific market expansion strategy by tobacco companies using movies as a vehicle. General public does not feel that banning tobacco scenes in the movie will affect their decision to watch movies or the quality of movies. It was found that favourable images through mass media created a considerable influence on youngsters and increased their receptivity to tobacco smoking. Legal action against offenders, investigation of the relationship and financial irregularities between film-makers and tobacco industry and recall of the movies showing tobacco brand are the important measures recommended.

Kostygina G, Hahn EJ and Rayens MK, (2014)16, Rural residents are exposed to sophisticated tobacco advertising. To determine relevant cultural themes and key message features that affect receptivity to pro-health advertisements among rural

38 Review of Literature residents, 11 exploratory focus groups and surveys with community advocates in 3 rural Kentucky counties were conducted. Participants reviewed and rated a collection of print media advertisements and branding materials used by rural communities to promote smoke-free policies. Findings reveal that negative emotional tone, loss framing, appeals to religiosity, and shifting focus away from smokers are effective strategies with rural audiences .There is a need for effective health messages to counter the pro-tobacco culture in these communities.

Allen JA, Duke JC, Davis KC et al (2015)76, reviewed studies that evaluate an anti- tobacco media campaign intended to influence youth cognitions or behaviour or explore the relative effectiveness of campaign characteristics. Anti-tobacco media campaigns effect may differ by race/ethnicity. Evidence is insufficient to determine whether campaign outcomes differ by socioeconomic status (SES). Youth are more likely to recall and think about advertising that includes personal testimonials; a surprising narrative; and intense images, sound, and editing. Evidence in support of using a health consequences message theme is mixed; an industry manipulation theme may be effective in combination with a health consequences message. Research is insufficient to determine whether advertising with a second hand smoke or social norms theme influences youth tobacco use. g. Mass media Intervention:

A major public health challenge of this century is finding a way to harness the powerful influence of the media to curtail tobacco use. Now—as media has expanded beyond traditional channels such as newspapers, magazines, radio, and television to the internet and interactive video gaming—the challenge is even more urgent. Both tobacco control and tobacco industry forces are using the media to influence the attitudes and behaviour of the general public.

Mass media interventions involve communication through television, radio, newspapers, billboards, posters, leaflets or booklets and now a days with latest technology of internet, blogs social media etc. These intend to encourage the tobacco users to stop and to stop initiation and maintain abstinence in non-smokers. The intensity and duration of mass media campaigns may influence effectiveness but

39 Review of Literature length of follow-up and concurrent events in the community can make this difficult to verify. Patterns between the effects of the campaigns, age, education, ethnicity or gender of those taking part need to be estimated. Evidence shows that mass media campaigns designed to discourage tobacco use can change youth attitudes about tobacco use, curb smoking initiation, and encourage adult cessation. The effect appears greater when mass media campaigns are combined with school- and/or community-based programming. Many population studies document reductions in smoking prevalence when mass media campaigns are combined with other strategies in multi-component tobacco control programs. 71

Bala MM, Strzeszynski L, Topor-Madry R (2013) 35, assessed the effectiveness of mass media interventions in reducing smoking among adults. Comprehensive tobacco control programmes which include mass media campaigns were found to be effective in changing smoking behaviour in adults. Massachusetts state-wide tobacco control programme showed positive results up to 8 years after the campaign. California showed positive results during the period of adequate funding and implementation. 6 of nine studies carried out in communities or regions showed some positive effects on smoking behaviour and at least significant change in smoking prevalence in Sydney. The intensity and duration of mass media campaigns may influence effectiveness, but length of follow-up, concurrent secular trends and events can make this difficult to quantify. No consistent relationship was observed between campaign effectiveness and age, education, ethnicity or gender.

Farrelly MC, Davis KC, Duke J et al , (2009)15 examined how two American campaigns the American Legacy Foundation‘s ‗truth‘ campaign and Philip Morris‘s ‗Think. Don‘t Smoke‘ campaign have influenced youth‘s tobacco-related attitudes, beliefs and intentions during the first 3 years of the truth campaign. Data from 8 nationally representative cross-sectional telephone surveys of 35 074 , 12- to 17-year olds to estimate time series logistic regressions that assess the association between recall of truth and TDS and attitudes, beliefs and intentions toward smoking. An alternative measure of exposure to TDS was also used. Findings indicate that exposure to advertisements (ads) to well-executed antismoking campaigns can

40 Review of Literature positively and consistently change youth‘s beliefs and attitudes, whereas a tobacco industry-sponsored campaign can have a counterproductive influence.

Durkin S, Brennan E and Wakefield M (2011) 56, summarise the impact of mass media campaigns on promoting quitting among adult smokers. 194 relevant articles were evaluated. The studies evidenced that mass media campaigns conducted in the context of comprehensive tobacco control programmes can promote quitting and reduce adult smoking prevalence but that campaign reach, intensity, duration and message type may influence success. Achievement of sufficient population exposure is vital, especially for lower socioeconomic status smokers with television remaining the primary channel to effectively reach and influence adult smokers. Negative health effects messages were most effective at generating increased knowledge, beliefs or quitting behaviour. Mass media campaigns were found to be important to promote quitting as part of comprehensive tobacco control programmes.

Bogliacino F, Codagnone C, Veltri GA (2015) 81, suggest that the odds of buying a tobacco product can be reduced by 80% if the negative affect elicited by the images increases. More importantly from a public policy perspective, not all emotions behave alike, as eliciting shame, anger, or distress proves more effective in reducing smoking than fear and disgust.

Hyland A, Wakefield M , Higbee C , et al (2006) 83, assessed the relationship between exposure to state-sponsored anti-tobacco advertising and smoking cessation. The relative risk for quitting was estimated to be 10% higher for every 5000 units of exposure to state anti-tobacco television advertising over the 2-year period concluding that increased exposure to state anti-tobacco media increases smoking cessation rates.

The growth of mass media has been critical to the rapid expansion of tobacco use in the and the subsequent evolution of effective tobacco control interventions into the early 21st century. The public health field understands of this relationship has paralleled the growth of tobacco control efforts. Media communications play a key role in shaping attitudes toward tobacco. Mass media have also changed the environment by influencing social norms surrounding tobacco use. Tobacco media

41 Review of Literature play a critical role in tobacco control, helping to counterbalance the pro-tobacco cues in the environment. Policy interventions for tobacco control have moved increasingly toward strong limitations on tobacco marketing including legislative and regulatory efforts by governmental agencies. 71

Figure 4.3: Conceptual framework for evaluation of anti-tobacco public communication campaigns 1

42 Review of Literature h. Price and Taxation:

Increase in taxes levied on tobacco products and raising the price has proven to be a successful anti tobacco measure worldwide. Reduction in tobacco consumption and increased cessation attempts are often noticed as a result of increased taxes on tobacco.

Choi K , Boyle RG (2009) 48 , asked 727 smokers whether they thought the federal tobacco tax increase helped them to: (1) think about quitting (2) cut down on cigarettes (3) make a quit attempt. Demographics, number of cigarette price- minimizing strategies used and cigarette consumption were also noticed. A year later it was assessed if these smokers had made a quit attempt, cut down on their cigarette consumption or had stopped smoking. Logistic regression models were used to assess the characteristics associated with the perceptions that the tax increase was helpful in assisting smoking cessation and the association between these perceptions in 2009 and cessation behaviours in 2010.Overall, 65% of the sample thought that the 2009 tax increase helped them think about quitting, 47% thought it helped them cut down on cigarettes and 29% thought it helped them make a quit attempt.

Choi KTC, Toomey TL and Chen V, (2011), 49 conducted a survey in Minnesota before and after cigarette tax increase.3167 adolescents and young adults were surveyed.42% noticed an increase in cigarette prices after the tax increase. 16.7% reported quit attempts and 24.1% reported reducing smoking because of the tax increase. Because fewer than half of the participants noticed the cigarette tax increase, media campaigns to raise awareness of tax changes may increase its effectiveness.

Hu T, Sung HY, Keeler TE (1995), 50 examined relative effects of taxation vs an anti-smoking media campaign on cigarette consumption in California. Sale of cigarettes reduced by 819 million packs from third quarter of 1990 to fourth quarter of 1992 owing to an additional 25 cent tax increase. While anti-smoking media campaigns reduced cigarette sales by 232 million packs during the same period. Both taxation and media campaigns are effective means of reducing cigarette consumption. The strength of these effects is influenced by the magnitude of taxes and amount of media campaign expenditures.

43 Review of Literature

Ross H, Blecher E, Yan L and Hyland A (2011), 51 examined the importance of cigarette prices in influencing smoking cessation and the motivation to quit by using longitudinal data from 3 waves of the International TCP Evaluation Survey (ITC). The study contrasts smoking cessation and motivation to quit among US and Canadian smokers and evaluates how this relationship is modified by cigarette prices, nicotine dependence and health knowledge. Attempts are made to understand how the ability to purchase cheaper cigarettes may reduce the influence of prices. 4352 smokers from Wave 1and 2000 smokers completing all 3 waves participated. Smokers living in areas with higher cigarette prices were significantly more motivated to quit. Higher cigarette prices increase the likelihood of actual quitting. Access to cheaper cigarette sources does not impede cessation although smokers would respond more aggressively (in terms of cessation) to price increases if cheaper cigarette sources were not available.

Availability of tobacco cessation media interventions via telephonic, online, mobile apps, blogs and other latest media avenues have been very limited in India, confined to access only by urban elites. Although these avenues have been successful in developed countries.

Government interventions are critical to addressing the global tobacco epidemic, a major public health problem that continues to deepen. The overview of these policies indicated:

Hoffman SJ, Tan C (2015) 52, systematically synthesized research evidence on the effectiveness of government tobacco control policies promoted by the Framework Convention on Tobacco Control (FCTC). Of 612 reviews retrieved, those published since 2000 were prioritized. Protecting people from tobacco smoke was the most strongly supported government intervention, with smoke-free policies associated with decreased smoking behaviour, second hand smoke exposure and adverse health outcomes. Raising taxes on tobacco products also consistently demonstrated reductions in smoking behaviour. Tobacco product packaging interventions and anti- tobacco mass media campaigns may decrease smoking behaviour, with the latter likely an important part of larger multicomponent programs. Financial interventions

44 Review of Literature for smoking cessation are most effective when targeted at smokers to reduce the cost of cessation products; incentivizing quitting is effective as well. Although the findings for bans on tobacco advertising were inconclusive, other evidence suggests they remain an important intervention. When designing and implementing tobacco control programs, governments should prioritize smoking bans and price increases of tobacco products followed by other interventions.

McKay AJ, Patel RK, Majeed A (2015) 59, reviewed the extent of tobacco control measures and the outcomes of associated trialled interventions in India. Widespread understanding of tobacco-related harm but less knowledge about specific consequences of use was noted. Healthcare professionals reported low confidence in cessation assistance, in keeping with low levels of training. Training for schoolteachers also appeared suboptimal. Educational and cessation assistance interventions demonstrated positive impact on tobacco use. Smoke-free policies, tobacco advertisements and availability indicated increasingly widespread smoke-free policies but persistence of high levels of SHS exposure, tobacco promotions and availability—including to minors were unregulated. Data relating to taxation/pricing and packaging were limited. Tobacco-use outcomes could be improved by school/community-based and adult education interventions and cessation assistance, facilitated by training for health professionals and schoolteachers.

Guillaumier A, Bonevski B and Paul C (2015) 60, explored how socioeconomically disadvantaged smokers engage with health risk and cessation benefit messages. Television advertisements, packaging regulations and health warning labels (HWLs) are designed to communicate anti-smoking messages to large number of smokers. Highly emotive warnings delivering messages of negative health effects were most likely to capture the attention of the study participants; however, these warning messages did not prompt quit attempts and participants were sceptical about the effectiveness of cessation programmes such as telephone quitlines. Active avoidance of health warning messages was common, and many expressed false and self exempting beliefs towards the harms of tobacco. Careful consideration of message content and medium is required to communicate the antismoking message to disadvantaged smokers who consider themselves desensitized to warnings. Health

45 Review of Literature communication strategies should continue to address false beliefs about smoking and educate on cessation services that are currently underutilized. i. Understanding the socio demographic co relates of tobacco use :

Rani M, Bonu S, Jha P, et al (2003) 77, conducted a cross sectional, nationally representative population based household survey to estimate the prevalence and the socioeconomic and demographic correlates of tobacco consumption in India.315 598 individuals > than15 years from 91196 households were sampled and data on tobacco consumption were elicited from household informants. Prevalence of current smoking and current chewing of tobacco were used as outcome measures. 30% of the population 15 years or older—47% men and 14% of women—either smoked or chewed tobacco. Tobacco consumption was significantly higher in poor, less educated, scheduled castes and scheduled tribe populations. The prevalence of tobacco consumption increased up to the age of 50 years and then levelled or declined. The prevalence of smoking and chewing also varied widely between different states and had a strong association with individual‘s sociocultural characteristics.

Subramanian SV, Nandy S, Kelly M et al (2004) 78, conducted a cross sectional analysis investigate the demographic, socioeconomic and geographical distribution of tobacco consumption in India. 301 984 individuals (≥ 18 years) from 92447 households in 3215 villages in 440 districts in 26 states participated. Smoking and chewing tobacco were systematically associated with socioeconomic markers at the individual and household level. Individuals with no education are 2.69 times more likely to smoke and chew tobacco than those with postgraduate education. Households belonging to the lowest fifth of a standard of living index were 2.54 times more likely to consume tobacco than those in the highest fifth. Scheduled tribes (odds ratio 1.23, 95% confidence interval 1.18 to 1.29) and scheduled castes (1.19, 1.16 to 1.23) were more likely to consume tobacco than other caste groups. The socioeconomic differences are more marked for smoking than for chewing tobacco.

Kelly MM, Jensen KP, Sofuoglu M (2014) 80, conducted an observational study with a cross-sectional design to assess the major influencing factors for alcohol and

46 Review of Literature tobacco use and addiction .Alcohol and tobacco use are highly correlated behaviors and people who are dependent on alcohol are also frequently dependent on some form of nicotine.

Several potential mechanisms promote the combined use of alcohol and nicotine. Out of 200 patients, 96% were male. 0.5% were between 10 -19 years old; 21.5% were 20-29 years old; 33% were 30-39 years old; 34.5% were 40-49 years old and 10.5% between 50- 59 years. 23% were unemployed, 1% were government employees, 39% were farmers and 37% were doing business. Distribution according to their education level showed 16.5% were uneducated, 30.5% were educated up to middle school, 30% up to high school, 17.5% up to pre-university and 5.5% had completed graduation. As the education level increased, the number of participants addicted to tobacco and alcohol decreased (p< 0.05). The distribution according to initiation age out of 200 participants, no habit was found among 10-15-year olds, 10.5%were addicted at the age of 16-20 years, 67.5% at 21-25 years and 22% at 26-30 years. 41.5% - influenced by peer pressure, 4.55 - family problems, 8% -financial drawbacks 7% - job-related stress, 6% - family problems and peer pressure, 3.5% - feeling of loneliness and insecurity, 2% - unable to cope with the challenges and 2% - influenced by elders in the family with similar habits. The distribution according to the habits found among their relatives and friends revealed that 70%- had peers having these habits, 29% - parents 26% had siblings who were involved in these habits.

Sharma I, Sarma PS and Thankappan KR et al (2010) 82, The Cigarettes and Other Tobacco Products Act (COTPA) was developed to curb tobacco epidemic in India. To assess awareness, attitude and perceived barriers regarding the implementation of COTPA, a community based cross sectional survey was conducted among 300 adults (mean age 41 years, 52%men) selected from Guwahati. Information on awareness, attitude, their predictors and barriers for implementation was collected using a pretested, structured interview schedule. Adults > 50 years were 3 times (odds ratio [OR] 3.02, 95% CI 1.446.31) and those with more than 10 years of schooling were 4 times (OR 3.60, 95% CI 1.707.70) more likely to have good awareness of COTPA compared with their counter parts. Those belonging to the middle socioeconomic

47 Review of Literature status (SES) were 3 times (OR 3.36, 95% CI 1.1310.01),those who reported second hand smoking harmful were 3 times (OR 3.32, 95% CI 1.457.62) and those with more than 10 years of schooling were 3 times (OR 2.92, 95% CI 1.018.45)more likely to have positive attitude toward COTPA compared with their counterparts. Lack of complete information, awareness of the Act, public opposition cultural acceptance of tobacco use, lack of political support, and less priority for tobacco control were reported as barriers for COTPA implementation.

Agrawal M, Jain S, Maitin N (2015) 86, determined the prevalence and demographic correlates of tobacco use in the adult population. The prevalence of tobacco use was 31.1% for males and 6.1 for females. The rural population showed a higher prevalence of tobacco use among both males and females; the male smoking prevalence was higher in the urban population (23.0%) than in rural (18.1%). The prevalence of tobacco use was directly proportionate to age increasing up to the age of 60 years, then declined. Stepwise Regression analysis showed gender as the strongest predictor for smoking followed by area of residence, education and age. Whereas education was the most significant predictors for chewing tobacco, followed by gender and age.

Kelly MM, Jensen KP, Sofuoglu M (2015) 79, Smokers with PTSD have higher rates of smoking and have greater difficulty quitting compared to smokers without PTSD. Stress-response pathways and affect regulation appear to be important mechanisms involved in the development and maintenance of smoking in individuals with PTSD.

Aforementioned studies analyzed the impact of various tobacco cessation measures, public response and the barriers for the success or modest impact of these measures. The present study further explores how Central Indian population reacts to present tobacco cessation measures.

48 Material & Methods

4.2 Material & Methods

1. Setting:

For wider inclusion of participants from all socio demographic backgrounds a wider sampling base was considered. Tobacco users visiting the outpatient section of Department of Oral Medicine and Radiology, from Sharad Pawar Dental College and Hospital, Sawangi (Meghe) , VSPM Dental College and Research Centre Hingna Nagpur and SDKS Dental College and Hospital Wanadongri Nagpur were included after obtaining formal permission from respective ‗Heads of institutions‘ .This was a cross sectional study.

2. Research Design:

To assess knowledge, attitude and practices of tobacco users and impact of tobacco cessation measures

An interview questionnaire was designed to assess knowledge; attitude & practices of the tobacco users. After analyzing the pilot results, the necessary modifications were

49 Material & Methods made to the interview questionnaire. The following points were stressed upon among others for validation of the interview questionnaire; 157,158

Reliability: The degree to which a questionnaire is reproducible.

Validity: The degree to which a questionnaire reflects reality.

Internal validity: The degree to which questions within an instrument agree with each other, i.e., that a subject will respond to similar questions in a similar way.

External validity: The ability to make generalizations about a population beyond that of the sample tested.

The interviews were conducted face to face to gauge whether current anti-tobacco campaigns increased awareness level amongst the population about the hazards of tobacco consumption and if the present campaign methods encouraged the tobacco users from quitting the habit. Tobacco users were interviewed about details of their tobacco use, awareness of current anti-tobacco campaigns and hazards of tobacco use. Participant‘s requirements for the process of tobacco de-addiction were recorded along with inputs for improvements of cessation programs to ascertain knowledge, gaps in knowledge and to evaluate the impact and effectiveness of on-going anti- tobacco policies.

3. Sampling: As derived from various references 4, 18,25,26,27, 88, 97, 98, 99 159,160,161, 164 the prevalence of tobacco users was about 46.5 %. While that reported in females was 13.8%. 164 These proportions were considered for determining the number of males and females to be screened for presence or absence of tobacco use during the presence study.

z2 p(1 p ) n   2 Where: z = z value (e.g. 1.96 for 95 % confidence level) p= percentage picking a choice, expressed as decimal (0.45 used for sample size needed)

= tolerable error, expressed as decimal (e.g., 0.02 = + 2%)

50 Material & Methods

For a tolerable error of 3% in estimating true proportion with 95 % confidence and 80 % power, an estimated number of males was 1061, while number of females was 514; to be checked for presence or absence of tobacco use. Thus a total of 1575 individuals were required to be inquired about presence or absence of tobacco habit in a period of one year.

Out of these 1037 were tobacco users, 27 responses were not valid mainly due to incomplete, nonchalant, unclear or unusable answers. Hence, responses from 1010 individuals, which were complete and followed the inclusion and exclusion criteria, were considered for downstream analysis. The consenting tobacco users were interviewed to obtain an unbiased sample of tobacco users. Participants belonged to both rural and urban parts of Nagpur, Wardha and adjoining districts of Vidharbha region along with participants from adjoining state of Madhya Pradesh (MP) and Chhattisgarh (CG).

Questions studying knowledge, attitude and practices of tobacco use habit. Self- reported tobacco use behavior was noted which included information about previous quit attempts, successful quitting, quit intentions.

4. Participants: i. Inclusion criteria: 1. Tobacco users of both the sexes who had the habit of tobacco consumption for more than 2 years. 2. Tobacco users who consented for participation in this study. 3. Participants without life threatening conditions resulting from tobacco use. 4. Participants without other addictive habits eg. alcoholism ii. Exclusion criteria:

1. Participants who were unwilling to participate. 2. Participants with life threatening conditions resulting from tobacco use. 3. Individuals who consumed alcohol

51 Material & Methods

5. Observations:

1. The demographic data like age, gender, education, occupation of each subject 2. Knowledge, attitude and practice of tobacco consumption among the population 3. The obtained data will be utilized : a. To observe the effect of current anti-tobacco campaigns in dissuading the tobacco user for giving up the habit. b. To evaluate if the current anti tobacco campaigns increased the awareness level amongst the population about the hazards of tobacco consumption and whether present methods encourage the tobacco users from quitting the habit. c. To identify the gaps in knowledge and the reasons for non compliance of tobacco users.

6. Data Collection tools and Process:

Both interview and tobacco cessation intervention were carried out with all due precautions to maintain privacy and comfortable atmosphere for the participant.

I. Armamentarium: a. Dental diagnostic instruments for examination of oral cavity: Mouth mirror, probe , explorer and kidney tray b. Record sheets II. Process: Interview: A questionnaire was designed and interviews were conducted after obtaining due consent

7. Data analysis:

Results were summarized, after interviews and intervention to comment upon knowledge, attitude and perception of the general population about tobacco consumption and effectiveness of counselling to aid tobacco cessation. Appropriate variables from the study were statistically analyzed for the mean values, standard deviation, standard error, range and ―p‖ value. The data was tabulated and analyzed using software SPSS© Versión 20.1 (Chicago, USA Inc.)

52 Material & Methods

The dependent variable was primarily ‗willingness to quit tobacco‘. The socio demographic variables - age, gender and socio-economic status (SES) were treated as independent variables. The descriptive statistics like mean, standard deviation, median and range were obtained for age. The numbers and percentage were obtained for gender and SES. Other important variables included knowledge of participants pertaining to awareness about different preparations of tobacco, ill effects of tobacco, exposure to different anti-tobacco campaigns, damage perception and reception to anti tobacco messages from different media of communications. The frequencies were obtained for discrete responses and expressed in terms of percentages. Further, responses were also obtained on questions relating attitude of individuals. The questions were aimed at finding out reason for starting consumption of tobacco, continuation of habit, feeling with and without tobacco usage, reaction to different tobacco infomercials, access to tobacco and willingness to quit tobacco. The frequency of responses on the levels of each question were obtained and expressed in terms of percentages. Also, the responses were obtained about the onset of tobacco habit, duration of tobacco use and frequency of daily tobacco consumption, type of product used, time of tobacco intake, preferred company and activity during tobacco use, consumption by other family members and peer group; prior cessation attempts . The responses were counted and expressed in terms of percentages.

8. Statistical Analysis:

Descriptive and analytical statistics were performed for analysing the responses gathered from the interview.

The association between SES and reaction was tested for significance using Pearson’s Chi-square test. Further, the association of SES, gender, age with type of tobacco product used, reason for continued habit and willingness to quit tobacco consumption habit, awareness about ill-effect and willingness to quit, association between gender and aids required to quit the habit, relapse and willingness to quit habit were also evaluated statistically using Pearson’s Chi-square test.

The effect of different factors on willingness to quit tobacco was studied through univariate analysis. The odds ratios, as a measure of effect of different factors on willingness to quit were obtained along with corresponding 95% confidence interval.

53 Material & Methods

Chi square test: The chi-square test was used to determine if there is a significantrelationship between two nominal (categorical) variables. The frequency of one nominal variable was compared with different values of the second nominal variable.The statistical significance was determined at p<0.05.

Software: All the analyses were performed using SPSS ver. 20.0 (SPSS Inc.) and R – 3.0.0 programming language. The statistical significance was tested at 5% level.

The following formula was used to calculate chi-square statistic –

The mathematical details of the techniques used in the study are as below:

A) Sample mean for a set of observations is given by 1 n xx  i n i1

B) Standard deviation for a set of observations in given by

n 1 2 s() xi x (n  1) i1 Where xi = observation on each object and n = number of objects

C) Median: It is the middle value of a set of values when arranged in the increasing order of magnitude.

D) Range is the difference between maximum and minimum value of the variable.

E) Chi-square test: Let X and Y be two variables under study with r and s levels respectively; and the data on rs levels be in the form of counts. Let the null hypothesis be that the two variables are independent. That is, knowing the levels of X does not help in predicting the levels of Y; against the alternative hypothesis that the two factors are not independent. That is, knowing the level of X can help in predicting levels of Y. To decide about the acceptance of hypothesis, the Chi-square test statistic is used which is defined as:

54 Material & Methods

rs 2 2 ()OEij ij th    where Oij is the observed frequency count for i level of ij11 Eij th variable X and j level of variable Y. Eij is the expected frequency count for same cell. The expected count is given by

nnij E  ij n th th where ni and nj are the total counts for i level of variable X and j level of variable Y; and n is the total count. The calculated Chi-square value is compared with the tabulated one for (r-1)(s-1) degrees of freedom. If the corresponding p-value is smaller than the pre-decided significance level, say 0.05, then we reject the null hypothesis and accept the alternative one. If the p-value is more than 0.05, then we accept null hypothesis.

F) Odds ratio Odds ratio is the measure of association between exposure and outcome. It gives the odds that an outcome can occur given a particular exposure, as compared to the odds of outcome occurring in the absence of exposure. The odds ratio can be used to determine whether a particular exposure is a risk factor for a particular outcome. An OR = 1 indicates exposure does not affect the odds of outcome. An OR > 1 indicates that exposure is associated with higher odds of outcome and an OR < 1 indicates that exposure is associated with lower odds of outcome.

Exposed Not exposed Cases a c Controls b d

If number of exposed cases are: a Number of exposed controls is: b Number of non-exposed cases is: c Number of non-exposed controls is: d Then odds ratio is given by: OR = ad / bc

55 Material & Methods

The 95% confidence interval for OR is given by:

Upper 95% limit = e[ln(OR ) 1.96 1/ a  1/ b  1/ c  1/ d ]

Lower 95% limit = e[ln(OR ) 1.96 1/ a  1/ b  1/ c  1/ d ]

G) Multiple logistic regressions

Multiple logistic regression analysis refers to the regression application with one dichotomous outcome and one or more independent variable(s). The outcome in logistic regression analysis is often binary as 0 or 1, where 1 indicates that the outcome of interest is present, and 0 indicates that the outcome of interest is absent. If we define p as the probability that the outcome is 1, then multiple logistic regression model can be written as follows:

where X1, X2…Xp are the independent variables and b0 through bp are the regression coefficients. The model can be rewritten as:

The parameters of the model are estimated using maximum likelihood estimation method. The coefficient indicates the change in the expected log odds relative to one unit change in one variable, holding all other variables constant. The anti log of an estimated regression coefficient (exp (bi)) gives the odds ratio associated with the variable.

Tobacco users participating in this study belonged to the highlighted area;

 Maharashtra  Madhya Pradesh  Chhattisgarh

56 Results

4.3 Results

The parameters of education, occupation, income and socioeconomic status were determined according to Kuppuswamy‘s Socio-Economic Status Scale –Revision for 2014. 132

I. Demographic details and socioeconomic status:

Total 1010 tobacco users were interviewed to assess their knowledge, attitudes and practice with respect to tobacco use habit, the data was tabulated and following results were obtained.

Distribution of Age [Table 1 & Graph 1]: The age range for tobacco users was 16- 75 years. 116 (11.49%) of participants were in 0-20 age group, 596 (59.01%) users in 21-40 years age, 274 (27.13%) were in 41-60 age group and 24 (2.38%) users were in 61-80 age group. Mean age was 32.84 years with standard division of + 12.22 years.

57 Results

Distribution of Gender [Table 2 (a) & (b) & Graph 2 (a) & (b)]: There were 646 (63.96%) males, while 364 (36.04%) females in the study. 96 (14.86 %) males and 20 (5.49 %) females were between 10- 20 years of age. 200 (30.96%) males and 193 (53.02%) females were aged between 21- 30 years. 137 (21.21%) males and 66 (18.13%) females were aged between 31- 40 years. 156 (24. 15 %) males and 53 (14.56%) females were aged between 41- 50 years. 36 (5. 57 %) males and 29 (7.97%) females were aged between 51- 60 years. 16 (2. 48 %) males and 3 (0.82%) females were aged between 61- 70 years and 5 (0.77%) males were between 71-80 years of age.

Distribution of participants according to Educational Qualifications [Table 3 (a) & (b) & Graph 3]: According to education qualifications defined as per Kuppuswamy‘s SES Scale 2014 ; 371 (36.73%) participants had graduate or post- graduate qualifications, followed by 332 (32.87%) with high school certification. 72 (7.13%) had honours, 53 (5.25%) had primary school certification, 49 (4.85%) with middle school certification. Number of illiterates was 121 (11.98%) amongst the participants.

Distribution of participants according to Occupation [Table 4 & Graph 4]: Out of 1010 participants, 271 (26.83%) participants were unemployed, 234 (23.17%) participants were in clerical, shop-owner and farmer category followed by 224 (22.18%) unskilled employees. 170 (16.83%) individuals had professional qualifications, 66 (6.53%) semi-skilled workers and 28 (2.77%) skilled workers.

Distribution of participants according to Income [Table 5 & Graph 5]: 894 (88.51%) participants had annual income more than Rs. 36,997, while 95 (9.41%) had income in the range of Rs. 18,498 – Rs.36, 996 and 21 (2.08%) had in the range of Rs. 13,874 – Rs. 18,497.

Distribution of participants according to Accommodation [Table 6 & Graph 6]: 491 (48.61%) participants were staying with their spouse and children, followed by 233 (23.07%) staying with their parents. Hostel accommodation was availed by 103 (10.20%) participants, while 76 (7.52%) were staying with spouse and 52 (5.15%)

58 Results with friends. Equally same number i.e. 52 (5.15%) were staying in joint family. 573 (56.73%) participants belonged to rural areas; whereas 437 (43.26 %) belonged to urban areas.

Distribution of participants according to socioeconomic status [Table 7 & Graph 7]: 693 (68.61%) participants were in the upper/lower middle class category, followed by 170 (16.83%) in the upper and 147 (14.55%) upper lower/ lower category; as per Kuppuswamy‘s SES Scale –Revision for 2014.

The interview questionnaire included questions that determined knowledge/ awareness, attitude and perception of the population regarding the tobacco use habit.

Knowledge/ Awareness:

Awareness of tobacco hazards during the initiation period [Table 8 & Graph 8]: 910 (90.10%) participants were unaware of the harmful effects of tobacco consumption when they started their habit while only 54 (5.35%) had awareness but still started the habit. 46 (4.55%) participants with misconceptions about the effects. Out of these, 24 felt that the habit can be easily given up, while 16 felt that chewable tobacco preparations have less concentration and are not harmful.

Awareness about different type of tobacco products and preparations [Table 9 & Graph 9]: 696 (68.91%) participants were aware about different types of tobacco products and preparations, while 314 (31.09%) were not.

Awareness about tobacco hazards at the time of the interview [Table 10 & Graph 10]: 788 (78.02%) were aware about ill effects of tobacco consumption, while 222 (21.98%) were not.

Awareness of health hazards from tobacco preparations [Table 11 & Graph 11]: 297 (29.41%) participants were aware that even preparations containing tobacco are harmful, while 232 (22.97%) were not. Majority i.e. 481 (47.62%) had misconception , amongst these, 224 participants felt that only smoking is harmful, while 172 felt that less intake causes no harm. Preparations have small amount of tobacco to cause any harm was felt by 44 participants, while 12 felt that it can harm only older individuals.

59 Results

Awareness about the harmful effect of tobacco on various organs [Table 12 & Graph 12]:686 (67.65%) participants were aware that tobacco usage can have harmful effect on various organs, out of these 671 (66.44%) were aware that tobacco use can harm the oral cavity, 334 (33.06%) were aware that tobacco usage can harm the lungs, 34 (3.37%) were aware about the harmful effects on foetus and 26 (2.57%) were aware of the effects on male fertility. 336 (33.37% ) were aware of harmful effects of tobacco use on other organs and systems as well such as cardiac system , blood etc. 334 (33.06%) were not aware of any harmful effects.

Awareness of tobacco cessation advertising campaigns [Table 13 & Graph 13]: 883 (87.43%) participants were aware about tobacco cessation advertising campaigns, while 127 (12.57%) were not.

Medium of information [Table 14 & Graph 14]: The main source of information about harmful effects of tobacco was television. 756 (74.85%) participants got information through television channels, followed by 639 (63.27%) participants who received information from public places, 281 (27.68%) from public transport, 252 (24.95%) from announcements in the movie hall, 237 (23.47%) through camps and 219 (21.68%) through work places. Less than 20% received information through print media, hoardings, packaging and internet.

NRT awareness [Table 15 & Graph 15]: Out of 1010 participants,. 820 (81.19%) participants were not aware about Nicotine Replacement Therapy, while only 190 (18.81%) were aware.

Attitude / Perception:

Reason for starting consumption of tobacco products [Table 16 & Graph 16]: 731 (72.38%) participants had started tobacco use due to influence of friends, followed by 475 (47.03%) who were advised it as a home remedy for various health issues. 374 (37.03%) participants imitated their family members, while 326 (32.28%) started habit due to peer pressure. Experimentation and adventure were the starting causes for 186 (18.42%) and 159 (15.74%) participants respectively, while 140 (13.86%) imitated the celebrities.

60 Results

Reason for continuation of tobacco use [Table 17 & Graph 17]: The reasons for continuing the habit were sought from the participants. Out of 1010 participants, 422 (41.78%) used tobacco to relieve professional stress, while 378 (37.43%) stated that they feel good after tobacco consumption. There were 299 (29.6%) who stated that they are habituated, while 283 (28.02%) expressed personal stress. The awareness about harmful effect of consumption was missing in 126 (12.48%) participants. Inability to quit (addiction) smoking was expressed by 184 (18.22%) participants.

Distribution of participants according to according to their feelings after tobacco consumption [Table 18 & Graph 18]: 448 (44.36%) participants experience a good feeling after consumption, while 387 (38.32%) stated that they consume tobacco to increase concentration level. Performance enhancement was experienced by 314 (31.09%) participants, while 287 (28.42%) said that they felt energetic. Alert and relaxed feeling were mentioned by 221 (21.88%) and 160 (15.84%) participants respectively.

Distribution of participants according to feelings in absence of tobacco consumption [Table 19 & Graph 19]: 363 (35.94%) stated that they felt distracted without consumption, followed by 352 (34.85%) stated that they felt nothing specific. 333 (32.97%) participants stated that their concentration decreases without consumption, while 233 (23.07%) felt tired. Anxiety was experienced by 203 (20.1%) participants.

Details noticed from tobacco cessation infomercials [Table 20 & Graph 20]: Out of 1010 participants interviewed 607(60.10%) noticed the warning - smoking causes cancer, 463 (45.84%) failed to recollect any infomercials or any details from these, 330 (32.67%) noticed and recollected the advice to stop tobacco use.252 (24.95%) noticed patients images, 220 (21.78%) developed misconceptions such as only smoking is harmful or other, 49 (4.85%) noticed treatment centers and 31(3.07%) noticed help line numbers shown in the infomercials.

Reactions to tobacco cessation infomercials [Table 21 & Graph 21]: 651 (64.46%) participants had no reaction to infomercials, while 305 (30.2%) ignored the

61 Results infomercial. There were 220 (21.78%) who noticed the infomercial. Other reactions were observed in less than 20% participants.

Willingness to quit tobacco [Table 22 & Graph 22]: Out of 1010, 841 (83.27%) showed willingness to quit, while 168 (16.63%) did not have inclination to cease tobacco use.

Aids opted for tobacco cessation [Table 23 & Graph 23]: Out of 1010, 467 (46.24%) participants said that guidance about cessation process will help them quit, while 209 (20.69%) wanted NRTs. Medications for other minor ailments ; for which tobacco was used a home remedy were expected by 174 (17.23%) participants; while 166 (16.44%) participants opted for tobacco cessation counselling. 199 (19.70 %) participants said that they do not require any aid to stop their habit.

Access to tobacco products despite ban [Table 24 & Graph 24]: All 1010 participants were able to access tobacco products despite the ban.

Inputs for improving the tobacco cessation campaign [Table 25 & Graph 25]: Various inputs suggested for improving tobacco cessation campaigns included ; 264 (26.14%) participants suggested to provide tips for cessation, 234 (23.17%) wanted cessation campaigns to provide awareness about smokeless products. There were 178 (17.62%) participants suggesting easy availability of NRT. 200 (19.8%) participants had no suggestions.

Practice:

Age of onset of tobacco consumption [Table 26 & Graph 26]: Out of 1010 participants included in the study, there were 646 males - 568 (87.93%) started using tobacco between 10-20 years, 54 (8.36%) started between 20-30 years and 24 (3.72%) with age before 10 years of age. Amongst females, 201 (55.22%) started using tobacco between 10-20 years, 117 (32.14%) between 20-30 years.

Duration of tobacco use [Table 27 & Graph 27]: 508 (50.3%) participants used tobacco from 0-10 years, followed by 225 (22.28%) participants for 20-30 years and 181 (17.92%) participants in the duration range of 10-20 years.

62 Results

Frequency of tobacco use (per day) [Table 28 & Graph 28]: Out of 646 males, 355 (54.95%) consumed 6-10 times per day, 280 (43.34%) individuals consumed tobacco less than 5 times per day, while 11 (1.7%) had frequency above 10 times per day. Amongst females, 346 (95.05%) consumed less than 5 times per day and 16 (4.4%) consumed tobacco between 6-10 per day.

Gender wise distribution of tobacco products used [Table 29 & Graph 29]: The division of number of males and females in this study consuming various tobacco products was; among males, 394 (60. 99%) had habit of consuming kharra, followed by 162 (25.08%) with habit of cigarette smoking and 99 (15.33%) had habit of consuming tobacco pouch while 4 (0.62%) consumed pan quid. Among females, 174 (47. 80%) had habit of taking pan quid, followed by 72 (19.78%) with habit of tobacco pouch and 50 (13.73%) with habit of kharra chewing. 46 (12.64%) females used snuff and 6 (1.64%) with habit of smoking cigarettes. One female reported having access to hookah in an urban lounge bar. Many individuals consumed more than one tobacco product.

Usage of same tobacco products from the time of habit initiation [Table 30 & Graph 30]: Out of 1010 participants, 952 (94.26%) were consuming same product from the beginning of their habit, while 47 (4.65%) had experimented with different products. Amongst those who changed, 36 shifted to lesser number of products.

Habit alteration [Table 31 & Graph 31]: Out of 1010 participants, 314 (31.09%) had decreased their tobacco consumption, while 257 (25.45%) had their tobacco consumption unaltered. 269 (26.63%) participants habits increased or decreased intermittently.

Sources of obtaining tobacco product [Table 32 & Graph 32]: 740 (73.2%) participants bought the tobacco products, 731(72.38 %) shared tobacco products with friends while 365 (36.14%) shared with family members and 340 (33.66%) stated that borrowing from colleagues is the main source of tobacco products.

Time of tobacco consumption after waking up [Table 33 & Graph 33]: 23 (2.28%) participants consumed tobacco within 30 min waking up while 330 (32.67%)

63 Results consumed tobacco within one hour of waking up. 600 (59.41%) participants consumed tobacco beyond 60 minutes after waking up. 57 participants had no specified time of tobacco consumption, these participants used tobacco products only during night shifts, as a home remedy etc.

Company during tobacco use [Table 34 & Graph 34]: 897 (88.81%) participants stated that they consume tobacco alone, 877 (86.83%) also consumed tobacco with friends, 677 (67.03%) consumed with colleagues. 569 (56.34%) participants stated that they consume tobacco with family members. Majority of the participants consumed tobacco in varying company.

Tobacco consumption in presence of non-tobacco users in the family [Table 35 & Graph 35]: 688 (68.12%) participants consumed tobacco products in presence of non-tobacco users in the family, while 322 (31.88%) did not consume in front of non- tobacco users in the family.

Tobacco consumption in presence of children and younger family members [Table 36 & Graph 36]: 667 (66.04%) participants stated that they consumed tobacco in presence of children and younger members of family, while 343 (33.96%) stated that they do not consume tobacco in presence of children and younger members of family.

Activity during tobacco consumption [Table 37 & Graph 37]: 854 (84.55%) had habit of consuming tobacco during breaks, while 811 (80.3%) had habit of taking it at home, 618 (61.19%) while commuting and 551 (54.55%) during working.

Place of tobacco consumption [Table 38 & Graph 38]: 781 (77.33%) participants consumed tobacco at place of stay (home or hostel) 584 (57.82%), 565 (55.94%), 557 (55.15%) with habits of consuming at pan kiosk, work place and places of hang outs respectively. Friends place and restaurants were preferred choices for 485 (48.02%) and 346 (34.26%) participants.

Social circles knowledge of participants habit [Table 39 & Graph 39]: 721 (71.39%) participants stated that their parents are aware about their habits, 595

64 Results

(58.91%), 812 (80.4%) and 555 (54.95%) participants who stated that their habit is known to spouse, siblings and children. Awareness amongst friends was stated by 983 (97.33%) participants, while amongst colleagues was stated by 691 (68.42%) participants.

Prior tobacco cessation attempts [Table 40 & Graph 40]: 303 (30.0%) participants who made an attempt for tobacco cessation, while 706 (69.9%) never made such an attempt in the past. Awareness 196 (19.41%), Staining of teeth 53 (5.277 %) and being advised by a health care professional in a camp, 28 (2.77%) were the main reasons for attempting tobacco cessation, whereas unawareness 259 (25.64 %) misconceptions 142 (14.06 %), dependency 182 (18.02 %) were the chief reasons not to attempt cessation. 123 (12.16 %) participants had no specific reason for tobacco habit continuation.

Duration of prior cessation attempt [Table 41 & Graph 41]: 59 (5.84%) stopped using tobacco for 1-6 days and restarted it ,127 (12. 57 %) participants ceased their habit for less than a month, while 87 (8.61%) ceased it for less than a year, 25 (2.48%) had duration of more than one year . 714 (70.69 %) participants had no recollection of their cessation attempt or its duration.

Reason for relapse [Table 42 & Graph 42]: 369 (36.53%) participants stated that they restarted the habit, while 609 (60.3%) stated that they never discontinued the habit. Amongst those who restarted the habit, 157 stated that the reason for restart was stress, while 119 stated reason as craving.

Association between Socio economic, Demographic details and knowledge , attitude and practice of tobacco use among the participants

The division of socioeconomic class according to Kuppuswamys socio economic scale 132 (Annexure 1) was reassigned to simplify the associations as:

Distribution of participant’s according to type of tobacco product used [Table 43 & Graph 43]: Maximum 443 (43.86%) participants were Kharra chewers, followed by 228 (22.57%) smokers, 178 (17.62%) tobacco pouch users and 164 (16.24%) pan

65 Results quid users. Other product consumption was observed in less than 10% of the participants.

SES & choice of tobacco product [Table 44 a, Table 44 b & Graph 44]:.In the SES group I, 95 (55.88%) participants smoked cigarettes, 36 (21.18%) consumed kharra. Other habits were observed in less than 10% of the participants. In SES group II, out of 693 participants 353 (50.94%) had habit of chewing kharra, followed by 134 (19.33%) with habit of pan quid, 121 (17.46%) with habit of cigarette smoking and 98 (14.14%) with tobacco pouch. Other products were used in less than 10% of the participants in this group. In group III of SES, out of 147 participants, 64 (43.54%) had habit of tobacco pouch, followed by 54 (36.73%) with habit of eating kharra and 15 (10.2%) with habit of pan quid.

The proportion of participants consuming Bidi in SES category II was significantly higher than the other two categories (p-value < 0.0089) Participants smoking cigarettes were highly significantly different across SES categories as indicated by (p < 0.0001). The participants consuming pan quid in SES group II was significantly higher as compared to other two groups. Kharra consumption was significantly higher in SES group II as compared to other two groups. Tobacco pouch usage was significantly higher in SES group III as compared to group I and II. Further, Snuff usage was significantly higher in SES group II as compared to other two groups.

Distribution of smoking / smokeless tobacco product use [Table 45 &Graph 45]: Out of 1010 participants, 724 (71.68%) consumed smokeless tobacco products, while 228 (22.28%) had smoking habit and 61 (6.04%) used both smoking as well as smokeless tobacco products.

Association between SES and choice of smoking or SLT product use [Table 46 & Graph 46]: Participants were divided according to SES and product type classified as smoking and smokeless. Smoking was observed almost equally in SES group I 45.33% and II 48% , while it was less in group III 6.66%. SLT consumption was predominantly observed in SES group II 73.2%, followed by 17.4% in group III and 9.39% in group I. Both the habits were predominant in SES group II 90.16%,

66 Results followed by group III 9.84%. Overall, the association between SES status and habits was statistically significant with p-value < 0.0001.

Age and SLT or smoking tobacco product use [Table 47 & Graph 47]: Out of 228 participants with smoking habit, 166 (73.77%) were in the age range of 21-30 years, followed by 28 (12.28%) in the 11-20 years age group. 724 participants consumed smokeless tobacco with maximum in the range of 21-50 years. Also, out of 61 participants with habit of consuming both smoking and smokeless products, maximum participants were in the age group of 21-50 years.

Association of gender and use of SLT or smoking tobacco consumption [Table 48 & Graph 48]: In all the three usage groups of smokers, smokeless tobacco users and mixed tobacco users, the proportion in males was higher than females. The association between gender and tobacco product type was statistically significant with P-value of 0.0007 (P < 0.05); with statistically higher use among males.

Education level and type of tobacco product used [Table 49 & Graph 49]: Smoking was common among those having graduate or post-graduate qualification 102 (45.33%), followed by 64 (28.44%) with high school certification and 38 (16.88%) with professional or honours degree. In the smokeless category, 267 (36.88%) participants were both graduate/post-graduates and 238(32.87%) were higher school certificate holders, 100 (13.81%) were illiterate. Out of 61 participants with both the type of habits, 30 (49.18%) participants were higher school certificate holders, followed by 12 (19.67%) with primary school certification and 10 (16.39%) with middle school certification.

Occupation and tobacco product used [Table 50 & Graph 50]: Among cigarette smokers out of 228 participant‘s, 102 (45.33%) were professionals, while 74 (32.88%) were unemployed. There were 27 (12%) participants with clerical, shops and farming occupation. In the smokeless category, maximum 207 (28.59%) were from clerical, shop, farming occupation, followed by 179 (24.72%) unskilled workers, 170 (23.48%) unemployed participants. Out of those consuming both products, 31 (50.82%) were unskilled workers, 27 (44.26%) were unemployed.

67 Results

Tobacco use and accommodation [Table 51 & Table 51]: Out of 228 smokers, majority were staying either with their spouse only 52 (23.11%), with spouse and children 20%, with parents 26.66% and with friends 18.66%. Among the smokeless users, 417 (57.59%) were staying with spouse and children, while 153 (21.13%) with parents. Those consuming both the products, majority were staying with spouse and children 47.54% and with parents 32.79%. 16.39% participants were staying in hostel.

Alterations in tobacco consumption [Table 52 & Graph 52]: Increased habit was mostly observed in the age group of 21-30 years (66.88%), followed by 10-20 years (29.29%). Decreased habit was in the age range of 31-40 (25.88%) and 41-50 (25.29%) years, followed by 21-30 years (21.18%) and 51-60 years (21.17%). Continuation of same habit, was seen in 126 (49.03%) participants in the age range of 21-30 years, followed by 70 (27.24%) in the age range of 41-50 years and 45 (17.51%) in the range of 31-40 years. There were 104 (38.66%) participants in the age range of 31-40 years with intermittently increased and decreased habit of consumption, followed by 96 (35.69%) in the range of 41-50 years.

Sources of obtaining tobacco and prior tobacco cessation attempts [Table 53 & Graph 53]: This table gives the number of individuals with more than one source of getting tobacco and previously attempted habit stoppage. Those who attempted to quit the habit, majority i.e. 276 (91.09%) buy the product on their own, followed by 253 (83.5%) participants borrowing tobacco from friends and 86 (28.38%) from colleagues. Amongst those who previously did not cease their tobacco habit; 67.56% borrowed the products from their friends (67.56%). 333 (47.17%) participants got the products from family and 254 (35.98%) from colleagues.

Tobacco availability and restarting the habit [Table 54 & Graph 54]: Out of 369 participants who restarted tobacco use after brief cessation attempt, 348 (94.31%) bought the products from market on their own, 291 (78.86%) also got it from friends, 127 (34.42%) from colleagues and 47 (12.74%) from families. Out of those who never discontinued, 366 (60.1%) bought the product, 425 (69.79%) got it from friends, 301 (49.43%) from family and 213 (34.98%) from colleagues. Many participants had multiple sources of acquiring the tobacco product.

68 Results

Awareness of tobacco hazards and willingness to quit the habit [Table 55 & Graph 55]: The willingness to cease the tobacco habit was significantly higher in participants knowing about the ill effects of tobacco (p-value < 0.0032).

Prior cessation attempts and willingness to quit the habit [Table 56 & Graph 56]: Willingness to quit the tobacco habit was statistically highly significant (p-value < 0.0001) among individuals who had attempted cessation previously.

Willingness to quit tobacco and knowledge of habit among peer group [Table 57 & Graph 57]: Out of those willing to quit the habit, 814 (96.79%) participant‘s friends knew about the habit, 645 (76.81%) participant‘s siblings were aware of their habit, 560 (66.58%) participant‘s parents and 531 (63.14%) participant‘s colleagues knew about their habits. Similarly, among those not willing to quit, 168 (99.4%) participant ‘s friends were knowing about their habits, followed by 167 (98.81%) participant ‘s siblings, 160 (94.67%) participant ‘s parents, 159 (94.08%) colleagues, and 154 (91.12%) participants ‘s spouse were knowing about their habits. It is considered that social taboo about smoking may encourage the users from quitting their habit. Knowledge among the peer group may encourage tobacco users to quit.

Continued habit and willingness to quit [Table 58 & Graph 58]: The desire to quit the habit is different across reasons for continuing the habit. The association between the two factors was statistically highly significant as indicated by p-value < 0.0001.

Age wise preference of cessation aids [Table 59 & Graph 59]: NRT was opted for by 209 (20.7%) participants. Out of these, 153 (73.21%) were in the age group of 21- 30 years, followed by 25 (11.96%) in the range of 11-20 years. There were 174 (17.23%) participants who requested for medications for other minor ailments for which they were using tobacco as a remedy so far. Among these, 62 (35.63%) were in the age range of 21-30 years, while 21 (12.07%) in the range of 41-50 years. There were 467 participants who asked for guidance for stopping the habit. Amongst these, 211 (45.18%) were in the age range of 21-30 years, 96 (20.56%) in 31-40 years and 88 (18.44%) in 41-50 yrs. 166 participants opted for counselling for stopping the habit. Of these 61 (36.75%) were in the age range of 21-30 years, 51 (30.72%) in the

69 Results range of 41-50 years, 28 (16.87%) in the range of 31-40 years, and 22 (13.25%) in the age range of 11-20 years. There were 199 (19.7%) participants who did not mentioned about any aid.

Continued habit & cessation aids [Table 60 & Graph 60]: In participants with stress as the main reason, 120 (40.13%) suggested the requirement of guidance for habit stoppage, 93 (31.1%) counselling for quitting the habit, 57 (19.06%) opted for NRT and 37 (12.37%) said that required nothing. In the unawareness category, 168 (55.44%) required guidance for habit stoppage and 46 (15.18%) asked for medications for other ailments for which they were using tobacco as a remedy so far. In the addicted category, 102 (61.45%) asked for guidance for habit stoppage, 92 (55.42%) for NRT and 35 (21.08%) for counselling. Those with more than one of reasons, 77 (31.81%) asked for guidance, 45 (18.59%) for NRT and 27 (11.16%) for counselling. The association between reason for continuing habit and aid for quitting habit was statistically highly significant (p< 0.0001).

Gender and aids opted for tobacco cessation [Table 61 & Graph 61]: Statistically significant number males opted for aids than females (p-value < 0.0001).

Response to infomercials and willingness to quit the habit [Table 62 & Graph 62]: Participants with positive reactions were 100% willing to quit the habit. Those with non-specific reaction or mixed response were predominantly willing to cease their habit. The willingness to cease the tobacco habit differed significantly among individuals with different reactions (p-value < 0.0001).

SES status & response to tobacco cessation infomercials [Table 63 & Graph 63]: Reactions of the participants were clubbed together as positive, negative, mixed and no reactions. SES group II, i.e. participants belonging to socio economic middle class had majority of reactions. Positive reaction towards tobacco cessation was predominantly observed in SES group II (93.71%). 60.49% negative reaction, were from SES group II as well , followed by 35.8% from group I. 55.91% participants from SES group II had no reaction to the infomercials. Maximum mixed responses (92.13%) were from SES group II also. The association between SES status and type

70 Results of reaction was statistically highly significant with P-value < 0.0001 indicating that participants belonging to socioeconomic middle class had statistically significant positive reaction to tobacco cessation infomercials.

Age and reaction to tobacco cessation infomercials [Table 64 & Graph 64]: The age group of 21-50 years predominantly gave a positive reaction towards tobacco cessation, while beyond this age category; less than 10% of participants gave a positive reaction. Further, those giving negative reaction and non-specific reaction were also predominantly in the age range of 21-50 years. Mixed response was mainly observed below 30 years.

Age and inputs for improving tobacco cessation measures [Table 65]: 264 (26.1%) participants suggested tips for cessation should be included in infomercials. Amongst these, 130 (49.24%) belonged to age group of 21-30 years, 60 (22.72%) in 41-50 years, 43 (16.29%) - 31-40 years. 234 participants suggested for creating awareness about smokeless tobacco consumption. Majority of these participants i.e. 99 (42.31%) were in the age range of 31-40 years, 57 (24.36%) in the range of 21-30 years and 47 (20.29%) in the range of 41-50 years. Out of total participants surveyed, 89 (8.81%) suggested for NRT availability. Those who gave this input, 72 (80.89%) were in the age range of 21-30 years, while 12 (13.84%) were in the age range of 11- 20 years. 57 (5.64%) participants suggested for availability of one-on-one facility for promoting tobacco cessation. 26 (45.61%) were in the age group of 41-50 years, while 17 (29.82%) were in the age range of 21-30 years. Ban on sales near schools and college was suggested by 43 (4.26%). Amongst these, majority were in the age range of 11-20 years. There were 34 (3.36%) participants who suggested for more camps, 16 (1.58%) suggested cheap NRT and 20 (1.98%) suggested for inclusion of NRT in curriculum.

Gender and inputs for improving tobacco cessation measures [Table 66 & Graph 66]: Out of 646 males, maximum 162 (25.08%) suggested that infomercials should also highlight possible dangers of smokeless tobacco and create awareness about smokeless tobacco preparations, followed by 147 (22.76%) who suggested that tips for cessation should be highlighted, 89 (13.77%) suggested for easy NRT availability.

71 Results

Among the females, 117 (33.82%) suggested tips for cessation, 72 (20.81%) suggested to create awareness about smokeless tobacco. Majority, i.e. 155 (44.8%) females had no inputs.

Occupation and inputs for improving tobacco cessation measures [Table 67]: 234 (23.17%) participants were clerical, shop owner or farmers. Out of these, 114 (61.54%) suggested that there should be awareness about smokeless tobacco, 80 (34.18%) felt that tips should be given for cessation. Out of 224 (22.17%) unskilled workers, 57 (25.45%) participants felt that there should be awareness about smokeless tobacco consumption, 22 (9.82%) suggested tips for cessation. There were 271 (26.8%) participants were unemployed. Amongst these, 91 (33.58%) suggested for inclusion of cessation tips in infomercials, 38 (14.02%) suggested ban on sale of products near schools and colleges, 30 (11.07%) suggested easy NRT availability, while 28 (10.33%) suggested awareness about smokeless tobacco. There were 170 (16.83%) professionals included in the study. Amongst these, 64 (37.65%) suggested tips for cessation, 51 (30%) suggested for NRT availability. Out of 66 (6.53%) semi- skilled workers, 32 (48.48%) suggested for more one-on-one facility for tobacco cessation, while 14 (21.21%) suggested for more number of camps. Out of 28 (2.72%) skilled workers, 8 (28.57%) suggested for awareness about smokeless tobacco, while 7 (25%) suggested tips for tobacco cessation. There were 17 (16.8%) cases with semi- professional background, out of which 12 (70.58%) suggested more one-on-one facility.

SES and inputs for improving tobacco cessation measures [Table 68 & Graph 68]: Out of 170 participants in group I, 64 (37.65%) suggested for including tips of cessation, 51 (30%) for NRT. 21 (12.35%) participants were satisfied with current tobacco cessation methods. In the SES group II, out of 693 participants, 187 (26.98%) suggested for including tips for cessation, 184 (26.55%) suggested to highlight aware of smokeless tobacco, while 127 (18.33%) gave no inputs. In the SES group III category, 68 (46.26%) had no response, 29 (19.73%) suggested to highlight aware of smokeless tobacco and 13 (8.84%) suggested cessation tips. Statistically significant difference in the inputs suggested was noted among individuals from different SES groups (p < 0.0001).

72 Results

Oral lesions present [Table 69 & Graph 69]: Among 1010 tobacco users participating in the study; 885 (87.62 %) had lesions and 125 (12.38 %) did not. 435 (43.07%) had leukoplakia , 263 (26.03%) had OSMF ( Stage I to IV) , 81 (8.02%) had tobacco induced melanosis , 76 (7.52 %) had tobacco pouch keratosis , 30 (2.97 %) participants had developed habit induced oral lichen planus.

Univariate Analysis: For factors associated with willingness to quit tobacco usage.

The outcome variable was willingness to quit tobacco, in a dichotomous form (Yes/No). Other factors were studied with reference to outcome variable and the odds ratio associated with the levels of each factor were determined.

As regards age, considering > 60 years (old age) as reference, the odds associated with younger age categories i.e. 41-60 years, 21-40 years and <= 20 years were 5.12 [95% CI: 2.123 – 12.728], 7.43 [95% CI: 3.148 – 18.114] and 10.886 [95% CI: 3.963 – 31.531] respectively. The higher (more than 1) odds indicate that the younger age group is more willing to quit tobacco as compared to older group based on their responses. The effect of age groups is statistically highly significant (p < 0.0001).

Analysis of gender revealed that higher odds i.e. 3.427 [95% CI: 2.438 – 4.846] is significantly associated with males as compared to females for willingness to quit the habits (p < 0.0001).

SES suggested that middle and higher class participants are more willing to quit tobacco as compared to lower class of participants as indicated by ORs of 4.761 [95% CI: 3.170 – 7.141], 3.095 [95% CI: 1.851 – 5.268] respectively.

Smokers and those consuming both smoking and smokeless tobacco were less willing to quit compared to those who used only SLT, as indicated by OR of 0.551 [95% CI: 0.376 – 0.815] and 0.201 [ 95% CI: 0.116 – 0.353] respectively.

Those aware of ill effects of tobacco consumption were more willing to quit as compared to those who are unaware of the effects, as indicated by OR of 2.193 [95% CI: 1.521 – 3.139].

73 Results

The effect of different anti-tobacco messaging was evaluated on willingness to quit. The adds mentioning harmful effect of tobacco has significant effect on subject‘s willingness to quit. The odds ratio corresponding to watching such adds is 9.544 [95% CI: 6.354 – 14.427] as compared to those not watching the adds.

The impact of medium of information was also evaluated by comparing effect with outcome. Amongst different media, public place adds shows the maximum effect (OR: 3.697; 95% CI: 2.811 – 5.646), followed by Television (OR: 2.453; 95% CI: 1.727 – 3.471), public transport (OR: 1.701; 95% CI: 1.423 – 2.598), Movie halls (OR: 1.317; 95% CI: 0.888 – 1.998) and camps (OR: 1.306; 95% CI: 0.874 – 2.000).

74 Tables

I. Demographic Details & Socioeconomic Status:

Table 1: Distribution of Age

Age Groups No. of participants Percentage 0-20 116 11.49 21-40 596 59.01 41-60 274 27.13 61-80 24 2.38 Total 1010 100% Mean Age 32.84 S.D. 12.22 Median 30 Minimum age 16 Maximum age 75

Table 2 (a): Distribution of Gender

Gender No. of participants Percentage Male 646 63.93 Female 364 36.04 Total 1010 100%

Table 2 (b): Distribution of participants according to gender in different age groups

Male Female Total Age Groups n % n % n % 0-10 0 0 0 0 0 0 11-20 96 14.86 20 5.49 116 11.49 21-30 200 30.96 193 53.02 393 38.91 31-40 137 21.21 66 18.13 203 20.09 41-50 156 24.15 53 14.56 209 20.69 51-60 36 5.57 29 7.97 65 6.44 61-70 16 2.48 3 0.82 19 1.88 71-80 5 0.77 0 0 5 0.50 Total 646 63.96 364 36.04 1010 100

75 Tables

Table 3 (a): Distribution of participants according to Educational Qualification

Education Score* No. of participants Percentage Profession or honours 7 72 7.13 Graduate or post graduate 6 371 36.73 Intermediate / post high school diploma 5 12 1.19 High school certificate 4 332 32.87 Middle school certificate 3 49 4.85 Primary school certificate 2 53 5.25 Illiterate 1 121 11.98 Total 1010 100 *Kuppuswamy‘s SES Scale 2014

Table 3 (b): Distribution of Education Qualification according to Gender

Male Female Total Education n % n % n % Profession or honours 44 6.81 28 7.69 72 7.13 Graduate or post graduate 240 37.15 131 35.99 371 36.73 Intermediate /post high school 4 0.62 8 2.20 12 1.19 diploma High school certificate 257 39.78 75 20.6 332 32.87 Middle school certificate 39 6.04 10 2.74 49 4.85 Primary school certificate 18 2.79 35 9.62 53 5.25 Illiterate 44 6.81 77 21.15 121 11.98 Total 646 63.96 364 36.04 1010 100 *Kuppuswamy‘s Socio-Economic Status Scale 2014

Table 4: Distribution of participants according to Occupation

Occupation Score* No. of participants Percentage Profession 10 170 16.83 Semi-profession 6 17 1.68 Clerical, shop-owner, farmer 5 234 23.17 Skilled worker 4 28 2.77 Semi-skilled worker 3 66 6.53 Unskilled worker 2 224 22.18 Unemployed 1 271 26.83 Total 1010 100 *Kuppuswamy‘s SES Scale 2014

76 Tables

Table 5: Distribution of participants according to Income

Family Income per month Score* No. of participants Percentage

13,874-18.497 6 21 2.08 18,498-36,996 10 95 9.41 ≥ 36,997 12 894 88.51 Total 1010 100 *Kuppuswamy‘s SES Scale 201

Table 6: Distribution of participants according to Accommodation

Accommodation No. of participants Percentage Alone 3 0.30 With friends 52 5.15 With spouse 76 7.52 With spouse and children 491 48.61 With Parents 233 23.07 Joint family 52 5.15 Hostel 103 10.20 Total 1010 100

Table 7: Distribution of participants according to Socioeconomic Status

Socioeconomic background Score* No. of participants Percentage

Upper I 170 16.83 Upper middle/ Lower Middle II 693 68.61 Upper Lower / Lower III 147 14.55 Total 1010 100 *Kuppuswamy‘s SES Scale 2014

77 Tables

II. Knowledge / Awareness

Table 8: Awareness of tobacco hazards during the initiation period

Awareness of harmful effects of tobacco No. of participants Percentage Yes 54 5.35 No 910 90.10 Misconceptions 46 4.55 Remedy/ health benefits 5 0.49 Less concentration-no harm 16 1.58 Can be easily given up 24 2.38 Preparation not harmful 1 0.1 Total 1010 100

Table 9: Awareness of different type of tobacco products & preparations

Awareness of different types of tobacco No. of participants Percentage Yes 696 68.91 No 314 31.09 Total 1010 100

Table 10: Awareness about tobacco hazards at the time of the interview

Awareness about ill effects of tobacco No. of participants Percentage Yes 788 78.02 No 222 21.98 Total 1010 100

Table 11: Awareness of health hazards from tobacco preparations

Awareness about ill effects of tobacco No. of participants Percentage a) Yes 297 29.41 b) No 232 22.97 c) Misconceptions 481 47.62 Not small amount 40 3.96 Preparations have small amount 44 4.36 Very less intake to cause harm 172 17.03 Harms only older individuals 12 1.19 Only smoking is harmful 224 22.19 Total 1010 100

78 Tables

Table 12: Awareness about the harmful effect of tobacco on various organs

Awareness about ill effects of tobacco on various No. of organs Percentage participants a) Yes 676 67.65 Oral Cavity 671 66.44 Lungs 280 27.72 Foetus 34 3.37 Male fertility 26 2.57 Others 336 33.27 b) No 334 33.04 Total 1010 100

Table 13: Awareness of tobacco cessation advertising campaigns

No. of Percentage Awareness about tobacco cessation advertising participants a) Yes 883 87.43 b) No 127 12.57 Total 1010 100

Table 14: Medium of information

Medium of information No. of participants Percentage Print 200 19.80 TV 756 74.85 Camps 237 23.47 Hoardings 198 19.60 Movie hall 252 24.95 Public places 639 63.27 Public transport 281 27.82 Work place 219 21.68 Packaging 178 17.62 Internet 173 17.13 None 120 11.88

Table 15: NRT awareness

Awareness about NRTs No. of participants Percentage a) Yes 190 18.81 b) No 820 81.19 Total 1010 100

79 Tables

Attitude / Perception:

Table 16: Reason for starting consumption of tobacco products

Started consuming tobacco product No. of participants Percentage Experimentation 186 18.42 Adventure 159 15.74 Imitating celebrities 140 13.86 Imitating family members 374 37.03 Peer pressure 326 32.28 Influence of friend circle 731 72.38 It looks cool 94 9.31 Advised as a remedy for 475 47.03 Regular Bowel movements / Constipation/ Acidity 31 3.07 To Relieve Exertion/exhaustion/For energy 141 14.96 Night shifts 102 10.10 Body pain 62 6.14 Dental pain 35 3.47 To Quit smoking 32 3.17 To increase Concentration 16 1.58 As dentifrice 59 5.84

Table 17: Reasons for continuation of tobacco use

Reason for continued habit No. of participants Percentage Professional stress 422 41.78 Personal stress 283 28.02 Feels good after tobacco use 378 37.43 As a remedy 43 4.26 Wasn't aware of harmful effect 126 12.48 Habituated 299 29.60 Unable to quit 184 18.22

Table 18: Distribution of participants according to according to their feelings after tobacco consumption

Feeling after tobacco consumption No. of participants Percentage Good 448 44.36 Increased concentration 387 38.32 Performance enhanced 314 31.09 Energetic 287 28.42 Alert 221 21.88 Relaxed 160 15.84 Nothing Specific 67 6.63 Awake 46 4.55 Bad 17 1.68 High 10 0.99 Depressed 1 0.10

80 Tables

Table 19: Distribution of participants according to feelings in absence of tobacco consumption

Feeling in absence of tobacco consumption No. of participants Percentage Distracted 363 35.94 Nothing specific 352 34.85 Decreased concentration 333 32.97 Tired 240 24.45 Anxious 203 20.10 Irritated 102 10.10 Good 39 3.86 Breathlessness 16 1.58 Headache 0 0.00 Nauseous 0 0.00

Table 20: Details noticed from tobacco cessation infomercials

Details Noticed from tobacco cessation infomercials No. of participants Percentage Warning- Smoking causes cancer 607 60.1 Nothing 463 45.8 Advice to stop tobacco use 330 32.67 Patients images 252 24.95 Misconception only smoking is harmful 220 21.78 Treatment centres 49 4.85 Help lines 31 3.07

Table 21: Reactions to tobacco cessation infomercials

Reaction to infomercials No. of participants Percentage Felt uncomfortable 28 2.72 Quit habit 33 3.27 Scared of tobacco induced cancer 63 6.24 Want to quit tobacco 79 7.82 Reduced habit 88 8.71 Noticed but did not alter the habit 108 10.69 Noticed 220 21.78 Ignored 305 30.20 No reaction 651 64.46

Table 22: Willingness to quit tobacco

Willingness to quit tobacco No. of participants Percentage

Yes 841 83.27 No 169 16.73 Total 1010 100

81 Tables

Table 23: Aids opted for tobacco cessation

Aids preferred to quit the tobacco use No. of participants Percentage

Guidance for habit stoppage 467 46.24 NRT 209 20.69 Counselling for habit stoppage 166 16.44 Other medication 174 17.23 Constipation 85 8.42 Stress relief 13 1.29 Energy 21 2.08 Pain relief 55 5.45 Information 52 5.15 Nothing 199 19.70

Table 24: Access to tobacco products despite ban

Accesses tobacco products despite ban No. of participants Percentage Yes 1010 100 Total 1010 100

Table 25: Inputs for improving the tobacco cessation campaign

Inputs for improving no tobacco campaign No. of participants Percentage Tips for cessation 264 26.14 Awareness about smokeless 234 23.17 None 200 19.80 NRT availability 178 17.62 More one on one facility 57 5.64 Ban sale near school/college/hostel 43 4.26 Satisfied 39 3.86 More camps 34 3.37 NRT in curriculum 20 1.98 Cheap NRT 16 1.58

Practice:

Table 26: Age of onset of tobacco consumption

Male (n=646) Female (n=364) Onset age of tobacco No. of No. of consumption (years) Percentage Percentage participants participants 0-10 24 3.72 41 11.26 10-20 568 87.93 201 55.22 20-30 54 8.36 117 32.14 30-40 0 0.00 5 1.37

82 Tables

Table 27: Duration of tobacco use

Duration (in years) No. of participants Percentage 0-10 508 50.30 10-20 181 17.92 20-30 225 22.28 30-40 70 6.93 40-50 24 2.38 50-60 2 0.20 Total 1010 100

Table 28: Frequency of tobacco use (per day)

Male (n=646) Female (n=364) Frequency per day No. of No. of Percentage Percentage participants participants ≤ 5 280 43.34 346 95.05 6-10 355 54.95 16 4.40 ≥ 10 11 1.70 2 0.55

Table 29: Gender wise distribution of participants according to tobacco products used

Male (n=646) Female (n=364) Tobacco Product No. of No. of Percentage Percentage participants participants Kharra 394 60.99 50 13.73 Cigarettes 162 25.08 6 1.64 Tobacco pouch 99 15.33 72 19.78 Pan quid 4 0.62 174 47.80 Snuff 22 3.41 46 12.63 Bidi 37 5.73 12 3.30 Gutkha 3 0.46 0 0 Jarda 11 1.7 4 1.1 Cigar 5 0.77 0 0.00 Hooka 0 0 1 0.27 Pipe 5 0.77 0 0.00 Hand rolled 0 0.00 0 0.00 Khaini 0 0.00 0 0.00 *Participants used more than one product

83 Tables

Table 30: Usage of same tobacco products from the time of habit initiation

Usage of same tobacco product No. of participants Percentage a) Same Products - Yes 952 94.26 b) Different Product 11 1.09 c) Change if any 47 4.65 More products 11 1.09 Lesser products 36 3.56 Less concentrated product 7 0.69 Concentrated forms 0 0.00 Total (a + b + c) 1010 100

Table 31: Habit alteration

Usage of same tobacco product No. of participants Percentage Decreased 314 31.09 Increased 170 16.83 Remained the same 257 25.45 Increased and decreased intermittently 269 26.63 Total 1010 100

Table 32: Sources of obtaining tobacco products

Source of acquiring tobacco product No. of participants Percentage Buy the product 740 73.27 Friends 731 72.38 Family 365 36.14 Colleagues 340 33.66

Table 33: Time of tobacco consumption after waking up

Source of acquiring tobacco product No. of participants Percentage Within 30 min 23 2.28 Within 60 min 330 32.67 Later than 60 minutes 600 59.41 Not Specified 57 5. 64

Table 34: Company during tobacco use

Company No. of participants Percentage Alone 897 88.81 Family 569 56.34 Friends 877 86.83 Colleagues 677 67.03

84 Tables

Table 35: Tobacco consumption in presence of non-tobacco users in the family

Habit of consuming tobacco in presence of non- No. of participants Percentage tobacco users in the family Yes 688 68.12 No 322 31.88 Total 1010 100

Table 36: Tobacco consumption in presence of children and younger family members

Tobacco use in presence of children and younger No. of participants Percentage family members

Yes 667 66.04 No 343 33.96 Total 1010 100

Table 37: Activity during tobacco consumption

Activity during tobacco consumption No. of participants Percentage At home 811 80.30 While commuting 618 61.19 Working 551 54.55 During breaks 854 84.55

Table 38: Place of tobacco consumption

Place of tobacco consumption No. of participants Percentage Home/hostel 781 77.33 Work 565 55.94 Restaurant 346 34.26 Pan kiosk 584 57.82 Friends place 485 48.02 Place of hang out 557 55.15 Others 49 4.85

Table 39: Social circles knowledge of participant’s habit

Knowledge in the social circle No. of participants Percentage Parents 721 71.39 Spouse 595 58.91 Siblings 812 80.40 Children 555 54.95 Friends 983 97.33 Colleagues 691 68.42

85 Tables

Table 40: Prior tobacco cessation attempts

Prior tobacco cessation attempts No. of participants Percentage Yes 304 30.10 Awareness 196 19.41 Staining of teeth 53 5.25 Was advised in camp 28 2.77 Health Conscious 27 2.6 No 706 69.90 Misconceptions 142 14.06 Unawareness 259 25.64 Dependency 182 18.02 Nothing specific 123 12.16

Table 41: Duration of prior cessation attempt

Duration without consuming tobacco No. of participants Percentage 1-6 Days 59 5.84 1-4 Weeks 127 12.57 1-12 months 87 8.61 More than 1 Year 25 2.48 Don't remember 714 70.69

Table 42: Reasons for relapse

No. of participants Percentage Reason for relapse a. Yes 369 36.53 Craving 119 11.78 Stress 157 15.54 Withdrawal symptoms 50 4.95 Peer pressure 38 3.76 b. No 32 3.17 c. Never discontinued 609 60.30 Total (a+b+c) 1010 100.00

86 Tables

Table 43: Distribution of participant’s according to type of tobacco product used

Tobacco product use Number Percentage Kharra 444 43.96 Pan quid 178 17.62 Tobacco pouch 171 16.93 Cigarettes 168 16.63 Snuff 68 6.73 Bidi 49 4.85 Cigar 5 0.99 Jarda 15 1.49 Pipe 5 0.50 Gutkha 3 0.30 Hooka 1 0.10 Hand rolled 0 0.00 Khaini 0 0.00 *Participants used more than one product

Table 44 a: SES and choice of tobacco product

SES Product I (n=170) II (n=693) III (n=147) Bidi 0 (0) 33 (4.76) 12 (8.16) Cigarettes 95 (55.88) 121 (17.46) 12 (8.16) Cigar 5 (2.94) 5 (0.72) 0 (0) Pipe 2 (1.17) 3 (0.43) 0 (0) Hooka 0 (0) 0 (0) 0 (0) Pan quid 15 (8.82) 134 (19.33) 15 (10.20) Kharra 36 (21.18) 353 (50.94) 54 (36.73) Hand rolled 0 (0) 0 (0) 0 (0) Khaini 0 (0) 0 (0) 0 (0) Gutkha 3 (1.76) 0 (0) 0 (0) Jarda 2 (1.18) 8 (1.15) 5 (3.40) Tobacco pouch 16 (9.41) 98 (14.14) 64 (43.54) Snuff 0 (0) 63 (9.09) 5 (3.40)

* Participants used more than one product

87 Tables

Table 44 b: SES and choice of tobacco product

SES Product I (n=170) II (n=693) III (n=147) p-value* Bidi 0 (0) 33 (4.76) 9 (6.12) 0.0089 Cigarettes 95 (55.88) 121 (17.46) 12 (8.16) < 0.0001 Pan quid 15 (8.82) 134 (19.33) 15 (10.20) 0.0004 Kharra 36 (21.18) 353 (50.94) 54 (36.73) < 0.0001 Jarda 2 (1.18) 8 (1.15) 5 (3.40) 0.1154 Tobacco pouch 16 (9.41) 98 (14.14) 64 (43.54) < 0.0001 Snuff 0 (0) 63 (9.09) 5 (3.40) < 0.0001

Table 45: Distribution according to smoking / SLT product use

Product Number of Participants Percentage Smoking 228 22.28 Smokeless 724 71.68 Both 61 6.04

Table 46: Association between SES & choice of smoking or SLT product use

Type of product SES p-value* Smoking (n=228) Smokeless (n=724) Both (n=61) I 102 (45.33) 68 (9.39) 0 (0) <0.0001 II 108 (48.00) 530 (73.20) 55 (90.16) (HS) III 18 (7.89) 126 (17.40) 6 (9.84) *Obtained using Chi-square test; HS: Highly Significant

Table 47: Age and SLT or smoking tobacco product use

Type of tobacco product Age Smoking (n=228) Smokeless (n=724) Both (n=61) 0-10 - - - 11-20 28 (11.11) 85 (11.74) 6 (9.84) 21-30 166 (73.77) 206 (28.45) 21 (34.43) 31-40 12 (5.33) 181 (25.00) 10 (16.39) 41-50 0 (0) 192 (26.52) 17 (27.87) 51-60 8 (3.55) 50 (6.91) 7 (11.48) 61-70 12 (5.33) 7 (0.97) 0 (0) 71-80 2 (0.88) 3 (0.41) 0 (0)

88 Tables

Table 48: Association of gender and use of SLT or smoking tobacco

Type of tobacco product Gender p-value* Smoking (n=228) Smokeless (n=724) Both (n=61) Male 158 (70.22) 439 (60.64) 49 (80.33) 0.0007(S) Female 67 (29.77) 285 (39.36) 12 (19.67) *Obtained using Chi square test; S: Significant

Table 49: Education level & type of tobacco product used

Type of tobacco product Education Smoking (n=228) Smokeless (n=724) Both (n=61) Profession or honors 38 (16.88) 34 (4.70) 0 (0) Graduate or post graduate 102 (45.33) 267 (36.88) 2 (3.28) Intermediate or post high school diploma 4 (1.78) 8 (1.10) 0 (0) High school certificate 64 (28.44) 238 (32.87) 30 (49.18) Middle school certificate 3 (1.33) 36 (4.97) 10 (16.39) Primary school certificate 3 (1.32) 41 (5.66) 12 (19.67) Illiterate 14 (6.22) 100 (13.81) 7 (11.48)

Table 50: Occupation & type of tobacco product used

Type of tobacco product Occupation Smoking (n=228) Smokeless (n=724) Both (n=61) Profession 102 (45.33) 68 (9.39) 0 (0) Semi-profession 3(0) 17 (2.35) 0 (0) Clerical, shop-owner, farmer 27 (12) 207 (28.59) 0 (0) Skilled worker 3 (1.33) 25 (3.45) 0 (0) Semi-skilled worker 5 (2.22) 58 (8.01) 3 (4.92) Unskilled worker 14 (6.22) 179 (24.72) 31 (50.82) Unemployed 74 (32.88) 170 (23.48) 27 (44.26)

Table 51: Tobacco use & accommodation

Type of product Accommodation Smoking (n=228) Smokeless (n=724) Both (n=61) Alone 6 (2.33) 0 (0) 0 (0) With friends 42 (18.66) 8 (1.10) 2 (3.28) With spouse 52 (23.11) 24 (3.31) 0 (0) With spouse and children 45 (20.00) 417 (57.59) 29 (47.54) With Parents 60 (26.66) 153 (21.13) 20 (32.79) Joint Family 2 (0.88) 50 (6.91) 0 (0) Hostel 21 (9.33) 72 (9.94) 10 (16.39)

89 Tables

Table 52: Alterations in tobacco consumption

Age Tobacco consumption [No. (%)] (in years) Increase Decrease Same Increased and decreased (n=314) (n=170) (n=257) intermittently (n=269) 10-20 92 (29.29) 9 (5.29) 3 (1.17) 12 (4.46) 21-30 210 (66.88) 36 (21.18) 126 (49.03) 21 (7.81) 31-40 10 (3.18) 44 (25.88) 45 (17.51) 104 (38.66) 41-50 0 (0) 43 (25.29) 70 (27.24) 96 (35.69) 51-60 2 (0.64) 36 (21.17) 13 (5.06) 14 (5.20) 61-70 0 2 (1.18) 0 (0) 17 (6.32) 71-80 0 0 (0) 0 (0) 5 (1.86)

Table 53: Sources of obtaining tobacco & prior tobacco cessation attempts

Previous cessation attempts Source of tobacco product Yes (n=303) No (n=707) Buy the product 276 (91.09) 463 (65.58) Friends 253 (83.50) 478 (67.56) Family 32 (10.56) 333 (47.17) Colleagues 86 (28.38) 254 (35.98) *Participants had more than one source for procuring tobacco product

Table 54: Tobacco availability and restarting the habit

Tobacco Use Restarted Source Yes (n=369) No (n=32) Never discontinued (n=609) Buy the product 348 (94.31) 0 (0) 366 (60.10) Friends 291 (78.86) 15 (46.88) 425 (69.79) Family 47( 12.47) 07 301 (49.43) Colleagues 127 (34.42) 0 (0) 213 (34.98)

*Participants had more than one source for procuring tobacco product

Table 55: Awareness of tobacco hazards & willingness to quit the habit

Willingness to quit habit (No. %) Awareness of ill effect of tobacco† p-value* Yes (n=841) No (n=169) Yes 672 (79.90) 101 (59.80) 0.0032(S) No 16 9(20.10) 68 (40.23) *Obtained using Chi square test; S: Significant

90 Tables

Table 56: Prior cessation attempts & willingness to quit the habit

Willingness to quit habit * Restart habit p-value* Yes (n=841) No (n=169) Yes 352 (41.85) 17 (10.06) No 32 (3.80) 0 (0) p<0.0001(HS) Never Discontinued 457 (54.34) 152 (89.94) *Obtained using Chi square test; HS: Highly Significant

Table 57: Willingness to quit tobacco and knowledge of habit among peer group

Desire to quit [No. (%)] Know about habit Yes (n=841) No (n=169) Parents 560 (66.58) 160 (94.67) Spouse 440 (52.32) 154 (91.12) Siblings 645 (76.81) 167 (98.81) Children 419 (49.82) 136 (80.47) Friends 814 (96.79) 168 (99.40) Colleagues 531 (63.14) 159 (94.08)

Table 58: Continued habit and willingness to quit

Desire to quit [(No. %)] Reason for continued habit p-value* Yes (n=841) No (n=169) Stress 281 (33.41) 18 (10.65) Unawareness 231 (27.46) 73 (43.19) <0.0001(HS) Addicted 146 (17.36) 19 (11.24) Mixed response 183 (21.76) 59 (34.91) *Obtained using Chi square test; HS: Highly Significant

Table 59: Age and preference of cessation aids

Aids preferred to quit the habit

Age NRT Other Info Guidance for Counselling for Nothing ( Yrs) (n=209) medication (n=52) habit habit stoppage (n=199) (n=174) stoppage (n=166) (n=467) 11-20 25 (11.96) 0 (0) 4 (7.69) 50 (10.71) 22 (13.25) 34 (17.09) 21-30 153 (73.21) 62 (35.63) 18 (34.62) 211 (45.18) 61 (36.75) 71 (35.68) 31-40 14 (6.69) 12 (6.89) 17 (32.69) 96 (20.56) 28 (16.87) 29 (14.57) 41-50 17 (8.13) 21 (12.07) 13 (25) 88 (18.84) 51 (30.72) 32 (16.08) 51-60 0 0 0 19 (4.07) 4 (2.41) 2 (13.07) 61-70 0 0 0 3 (0.64) 0 4 (2.01) 70-80 0 0 0 0 0 3 (1.51)

91 Tables

Table 60: Continued habit & cessation aids

Reason for continued habit Required to Stress Unawareness Multiple reasons quit habit Addicted (n=166) (n= 299) (n= 303) (n=242) NRT 57 (19.06) 15 (4.95) 92 (55.42) 45 (18.59) Other medication 18 (6.02) 46(15.18) 19 (11.45) 13 (5.37) Information 0 28 (9.24) 4 (2.41) 20 (8.26) Guidance for habit 120 (40.13) 168 (55.44) 102 (61.45) 77 (31.81) stoppage Counselling for 93 (31.10) 11 (3.63) 35 (21.08) 27 (11.16) habit stoppage Nothing 37(12.37) 84 (27.72) 2 (1.20) 75(30.99)

Table 61: Gender and aids opted for tobacco cessation

Required to quit habit Guidance Counselling Other Gender NRT Information for habit for habit Nothing p-value* medication (n=209) (n=52) stoppage stoppage (n=199) (n=95) (n=467) (n=166) 154 50 26 280 165 75 Male (73.68) (28.74) (50.00) (59.96) (99.39) (37.69) < 0.0001 55 45 26 187 1 124 (HS) Female (26.32) (25.86) (50.00) (40.04) (0.60) (62.31) *Obtained using Chi square test; HS: Highly Significant;

Table 62: Response to infomercials and willingness to quit the habit

Willingne Reaction [No. (%)] ss to quit habit Positive Negative Not specific Mixed response (n=159) (n=81) (n=592) (n=178) Yes 159 (100) 81 (100) 446 (75.34) 155 (87.08) No 0 (0) 0 (0) 146 (24.66) 23 (12.92)

Table 63: SES status & response to tobacco cessation infomercials

Reaction [No. (%)] SE p- S Positive Negative No Reaction Mixed response value* (n=159) (n=81) (n=592) (n=178) I 1 (0.63) 29 (35.80) 136 (22.97) 4 (2.25) p < II 149 (93.71) 49 (60.49) 331 (55.91) 164 (92.13) 0.0001 III 9 (5.66) 3 (3.70) 125 (21.11) 10 (5.62) (HS) *Obtained using Chi-square test; HS: Highly Significant

92 Tables

Table 64: Age and reaction to tobacco cessation infomercials

Age Reaction [No. (%)] No reaction (in years) Positive (n=159) Negative (n=81) Mixed response (n=178) (n=592) 11-20 13 (8.18) 11 (13.58) 29 (4.89) 63 (35.39) 21-30 49 (30.82) 18 (22.22) 232 (39.19) 94 (52.81) 31-40 37 (23.27) 22 (27.16) 142 (23.99) 2 (1.12) 41-50 46 (28.93) 20 (24.69) 138 (23.31) 5 (2.81) 51-60 13 (8.18) 9 (11.11) 37 (6.25) 6 (3.37) 61-70 1 (0.63) 1 (1.23) 10 (1.69) 7 (3.93) 71-80 0 (0) 0 (0) 4(0.68) 1 (0.56)

Table 65: Age and reaction to tobacco cessation infomercials

Age (in years) [No. (%)] Inputs 11-20 21-30 31-40 41-50 51-60 61-70 70-80 More Camps 1 11 4 4 13 1 0 (n=34) (2.94) (32.35) (11.76) (11.76) (38.24) (2.94) NRT availability 12 72 0 2 3 0 0 (n=89) (13.84) (80.89) (0) (2.25) (3.37) (0) (0) Awareness about smokeless 31 57 99 47 0 0 0 (n=234) (13.25) (24.36) (42.31) (20.29) (0) (0) (0) Ban sale near 29 9 5 0 0 0 0 school/college/hostel (n=43) (67.41) (20.93) (11.63) (0) (0) (0) (0) Tips for cessation 17 130 43 60 14 0 0 (n=264) (6.44) (49.24) (16.29) (22.72) (5.30) (0) (0) More one on one facility 5 17 5 26 4 0 0 (n=57) (8.77) (29.82) (8.77) (45.61) (7.02) (0) (0) None 19 69 39 41 29 3 (n=200) (9.5) (34.5) (19.5) (20.5) (14.5) (1.5) 0 Satisfied 0 9 6 9 2 11 2 (n=39) (0) (23.08) (15.38) (23.08) (5.13) (28.21) (5.13) Cheap NRT 2 7 0 0 0 4 3 (n=16) (12.5) (43.75) (0) (0) (0) (25) (18.75) NRT in curriculum 0 10 0 10 0 0 0 (n=20) (0) (50) (0) (50) (0) (0) (0)

93 Tables

Table 66: Gender and inputs for improving tobacco cessation measures

Gender Input Male (n=646) Female(n=364)

More Camps 25 (3.87) 9 (2.60) NRT availability 89 (13.77) 0 (0) Awareness about smokeless 162 (25.08) 72 (20.81) Ban sale near school/college/hostel 42 (6.50) 1 (0.29) Tips for cessation 147 (22.76) 117 (33.82) More one on one facility 57 (8.82) 0 (0) None 45 (6.97) 155 (44.80) Satisfied 30 (4.64) 9 (2.60) Cheap NRT 16 (2.48) 0 (0) NRT in curriculum 20 (3.09) 0 (0)

Table 67: Occupation and inputs for improving tobacco cessation measures

Occupation Semi- Profess Semi- Clerical, shop- Skilled Unskilled Unempl Inputs skilled ion professio owner, farmer worker worker oyed worker (n=170) n (n=17) (n=234) (n=28) (n=224) (n=271) (n=66) 0 0 0 0 14 8 12 More Camps (0) (0) (0) (0) (21.21) (3.57) (4.43) 30 NRT 51 0 2 1 5 0 (11.07) availability (30) (0) (0.85) (3.57) (7.57) (0)

Awareness 21 0 114 6 28 about 8 (28.57) 57 (25.45) (12.35) (0) (61.54) (9.09) (10.33) smokeless Ban sale near 1 0 2 2 0 0 38 school/college/ (0.59) (0) (0.85) (7.14) (0) (0) (14.02) hostel 64 0 80 7 0 22 91 Cessation tips (37.65) (0) (34.18) (25.00) (0) (9.82) (33.58) More one on 4 12 0 0 32 9 0 one facility (2.35) (70.58) (0) (0) (48.48) (4.02) 5 0 25 8 6 103 53 None (2.94) (0) (10.68) (28.57) (9.09) (45.98) (19.56) 21 11 2 0 0 0 Satisfied 5 (29.41) (12.35) (4.70) (7.14) (0) (0) (0) 0 0 0 0 1 6 9 Cheap NRT (0) (0) (0) (0) (1.51) (2.67) (3.32) NRT in 0 0 0 0 2 8 10 curriculum (0) (0) (0) (0) (3.03) (3.57) (3.69)

94 Tables

Table 68: SES and inputs for improving tobacco cessation measures

SES Inputs I (n=170) II (n=693) III (n=147 )

More Camps 0 (0) 25 (3.61) 9 (6.12)

NRT availability 51 (30) 38 (5.48) 0 (0)

Awareness about smokeless 21 (12.35) 184 (26.55) 29 (19.73)

Ban sale near school/college/hostel 1 (0.59) 42 (6.06) 0 (0)

Tips for cessation 64 (37.65) 187 (26.98) 13 (8.84)

More one on one facility 4 (2.35) 43 (6.20) 10 (6.80)

None 5 (2.94) 127 (18.33) 68 (46.26)

Satisfied 21 (12.35) 18 (2.60) 0 (0)

Cheap NRT 0 (0) 10 (1.44) 6 (4.08)

NRT in curriculum 0 (0) 19 (2.74) 1 (0.68)

Table 69: Oral Lesions present

Lesions Number of Participants Percentage Leukoplakia 435 43.07% OSMF ( Stage I to IV) 263 26.03% Tobacco induced melanosis 81 8.02% Tobacco pouch keratosis 76 7.52 % Habit induced oral lichen planus 30 2.97 % No Lesions 125 12.38 % Total 1010 100 %

95 Tables

70. Univartiate Analysis:

Factors associated with Willingness to quit tobacco usage

Willingness to quit Univariate Analysis

Variables Willingness to quit/Total 95% CI p-value in the category (%) OR L Low Upper

Age (in years)

> 60 (10/23) 43.47 1.000

41-60 (219/274) 79.92 5.120 2.123 12.728 <0.0001(HS)

21-40 (508/596 ) 85.32 7.439 3.148 18.114 <0.0001(HS)

<= 20 (104/117) 88.88 10.886 3.963 31.531 <0.0001(HS)

Gender

Female (261/363) 71.90 1.000

Male (580/647) 89.64 3.427 2.438 4.846 <0.0001(HS)

Socio economic status

Low (89/146) 60.95 1.000

Middle (611/693) 88.16 4.761 3.170 7.141 <0.0001(HS)

Higher (141/170) 82.94 3.095 1.851 5.268 <0.0001(HS)

Smoking

Smokeless (629/724) 86.87 1.000

Smoke (177/225) 78.66 0.551 0.376 0.815 <0.0001(HS)

Both (35/61) 57.37 0.201 0.116 0.353 <0.0001(HS)

Damage perception

Aware about different tobacco preparation

No (228/313) 72.84 1.000

Yes (613/697) 87.94 2.749 1.959 3.863 <0.0001(HS)

Aware of ill effect of tobacco

No (163/221) 73.75 1.000

Yes (678/788) 86.04 2.193 1.521 3.139 <0.0001(HS)

Exposure to anti-tobacco massages

Ads mentioning harmful effect

No (57/126) 45.23 1.000

Yes (784/884) 88.68 9.544 6.354 14.427 <0.0001(HS)

96 Tables

Medium of information

Print

No (676/811) 85.35 1.000

Yes (165/199) 82.91 0.995 0.662 1.532 0.994 (NS)

Television

No (186/255) 72.94 1.000

Yes (655/755) 86.75 2.453 1.727 3.471 <0.0001(HS)

Camps

No (637/772) 82.51 1.000

Yes (204/238) 85.71 1.306 0.874 2.000 0.1977(NS)

Hoardings

No (682/811) 84.09 1.000

Yes (159/199) 79.89 0.769 0.521 1.158 0.199 (NS)

Movie halls

No (624/757) 82.43 1.000

Yes (217/253) 85.77 1.317 0.888 1.998 0.1743(NS)

Public places

No (262/370) 70.81 1.000

Yes (579/640) 90.46 3.697 2.811 5.646 <0.0001(HS)

Public transport

No (594/729) 81.48 1.000

Yes (248/281) 88.25 1.701 1.423 2.598 0.009 (S)

Work place

No (656/791) 82.93 1.000

Yes (186/219) 84.93 1.156 0.772 1.774 0.482 (NS)

Packaging

No (696/832) 83.65 1.000

Yes (145/178) 81.46 0.849 0.563 1.312 0.456 (NS)

Internet

No (702/837) 83.87 1.000

Yes (140/173) 80.92 0.814 0.538 1.257 0.343 (NS)

97 Graphs

I. Demographic Details & Socioeconomic Status:

Graph 1: Distribution of Age

596 600

500

400 300 274 200 116 100 24

Number of participantsofNumber 0 ≤ 20 21-40 41-60 61-80

Age in Years

Graph 2 (a): Distribution of Gender

Gender Distribution

364 Male (26.08 %) 646 Female ( 76.92%)

98 Graphs

Graph 2 (b): Distribution of according to gender in different age groups

200

200

s s 156 150 137 Fema 96 100 93 le 66 53 50 36

Number of Participant of Number 29 20 16 3 0 5 0 10-20 21-30 31-40 41-50 51-60 61-70 71-80 yrs

Age in Years

Graph 3: Distribution of participants according to educational Qualifications

400 371 350 332

300 Education 250 200

150 121

100 72 49 53 50 No. of participants of No. 12 0 Profession or Graduate or Intermediate High school Middle Primary Illiterate honours post or post high certificate school school graduate school certificate certificate diploma

99 Graphs

Graph 4: Distribution of participants according to Occupation

300 271 Occupation

250 234 224

200 170 150

100 66 50 17 28

0 No. of participants of No.

Graph 5: Distribution of participants according to Income * 132

900 894

800

700 Income level 600 500 400 300 200 No. of Participants of No. 95 100 21 0 ≥36997 18498-36996 13874-18497

100 Graphs

Graph 6: Distribution of participants according to Accommodation

491 500 450 Accommodation 400

350 300 233 250 200 150 103 76 100 52 52 50 3 0 Alone With With With With Joint Hostel No. of participants of No. friends spouse spouse Parents Family and children

Graph 7: Distribution of participants according to SES

693 700

600

500

400

300

200 170 147 No. of participants of No. 100

0 Upper Upper Middle Middle/Lower Middle

101 Graphs

II. Knowledge/ Awareness:

Graph 8: Awareness of tobacco hazards during the initiation period:

Graph 9: Awareness about different type of tobacco products and preparation

Graph 10: Awareness about tobacco hazards at the time of the interview

102 Graphs

Graph 11: Awareness of health hazards from tobacco preparations

Graph 12: Awareness about the harmful effect of tobacco on various organs

Yes No

334 (33%)

686 (67%)

Graph 13: Awareness of tobacco cessation advertising campaigns

103 Graphs

Graph 14: Distribution of participants according to medium of information

TV 756 Public Places 639 Public… 281 Movie Halls 252 Camps 237 Work Place 219 Print 200 Medium of Information Hoarding 198 Packaging 178 Internet 173 None 120

0 200 400 600 800

Number of Participants

Graph 15: NRT Awareness

104 Graphs

Attitude / Perception:

Graph 16: Reason for starting consumption of Tobacco products

Friend circle 731

Remedy 475

Family members 374

Peer pressure 326

Experimentation 186

Adventure 159 Reasons for strating tobacco use Celebrities 140

Looks cool 94

0 200 400 600 800

Number of Participants

Graph 17: Reason for continuation of tobacco use

Reason for Continued habit

Professinal stress 422

Feels good 378

Habituated 299

Personal stress 283

Unable to quit 184

Unaware 126 Number of Participants As a remedy 43

0 100 200 300 400 500

105 Graphs

Graph 18: Distribution of participants according to according to their feelings after tobacco consumption

Feeling after tobacco consumption

Good 448 Increased… 387 Performance enhanced 314 Energetic 287 Alert 221 Relaxed 160 Nothing specific 67 Awake 46 Bad 17 Number of participants High 10 Depressed 1

0 200 400 600

Graph 19: Distribution of participants according to feelings in absence of tobacco consumption

Feelings in absence tobacco consumption

Distracted 363

Nothing specific 352

Decreased concentration 333

Tired 240

Anxious 203

Irritated 102

Good 39 Number of Participants

Breathlessness 16

Headache 0

0 50 100 150 200 250 300 350 400

106 Graphs

Graph 20: Details noticed from tobacco cessation infomercials

Details Noticed from tobacco Cessation Infomercials

Warning- Smoking causes cancer 607

Nothing 463

Advice to stop tobacco use 330

Patients images 252

Misconception only smoking is harmful 220 Number of Participants Treatment centres 49

Help lines 31

0 100 200 300 400 500 600 700

Graph 21: Reactions to tobacco cessation infomercials

Reaction to Tobacco cessation infomercials

Felt uncomfortable 28 Quit habit 33 Scared of tobacco induced cancer 63 Want to quit tobacco 79 Number of Participants Noticed and Reduced the habit 88 Noticed but did not alter the habit 108 Noticed 220 Ignored 305 No reaction 651

0 100 200 300 400 500 600 700

107 Graphs

Graph 22: Willingness to quit tobacco

Graph 23: Aids opted for tobacco cessation

Aids preferred to quit tobacco use habit

Guidance for habit stoppage 467

NRT 209

Counselling for habit stoppage 166 Number of Medication as remedy 174 Participants

Information 52

Nothing 199

0 100 200 300 400 500

108 Graphs

Graph 24: Access to tobacco products despite ban

Subjects able to acess tobacco despite the ban

1010 Subjects

Graph 25: Inputs for improving the tobacco cessation campaign

Inputs for improving no tobacco campaign

Tips for cessation 264 Awareness about smokeless 234 None 200 NRT availability 178 More one on one facility 57 Ban sale near school/college/hostel 43 Satisfied 39 More Camps 34 NRT in curriculum 20 Cheap NRT 16

0 50 100 150 200 250 300

109 Graphs

Graph 26: Age of onset of tobacco consumption

600 568 Number of Participants 500

400 Male 300 201 Female 200 117 54 100 24 41 0 5 0 0 to10 10 to 20 20 to 30 30 to 40

Age of Onset of Tobacco use

Graph 27: Duration of tobacco use

600 508

500

400

300 225 181 200

100 70 No. of subjects of No. 24 2 0 0-10 10-20 20-30 30-40 40-50 50-60

Duration (in years)

110 Graphs

Graph 28: Frequency of tobacco use (per day)

400 355 346

350

280 300 ≤ 5 250 06 to 10

200 > 10

150

100 Number of Patients Patients of Number 50 16 11 2 0 Male Female

Graph 29: Gender wise distribution of tobacco products used

394 400 350 Tobacco Products 300 Male 250 Female 200 174 162 150 99 83 100 72 50 4050 43 50 37 12 11 6 0 4 100 8 1 5 0 0 0 0 0

Number of Subjects of Number 0

111 Graphs

Graph 30: Usage of same tobacco products from the time of habit initiation

Using same or different tobacco products 47 11

Same Product

Different Product

Changes 952

Graph 31: Habit Alteration Changes in amount of tobacco consumption

350 314 300 269 257 250

200 170

150

100 Number of Subjects of Number

50

0 Decreased Increased Remained the Intermittent same Changes

112 Graphs

Graph 32: Source of obtaining tobacco product

800 740 731 700

Source of tobacco

600 products 500 365 400 340 300

No. of Participants of No. 200

100

0 Buy the Friends Family Work product Colleagues

Graph 33: Time of tobacco consumption after waking up

600 600

500 Time of Tobacco Consumption 400 330 300 200 57 100 23

Number of Participants Participants ofNumber 0 Later than 60 Within 60 Within 30 Not mins minutes minutes Specified

113 Graphs

Graph 34: Company during tobacco use

Company during tobacco use

897 877 900 800 677 700 569 600 Alone 500 Family 400 Friends 300 Colleagues 200 100 0 Alone Family Friends Colleagues

Graph 35: Tobacco consumption in presence of non-tobacco users in the family

114 Graphs

Graph 36: Tobacco consumption in presence of children and younger family members

Graph 37: Activity during tobacco consumption

Activity during Tobacco consumption

1000 854

811 800 618 551 600

400

200 Number of Subjects of Number 0 At home While Working During breaks commuting

115 Graphs

Graph 38: Place of tobacco consumption

Place of tobacco consumption

781 800

700 584 565 557 600 485 500 346 400

300

200 49 100

0 Home / Work Restaurant Pan kiosk Friends Place of Others Hostel place hang out

Graph 39: Social circles knowledge of participant’s habit

Social Circle 983

1000 812 900 691 721 800 595 700 555 600 500 400 300 200 100 0

116 Graphs

Graph 40: Prior tobacco cessation attempts

Graph 41: Duration of prior cessation attempt

Duration - without tobacco consumption

1-6 Days 1-4 Weeks 1-12 months More than 1 Year Don't remember 6%

12%

9%

71% 2%

117 Graphs

Graph 42: Reason for Relapse

Graph 43: Distribution of participant’s according to type of tobacco product used

444 450 400 350 300 Tobacco Products 250 178 200 171 168 150 68 100 49 50 10 15 5 3 1 0

118 Graphs

Graph 44: SES and choice of tobacco product

5 Socio economic status Snuff 63 64 Tobacco… 98 16 III II I 5 Jarda 8 2

Gutkha 3 54 Kharra 353 36 15 Pan quid 134 15 Pipe 3 2 Tobacco Cigar 5 5 Products 12 Cigarettes 121 95 12 Bidi 33

0 100 200 300 400

Number of Users

Graph 45: Distribution of smoking / smokeless tobacco product use

61 (6.04%)

Type of product

225 (22.28%) Smoking Smokeless Both 724 (71.68%)

119 Graphs

Graph 46: Association between SES and choice of smoking or SLT product use

600 530 SES 500 I Number of 400 II Participants III 300 Type of product

200 126 102 108 100 68 55 18 0 6 0 Smoking Smokeless Both

Graph 47: Age and SLT or smoking tobacco product use

250

206 Type of product 200 192

181 166 Smoking 150 Smokeless

Both 100 85

No. of Participants of No. 50 50 25 21 17 12 10 12 6 8 7 7 2 3 0 11-20 21-30 31-40 41-50 51-60 61-70 71-80 Age (in years)

120 Graphs

Graph 48: Association of gender & use of SLT/ smoking tobacco consumption

Type of product 500 439 Smoking 400 Smokeless Both 285 300

200 158

No. of Participants of No. 67 100 49 12 0 Male Female Gender

Graph 49: Education level and type of tobacco product used

300 267 Smoking 238 Smokeless 250 Both 200

150 102 100 100 64 38 36 41 50 34 30 10 12 14 0 2 4 8 0 3 3 7 0

Education

121 Graphs

Graph 50: Occupation & tobacco product used

250 Smoking Smokeless Both 207 179 200 170

150 102 100 68 74 58 50 27 25 31 27 17 14 0 0 0 0 3 0 5 3 0

Graph 51: Tobacco use and accommodation

450 417 400 Accommodation Type of product 350 Smoking 300 Smokeless 250 Both 200 153

150 No. of Participants of No. 100 60 72 42 52 45 50 50 24 29 20 21 6 0 0 8 2 0 2 0 10 0 Alone With With With With Joint Hostel friends spouse spouse & Parents Family children

122 Graphs

Graph 52: Alterations in tobacco consumption

250 Increased 210

200 Deacreased

150 Same 126 104 Increased &Deacreased 92 96 100 Intermittently 70

44 43 50 36 45 36 9 21 17 12 10 1314 3 0 2 0 2 0 0 0 0 5 0 10 to 20 21-30 31-40 41-50 51-60 61-70 71-80

Graph 53: Sources of obtaining tobacco and prior tobacco cessation attempts

Previous Cessation attempts (n=303)

300 276 253 250 Sources of accquiring tobacco 200

150

100 86 No. of participants of No. 50 32

0 Buy the Friends Family Colleagues product

123 Graphs

Table 54: Tobacco availability and restarting the habit

Restart habit 450 425

400 366 Yes 348 350 291 301 300 No 250 213 200 Never 150 127 discontinued

No. of participants of No. 100 47 50 26 15 17 0 0 Buy the Friends Family Colleagues product Sources

Table 55: Awareness of tobacco hazards and willingness to quit the habit

672 700 Willing ness to quit tobacco 600

500

400

300 169 200 101 68 100

0 Yes No Awareness of harmful effects of tobacco

124 Graphs

Graph 56: Prior cessation attempts & willingness to quit the habit

500 457 450 Willingness to quit habit (n=841) 400

352 350 300 250 200 150

100 No. of participants of No. 50 32 0 Yes No Never Discontinued Prior Cessation attempt

Graph 57: Willingness to quit tobacco and knowledge of habit among peer group

Desire to quit (n=841)

900 814

800 700 645 600 560 531 500 440 419 400 300

No. of Participants of No. 200 100 0

125 Graphs

Graph 58: Reasons for continued habit & willingness to quit

Willingness to quit (n=841) 300 281

250 231 Reasons 200 183 146 150

100 No. of Participants of No. 50

0 Stress Unawareness Addicted Multiple Reasons

Graph 59: Age wise preference of cessation aids

250 NRT Other Meds Info

200 Info Guidance

Counselling Nothing 150

100

50

0 11 to 20 21-30 31-40 41-50 51-60 61-70 70-80

126 Graphs

Table 60: Continued habit & cessation aids opted for

180 NRT

160 Other Meds Reason for Continued habit Info 140 Info

120 Guidance

100 Counselling

80 Nothing

60

40

20

0 Stress Unawareness Addicted Mixed Response

Table 61: Gender and aids opted for tobacco cessation

NRT Other Meds 300 Info Guidance 250 Counselling Nothing

200

150

100

50

0 Male Female

127 Graphs

Table 62: Response to infomercials and willingness to quit the habit

446 450 Willingness to Quit

400

350 Reaction

300 Positive Negative

250 None Mixed Response 155 200 159 146

150 81 100 23 50 0 0 0 Yes No

Graph 63: SES status and response to tobacco cessation infomercials

128 Graphs

Graph 64: Age & reaction to tobacco cessation infomercials

250 232 Positive 200 Negative None 142 138 150 Mixed

100 49 37 46 37 50 29 22 20 1311 18 13 10 9 1 1 0 0 4 0 11yr- 21-30 31-40 41-50 51-60 61-70 71-80 20 Reaction

Graph 66: Gender wise inputs for improving tobacco cessation measures

180 160 140 Male Female 120 100 80 60 40 20 0

129 Graphs

Graph 68: SES and inputs for improving tobacco cessation measures

200 SES I SES II SES III 150

100

50

0

Graph 69: Oral Lesions present

Lesions

435 450 400 350 300 263 250 200 125 150 81 76 100 30 50 0 Leukoplakia OSMF ( Tobacco Tobacco Habit No Lesions Stage I to IV) induced pouch induced oral melanosis keratosis leukoplakia

130 Discussion

4.4 Discussion

Tobacco use is common all over the world and remarkably higher in third world nations. India has one of the largest numbers of tobacco users in the world with tobacco use pattern that varies from international model; this can be attributed to a high prevalence of tobacco habit, considerable variations in the socioeconomic gradients and use of different types of tobacco products used 96. There is increasing interest in broadly inclusive public health interventions along with self-help materials and support from professionals 2. In this section of the present study; 1010 tobacco users were interviewed to assess their knowledge, attitudes and practice with respect to tobacco use habit to study their responses towards current tobacco cessation measures.

Association between SES, Demographic details and Knowledge, Attitude and Practice of tobacco use among the participants

SES parameters were assessed according to levels defined by Kuppuswamy‘s Socio- Economic Status Scale 2014 (Annexure 1)

131 Discussion

The overall prevalence of tobacco use in present study was found to be 65.84 %. The prevalence of use among men was 63.4 % and 61.2 % among women which is similar to many previous studies 4, 86 but greater among women than some other similar studies.

Tobacco is used for smoking as well as in smokeless forms in India. Patil PU et al (2015)3 report that among the tobacco users, bidi smokers constitute 40%, cigarette smokers 20% and those using SLT 40%. The prevalence of tobacco use in 1993-1994 was 23.2% in males (any age) and 4% in females (any age) in urban areas, 33.6% in males and 8.8% in females in rural areas.

Age: In the present study the mean age of tobacco users was 32.84 years with standard deviation of + 12.22 years. Tobacco users were aged between 16-75 years. 116 (11.49%) participants were between 0-20 years, 596 (59.01%) were between 21- 40 years, 274 (27.13%) were between 41-60 years and 24 (2.38%) were between 61- 80 age group. This is in agreement to the previous studies which also found tobacco use wide spread across all age groups especially among 2nd to 5th decade of life 3, 4. Tobacco use among adults aged > 15 years ranged from 23% to 47% according to TCP survey (2013) 4.

Age of Onset: In the present study 568 (87.93%) males and 201 (55.22%) females started using tobacco between 10-20 years mostly in the adolescent age group which was similar to findings by Kumar R et al (2010) 18 , Bhimarasetty DM et al (2013) 26 , Mac Fadyen L et al (2001) 38 and Kelly MM et al (2014)80. This shows there is a gap in the implementation of legislation regarding restriction of access to tobacco products for minors. As seen in present study and by Rani M et al (2003)77 and Agarwal M et al (2015) 86 that tobacco consumption increased up to middle ages (50 years) and then levelled or declined.

Type of tobacco product used: In the present study; out of 1010 participants, 724 (71.68%) consumed smokeless tobacco products (SLTs), 228 (22.28%) had smoking habit and 61 (6.04%) used both smoking as well as SLT products. Similar observations were made by TCP survey 4 (2013), Kumar A et al (2013) 25, Desai V

132 Discussion et al (2012)27 and Agarwal M et al (2015) 86, SLT is the most common form used (84 % in Maharashtra 4). In present study smokers and those consuming both smoking and SLT were less willing to quit compared to those who used only SLT, as indicated by OR of 0.551 [95% CI: 0.376 – 0.815] and 0.201 [ 95% CI: 0.116 – 0.353] respectively. Concurring with the findings of present study Subramanian SV et al (2004)78 and Singh A et al (2015) 96 also stated that choice of consumption of SLT or smoking tobacco products is associated with SES markers. Aroral M et al (2012) 55 stated that India is the 2nd largest producer and 3rd largest consumer of tobacco. According to GATS India Report (2009-10), the users of only SLT are more than double than that of smokers. SLT is an imminent public health problem, contributing to high disease burden in India. It‘s availability in myriad varieties, easy access and affordability especially for adolescents has made it in to a gateway to facilitate initiation; however ban on SLT is pending. It was seen in present study and by Agarwal M et al (2015) 86 as well that smoking is more common among urban males.

Gender and tobacco product used: 444 (43.96%) participants were kharra chewers (394 males, 174 females), 228 (22.57%) cigarette smokers (162 males, 6 females) and 171 (99 males, 72 females) were tobacco pouch (quid) users and 164 (4 males, 174 females) pan quid consumers. Other product consumption was observed in less than 10% (pipe, cigar, hookah, khaini, jarda) of the participants. One female reported having access to hookah in an urban lounge bar. The association between gender and tobacco product type was statistically significant with p-value of 0.0007 (p < 0.05); with statistically higher use among males which was similar to findings by Kumar R et al (2010) 18, Nagpal R et al (2014) 84 and TCP survey (2013) 4. Findings of present study also re-affirmed that smoking was more common among males than females. However TCP survey (2013) 4 reported that khaini was the smokeless product used most often in Maharashtra as; opposed to kharra (43.96%) observed in our study, while plain chewing tobacco was used more in MP. Use of smokeless tobacco only was highest in Maharashtra - 84%, cigarettes smokers were 67% and bidi smokers were 72 % in MP.

Less than 1/4 of adult tobacco users used mixed (both smoked and smokeless) tobacco products according to TCP survey (2013)4. Analysis of gender in present

133 Discussion study revealed that higher odds i.e. 3.427 [95% CI: 2.438 – 4.846] is significantly associated with males as compared to females for willingness to quit the habits (p < 0.0001).

Education, Income, Occupation, SES and type of tobacco product used: In the present study 693 (68.61%) participants belonged to SES II, 170 (16.83%) to SES I and 147 (14.55%) to SES III; (Kuppuswamy‘s SES Scale –Revision for 2014).Smoking cigarettes was; 45.33% in SES I, 48% in SES II and 6.66% in SES III. SLT consumption was predominant in SES II (73.2%), followed by (17.4%) in SES III and 9.39% in SES I.

Overall; the association between SES status and habits was statistically significant with p-value < 0.0001. According to TCP survey (2013) prevalence of tobacco use was higher among low-income adults than among high-income adults 4 which was also found in the present study. The National Family Health Survey (India) had revealed that individuals with no education were 2.69 times more likely to smoke and chew tobacco than those with postgraduate education. In the present study smoking was common among those having graduate or post-graduate qualification 102 (45.33%), followed by 64 (28.44%) with high school certification and 38 (16.88%) with professional or honours degree. Among SLT users, 267 (36.88%) participants were both graduate/post-graduates and 238 (32.87%) were higher school certificate holders, 100 (13.81%) were illiterate. Out of 61 participants with both the type of habits, 30 (49.18%) participants were higher school certificate holders, followed by 12 (19.67%) with primary school certification and 10 (16.39%) with middle school certification. 271 (26.83%) participants were unemployed, 234 (23.17%) participants were involved in clerical, shop or farming activity, 224 (22.18%) participants were in the unskilled labourers; 170 (16.83%) were professionals, 66 (6.53%) semi-skilled workers and 28 (2.77%) skilled workers.

This is similar to findings by TCP survey (2013) 4, Kumar R et al (2010) 18, Kumar A et al (2013)25 and Kelly MM et al (2014)80 that prevalence of tobacco use was higher among less-educated adults than high educated adults 4. Raval S et al (2010) 19 also reported direct correlation between the literacy and awareness levels ; inverse

134 Discussion relationship between education and tobacco use and a direct relationship between poverty and tobacco use. Subramanian SV et al (2004) 78 also reported that individuals with no education are 2.69 times more likely to smoke and chew tobacco than those with postgraduate education. Households belonging to the lowest standard of living index were 2.54 times more likely to consume tobacco than those in the highest.

Middle and higher class subjects were also more willing to quit tobacco as compared to lower class of subjects as indicated by ORs of 4.761 [95% CI: 3.170 – 7.141], 3.095 [95%

CI: 1.851 – 5.268] respectively. Similar to findings in this study; American Cancer society’s India report (2009)11 stated that cigarette smoking is more common in the urban India and cigar use is seen in the big cities. Cigarette smoking a rising trend among teenage girls and young women as well . 6 females with habit of cigarette smoking , 1 with access to hookah in urban lounge bars and 5 males each with habit of pipe and cigar smoking, all belonging to SES I were noted in present study. Rani M et al (2003)77, Kelly MM et al (2014)80 and Majmudar VP et al (2015) 8 also highlighted that tobacco consumption was significantly higher in poor, less educated, scheduled sections of the society and choice of product varied greatly with individuals socio-cultural characteristics. Nagpal R et al (2014)84 reported that tobacco use is greater among rural participants than urban, this was marginally correct in present study difference between rural [573 (56.73%)] and urban [437 (43.26 %)] participants was unremarkable.

The findings of present study concurred with Agarwal M et al (2015) 86 that gender was the strongest predictor for smoking followed by area of residence, education and age. Whereas education, gender and age were the most significant predictors for chewing tobacco. In the current study ; out of 228 participants with smoking habit, 166 (73.77%) were in the age range of 21-30 years, followed by 28 (12.28%) in the 11-20 years age group. 724 participants consumed SLT- 85 were between 11- 20 years, 206 between 21-30 years, 373 between 31- 50 years. Also, out of 61 participants with habit of consuming both smoking and smokeless products, 21 were between 21-30 years and 10 between 31-40 years and 17 between 41- 50 years.

135 Discussion

Singh A et al (2015)96 stated that wealth, education, occupation, residence and gender are the main variables determining choice of tobacco use and choice of tobacco product being used. Positive association is observed between wealth and prevalence of cigarette smoking while inverse associations were observed for bidi smoking, SLT and dual use. An inverse association with education was observed. Significant interactions were observed for gender and area in the association between cigarette, bidi, and SLT use with wealth and education. The probability of cigarette smoking was higher for wealthier individuals while the probability of bidi smoking, SLT and dual use was higher for those with lesser wealth and education. Tobacco use specially smoking was found to be more common in males from affluent backgrounds as compared to those from lower SES and females.

Knowledge a, attitude and practices of tobacco users:

910 (90.10%) participants of the present study were unaware of the harmful effects of tobacco when they started its use, 54 (5.35%) were aware but still began using tobacco due to preer pressure or as experimentation and 46 (4.55%) had misconceptions such as tobacco can be given up easily , while 16 felt that SLTs have less concentration and are not harmful. Gradually 788 (78.02%) participants had become aware about ill effects of tobacco consumption and 696 were aware about different types of tobacco products and preparations. 297 participants were aware that SLT preparations were also harmful, while 232 (22.97%) were not and 481 (47.62%) had misconception. Amongst these, 224 participants felt that only smoking is harmful, while 172 felt that less amount tobacco of intake causes no harm; 44 participants thought that SLT preparations have very small concentration of tobacco to cause any harm, while 12 felt that tobacco can harm only older individuals. Misconceptions about SLT among general population were also reported by McKay AJ et al (2015) 59. Previous literature does not comment on misconceptions in detail , public awareness about various aspects of tobacco preparations use and associated possible hazards.

686 (67.65%) participants were aware of tobacco hazards; 671 (66.44%) were aware of harmful effects in the oral cavity including cancer and periodontal diseases;

136 Discussion however there was no awareness about oral pre-cancer . 334 (33.06%) participants were aware that tobacco usage can harm the lungs, 34 (3.37%) were aware about the harmful effects on foetus and 26 (2.57%) were aware of the effects on male fertility. 336 (33.37% ) were aware of harmful effects of tobacco use on other organs and systems as well such as cardiac system , blood etc. 334 (33.06%) were not aware of any harmful effects. In the present study those aware of ill effects of tobacco consumption were more willing to quit as compared to those unaware, as indicated by OR of 2.193 [95% CI: 1.521 – 3.139]. Females and those aged > 20 appeared more aware of tobacco hazards in the present study; gaps existed in knowledge and awareness of the at risk population - pointing need for targeted health education and risk factor cessation counselling. 119

Widespread but vague understanding of tobacco-related harm and less knowledge about specific consequences of tobacco use is observed among general population. In TCP survey 4 (2013) ; 3/4 of smokers were aware that cigarettes / bidi‘s can lead to lung, throat and mouth cancers ; < 1/2 were aware that smoking can cause tuberculosis and lung cancer in non-smokers. Awareness was especially low in MP and negligible about other hazards. Similar findings were noticed by Bhimarasetty DM et al (2013) 26, McKay AJ et al (2015) 59, Nagpal R et al (2014) 84 and others 28

Reason for starting consumption of tobacco products: A trend was observed among participants to ascend from products like fennel to tobacco products gradually. In the Indian hospitality culture it is a customary to have a ―pan daan” or a container with items such as fennel, betel nut, flavoured/ sweetened betel nut, cloves, cardamoms and even inclusion of betel leaf quid with lime and tobacco and tobacco itself. This paan-dan is customarily used in households‘ often after meals and offered to guests and visitors as well. Children are often exposed to these items from age as young as four years and the items preferred ascend towards more concentrated forms; usually starting from fennel and progressing towards preparations containing smokeless tobacco. This customary trend is greatly responsible among others for initiation of tobacco form a young age and underestimating the possibility of tobacco hazards

137 Discussion

In the present study, 731 (72.38%) participants had started tobacco use due to influence of friends and 326 (32.28%) due to peer pressure. 475 (47.03%) used tobacco as a home remedy for various issues, 374 (37.03%) participants - imitated their family members. Experimentation and adventure were the starting causes for 186 (18.42%) and 159 (15.74%) participants respectively, while 140 (13.86%) imitated the celebrities. Kumar R et al (2010) 18, Raval S et al 19 reported that peer pressure and family influence are major reasons for start of tobacco use during adolescence. Very limited literature with regard to the influence of family structure and tobacco use exist; further studies are recommended in this direction. Nagpal R et al (2014) 84 pointed out that smoking cigarettes, specially by women is considered as a taboo in the Indian society ; however depiction of the habit in positive light by protagonists in entertainment programming affects this view inversely. Jiloha R C (2012) 58, Sardana M et al (2015) 62, Yoo W 63 (2016), Rao S 64 (2016) , Sargent JD et al (2001) 65 , Distefan JM et al (2004) 66 , Song AV et al (2007) 67 , Harakeh Z et al ( 2010) 68 , Dalton MA et al (2003) 69, McCool JP (2001)70 and several other studies and policy statements by international health care agencies such as NCI 71 ,

WHO 72, 73,74,75 stated that portrayal of smoking as a glamorous activity by the celebrities, in movies , programs , advertisements and product placements by tobacco industry are an important factor for the initiation of tobacco use at an early age specially by adolescents who take up tobacco under influence or as experiment or adventure.

MacKay AJ et al (2015)59 also evidenced beliefs in medicinal uses of tobacco as seen in the present study.

The reasons for continuing tobacco use were - 422 (41.78%) to relieve professional stress, 378 (37.43%) feel good factor, 299 (29.6%) habituation and 283 (28.02%) personal stress. 126 (12.48%) were unaware of any consequences and inability to quit tobacco was expressed by 184 (18.22%) participants which is similar to findings by Bhimarasetty DM et al (2013) 26, Kelly MM et al (2014)80 and Nagpal R et al (2014) 84. Kelly MM et al (2015) 79 highlighted association between ―post traumatic stress disorder (PTSD)‖ and increased possibility of smoking.

138 Discussion

After tobacco consumption; 448 (44.36%) participants felt good, 387 (38.32%) experienced enhanced concentration, 314 (31.09%) experienced performance enhancement while 287 (28.42%) said that they felt energetic. Alert and relaxed feeling was expressed by 221 (21.88%) and 160 (15.84%) participants respectively.

In absence of tobacco 363 (35.94%) felt distracted, 333 (32.97%) sensed decrease in concentration and performance, 352 (34.85%) felt nothing specific, while 233 (23.07%) felt tired. Anxiety was experienced by 203 (20.1%) participants.

Tobacco use habit: In the present study 491 (48.61%) participants stayed with their spouse and children, 233 (23.07%) with parents, 103 (10.20%) in hostels, 76 (7.52%) with spouse only and 52 (5.15%) shared accommodation with friends. 52 (5.15%) stayed in joint family. 573 (56.73%) participants belonged to rural areas; whereas 437 (43.26 %) belonged to urban areas. Which concurs with the findings of Kelly MM et al (2014) 80.

In the present study, 781 (77.33%) participants consumed tobacco at place of stay (home or hostel) 584 (57.82%), 565 (55.94%), 557 (55.15%) with habits of consuming at pan kiosk, work place and places of hang outs respectively. Friends place and restaurants were preferred choices for 485 (48.02%) and 346 (34.26%) participants. 854 (84.55%) had habit of consuming tobacco during breaks, while 811 (80.3%) had habit of taking it at home, 618 (61.19%) while commuting and 551 (54.55%) during working.

573 (56.73%) participants belonged to rural areas; whereas 437 (43.26 %) belonged to urban areas. 688 (68.12%) participants consumed tobacco products in presence of non-tobacco users in the family. 667 (66.04%) participants stated that they consumed tobacco in presence of children and younger members of family. According to TCP survey 4 (2013) voluntary bans on tobacco use inside the home was less likely. There was lack of awareness about harms of second-hand smoke to children among smokers who allowed smoking in the home only about 1/3rd of smokers were concerned that their own smoking in the home would harm their children‘s health. 374 (37.03%) participants had using tobacco as they imitated their family members.

139 Discussion

721 (71.39%) participants stated that their parents are aware about their habits, 595 (58.91%), 812 (80.4%) and 555 (54.95%) participants who stated that their habit is known to spouse, siblings and children. Awareness amongst friends was stated by 983 (97.33%) participants, while amongst colleagues was stated by 691 (68.42%) participants. 740 (73.2%) participants bought the tobacco products, 731(72.38 %) shared tobacco products with friends while 365 (36.14%) shared with family members and 340 (33.66%) stated that borrowing from colleagues is the main source of tobacco products. According to Nagpal R et al (2014) 84 and TCP survey 4 tobacco users perception that Indian society disapproves of the use of tobacco and regret for ever having started tobacco use; is an important indicator of societal norms about tobacco use and a predictor of future quitting behaviour. However findings by Kumar A et al (2013) 25 that more than 85 % of the participants want to restrict tobacco usage in front of children is in contrast to practice observed by participants of present study.

Russell MAH (1986) 8 and Luty J (2002) 12 state that less than 4% of smokers smoke less frequently than daily. The majority smoke at least 10 cigarettes per day and most light a cigarette within 30 minutes of waking. The majority smoke at least 10 cigarettes per day and most light a cigarette within 30 minutes of waking. In the present study 96 % smokers smoked daily and reported more frequency of tobacco use during weekends. SLT users - 89 % used tobacco daily. 369 participants restarted tobacco use after brief cessation attempt of these 291 (78.86%) got it from friends, 127 (34.42%) from colleagues and 47 (12.74%) from families. Out of those who never discontinued, 425 (69.79%) got it from friends, 301 (49.43%) from family and 213 (34.98%) from colleagues. Many participants had multiple sources of acquiring the tobacco product.

Tobacco cessation measures and tobacco user’s reactions: Television advertisements, packaging regulations and health warning labels (HWLs) are designed to communicate anti-smoking messages to large number of smokers. However, only a few studies have examined how high smoking prevalence groups respond to these warnings. This study explored how socioeconomically disadvantaged smokers engage with health risk and cessation benefit messages. 883 (87.43%) participants were aware about tobacco cessation advertising campaigns, while 127

140 Discussion

(12.57%) were not. The main source of information about harmful effects of tobacco was television; 756 (74.85%) participants, followed by 639 (63.27%) participants who received information from public places, 281 (27.68%) from public transport, 252 (24.95%) from announcements in the movie hall, 237 (23.47%) through camps and 219 (21.68%) through work places. Less than 20% received information through print media, hoardings, packaging and internet.

In this study 651 (64.46%) participants had no reaction to, 305 (30.2%) ignored them while 220 (21.78%) noticed the infomercials. 607(60.10%) noticed the warning - smoking causes cancer, 463 (45.84%) failed to recollect any infomercials or any details from these, 330 (32.67%) noticed and recollected the advice to stop tobacco use.252 (24.95%) noticed patients images, 220 (21.78%) developed misconceptions such as only smoking is harmful or other, 49 (4.85%) noticed treatment centres and 31(3.07%) noticed help line numbers shown in the infomercials. The effect of different anti-tobacco messaging was evaluated on willingness to quit. Well-executed anti – tobacco campaigns can positively and consistently change youth‘s beliefs and attitude 15 while emotional attacks on tobacco users may not be a useful strategy16. Bogliacino F et al (2015) 81 suggested that eliciting shame, anger, or distress proves more effective in reducing smoking than fear and disgust.

This was also seen in our study that the adds mentioning harmful effect of tobacco has significant effect on subject‘s willingness to quit. The odds ratio corresponding to watching such adds is 9.544 [95% CI: 6.354 – 14.427] as compared to those not watching the adds. The impact of medium of information was also evaluated by comparing effect with outcome. Amongst different media, public place adds shows the maximum effect (OR: 3.697; 95% CI: 2.811 – 5.646), followed by TV (OR: 2.453; 95% CI: 1.727 – 3.471), public transport (OR: 1.701; 95% CI: 1.423 – 2.598), Movie halls (OR: 1.317; 95% CI: 0.888 – 1.998) and camps (OR: 1.306; 95% CI: 0.874 – 2.000). Participants with positive reactions were 100% willing to quit the habit SES II predominantly gave positive reactions, indicating that participants belonging to SES II had statistically significant positive response to tobacco cessation (p - value < 0.0001). Also the age group of 21-50 years predominantly gave a positive reaction towards tobacco cessation.

141 Discussion

Effectiveness of mass media campaigns has been hailed by and use of media has been called upon by Durkin S et al (2011) 56, Allen JA et al (2015)76, Hayland A et al (2006) 83, Surani SM et al (2015)89 but Munoz MA (2013) 57 states that such campaigns are not effective for general population abut only for selected masses. The television advertisement about a patient named “Mukesh Harne” was most recollected by the participants of present study (by 584 participants). However the participants also remarked that TV ads and public service announcements were very few numbers and repetitive which made them ignore such ads which is similar to conclusion by McKay AJ et al (2015) 59 and Bala MM (2013) 35 that intensity and duration of mass media campaigns can influence its effectiveness and that no consistent relationship was observed between campaign effectiveness and age, education, ethnicity or gender. Ironically despite having one of the largest entertainment industries in the world the quantity and quality of anti- tobacco mass media campaigns in India fail to meet the mark.

This also highlights the lack of follow up and evaluation of public health programs; Glassgow et al (1999) 34 failures to evaluation programs often leads to wastage of resources and limits improvement of public health. Rooban T et al (2010) 95, Amit S et al (2011) 99 also stated that monitoring of effective planning and execution of these programs by appropriate authorities at regular intervals is vital for successful achievement of the goal of ―Tobacco Free Society‖ ; periodical surveys will also help in further planning of effective interventions.

As suggested by John R M et al (2010) 14, Choi K et al (2013) 48, Ross H et al (2011)51 raising the tax would increase the retail price and avert 15.5 million premature deaths and raise new tax revenues 14 and promote cessation 48 however the price of tobacco products and restrictions at work were cited by less than half of tobacco users as important reasons to think about quitting in TCP survey 4. Price was not mentioned as a factor for cessation consideration by participants of present study, tobacco products were available starting from very low price ranges. Because fewer than half of the tobacco users notice the tobacco tax increase, Choi KTC et al (2011) 49 suggested use of media campaigns to raise awareness of tax changes may increase its effectiveness.

142 Discussion

It was noticed in the present study and by Chang FC et al (2011) 61 and Guillaumier A et al (2015) 60 that package warnings have raised awareness; however they too did not prompt cessation. Less than 20 % of the participants of the present study noticed package warning, similar to findings by Kumar A et al (2013) 25, Hamond D et al (2009) 36, Hamond D (2011) 54 and TCP Survey 4 that less than 50 % of tobacco users looked at the package warnings closely Misunderstandings such as only smoking are harmful or can cause cancer and SLT is not harmful was noticed in less than 20 % of the population which to findings by Kumar A et al (2013) 25, Bhimarasetty DM et al (2013) 26. It is evidenced from the results of present study and reported by Panda R (2014) 88 that smoke free laws and health warnings on cigarette packages appeared to be a weaker motivator for quitting .

However Borland R et al (2016) 37 and other studies 42, 44,45,46,47 stated that warning size increases its effectiveness and graphic warnings may be superior to text-based warning ; stronger warnings tend to sustain their effects for longer and that health warnings increased reactions that are prospectively predictive of cessation. In India a constant debate between tobacco companies and government policy makers is on going about graphic warnings on tobacco packaging‘s where public opinion largely remains unaccounted for whereas a great deal of support for this measure is seen internationally

Wade B et al (2010) 41 report of support among Russian population. Hitchman SC et al (2011) 43 and Guillaumier A et al (2015) 60suggested that health warnings could be more effective among smokers from lower SES groups. Bogliacino F et al (2015) 81 reported that imagery based information is more salient and elicits faster cognitive processing and stronger attitudes through more intense emotional reactions and that these are more effective than textual warnings alone , combined warnings are suggested for greater impact.

In this study 740 (73.2%) participants bought the tobacco products, 731(72.38 %) shared tobacco products with friends and 340 (33.66%) stated that borrowing from colleagues is the main source of tobacco products. 854 (84.55%) had habit of consuming tobacco during breaks, 618 (61.19%) while commuting and 551 (54.55%)

143 Discussion during working. According to TCP survey 4(2013), only 18% smokers in MP and 35 % in Maharashtra were aware of smoke free laws. Lack of compliance with indoor smoking bans in offices and hospitality venues was noted; however unanimous support for a ban on smoking inside public transport was present. Myeres DG et al (2009) 29 reported that smoking bans in public places and workplaces are significantly associated with a reduction in acute myocardial infarction incidence particularly if enforced over several years; similar to findings by Samet JM et al (2014) 30, 31, 32, Radke PW et al (2006) 40, Stallings-Smith S et al (2013) 53, Ohmi H et al (2013) 39 stated that the ban on smoking served a motivator for smokers to reduce smoking, but not to quit smoking.

Very limited projects in India have followed up, studied and analysed the impact of tobacco cessation measures implemented. . The present study found that the current anti tobacco measures have been successful in creating awareness and increasing willingness to quit however these are not having desired impact in terms of bringing about tobacco cessation proper. According to Wilson LM et al (2012) 33, Hu T et al (1995) 50 , Hoffman SJ et al (2015)52 the most successful measures were increasing tobacco prices, smoking bans in public places and anti-tobacco mass media campaigns. Raute LJ (2013) 92, Garg A et al (2012) 93 reported that increased awareness about harmful effects of tobacco increased the willingness to quit tobacco.

Prior tobacco cessation attempts: 303 (30.0%) participants attempted tobacco cessation previously. Awareness 196 (19.41%), staining of teeth 53 (5.277 %) and being advised by a health care professional in a camp, 28 (2.77%) were the main reasons for attempting tobacco cessation, whereas unawareness 259 (25.64 %) misconceptions 142 (14.06 %), dependency 182 (18.02 %) were the chief reasons not to attempt cessation. 123 (12.16 %) participants had no specific reason for tobacco habit continuation.

59 (5.84%) stopped using tobacco for 1-6 days and restarted it, 127 (12. 57 %) participants ceased their habit for less than a month, while 87 (8.61%) ceased it for less than a year, 25 (2.48%) had duration of > 1 year. 714 (70.69 %) participants had no recollection of their cessation attempt or its duration. 369 (36.53%) participants

144 Discussion stated that they restarted the habit, 157 stated that the reason for restart was stress, while 119 stated reason as craving.

These findings were similar to findings by Kumar R et al (2010) 18 that previous quit attempts were present in about half of the tobacco users and that awareness of the harmful effects of tobacco is one of the main reasons. Kelly MM et al (2014)80 highlighted that educated class is visited de- addiction unit more often when compared to uneducated ones depicting their level of awareness, affordability, and accessibility.

Those who attempted to quit the habit, majority i.e. 276 (91.09%) buy the product on their own, the attempts decreased as the number of sources increased 253 (83.5%) participants borrowed tobacco from friends and 86 (28.38%) from colleagues. Amongst those who previously did not cease their tobacco habit; 67.56% borrowed the products from their friends, 47.17% participants got the products from family and 35.98% from colleagues as well. Co-relation between cessation attempts and sources of procuring tobacco remains unexplored in the literature. This may be very crucial while practical advice to the tobacco user about refraining from acquiring tobacco.

Willingness to quit tobacco: In this study 841 (83.27%) showed willingness to quit, while 168 (16.63%) did not have inclination to cease tobacco use; however only 240 complied. Participants were not aware and so unresponsive to the concepts of quit date and methods such as cold turkey. Panda R (2014) 88 and Sarkar BK (2013)91 SES, higher education, higher income, exposure to awareness programs and individual-level socio- demographic factors are important in depicting intention to quit .

Similar to TCP survey 4, Kumar A et al (2013) 25, Panda R et al (2014)88 and Grills NJ et al (2015) 97 a low degree of readiness to quit was noted in present study. The willingness to cease the tobacco habit was significantly higher in participants knowing about the ill effects of tobacco (p-value < 0.0032). Yang JJ et al (2015) 87 reported that ORs for successfully quitting increased with age, married status, educational achievement, having a non-manual job, drinking cessation and disease

145 Discussion morbidity. Those exposed to second-hand smoking showed less SM et al (2015)89 reported that exposure to anti tobacco messages increased the willingness to quit while tobacco use among peer group decreased the chances of quitting; which is similar to our study. Hatsukami DK et al (1997) 128 report that majority of smokeless tobacco users want advice and help from their dentists and indicate that discussion of the negative oral effects from the use of smokeless tobacco has an impact on their desire to quit.

1010 participants of the present study were asked what help they require to stop tobacco use. 467 (46.24%) participants said that guidance about cessation process will help them quit, while 209 (20.69%) wanted NRTs. Medications for other minor ailments; for which tobacco was used a home remedy were expected by 174 (17.23%) participants; while 166 (16.44%) participants opted for tobacco cessation counselling. 199 (19.70 %) participants said that they do not require any aid to stop their habit. Previous researchers have not attempted to inform the tobacco users about various cessation methods and then studied responses as informed choices about cessation methods.

508 (50.3%) participants used tobacco for < 0-10 years, followed by 225 (22.28%) participants for 20-30 years and 181 (17.92%) participants in the duration range of 10- 20 years. Duration of tobacco use as a parameter suggesting possibility of tobacco cessation remains to be studied by other researchers. Participants of this study pointed towards the trend that longer the duration lesser the willingness for cessation.

Frequency of tobacco consumption (daily frequency) is another such parameter which remains to be analysed in literature. Out of 646 males, 355 (54.95%) consumed 6-10 times per day, 280 (43.34%) individuals consumed tobacco less than 5 times per day, while 11 (1.7%) had frequency above 10 times per day. Amongst females, 346 (95.05%) consumed less than 5 times per day and 16 (4.4%) consumed tobacco between 6-10 per day. Participants with higher frequency visualised tobacco cessation as a greater challenge. This can be attributed to dependency on more amount of daily nicotine.

146 Discussion

In the present study Out of 1010 participants, 314 (31.09%) had decreased their tobacco consumption, while 257 (25.45%) had their tobacco consumption unaltered. 269 (26.63%) participants habits increased or decreased intermittently. 952 (94.26%) were consuming same product from the beginning of their habit, while 47 (4.65%) had experimented with different products. Amongst those who changed, 36 shifted to lesser number of products. Increased habit was mostly observed in the age group of 21-30 years (66.88%), followed by 10-20 years (29.29%). Decreased habit was in the age range of 31-40 (25.88%) and 41-50 (25.29%) years, followed by 21-30 years (21.18%) and 51-60 years (21.17%). Continuation of same habit, was seen in 126 (49.03%) participants in the age range of 21-30 years, followed by 70 (27.24%) in the age range of 41-50 years and 45 (17.51%) in the range of 31-40 years. The pattern observed here is indication of self regulation of habit among the higher age groups. There were 104 (38.66%) participants in the age range of 31-40 years with intermittently increased and decreased habit of consumption, followed by 96 (35.69%) in the range of 41-50 years.

Duration of tobacco habit is not detailed in previous literature but longer the duration of habit lesser willingness for cessation was observed.

23 (2.28%) participants consumed tobacco within 30 min waking up while 330 (32.67%) consumed tobacco within one hour of waking up. 600 (59.41%) participants consumed tobacco beyond 60 minutes after waking up. 57 participants had no specified time of tobacco consumption, these participants used tobacco products only during night shifts, as a home remedy etc. Time of tobacco consumption can again indicate dependency of an individual on tobacco. Similarly Awojobi O et al (2012) 110 reported that about 10% of smokers have their first cigarette > 5 minutes after waking up but the majority (53%) consumed tobacco about an hour or more after waking. On average smokers smoked more during the weekends than on weekdays.

Out of those willing to quit the habit, 814 (96.79%) participant‘s friends knew about the habit, 645 (76.81%) participant‘s siblings were aware of their habit, 560 (66.58%) participant‘s parents and 531 (63.14%) participant‘s colleagues knew about their habits. Similarly, among those not willing to quit, 168 (99.4%) participant ‘s friends

147 Discussion were knowing about their habits, followed by 167 (98.81%) participant ‘s siblings, 160 (94.67%) participant ‘s parents, 159 (94.08%) colleagues, and 154 (91.12%) participants ‘s spouse were knowing about their habits. It is considered that social taboo about smoking may encourage the users from quitting their habit. This however remains largely unexplored in current literature

Inputs for improving tobacco cessation measures: According to TCP survey 4 and Merzel et al (2003) 6, as well other studies 17 the current tobacco control policies are not providing strong motivation about quitting. Lack of complete information and awareness of the product and policies, public opposition, cultural acceptance of tobacco use, lack of political support and less priority for tobacco control are often reported as barriers for policies 82. Agarwal M et al (2015) 86 suggested that interventional measures for tobacco control should be planned to incorporate socio demographic predictors.

264 (26.1%) participants suggested tips for cessation should be included in infomercials, 234 - more awareness about SLT hazards. Requirement of more information was also reported by participants of TCP survey 4 and Bhimarasetty DM et al (2013) 26 . SLT is traditionally considered as a safe form of tobacco consumption which seen in the present study and is also confirmed by Nagpal R et al (2014) 84. The highlight of current anti tobacco messages remains ―Smoking causes cancer/ smoking kills” - this has unfortunately reinforced the public belief that only smoking is harmful and SLT is safe; further highlighted information about types, hazards and cessation of SLT is must for successful tobacco cessation measures. Yang JJ et al (2015)87 suggest that public interventions should promote and reinforce smoke-free environment, discouraging the initiation of, reducing, and quitting tobacco.

Despite bans all 1010 participants of this study were able to access tobacco products. Ban on sales near schools and college was suggested by 43 (4.26%) which is similar to findings by

Parakh et al (2013) 5, Shaik SS (2016) 10, Bhimarasetty DM et al (2013) 26 and MacKay AJ et al (2015)59. 21 (12.35%) participants were satisfied with current

148 Discussion tobacco cessation methods, while 127 (18.33%) gave no inputs. Statistically significant difference in the inputs suggested was noted among individuals from different SES groups (p < 0.0001).

In the present study also majority participants were unable to decipher signages and symbols indicating possible cancerous developments. Larger pictorial warnings on the packages were yet to start during the duration of the interviews however participants retained depiction of imageries from other sources. This concurs with TCP survey’s (2013) 4 findings that majority of tobacco users still wanted more health information on warning labels. There is evidently no awareness about oral pre cancer among general population and most of the mass media campaigns highlighted advanced stages of cancerous developments which members of general population did not visualise as plausible consequence of their habit. It is recommended that self examination techniques and mass media use for awareness should also highlight visuals of initial developments as a result of tobacco habit. Increased awareness of precancerous developments and its potential consequences will further encourage tobacco users to timely notice any changes and encourage tobacco cessation before development of life threatening ailments such as cancers, cardiac or pulmonary disorders etc.

In this study 57 (5.64%) participants also suggested - for more availability of one-on- one facility for tobacco cessation and 34 (3.36%) suggested for more camps. < 10 % the participants were aware of tobacco cessation counselling highlighting a serious lack of such avenues. As seen in the present study and by Kelly MM et al (2014)80 individuals with higher SES and higher education opted for more counselling facilities. Majmudar VP et al (2015) 85 also highlighted increased knowledge and willingness to quit as a result of camps as interventions among women from urban lower socio economic strata.

Dhumal GG et al (2014) 94 stated that doctor‘s advice along with education and anti- tobacco messages were positively associated with higher intention to quit tobacco. Hatsukami DK et al (1997) 128 report that majority of SLT users want advice and

149 Discussion help from their dentists and a significant number indicate that discussion of the negative oral effects from the use of SLT has an impact on their desire to quit.

In the present study only 190 (18.81%) were aware of NRT‘s and 89 (8.81%) suggested that NRTs should be available easily and only 16 (1.58%) suggested that NRTs should be economical. A very limited awareness about NRTs was seen among general public. In the present study 20 (1.98%) participants who were students of health science fraternity; these very less numbers are highly encouraging of the concept that health professionals should be role models for healthy habits .112These participants suggested for inclusion of NRT in curriculum which is similar to statement by Parakh et al (2013) 5, Awojobi O et al (2015) 114 and Binnal A et al (2012) 118 , that TCC in should be included in undergraduate curriculum and that there should be continuing education programs for clinicians to better and sharpen their skills in TCC. Saud M et al (2014) 7 stated that medical education system in India is failing to impart the necessary skills to doctors, which is needed to help patients quit smoking and suggested reforms in educational curriculum, similar to MacKay AJ et al (2015)59 that healthcare professionals reported low confidence in cessation assistance, due to low levels of training but reported more favourable outcomes in NRT users. Bhat et al (2014) 98, reported that majority of the dentists (98.7%) agreed that it was their responsibility to provide smoking cessation counselling but 54.3% of dentists agreed that such discussions were too time consuming.37.1% thought they lacked knowledge regarding this subject. 35.8% feared to an extent about patient leaving their clinic if counselled much. In general, the dentists had a favourable attitude in tobacco cessation counselling for the patients; however, the lack of time and knowledge and to an extent, a fear that the patients would leave their clinic, was the main identified barriers. Singla A et al (2014) 112, report that only 12.5% of the dentist had ever used the NRT in their practice.

The lack of the knowledge and information regarding TCC was the perceived barrier. Ajagannanavar SL et al (2015) 121 reported that a large portion of dental students in India were unaware about NRTs. Balappanavar AY et al (2015)122, studied 5th year dental students responses and found that; only 1 % were aware of the 5As, the 5Rs protocol and the motivational interviewing technique of TUC. Knowledge, attitudes,

150 Discussion and practices of these students were below normative level and they took a superficial approach to TUC.

The perceived barriers were very high and included curriculum inadequacy. The results of this study help show there is an urgent need to revise the tobacco curriculum in dental schools in India to make students more confident to practice this aspect of dentistry independently.

Russel MAH (1991) 8 stated that it is essential for policy makers to understand that people are more likely to give it up if a reasonably pleasant and less harmful alternative source of nicotine is available. Stolerman et al (1991) 9 stated that NRT enhances smoking cessation, roughly doubling success rates. Positive reviews for NRT use were also submitted by several other studies 12.Bogliacino F et al (2015) 81 suggest positive reinforcements such as light incentives to help tobacco cessation.

NRT were opted as an cessation aid by 209 (20.7%) participants. Out of these, 153 were aged 21-30 years and 25 between 11-20 years; i.e. mostly younger age group. 174 (17.23%) participants who requested for medications for other minor ailments for which they were using tobacco as a remedy so far; among these, 62 were of 21-30 years, while 21 in the range of 41-50 years ; i.e. the middle aged tobacco users.

There were 467 participants who asked for guidance for stopping the habit. ; 211 were aged between 21-30 years, 96 aged between 31-40 years and 88 in 41-50 yrs. This was seen throughout all age groups however more among the younger ages.

166 participants opted for counselling for stopping the habit. Of these 61 were in the age range of 21-30 years, 51 in the range of 41-50 years, 28 (16.87%) in the range of 31-40 years, and 22 in the age range of 11-20 years. This was seen throughout all age groups.

There were 199 (19.7%) participants who did not mentioned about any aid. Association of socio economic variables with informed choices about tobacco cessation methods remains unexplored in existing literature.

151 Discussion

As seen in the present study and TCP survey (2013) 4 tobacco users have negligible awareness about government‘s anti - tobacco policies , restrictions and legislations , mass media sources should also highlight these restrictions to help in the permeation of psyche of general population the concept that tobacco is a lawfully restricted entity due to the possible adverse effects on health . Sharma I et al (2010) 82 also recommended efforts to increase the awareness of COTPA among younger population, less educated and those belonging to the low SES. Yang JJ et al (2015) 87 suggested that underlying socio demographic and other initiating factors should be prioritized in establishing tobacco use prevention and cessation policy.

Association between reasons for continued habit & aids opted for tobacco cessation: Stress, unawareness, addiction (inability to discontinue) were the common reason for continued tobacco habit. In participants with stress as the main reason, 120 (40.13%) suggested the requirement of guidance for habit stoppage, 93 (31.1%) counselling for quitting the habit, 57 (19.06%) opted for NRT and 37 (12.37%) said that required nothing.

In the unawareness category, 168 (55.44%) required guidance for habit stoppage and 46 (15.18%) asked for medications for other ailments for which they were using tobacco as a remedy so far. In the addicted category, 102 (61.45%) asked for guidance for habit stoppage, 92 (55.42%) for NRT and 35 (21.08%) for counselling. Those with more than one of reasons, 77 (31.81%) asked for guidance, 45 (18.59%) for NRT and 27 (11.16%) for counselling. The association between reason for continuing habit and aid for quitting habit was statistically highly significant (p< 0.0001). This remains unexplored in current literature and may be very crucial while practical advice to the tobacco user about refraining from acquiring tobacco.

In hind sight from the present study tobacco users can be broadly described into 3 groups depending upon the reason for tobacco use:

1. Those in the adolescent age group, school and college students who have started using tobacco use to peer pressure, influence of friends, family and mass media.

152 Discussion

2. Adults who started use tobacco to relieve personal, professional stress and societal stress. 3. Adults who are mis-informed / unaware and use tobacco as a remedial alternative to minor ailments.

This classification is broadly categorizes tobacco users based on their reasons for tobacco use; this reasoning may prove useful in suggesting appropriate cessation method to tobacco users.

Lesions observed among the participants: Among tobacco users participating in the study; 885 (87.62 %) had lesions. 435 (43.07%) had leukoplakia , 263 (26.03%) had OSMF ( Stage I to IV) , 81 (8.02%) had tobacco induced melanosis , 76 (7.52 %) had tobacco pouch keratosis , 30 (2.97 %) participants had developed habit induced oral lichen planus. This distribution was similar to findings by Desai V et al (2012)27 that wealth, education, occupation and gender are the main variables determining choice of tobacco use and choice of tobacco product used. Positive association is observed between wealth and prevalence of cigarette smoking while inverse associations were observed for bidi smoking, SLT and dual use after adjustment for potential confounders. Inverse associations with education were observed. Significant interactions were observed for gender and area in the association between cigarette, bidi, and SLT use with wealth and education. The probability of cigarette smoking was higher for wealthier individuals while the probability of bidi smoking, smokeless tobacco use, and dual use was higher for those with lesser wealth and education. Tobacco use specially smoking was found to be more common in males from affluent backgrounds as compared to those from lower SES and females.

153 Conclusion

4.5 Conclusion

Tobacco use is a major cause of preventable death and disease in India. Unfortunately, very few people in India quit tobacco use. Lack of awareness of harm, ingrained cultural attitudes and lack of support for cessation maintains tobacco use in the community. Anti-tobacco measures at present are directed towards anti-tobacco mass media campaigns and legislations; intending towards creating awareness and curtailing its use. Though it is evidenced from literature that awareness campaigns have limited reach and modest impact on the vulnerable population sub groups (such as adolescents, individual from lower socio economic or rural backgrounds).Also the laws and regulations curtailing tobacco use and availability are more often than not – poorly enforced. Thus leaving the population susceptible to tobacco use and impending after effects.

154 Conclusion

Tobacco use is not just a habit but it is a complex, multifaceted problem involving cultural, socioeconomic, demographic factors, age, customs, culture, working environment public health awareness factors and individual coping powers. In order to institute efficient tobacco cessation measures and methods a study of underlying factors prompting both habit and cessation is necessary. Similarly there is a great need to follow up and analyse the impact of on-going tobacco cessation measures on the population. This study is important as it examined patients‘ responses to current anti- tobacco measures factors, influencing use and ―intention to quit‖ and what the tobacco users require to quit their habit.

Total 1010 tobacco users from Central India were interviewed to assess their knowledge, attitudes and practice with respect to tobacco use habit in context of present anti- tobacco campaigns. The SES parameters were assessed according to levels defined by Kuppuswamy‘s Socio-Economic Status Scale 2014 (Annexure 1) Following conclusions can be drawn from this study;

Socio economic and demographic profile of tobacco users :

1. Tobacco users were present across all age groups ranging from; 16-75 years. Maximum number of tobacco users participating in this study were in 3rd and 4th decade of life (59.01%), followed by those in their forties (27.13%) and 11.49 % of the participants belonged to the adolescent age group .Mean age of tobacco users was 32.84 years with standard deviation of + 12.22 years . It can be concluded that tobacco use mostly starts during adolescence increases upto 50 years of age and then decreases.

2. 63.96% participants were male, while 36.04 % were females highlighting that more males that females are tobacco users.

3. In the present study 568 (87.93%) males and 201 (55.22%) females started using tobacco between 10-20 years mostly in the adolescent age group.

4. The prevalence of tobacco use in present study was found to be 65.84 % (with 95 % confidence interval).

5. Tobacco use was also seen among all classes of education according to Kuppuswamy‘s Socio-Economic Status Scale 2014 (Annexure 1). Among the

155 Conclusion

participants of this study , 2/3rd were having qualification up to or less than high school and even illiteracy was observed ,only 1/3rd of the tobacco users had received higher education.

6. Tobacco use was noted in greater numbers among the participants who were unemployed (23.17%) and least among skilled workers (2.77%). Tobacco use was all seen among all SES classes higher among lower income individuals.

7. Tobacco use was prevalent among both rural (56.73%) and urban (43.26 %) participants and dwellers of all types of accommodations; with family, with friends, alone or in hostels which highlight that despite being social taboo; tobacco use is neither objected upon nor voluntarily restricted.

Thus in agreement with existing literature our findings also confirm that tobacco use is more among males , among individuals having lesser educated and lower SES; never the less tobacco use is prevalent among all strata of Indian society.

Knowledge / Awareness:

1. Maximum numbers of participants (90.10%) were unaware of the harmful effects of tobacco when they started its use, 5.35% were aware but still began using tobacco and 4.55% had misconceptions such as tobacco can be given up easily, while 16 felt that SLTs have less concentration and are not harmful. Gradually 78.02% participants had become aware about ill effects of tobacco consumption, about different types of tobacco products and preparations. 29. 4% participants were aware that SLT preparations were also harmful, while 22.97% were not and 47.62% had misconception. Amongst these, 224 participants felt that only smoking is harmful, while 172 felt that less amount tobacco of intake causes no harm; 44 participants thought that SLT preparations have very small concentration of tobacco to cause any harm, while 12 felt that tobacco can harm only older individuals. Thus it can be concluded that awareness campaigns and regulations are only modestly effective around vulnerable population such as adolescent age, rural and lower SES factors.

2. It can be concluded that somewhat incomplete, self perceived and contrived awareness about harmful effects of tobacco was evident among 2/3rd of

156 Conclusion

tobacco users participating in this study (67.65%). 66.44% were aware of harmful effects in the oral cavity including cancer and periodontal diseases; however there was no awareness about oral pre-cancer. 33.06% were not aware of any harmful effects. Only About 1/3rd participants were aware of possible diseases of cardiac, pulmonary and reproductive system due to tobacco. In the present study those aware of ill effects of tobacco consumption were more willing to quit as compared to those unaware, as indicated by OR of 2.193 [95% CI: 1.521 – 3.139]. Females and those aged > 20 appeared more aware of tobacco hazards Widespread but vague understanding of tobacco-related harm and less knowledge about specific consequences of tobacco use is observed among general population. Gaps existed in knowledge and awareness of the at risk population - pointing to a need for targeted health education and risk factor cessation counselling .

3. There seem to be wide spread exposure to tobacco cessation advertising campaigns as, majority (87.43%) of participants were aware about it. The main source of information for tobacco users was television (74.85%) followed by participants who received information from public places (63.27%) , public transport, (27.68%) , movie hall (24.95%) , camps (23.47%) and work places (21.68%). Less than 20% received information through print media, hoardings, packaging and internet. Online sources are yet too gain popular acess in Central India.

4. Very limited awareness about pharmacotherapy specialy NRTs exists among tobacco users (18.81%) thus highlighting lack of knowledge about tobacco cessation methods and aids .

Attitude / Perception:

1. Influence from peer group, family and media sources are the primary reasons for initiation of tobacco use habit. (adolescent age group, school and college students who have started using tobacco use to peer pressure (32.28%), influence of friends (72.38%), under influence of family members (37.03%) and mass media(13.86%) as experimentation or for adventure and later became addicted to tobacco habit).

157 Conclusion

2. Stress relief (personal, professional or societal stress), performance enhancement energy (increased concentration, night shifts) and misconceptions about use tobacco as a remedial alternative to minor ailments (constipation , better digestion , pain relief) were the chief reasons for tobacco habit continuation. Thus highlighting that tobacco user‘s harbor under various misapprehensions about their habit.

3. In absence of tobacco, participants often reported feeling distracted 363 (35.94 %), 333 (32.97%) sensed decreased concentration and performance, 352 (34.85%) felt nothing specific, while 233 (23.07%) felt tired. Anxiety was experienced by 203 (20.1%) participants. This is one of the first studies conducted in this region where how a tobacco user feels with and without tobacco use have been explored. It can be concluded that tobacco users experience a range of positive emotions and developments on tobacco consumption and negative ones in absence of tobacco.

4. It can be concluded from the present study that most of tobacco users(60.10%) come across anti tobacco infomercials or encounter such measures eg. public place ban , package warnings, office bans etc. and such messages do contribute to raised awareness but most of tobacco users do not react and choose to ignore the messages (64.46 %) and hence such campaigns do not materialize in habit cessation.

5. Images and messages are recollected by the tobacco users however most of the images displayed belong to advanced stage of tobacco induced disease and are often perceived to be a rare occurrence and ignored. Similarly very limited number of infomercials are being broadcast in India that too repeatedly; as a result these do not create the desired impact.

6. Advice to stop tobacco use is noticed and recollected (32.67%) however repeated stress on smoking cessation and unequal importance to SLT products has lead to development of misconceptions such as only smoking is harmful.

7. Package warnings, work and public places ban are often ignored or noticed and followed voluntarily by a few due to poorly reinforced regulations. Treatment centers, help line numbers are poorly highlighted and thus often go unnoticed by tobacco users.

158 Conclusion

8. Exposure to adds mentioning harmful effect of tobacco has significant effect on subject‘s willingness to quit. [9.544 [95% CI: 6.354 – 14.427]

9. Public place adds shows the maximum effect (OR: 3.697; 95% CI: 2.811 – 5.646), followed by TV (OR: 2.453; 95% CI: 1.727 – 3.471), public transport (OR: 1.701; 95% CI: 1.423 – 2.598), movie halls (OR: 1.317; 95% CI: 0.888 – 1.998) and camps (OR: 1.306; 95% CI: 0.874 – 2.000).

10. Participants with positive reactions were 100% willing to quit the habit. SES II predominantly gave positive reactions, response to tobacco cessation (p - value < 0.0001). Also the age group of 21-50 years predominantly gave a positive reaction towards tobacco cessation.

11. Package warnings on tobacco product crab , scorpion symbol and smoke free/tobacco free laws are at the moment a weak motivator for encouraging tobacco cessation as < 20 % of the participants are aware of them and even lesser abided.

12. A great majority of tobacco users (83.27%), showed interest in tobacco use cessation wanted more information and had intentions to attempt cessation now or in near future. However only 240 went through with cessation intervention program showing a low degree of readiness to quit.

13. Previous quit attempts were present in about half of the tobacco users and that awareness of the harmful effects of tobacco is one of the main reasons (p- value < 0.0032). Awareness about harmful effects of tobacco use (19.41%), staining of teeth 53 (5.28 %) , being advised by a health care professional in a camp (2.77%) were the main reasons for attempting tobacco cessation, whereas unawareness (25.64 %) misconceptions (14.06 %), addiction (18.02 %) were the chief reasons not to attempt cessation. 14. Unawareness about methods of tobacco cessation such as setting a quit date or quitting cold turkey was noticed among the participants. Participants were unaware and so unresponsive to these concepts. 15. Individuals with higher education, higher income, exposure to awareness programs and high-level socio-demographic factors displayed greater intention to quit. Similarly tobacco users with a nearing land mark life situation such as marriage, job acquisition, personal or professional achievements or health issues went ahead with tobacco cessation.

159 Conclusion

16. This study is among the first where tobacco users were told about different type of tobacco cessation methods and helped to make informed decisions about cessation attempt. Guidance about cessation process and methods is most sought after by tobacco users for making the cessation attempt. (46.24%), NRTs and medications for other minor ailments; for which tobacco was used a home remedy and lastly tobacco cessation counselling were other aids tobacco users wanted to assist their tobacco cessation attempt with.

17. Majority of participants were more comfortable with guided tobacco cessation attempt however a respectable number (19.70 %) participants wanted to attempt tobacco cessation on their own, that they do not require any aid to stop their habit . Such choices of patients should also be encouraged and supported without imposing clinician‘s opinion.

18. All 1010 participants were able to access and acquire desired tobacco product; smoking/ smokeless highlighting that the laws banning certain tobacco preparations have been poorly implemented. It can be concluded that bans and other restricted polices were not implemented stringently.

19. Tobacco users felt that present anti tobacco measures lacked necessary information to help them with cessation attempt, cessation tips (26.14%), SLT awareness (23.17%) affordable and easily available NRTs (17.62%), bans of sale near educational institutes and more camps incorporated public opinion about what more do present anti tobacco measures need. The highlight of current anti tobacco messages remains ―Smoking causes cancer/ smoking kills” -this has unfortunately reinforced the public belief that only smoking is harmful and SLT is safe; further highlighted information about types, hazards and cessation of SLT is must for successful tobacco cessation measure. Statistically significant difference in the inputs suggested was noted among individuals from different SES groups (p< 0.0001), higher SES with more education opted for counselling while others for more awareness. < 10 % the participants were aware of tobacco cessation counselling highlighting a serious lack of such avenues.

20. As seen in the present study tobacco users have negligible awareness about government‘s anti - tobacco policies , restrictions and legislations, mass media sources should also highlight these restrictions to help in the permeation of

160 Conclusion

psyche of general population the concept that tobacco is a lawfully restricted entity due to the possible adverse effects on health

20. There is evidently no awareness about oral pre cancer among general population and most of the mass media campaigns highlighted advanced stages of cancerous developments which members of general population did not visualise as plausible consequence of their habit.

21. Only 1.98% of tobacco users in this study belonged to health care fraternity highlighting that a encouraging scenario where health care providers can be role models for healthy habits. These participants suggested for inclusion of NRT in curriculum. None of the participants was advised or had used any form of NRT.

Practice / Tobacco use habit:

1. Longer the duration of tobacco use and greater frequency of daily tobacco consumption; lesser the willingness for tobacco cessation attempt was noticed. Duration of tobacco use as a parameter suggesting possibility of tobacco cessation remains to be studied by other researchers.

2. More men than women consumed all varieties i.e. smoked tobacco, SLT or both. Kharra chewing was highest among males, (60. 99%) followed by smoking (25.08%) and consuming tobacco pouch (15.33%) while 4 (0.62%) consumed pan quid. Among females, paan quid habit was highest (47. 80%), followed by tobacco quid (19.78%) and kharra (13.73%). Consumption of other tobacco products is present in < 15 % Many individuals consume more than one tobacco product simultaneously.

3. As a result of partial awareness tobacco users often opt for self instituted harm reduction practices such as consuming lesser concentrated tobacco product or switching from smoking to SLTs and altering the amount of tobacco consumed is observed in majority of participants (62. 1 %).

4. Buying the tobacco product and borrowing or sharing with friends is the commonest way to procure tobacco followed by sharing with family or colleagues.

161 Conclusion

5. About 1/3rd of the participants (34. 95%) consumed tobacco early in the morning within an hour of waking up which is indicative of high nicotine dependency other consumed tobacco later. Consumption of tobacco products during night shifts was also reported frequently.

6. Use of tobacco at home (56.34%) even in presence of non tobacco users and impressionable children in the family and at work place (67.03%) was commonly observed highlighting towards lack of voluntary control and poor restrictions at work places. There was lack of awareness about harms of second-hand smoke to children among smokers who allowed smoking in the home only about 1/3rd of smokers were concerned that their own smoking in the home would harm their children‘s health or influence them for tobacco use. .Other common occasions of tobacco consumption where when with friends, commuting and alone.

7. Tobacco user‘s family, friend and professional circles are mostly aware of their tobacco use, this demonstrates an unfavorable acceptance of the habit in the society but also leaves possibility for more successful cessation attempt with peer and group support.

8. Tobacco users often attempting tobacco cessation on their own are very few (369) and end up relapsing to their habit (18.13%). Duration of such attempts may be varied but relapse commonly occurs with first few days to weeks of cessation attempt due to stress (115) or craving (119).

Socio economic and demographic profile of tobacco users and its association with knowledge attitude and practices of tobacco use to analyse the impact of current anti tobacco campaigns.

1. SLT use was more common than smoking. 71.68% consumed SLTs, while 228 (22.28%) had smoking habit and 61 (6.04%) used both smoking as well as smokeless tobacco products.

2. The product used most by the participants of this study is Kharra (43.86%), followed by smoking (22.57%) and tobacco quid (17.62%) and (16.24%) pan

162 Conclusion

quid users. Other product consumption was observed in less than 10% of the participants.

3. Cigarette smoking was significantly higher among participants from SES I (upper and upper middle class, p < 0.0001). Consumption of SLTs -paan, kharra, snuff and bidi were consumed in the statistically higher amount by participants from SES II (lower middle and upper lower class), p< 0.0089. Plain tobacco and tobacco pouch use was highest in SES III.

4. Middle and higher class subjects were also more willing to quit tobacco as compared to lower class of subjects as indicated by ORs of 4.761 [95% CI: 3.170 – 7e asso.141], 3.095 [95% CI: 1.851 – 5.268] respectively. Association between SES status and habits was statistically significant with p value <0.0001. Tobacco use was higher among low income adults tan high income adults.

5. Smoking was noted most commonly in the third decade, use of other products was spread across all age groups.

6. In all three usage groups of smokers, SLT and mixed tobacco users, the proportion of male users was higher than females. The association between gender and tobacco product type was statistically significant with p value 0.0007 with statistically higher usage among males.

7. Higher odds i.e. 3.427 [95 % CI: 2.438 -4.846] were associated with males as compared to attempt tobacco cessation (p< 0.0001).

8. Cigarette smoking was more common among professionals having graduate or post graduate qualification (45.33%) followed by those with high school certification (38%) or with professional or honours degree. 6 female participants belonging to SES I also had the habit of cigarette smoking along with one having recreational use of hookah at a lounge bar. Cigars and pipes were used by males from affluent backgrounds. Use of SLT and both smoking as well as smokeless products together was more common among those employed as clerks or in shops, unskilled and unemployed individuals.

163 Conclusion

9. Majority of those who had previously attempted cessation, 276 (91.09%) bought the product on their own followed by 253 (83.5%) participants who borrowed from friends and (28.38%) from colleagues. Amongst those who previously did not cease their tobacco habit, 67.56% borrowed the products from their friends. 47.17% participants got the products from family and 254 (35.98%) from colleagues. More the sources of tobacco availability lesser the chances of successful tobacco cessation attempts. Participants with multiple sources of acquiring the tobacco product never attempted to cease their habit.

10. Significantly higher willingness to cease tobacco was noticed among participants aware about ill effects of tobacco (p < 0.0032). It can be deduced that awareness brought a desire to avoid potential hazards resulting from tobacco use and thus an increased willingness to cease the habit.

11. Significantly higher willingness to cease tobacco was noticed among participants who had attempted tobacco cessation previously (p < 0.0032).It can be concluded that these participants must have been more familiar with the challenges, aware about the tobacco cessation process and more motivated to control their habit.

12. Social taboo about tobacco use may encourage the users from quitting their habit. Knowledge among peer group encouraged tobacco users to quit.

13. The desire to quit the habit is different across reasons for continuing the habit. The association between the two factors was statistically highly significant (p <0.0001)

14. In absence of any tobacco induced lesions , younger participants and SES I and SES II with higher education participants and male tobacco users overall are more willing for NRT aids as well as counselling. Middle aged tobacco users sought medications for minor ailments for which they had been using tobacco as a remedy instead. Participants > 40 years and SES III refrained from seeking any aid usually refrain from seeking any aid to assist their tobacco use.

164 Conclusion

15. Participants with stress as the main reason for habit initiation, continuation or relapse opted for counselling and those with unawareness opt for guidance along with other methods suggested. The association between reason for continuing habit and aid for quitting habit was statistically highly significant (p < 0.0001)

16. Male tobacco users were significantly more open to tobacco cessation than females ( p < 0.0001).

17. Participants with positive reaction to tobacco cessation infomercials were 100 % willing to quit the habit (p < 0.0001). Those with non specific reaction or mixed response were predominantly willing to cease their habit. Thus it can be concluded that effective communications via mass media increased willingness to cease tobacco habit.

18. Positive reaction towards tobacco cessation was predominantly observed in SES II (93.7 %). Association between SES and type of reaction was statistically highly significant ( p< 0.0001) indicating that participants belonging to socioeconomic middle class had significant positive reaction to tobacco cessation infomercials, majority of participants from SES I noticed but did not modify their habit while SES III ignored such information.

19. Out of 646 males, maximum 162 (25.08 %) suggested that infomercials should also highlight possible dangers of SLT and create awareness about SLT preparations, followed by 147 (22.76%) who suggested that tips for cessation should be highlighted, 89 (13.77 %) suggested for easy NRT availability. Among the females, 117 (33.82 %) suggested inclusion of tips for cessation, 72 (20.81 %) suggested awareness about SLT. 145 (44.8%) females had no inputs.

20. 234 participants were employed as clerks, in shops or were farmers. Of these 114 (61.54%) suggested that there should be awareness about SLT, 80 (34.18%) suggested that cessation tips should be included in infomercials. Among 224 (22.17%) unskilled workers 57 (25.45 %) felt that there should be

165 Conclusion

awareness about SLT and 22 ( 9.82%) asked for cessation tips. There were 271 (26.8%) unemployed participants, with following suggestions inclusion of tips for cessation (91) , ban of tobacco sale near schools and colleges (38) , suggested easy NRT availability (30) and SLT awareness (28). 170 professionals had following suggestions inclusion of tips for cessation (64) and NRT availability (51) . From, 66 semi skilled workers 32 suggested more one on one facility for tobacco cessation while 14 suggested more camps. Awareness for SLT was suggested by 8 skilled workers who also suggested inclusion of tips for cessation (7). 12 semi professionals suggested more one on one facility for tobacco cessation.

21. SES I participants 37.65% suggested for inclusion of tips for cessation and 30 % opted for NRTs, 12.35 % participants were satisfied with current tobacco cessation methods. SES II, 26.98 % suggested inclusion of tips for cessation, 26.55 % suggested highlighting SLT, rest had no inputs. 46 .26 % of SLT III had no inputs while 19.73 % wanted information about SLT and 8.84 % wanted cessation tips from the infomercials. Statistically significant difference was noted among SES and inputs given for improvement of existing anti- tobacco measures.

22. Among 1010 participants , 885 ( 87. 62 %) had oral lesions and 125 ( 12.38 %) did not. 435 ( 43.07 %) had leukoplakia , 263 OSMF (stage I to IV) , 81 had tobacco induced melanosis. 76 had tobacco pouch keratosis , 30 had developed habit induced oral lichen planus. There is a possibility that individuals with tobacco induced lesions were concerned and participated in the study.

23. Younger participants had more willingness for cessation than older based on their responses ( p < 0.0001).

24. Analysis of gender revealed that higher odds i.e. 3.427 [95% CI: 2.438 – 4.846] is significantly associated with males as compared to females for willingness to quit the habits (p < 0.0001).

166 Conclusion

25. SES suggested that middle and higher class participants are more willing to quit tobacco as compared to lower class of participants as indicated by ORs of 4.761 [95% CI: 3.170 – 7.141], 3.095 [95% CI: 1.851 – 5.268] respectively.

26. Smokers and those consuming both smoking and smokeless tobacco were less willing to quit compared to those who used only SLT, as indicated by OR of 0.551 [95% CI: 0.376 – 0.815] and 0.201 [ 95% CI: 0.116 – 0.353] respectively.

27. Those aware of ill effects of tobacco consumption were more willing to quit as compared to those who are unaware of the effects, as indicated by OR of 2.193 [95% CI: 1.521 – 3.139].

28. The effect of different anti-tobacco messaging was evaluated on willingness to quit. The adds mentioning harmful effect of tobacco has significant effect on subject‘s willingness to quit. The odds ratio corresponding to watching such adds is 9.544 [95% CI: 6.354 – 14.427] as compared to those not watching the adds.

29. The impact of medium of information was also evaluated by comparing effect with outcome. Amongst different media, public place adds shows the maximum effect (OR: 3.697; 95% CI: 2.811 – 5.646), followed by Television (OR: 2.453; 95% CI: 1.727 – 3.471), public transport (OR: 1.701; 95% CI: 1.423 – 2.598), Movie halls (OR: 1.317; 95% CI: 0.888 – 1.998) and camps (OR: 1.306; 95% CI: 0.874 – 2.000).

30. Association of socio economic variables with informed choices – individuals with higher SES and higher education opted for more counselling facilities depicting level of awareness, affordability and accessibility among the educated classes.

31. Cessation attempts decreased as number of sources of obtaining tobacco increased. This may be very crucial while offering practical advice to tobacco users about tobacco abstinence.

167 Conclusion

32. It can be concluded that results of the present study represent the social scenario with respect to demographic factors associated with tobacco use. Very limited projects in India have followed up, studied and analyzed the impact of tobacco cessation measures implemented. Wealth, education, occupation, residence and gender are main variables determining the choice of tobacco products used. Positive association is observed between wealth, prevalence of cigarette smoking while inverse association is observed for bidi and SLT and mixed tobacco use. Inverse association between education was observed. Tobacco use specially smoking was found to be more common among males from affluent backgrounds as compared to those from lower SES and females.

33. The present study found that the current anti tobacco measures have been successful in creating awareness and increasing willingness to quit however theses are not having desired effect in terms of tobacco use cessation proper .

168 Review of Literature

5. SECTION II: TOBACCO CESSATION COUNSELLING

169 Review of Literature

5.1 Review of Literature

A) Interventions promoting tobacco cessation:

It is evident from many studies that in spite of being aware of the risks of having multiple health problems, a major proportion of population still uses tobacco. 84 Cessation advice and interventions have shown to promote cessation attempts among tobacco users.

Fig 5.1 :

165

Nagpal R, Nagpal N, Mehendiratta M et al (2014)84, assessed the overall prevalence of betel quid, areca nut, tobacco and alcohol use in the rural population of Muradnagar tehsil of Ghaziabad district and their awareness level towards adverse effects of these habits on general as well as oral health. A total of 422 persons from 4 villages were enrolled for the participation in the study. 72.5% of respondents reported indulgence in one or more tobacco product. Smoking tobacco was the most common type of adverse habit in males while chewing tobacco in females. In spite of being aware of risk of having multiple health problems, a major proportion of respondents were using betel quid, areca nut, tobacco and alcohol. 26% of

170 Review of Literature respondents believed that the community residents would quit the habit only if they personally experience any health problem due to the habit.

Majumdar VP, Mishra AG, Kulkarni VS et al (2015) 85, assessed changes in pre and post-intervention tobacco-related knowledge, attitudes and practices among women from urban low socioeconomic strata, after 3 rounds of interventions. A structured questionnaire was used to interview women, regarding their tobacco consumption, attitudes and practices. Interventions for tobacco cessation were provided 3 times over a span of 9 months, comprising of health education and counselling. Post-intervention questionnaire was introduced at 12 months. There was statistically significant improvement in the knowledge of women, following the interventions with particular reference to poor oral hygiene and tobacco use being main cause of oral cancer (p = 0.007), knowledge of ill effects of second hand smoke (p = 0.0001), knowledge about possibility of early detection of oral cancer (p = 0.0001), perception of pictorial and written warnings on tobacco products (p = 0.0001), and availability of help for quitting tobacco (p = 0.024).

Yang JJ, Song M, Yoon HS (2015)87, identified the factors significantly associated with smoking initiation and/or smoking cessation as well as the most important determinants of successful smoking cessation in a developed non-western setting ; among males (N= 24,490) who had participated in the Health Examinees (HEXA) study. Factors for successfully quitting smoking increased with age, married status, educational achievement, having a non-manual job, drinking cessation and disease morbidity. Those exposed to second-hand smoking showed less likelihood of quitting smoking. A continual decrease for successfully quitting smoking was observed according to increased smoking duration, smoking dose per day and lifetime tobacco exposure (p <0.001). Among the selected predictors, lifetime tobacco exposure, educational attainment, alcohol drinking status and birth cohort were the major determinants in the success of smoking cessation. Public interventions promoting a smoke-free environment are needed to reinforce discouraging the initiation of, reducing, and quitting cigarette smoking.

171 Review of Literature

Panda R, Venkatesan S, Persai D et al (2014) 88 , 1569 tobacco-users visiting public health facilities in 12 districts of the states of Andhra Pradesh and Gujarat were assessed through an interviewer-administered questionnaire to assess the effect of socio-demographic characteristics, nicotine dependence, previous quit attempts and motivational factors on “intention to quit within 30 days” and “setting a quit date”. Only 12% of patients intended to quit tobacco within 30 days and about 11% of them were ready to set a quit date. Respondents aged above 25 years were 53% less likely to quit tobacco within 30 days when compared to those below 25 years. Smokeless tobacco users were associated with an odds ratio (OR) of 2.05 (95% CI: 1.15 to 3.65) for “setting a quit date” when compared to smokers. Those with 1 to 5 previous quit attempts (in the past 12 months) were associated with an OR of 2.2 (95% CI: 1.38 to 3.51) for “intention to quit” and 2.46 (95% CI: 1.52 to 3.96) for “setting a quit date”. “Concern for personal health” and “setting an example for children” were associated with ORs of 3.42 (95% CI: 1.35 to 8.65) and 2.5 (95% CI: 1.03 to 6.03) respectively for “setting a quit date”. Findings suggest that socio-economic and individual-level factors are important factors depicting intention to quit and setting a quit date. Well- defined studies to understand the long term effects of factors influencing tobacco cessation for patients visiting public health facilities in India was recommended .

Surani NS, Gupta PC, Fong TG et al (2012) 89, surveyed a total of 764 adult respondents from urban and rural areas of Maharashtra and Bihar through face to face individual interviews, with a house to house approach. Dependent variable was “intention to quit tobacco.” Independent variables were demographic variables, peer influence, damage perception, receiving advice to quit, and referral to cessation services by healthcare professionals and exposure to anti tobacco messages. Of 493 tobacco users, 32.5% intended to quit. More numbers of users who were unaware about their friends‟ tobacco use intended to quit compared to those who were aware. More users who felt tobacco has damaged their health intended to quit compared to those who did not feel that way. Users exposed to anti-tobacco messages in newspapers/magazines, restaurants, radio, cinema halls and public transportation intended to quit more compared to unexposed users. Providing conclusion that anti- tobacco messages have positive influence on user‟s intentions to quit.

172 Review of Literature

Srivastava S, Malhotra S, Harries AD et al (2013)90, assessed the socio- demographic characteristics and cessation services used by adults i) who attempted to quit smoked and smokeless tobacco and ii) who were successful in quitting. A cross- sectional secondary data analysis of 25,175 ever tobacco users aged 21 years and above were included in the study. Bivariate and multivariate logistic regression analysis was done to determine associations between socio-demographic variables and cessation services utilized with attempts to quit tobacco and successful quitting. Of the ever tobacco users, 10,513 made an attempt to quit tobacco, and 4,395 were successful. Significant associations were demonstrated between male gender, increasing educational attainment and higher asset quintiles for both those who attempted to quit and those who were successful. Younger age groups had higher odds of quit attempts than all except the oldest age group, but also had the lowest odds of successful quitting. Health care provider‟s advice was positively associated with attempts to quit.

Sarkar BK, Arora M, Gupta VK et al (2013)91, undertook a cross-sectional study for the outcome of quit attempts made by current tobacco users in last 12 months in 2 states to identify the socio-demographic determinants of quit attempts among smokers and smokeless tobacco users to identify correlates of tobacco cessation behaviour in India. The smoker had higher predicted probability of attempting quitting in comparison to a smokeless tobacco user and a tobacco user in the state of Gujarat was less likely to attempt quitting than a user in Andhra Pradesh. The probability of making a quit attempt was higher among tobacco users who were more educated, having a higher socio economic status and belonging to non-agricultural labourer occupational group.

Raute LJ, Sansone G, Pednekar MS et al (2011) 92, studied data from the ITC India Pilot Study conducted in 2006 to examine beliefs about the harms of smokeless tobacco use, knowledge of health effects, and intentions to quit among current smokeless tobacco users in two states, Maharashtra and Bihar. A face-to-face cross sectional survey of 248 adults reporting exclusive current use of smokeless tobacco were analyzed with respect to the knowledge of health effects, beliefs about harmfulness and intentions to quit smokeless tobacco use. Around 36% of smokeless

173 Review of Literature tobacco users from Maharashtra and 62% from Bihar had a „bad‟ opinion about smokeless tobacco use. About 77% believed that smokeless tobacco use causes mouth cancer, followed by gum disease (66%) and difficulty in opening the mouth (56%). Significant differences were found in health knowledge between urban and rural smokeless tobacco users in both states. Only 38% of smokeless tobacco users reported having intentions to quit, and only 11% had intentions to quit within the next 6 months. Smokeless tobacco users who reported higher knowledge of the specific health effects from smokeless tobacco use were more likely to have intentions to quit.

Garg A, Singh MM, Gupta V K et al (2012) 93 ,conducted a cross-sectional study in Gokulpuri, a Delhi, on 911, persons aged 30 years and above to assess the prevalence and correlates of current smoking, awareness of hazards, and quitting behaviour among smokers 30 years and above. Prevalence of current smoking was found to be 24.6%. 88.4% of current smokers smoked bidi exclusively and on an average 13.5 bidi/cigarette were smoked per day. Multivariate analysis showed the factors associated with current smoking as male sex, advancing age, illiteracy, skilled occupation, low socio-economic status and low BMI (P < 0.001). 64.2% were aware of the hazards of smoking. 21.9% had quit smoking in the past, due to the health problems. Low educational status was associated with poor hazard awareness and quitting behavior.

Dhumal GG, Pednekar MS, Gupta PC et al (2014) 94, report the factors encouraging quitting tobacco products in India. Cross-sectional data from Wave 1 of the International Tobacco Control Policy Evaluation (TCP) India were analysed. A total of 8,051 tobacco users (15+ years) were randomly sampled. 19.6% of tobacco users intended to quit. Smokers had less intention to quit as compared to smokeless tobacco users whereas mixed users had more intention to quit compared to smokeless tobacco users. Highly educated people were more likely to report intention to quit compared to less educated ones. Advice by doctors to quit tobacco had a strong impact on intention to quit. Tobacco users who were exposed to anti-tobacco messages at work places, at restaurants, bars, on public transportation and on tobacco packages also expressed greater intention to quit tobacco use.

174 Review of Literature

Rooban T, Elizabeth J, Umadevi KR et al (2010) 95; conducted a cross-sectional, nationally representative population-based household survey to estimate the prevalence, the socioeconomic and demographic correlates of chewable smokeless tobacco consumption among males in India 74,369 males aged 15–54 yrs. participated. Data on tobacco consumption were elicited from male members in households selected for the study. 34 % of the study population used chewable smokeless tobacco. Smokeless tobacco consumption was significantly higher in poor, less educated, scheduled castes and scheduled tribe populations. The prevalence of chewing also varied widely between different states and had a strong association with an individual‟s socio-cultural characteristics.

Singh A, Arora M, English DR (2015)96, explored socioeconomic differences associated with cigarette, bidi, smokeless tobacco (SLT) and dual use (smoking and smokeless tobacco use) in India and tested whether these differences vary by gender and residential area. The primary outcomes were self-reported cigarette, bidi smoking, SLT and dual use. The main explanatory variables were wealth, education and occupation. Positive association was observed between wealth and prevalence of cigarette smoking while inverse associations were observed for bidi smoking, SLT. Significant interactions were observed for gender and area in the association between cigarette, bidi, and smokeless tobacco use with wealth and education. The probability of cigarette smoking was higher for wealthier individuals while the probability of bidi smoking, smokeless tobacco use, and dual use was higher for those with lesser wealth and education.

Grills NJ, Singh R, Singh R (2015) 97, performed a cross-sectional epidemiological prevalence survey of 20 villages and 50 households from which 1853 people were interviewed. Tobacco prevalence and KAP were analyzed by income level, occupation, age and sex. The overall prevalence of tobacco usage was 38.9%. 93% of smokers and 86% of tobacco chewers were male. Prevalence of tobacco use was associated with lower education, older age and male sex. 97.6% of users and 98.1% of nonusers wanted less tobacco. Except for lung cancer (89% awareness), awareness of diseases caused by tobacco usage was low (cardiac: 67%; infertility: 32.5%; stroke: 40.5%).

175 Review of Literature b) Role of Dentists in tobacco cessation counselling:

Screening, cessation advice and interventions if provided in health care facilities especially oral and dental care facilities can greatly help the tobacco users to cease their habit and ultimately reduce the burden of morbidity and mortality of disorders resulting from tobacco use. The International Classification of Disease (ICD-10) has recognized “Tobacco Dependence” as a disease however the health care profession especially in underdeveloped countries has not taken a serious view of this and there is lack of serious attempt to treat the tobacco dependence disease. 18 Considering the social and the economic impact of tobacco consumption, the cessation interventions are among the most cost effective of all interventions.

Oral health professionals can counsel tobacco users and reinforce the anti-tobacco message. Dentists are in a unique position to; educate and motivate patients concerning the hazards of tobacco to their oral and systemic health and to promote tobacco free-lifestyles to provide intervention programs as a part of routine patient care.

National Cancer Institute's suggested protocol for the dental office that can be summarized in a 4-step program for assisting patients to quit . The core of the NCI program involves identifying tobacco users, advising them to quit, providing assistance to patients trying to quit and following-up on patients as a means of enhancing success rates. Dentists who implement an effective cessation program in their practices can expect to achieve quit rates up to 10 to 15 % each year among their patients and if established nationwide and continued over a period of years, this would markedly reduce the prevalence of tobacco use.125

Assisting the tobacco users to quit:

Commonly used tobacco cessation methods in dental office use a combination of professional counselling on behavioural change and pharmacological interventions. The frequently used behavioural model includes “5A Method” 123:

176 Review of Literature

Table 5.1: The 5 A model 123: The 5 A’s Ask Ask about tobacco use Advice Advice to quit Assess Assess the willing to discuss ; to make cessation attempt Assist Assist in cessation attempt using counselling and pharmacotherapy Arrange Arrange follow up and monitor preferably within first week after cessation date Intervention in patient‟s cessation attempt should comprise of the following steps: 1) Helping the patient with a cessation plan – Setting a quit date 2) Providing practical solutions (problem solving) – tips to control craving 3) Providing social support and encouragement to overcome craving 4) Recommending the use of approved pharmacotherapy 5) Providing supplementary materials. These recommendations for counselling patients can be summarized as „„STAR‟‟ 124:

1) Set a cessation date

2) Tell family, friends, co-workers about quitting and request understanding and support

3) Anticipate challenges to the cessation attempt (withdrawal symptoms), particularly during the critical first few weeks and discuss practical situations for the same

4) Remove tobacco products from environment, avoid smoking in places where a lot of time will be spent (e.g. work, home and car).

Intervention efforts will not be successful without sufficient motivation or „„readiness‟‟ to quit smoking on the part of the tobacco user. For the patient who is presently unwilling to quit, recommending may be premature and ineffective. The USA practice guidelines suggest following the „„5 Rs‟‟ motivational intervention 124:

Table 5.2: Recommendations to enhance motivation to quit tobacco: the ‘‘5 Rs’’ 124 Relevance Encourage the patient to identify why cessation is relevant. Motivational information has the greatest impact if it is relevant to a patient‟s disease, family or social status (having children), health concerns, age, sex and other important characteristics (prior cessation experience and personal barriers to cessation).

177 Review of Literature

Risks Identify the potential negative consequences of tobacco use, highlighting those which are most relevant to the patient (e.g. exacerbation of cough; long-term risk of cardiovascular problems and cancer; risks of children of breathing second-hand smoke; increased probability that children will become smokers themselves). The clinician should emphasize that smoking low-tar and/or low-nicotine cigarettes or use of other forms of tobacco (smokeless tobacco, cigars and pipes) will not eliminate these risks. Rewards Identify rewards associated with cessation ( improved sense of taste , smell; clothes, house and car will smell better; financial savings) Roadblocks Identify roadblocks or barriers to cessation and note treatment elements that could address them (withdrawal symptoms, such as irritability; appetite increase and risk of depression, which could be attenuated by pharmacotherapy; lack of social support for cessation could be remedied by joining a cessation clinic or support group) Repetition Repeat this information for the patient.

Many myths surround use of tobacco; these can either encourage people to begin or continue or deter them from quitting. Besides behavioural and pharmacological assistance dentists can play a major role in dispelling myths such as; (a) tobacco, consumed regularly but in self perceived, small quantities is not harmful; rather it may be helpful in improving digestion, increasing concentration and even in pain relief (b) only smoking is harmful and chewable forms do not posses any threat (c) tobacco products may be harmful only in the old age and not the young (d) quantity of tobacco in preparations less to cause any potential harm (e )tobacco with beetle nut/areca nut and beetle leaf (pan) are used in many Hindu religious customs, so a great part of the population does not envision any probable disadvantages from consumption of these products (f) tobacco use can be stopped when desired or once started tobacco use cannot be controlled (g) “light” cigarettes are less harmful (h) environmental tobacco smoke may be nuisance but is not harmful (i) cessation medications are infective (j) with all the restrictions tobacco industry no longer indulges in promotion or marketing to newer potential customers (i) everyone knows tobacco is harmful , tobacco problem has been solved and tobacco use is no longer a threat.130,131

Advice to quit tobacco by health care professional produces 1 year abstinence rates up to 5 -10 % , which will have significant public health impact if provided routinely.123

178 Review of Literature

International researches have shown positive uptake by the patients for tobacco cessation interventions provided at dental set ups for both smokeless and smoking tobacco. Behavioural interventions increase abstinence rates for smokeless tobacco users. 129 Following studies analyze the understanding of dentists, dental school students and patients response about counselling in dental set ups as a tobacco cessation intervention and explore various challenges in its materialization.

Patil PU, Vivek S, Chandrasekhar T et al (2014) 3, conducted a survey among 660 patients attending a dental teaching institute. Among the study subjects 88.9% were planning to quit the habit, 72.27% had agreed that they discussed about ill-effects of tobacco, 82% of the subjects said that dentist should routinely offer quit tobacco assistance and services. This study indicates the majority of patients are receptive towards tobacco counselling and services in the dental setting.

Bhat N, Jyotirmai – Reddy J ,Gohil M et al (2014)98, Conducted a study to know the attitudes, practices and barriers in tobacco cessation among dentists of Udaipur city (Rajasthan, India). A pretested, close-ended, self-administered, coded questionnaire was distributed among all the 262 dental health practitioners and the teaching staff. Out of 262 questionnaires distributed among the dentist, 151 dentists filled out and returned the questionnaire. 98.7% agreed that it was their responsibility to provide smoking cessation counselling. 54.3% of dentists agreed that such discussions were too time consuming. 37.1% thought they lacked knowledge regarding this subject. 35.8% feared to an extent about patient leaving their clinic if counselled much.

Amit S, Bhambal A, Saxena V et al (2011)99, distributed a self-administered structured, coded questionnaire to 200 private practitioners and the teaching staff in all the dental colleges in Bhopal city. 168 (84%) responded. 97% of the dentists agreed that it is the duty of every dentist to advice patients about tobacco cessation. 58% strongly agree that formal training will be an effective tool to provide the guidelines to dentists in tobacco cessation and counselling. 47% were optimistic about the capability of dentists in tobacco cessation though 70% felt that the dentists are not presently well prepared to assist the patients. 49% dentists raise the topic of the

179 Review of Literature importance of tobacco cessation. 60% display patient education materials in their practice/reception areas and 43% engage even their staff in the process of tobacco cessation and counselling. 52% refer their patients to a general practitioner and rarely or even never recommend over-the-counter nicotine replacement therapy. As regards the most common barriers for successful tobacco cessation; 39% dentists attribute to lack of time, 49% to lack of printed resources, 64% to lack of persuasion on tobacco cessation, 48% dentists fear that the patients may not come back to them. The perceived role of the dental fraternity in tobacco cessation and counselling was 60% at clinical level, 64% at community level and 44% at the state and national levels.

Parakh A, Megalamanegowdru J, Agrawal R et al (2013)100, studied the knowledge, attitude, behaviours and barriers of the practicing dentists regarding tobacco cessation counselling (TCC) in Chhattisgarh Based on the dentists‟ self- reports, 76% were not confident in TCC, 48% assumed TCC to be their responsibility, 17% considered that it might have a negative impact on their clinical practice, whereas 24% considered it might take away precious time from their practice, 25% considered TCC by dentists to be effective to a considerable extent and 80% considered TCC activities are not effective due to lack of formal training, 69% considered dental clinics as an appropriate place for TCC but 82% thought there must be separate TCC centre and 100% of the dentists wanted TCC training to be a part of practice and that it should be included in dental curriculum. 95% of had the view that tobacco products should be banned in India and 86% responded that health professionals must refrain from tobacco habits so to act as role models for society.

Carr AB, Ebbert JO (2006) 106, reviewed clinical trials that assessed tobacco cessation interventions, conducted by oral health professionals, with at least 6 months of follow-up. Behavioural interventions dealing with tobacco use, conducted by oral health professionals, which included oral examination, in the dental office and community setting, may increase tobacco abstinence rates in smokeless tobacco users.

Tomar SL (2001)101, summarized the prevalence of tobacco use in the US by evaluating literature on the status of tobacco control activities in dental schools, dental practice and reviewed new guidelines on clinical and community-based interventions

180 Review of Literature for tobacco use.25 % adults and 35 % high-school students smoked cigarettes and many use other forms of tobacco. More than 1/2 adult smokers and nearly 3/4 of adolescents see a dentist each year. However, more than 40 % of dentists do not routinely ask about tobacco use and 60 % do not routinely advise tobacco users to quit. Less than 1/2 of dental schools programs provide clinical tobacco intervention services. At least 50 dental organizations had adopted policy statements about tobacco use but not translated those policy statements into action. Tobacco use remains prevalent in the United States, and dentistry has not yet maximized its efforts to reduce it.

Smith SE, Warnakulasuriya KA, Feyerabend C et al (2006)102, conducted a prospective study to examine the success of a smoking cessation programme at 54 primary care dental practices in the UK, to assess the feasibility of using primary care dentists and the dental team providing smoking cessation advice in practice. Recruitment was over 6 months and follow up for 9 months. Nicotine patches were made available, on request, at cost price. Salivary cotinine assay was used for validation of smoking levels at initial counselling and 9 months after recruitment. Out of 54 practices enrolled, only 22 recruited patients. Records of 154 eligible patients were evaluated. Compliance to attend follow up clinics was poor--only 74 reported at 9 months. Among them 17 (11%) were successful in giving-up tobacco for 9 months as validated by patient histories and salivary cotinine assay. A large variation performance of the dental practices was noted. Motivated dentists with staff support and access to information on smoking counselling were able to contribute to tobacco control measures in the community.

Johnson NW, Lowe JC, Warnakulasuriya KA (2006)103, investigated attitudes and opinions of the members of the British Dental Association towards implementing tobacco cessation strategies in dental practices; questions about tobacco and tobacco cessation were asked to 1,500 BDA members. 870 completed questionnaires were received. There was good awareness amongst respondents of the health risks of tobacco. 1/5th of respondents said that patients had asked them for advice on tobacco cessation. 64% stated that they gave advice on tobacco cessation 'fairly regularly' or 'always' (whether asked or not) and 37% of respondents recommended over-the-

181 Review of Literature counter nicotine replacement therapy. 68% agreed that offering advice about tobacco cessation was the duty of every dentist. The common barriers to tobacco cessation campaign were the amount of time required, lack of reimbursement, lack of training, lack of patient education materials and lack of knowledge of available referral resources. 92% respondents said that their practice was a completely smoke-free environment and 66% of respondents had never used tobacco. Patient education materials was displayed in practice waiting areas less than 60% of the time and 23% never had them available. The survey revealed that most respondents did not feel particularly well prepared to assist patients in quitting tobacco, but 70% of respondents said they would be willing to cooperate with a campaign to inform all tobacco using patients about the advantages of tobacco cessation. Respondents felt that leaflets for patients, staff training and posters in the practice would contribute to the success of the campaign.

Martin LM ,Bouquot JE, Wingo PA et al (1996) 104, analyzed the data from the 1992 National Health Interview Survey (NHIS) Cancer Control Supplement, sample of 12,035 adults 18 years of age and older. Less than 10 % adults reported oral cancer screening by a dentist within past 3 years. About half of adult current smokers had seen a dentist within 12 months and of those only 24.1 % had been advised to quit smoking. Heavy smokers (two or more packs a day) were more likely to have been advised to quit than light (pack or less per day) or occasional smokers.

Ibrahim H and Norkhafizah S (2008) 105, conducted a cross sectional study to determine the attitudes and practices and barriers of smoking cessation counselling among dentists. 152 dentists were given self-administered questionnaires. 55.2% usable responses were obtained. Though majority of the dentists 98.8% agreed that they have a role in smoking cessation counselling; 17.9% were actually involved. The barriers cited were lack of training and time in their practice.

West R, McNeill A and Raw M (2004) 107.Smokeless tobacco is used in the UK predominantly by members of the Indian, Pakistani and Bangladeshi communities. Most commonly used form is tobacco mixed with lime and additional psychoactive compounds, notably areca nut. The resulting „quid‟ is chewed or held in the mouth.

182 Review of Literature

Evidence suggests that advice to stop coupled with behavioural support and counselling may increase long-term abstinence rates by some 5–10%. Dental professionals should also examine the oral cavity of smokeless tobacco users for lesions. Patients expressing an interest in stopping should be referred to specialist smoking cessation services for behavioural support and specialists in areas of high smokeless tobacco use will need to ensure that they are sufficiently knowledgeable and their services sufficiently accessible to these users. There is insufficient evidence to recommend the use of nicotine replacement therapy or bupropion to aid smokeless tobacco cessation.

Awojobi O, Newton JT and Scott SE (2016)108, Conducted a pre and post session study to evaluate the effect of a brief, focused training session on the use of an oral cancer communication guide on dentists' intentions, self-efficacy and beliefs with regards to communicating about oral cancer with patients. Dentists (n = 39) completed questionnaires pre-training, immediately post-training (n = 31) and after 2 weeks (n = 23). A significantly higher proportion of dentists reported that they informed patients that they were being screened for oral cancer post-training (44%) than pre-training (16%). Significantly fewer perceived barriers and higher self- efficacy to discuss oral cancer ; highlighting that an oral cancer communication guide is an effective tool to equip dentists in communicating about oral cancer.

Rikard-Bell G, Donnelly N and Ward J (2003)109, evaluated patients‟ views regarding dentists‟ smoking cessation advice; from 135 dental practices in Sydney Australia. 2451 patients were evaluated and 1160 pre-consultation responses were obtained (80%), 26% were self-reported smokers. 73% patients expected dentists to be interested in their smoking status and to discuss smoking with them. Smokers and non-smokers equally would not change dentist even if asked about their smoking status opportunistically (59%, 62%) Less than one third of all smokers would try to quit if their dentist suggested they do so. Smokers‟ recall of quit advice from their recent consultation was low (18%).

Awojobi O, Scott SE and Newton T et al (2012)110, conducted a cross-sectional questionnaire survey of 184 adults, with no history of oral cancer. 20 % of

183 Review of Literature respondents had never heard of oral cancer; 77% knew little or nothing about it and 72% did not know that their Dentist routinely screens for oral cancer. Overall, attitudes to screening were positive. 92% of respondents would like their Dentist to tell them if they were being screened for signs of oral cancer and 97% would like help from their Dentists to reduce their risk.

Stevens VJ, Severson H and Lichtenistein E (1995)111, examined 518 male users of moist snuff and chewing tobacco, they were randomly assigned to usual care or intervention which included a routine oral examination with special attention to the part of the mouth in which tobacco was kept and were explained about the health risks of using tobacco . After receiving advice to stop tobacco use each patient viewed a 9 minute video tape, received a self-help manual and was counselled by the dental hygienist. The intervention increased the proportion of tobacco users who quit the use by one half highlighting the efficacy of brief tobacco intervention for smokeless tobacco users.

Singla A, Patthi B and Singh K (2014)112 assessed the attitude of dental professionals including the dentist and dental hygienist towards the TCC and identify the possible barriers towards the implementation of these practices in the rural and urban areas of Modinagar district. 69.2% of the dentist were of the view that dental health professionals should provide TCC as compared to 54.2% among the hygienist. Regarding the practice, only 12.5% and 5.8% of the dentist and dental hygienist had ever used the nicotine replacement therapy in their dental practice. The lack of the knowledge and information regarding TCC was the only perceived barrier among the dentists (51.7%) and dental hygienist (68.3%).

Mehta A and Kaur G (2012)113, reviewed studies and found that 70 % smokers indicate that they want to quit, but a meager 2% succeed. The dental practice setting provides a unique opportunity to assist tobacco users in achieving tobacco abstinence. Still, more than 40 % of dentists do not routinely ask about tobacco use and 60% do not routinely advise tobacco users to quit, while 61.5 % of dentists believe their patients do not expect tobacco cessation services.

184 Review of Literature

Awojobi O, Newton T and Scott SE et al (2012)114, explored opinions and practices of dentists regarding discussing oral cancer with patients including. In-depth interviews with dentists (n = 16) were conducted. Dentists recognized the importance of raising awareness but identified several barriers including system factors (for example, time constraints and a lack of financial incentive), patient factors (for example, fear of invoking undue anxiety) and dentist factors (for example, a lack of sufficient knowledge, training and self-confidence).

Sinusas K , Coroso JG (1993) 126. 14 male smokeless tobacco users in a professional baseball organization enrolled in a cessation program and were followed for up to 12 months. The program consisted of 2 support group sessions at the spring training camp followed by adjunctive use of nicotine polacrilex chewing gum. At 2 to 4 months, only 3 participants were completely abstinent from smokeless tobacco. Follow-up data at 6 to 12 months revealed that only 1 participant was abstinent. The 14 ballplayers experienced various side effects of nicotine chewing gum: bad taste (6), nausea (4) headache (4), jaw discomfort (3) and dizziness (1). Despite these side effects, 11 of the 14 participants replied that they would recommend the gum to others trying to quit. Most participants (10) felt that quitting the smokeless tobacco habit was "very difficult."

Hatsukami D, Jensen J , Sharon A et al (1996)127, examined effects of 2 mg of nicotine polacrilex versus placebo gum and of group behavioural treatment versus minimal contact on cessation of smokeless tobacco use. Participants (N 210) were randomly assigned 1 of the 4 treatment conditions. Withdrawal symptoms were assessed throughout the treatment. Follow-up assessments were made at 1, 6, and 12 months post treatment. Group behavioral therapy or placebo gum was equally effective and superior to the minimal contact plus 2 mg of nicotine gum treatment in terms of abstinence. Withdrawal symptoms were significantly reduced by nicotine gum, compared with placebo during the initial phases of cessation.

Hatsukami DK , Boyle RG (1997) 128, provided a review of the literature examining school-based prevention and treatment intervention programs for smokeless tobacco. Intervention in the dental office can be effective and that group behavioral treatment may also improve cessation rates over minimal contact. On the other hand,

185 Review of Literature pharmacological treatment with 2 mg nicotine gum, was not been found to be effective. Dentists are in an ideal position to advise and assist smokeless tobacco users to quit. The majority of smokeless tobacco users want advice and help from their dentists and a significant number indicate that discussion of the negative oral effects from the use of smokeless tobacco has an impact on their desire to quit. Dental educational institutes can also play a pivotal role as a cessation counselling avenue.

Kuruvilla J (2008)115, suggest how dental schools in the country can be utilized for preventing oral cancer. As the colleges transcend wide geographical areas including rural areas, collectively they will be able to cover a large number of populations. Community dentistry departments being already functional in the colleges, the need for further infrastructure supply will be negligible making it cost-effective. As dentists constitute the main manpower in conducting the screening programs, the validity of the cases identified will be high, thus reducing the number of false positive cases.

Treatment can be initiated without undue delay following detection. Dental colleges can provide all modalities for oral cancer care like prevention, treatment, and rehabilitation. Through dental colleges, both community-based and hospital-based oral screening can be carried out effectively. If a standardized approach is adopted dental colleges can act as a surveillance tool of oral cancer to estimate the frequency with type, location, study of etiology, age distribution, and prognosis of the condition.

Rajasundaram P, Sequeira PS, Jain J (2011)116, evaluated the knowledge and attitudes of dental students in Karnataka towards smoking cessation counselling. 329 dental students comprised of III year and IV year students and interns in 3 dental colleges participated. 22 students were current smokers and 15 were ex-smokers. Although 94 % responded they were giving antismoking advice to their patients, only 47 % said they had been taught antismoking advice suitable for patients. 95 % planned to advise patients about tobacco use in their professional careers, significantly fewer (66 %) indicated that such counselling would help patients to quit.

Salman K, Azharuddin M, Ganesh R (2014)117, conducted a study among clinical dental students of 3 different colleges in Tamil Nadu, to assess the dental students‟

186 Review of Literature attitude towards the tobacco cessation counselling. Response rate was 100%. Respondents were 40.7% males and 59.3% females. There were 107 (25%) 3rd year, 157 (37%) 4th year and 160 (38%) interns. 80 % agreed that it is within the scope of dental practice to advise patient to quit tobacco and 91 % agreed that tobacco cessation counselling in the dental office could impact patient‟s quitting. Nearly 15% were slightly or not interested in receiving tobacco cessation training.

Binnal A, Rajesh G , Denny C et al (2012)118, assessed knowledge, attitude, behavior, perceived effectiveness, perceived barriers and willingness to participate in tobacco cessation among 100 house surgeons in Manipal College of Dental Sciences, Manipal University, Mangalore. Mean knowledge, attitude, behavior, perceived effectiveness, perceived barrier scores were 73.2%, 90.2%, 67.4 %, 53.16% and 89.8% respectively. Overall, 97% respondents were willing to participate in tobacco cessation activities. Respondents reported high knowledge and attitude scores, along with willingness to participate in tobacco cessation activities.

119 Elango J K, Sundaram KR, Gangadharan P et al (2009) , evaluated the awareness of oral cancer and its risk factors in semi-urban population in India. A total of 1885 persons participated and 86% had heard about oral cancer, 32% knew someone with oral cancer. 62 % of the subjects correctly identified the causes; including, 77% smoking, 64% alcohol and 79% pan chewing as a cause of oral cancer. More than 42% believed that poor oral health could lead to oral cancer and 53% thought that oral cancer is an incurable disease. 40 % of males and 14% females had one or more high-risk habits. It was observed that the awareness was proportional to the education level and inversely proportional to the prevalence of risk factor habits. 82 % of the smokers, 75% of the tobacco chewers and 66% of those who consumed alcohol were aware that their habits could lead to oral cancer.

Murugaboopathy V, Ankola AV, Hebbal M (2013)120, examined 5 groups of Indian dental students‟ attitudes and practices regarding TCC. 456 students voluntarily participated. The sample consisted of 317 female and 139 male students. 94 % of the students reported that they give anti-tobacco usage advice to patients who smoke and planned to advise patients about tobacco cessation throughout their careers. 68.9 %

187 Review of Literature indicated that such counselling would assist patients to quit. The major barriers were reported to be patients‟ resistance, inadequate skills, and poor knowledge about nicotine replacement therapy.

121 Ajagannanavar SL, Alshahrani OA, Jhugroo C et al (2015) , assessed 1984 undergraduate students from Dental Colleges in Karnataka. Most of the students were unaware about NRT term and its forms. 54% of the students were aware about the effectiveness of NRT‟s for the rescue of the smokers to quit and felt transdermal patch (42%) could be the most effective way for smokers to quit followed by chewing gums, respectively. 53.5% respondents were unaware of e-cigar‟s and also felt that NRT‟s and counselling cumulatively can contribute for cessation of the tobacco habit.

Balappanavar AY, Sardana V, Gupta P (2013)122 , assessed the tobacco cessation knowledge, attitudes, practices and perceived barriers of 1,521 dental interns in India as well as to assess the adequacy of training in tobacco use cessation (TUC) counselling. 38.8 % had knowledge, 30.8 % positive attitudes, 19.2 % practiced TUC, 43 % experienced barriers and 85.2 % agreed on receiving curriculum on tobacco cessation. Only 1 % were aware of the 5As, the 5Rs protocol and the motivational interviewing technique of TUC. These respondents‟ knowledge, attitudes and practices were below normative level and they took a superficial approach to TUC. The perceived barriers were very high and included curriculum inadequacy. The results of this study help show there is an urgent need to revise the tobacco curriculum in dental schools in India to make students more confident to practice this aspect of dentistry independently.

This study further explores the effect of behavioral counselling in dental set ups on tobacco cessation.

188 Material & Methods

5.2 Material & Methods

This was an interventional study analyzing the responses of tobacco users to the delivery of three types of tobacco cessation interventions

1. Research Design : a. Making the manual for tobacco cessation:

Compiling the results of the interviews, to identify the gaps in the knowledge of the population and literature on tobacco cessation methods; a manual for tobacco cessation was made, for use in the clinical setting. Manual also included steps to counter withdrawal symptoms if any and relapse. Response of the tobacco users to a planned tobacco cessation program was evaluated. b. Evaluation of effectiveness and impact of the tobacco de-addiction / cessation tool (manual):

Tobacco users were helped for tobacco cessation according to 3 different types of tobacco cessation interventions;

189 Material & Methods

I. By verbal instructions (brief cessation intervention) II. By providing information about cessation process via a leaflet (self help) III. Planned tobacco cessation counselling as per the manual

Subjects were monitored at regular intervals of 3 months over the course of next 1 year to evaluate if they were successful in discontinuing the habit and maintaining dissociation from tobacco for a minimum period of 6 months.

2. Sampling: Sample size was determined using the formula;

2 zz1 /2 1 n p(1 p ) pp 0

Where: z1-/2 = 1.96 and z1-=0.84 p= proportion of users able to cease their habit (0.15) p0=possible proportion in the population (0.30)

Literature review revealed that the effect of intervention on an average was about 15% 123,124, i.e. about 15 % more tobacco users were able to cease their habit when they received intervention. Assuming the same proportion in the current study thereby setting the null hypothesis that the proportion of cessation is 15% as against alternative hypothesis that it could be greater than 15% (30%), the sample number of cases to be included in the intervention study was 74 using 1-sample binomial test, which would provide 80% power and true estimate of cessation with 95% confidence.

However, considering the drop out possibilities, 20% more cases were included in the study (~90) and were subjected to intervention. For 3 intervention modalities, a sample of 296 was fixed. But finally, 80 from each group were considered for downstream analysis.

3. Participants:

Out of 1010 tobacco users from section I, 841 participants showed positive attitude towards discontinuing tobacco use. 455 participants initially agreed to participate in the tobacco cessation program, however only 296 actually participated. Subjects who

190 Material & Methods consented for participation were divided into 3 equal groups with help of computerized division system. This section included comparative evaluation of 3 different types of tobacco cessation interventions. 2, participants dropped out, remaining 294 participants were divided in to 3 equal groups of 98 each. 28 participants were lost to follow up over the course of one year and 22 (16 smokers, 4 both smoker and SLT users and 2 kharra chewers) were able to alter (19 tobacco cessations & 3 reductions) their habit with help of NRT (Nicotine chewing gums) and 6 participants were irregular in their responses. A total of 240 tobacco users followed the instructed tobacco cessation modality for period of one year. Out of 240, 198 participants had symptomatic or asymptomatic, clinically visible tobacco induced lesions or conditions and were treated for same as well. This study exclusively analysed the effects of different types of communicational and behavioural guided interventions for tobacco cessation; tobacco users who opted for NRTs (n=22, all) were provided with same however these were excluded from final statistical analysis. i. Inclusion criteria: 1. Tobacco users over 18 years of age 2. Tobacco users willing to attempt tobacco cessation 3. Tobacco users without any systemic disorders. 4. Subjects of both sexes. 5. Subjects who were available for the entire monitoring period of one year ii. Exclusion Criteria:

1. Subjects who were unwilling to attempt tobacco cessation 2. Subjects who needed NRTs for tobacco cessation

4. Observations: a. The demographic data like age, gender, SES of each subject b. To test the effectiveness of manual created for clinicians; to help and guide tobacco users for cessation.

5. Data Collection tools and Process:

Tobacco cessation intervention was carried out with all due precautions to maintain privacy and comfortable atmosphere for the participant.

191 Material & Methods

Armamentarium: Record sheets

Process of evaluating the effectiveness and impact of tobacco de-addiction tool (manual): A manual was designed for use in the clinics for tobacco cessation intervention. Subjects who consented for participation were divided in to 3 groups of with help of computerised division system. After thorough explanation of purpose and method of study, consent was taken from all the subjects. Detailed history and thorough intra oral examination of patients was carried out followed by tobacco cessation intervention.

Group I: 80 tobacco users were informed about harmful effects of tobacco and advised to give up the habits through brief cessation counselling. Such patients were monitored without counselling sessions to ascertain if they can discontinue the habit without any professional help. Further guidance was available for them as and when opted for.

Group II: 80 tobacco users were offered with information about hazards of tobacco use and cessation methods along with practical solutions to cease their habit via a self- help leaflet (provided in , English and Marathi ) and further guidance was available for them as and when opted for.

Group III: 80 tobacco users who underwent the structured counselling sessions as per the designed manual where they were informed about harmful effects of tobacco, instructed & helped in a planned manner for tobacco de-addiction process, in weekly sessions over a period of 45 days.

Subjects were monitored at the regular intervals over the course of next one year to evaluate if they were successful in discontinuing the habit and maintaining dissociation from tobacco for a minimum period of 12 months.

Observation: Cessation time point, cravings (urge to consume tobacco) and withdrawal symptoms (distressing symptoms upon abrupt discontinuation or decreased intake of nicotine such weight gain, oral ulcerations, constipation, irritability, distractions), reduction of tobacco intake and relapse of habit were observed along with challenges experienced by participant.

192 Material & Methods

Abstinence from tobacco was determined from self-reports either during a visit or through phone contact. Complete stoppage of tobacco consumption for a period of 6 months at least was considered as tobacco cessation. Reduction in both quantity of tobacco consumed and procured by at least 50 % was considered as reduction in tobacco consumption. Reversion to tobacco use habit as it was, in terms of daily consumption frequency, procurement and without any remarkable alteration was considered as relapse of tobacco consumption habit. Participants who were able to quit tobacco with help of NRT‟s were excluded in the final analysis to evaluate the impact of communication intended to be behavioural modification cessation modality.

Data analysis: Results were summarized, after intervention to comment upon the effectiveness of counselling to aid tobacco cessation. The data was tabulated and analyzed using software SPSS© Versión 20.1 (Chicago, USA Inc.)

Responses on cessation, reduction of tobacco usage and relapse were obtained on the sampled set of individuals. The outcome variable was „cessation attempt‟ (quit or reduced and relapsed), which was treated as dependent. The independents were age, gender, socio-economic status, type of tobacco usage, prior attempts of quitting tobacco. The effect of these factors on cessation attempt was studied through univariate analysis in terms of odds ratio. The combined effect of these factors on outcome variable was evaluated through multivariate logistic regression. The goodness-of-fit of model was evaluated using Hosmer-Lemeshow test. The adjusted odds ratios were finally interpreted to understand the effect of different factors on cessation attempt. Further, the effect of treatments on type of habit, as well as final status (cessation or not) was evaluated statistically using Pearson’s Chi-square test. The mathematical details of the techniques used in the study are as below:

Chi-square test: Let X and Y be two variables under study with r and s levels respectively; and the data on rs levels be in the form of counts. Let the null hypothesis be that the 2 variables are independent. That is, knowing the levels of X does not help in predicting the levels of Y; against the alternative hypothesis that the

193 Material & Methods two factors are not independent. That is, knowing the level of X can help in predicting levels of Y. To decide about the acceptance of hypothesis, the Chi-square test statistic is used which is defined as:

rs 2 2 ()OEij ij th    Where Oij is the observed frequency count for i level of ij11 Eij th variable X and j level of variable Y. Eij is the expected frequency count for same cell.

nnij The expected count is given by E  where n and n are the total counts ij n i j for ith level of variable X and jth level of variable Y; and n is the total count. The calculated Chi-square value is compared with the tabulated one for (r-1)  (s-1) degrees of freedom. If the corresponding p-value is smaller than the pre-decided significance level, say 0.05, then we reject the null hypothesis and accept the alternative one. If the p-value is more than 0.05, then we accept null hypothesis.

Odds ratio: It is the measure of association between exposure and outcome. It gives the odds that an outcome can occur given a particular exposure, as compared to the odds of outcome occurring in the absence of exposure. This can be used to determine whether a particular exposure is a risk factor for a particular outcome. An OR = 1 indicates exposure does not affect the odds of outcome. An OR > 1 indicates that exposure is associated with higher odds of outcome and an OR < 1 indicates that exposure is associated with lower odds of outcome.

Exposed Not exposed Cases a c Controls b d

If number of exposed cases are: a Number of exposed controls is: b,

Number of non-exposed cases is: c Number of non-exposed controls is: d

Then odds ratio is given by: OR = ad / bc

The 95% confidence interval for OR is given by:

194 Material & Methods

Upper 95% limit = e[ln(OR ) 1.96 1/ a  1/ b  1/ c  1/ d ] , Lower 95% limit = e[ln(OR ) 1.96 1/ a  1/ b  1/ c  1/ d ]

Multiple logistic regression :

Multiple logistic regression analysis refers to the regression application with one dichotomous outcome and one or more independent variable(s). The outcome in logistic regression analysis is often binary as 0 or 1, where 1 indicates that the outcome of interest is present, and 0 indicates that the outcome of interest is absent. If we define p as the probability that the outcome is 1, then multiple logistic regression model can be written as follows:

where X1, X2…Xp are the independent variables and b0 through bp are the regression coefficients. The model can be rewritten as:

The parameters of the model are estimated using maximum likelihood estimation method. The coefficient indicates the change in the expected log odds relative to one unit change in one variable, holding all other variables constant. The anti log of an estimated regression coefficient (exp (bi)) gives the odds ratio associated with the variable.

195 Results

5.3 Results

This study was conducted in the Department of Oral Medicine and Radiology, Sharad Pawar Dental College and Hospital, Sawangi (Meghe). Out of 1010 tobacco users, 841 (83.26 %) participants showed positive attitude towards discontinuing tobacco use . 455 (45.05 %) participants initially agreed to participate in the tobacco cessation program, however only 296 (29.31%) actually participated. 2, participants dropped out, remaining 294 participants were divided in to 3 equal groups of 98 each with help of computerised division system. This was a randomised control trial for 3 different types of cessation interventions. 28 participants were lost to follow up over the course of one year; 22 were able to reduce their habit with help of NRT (Nicotine chewing gums) and 6 participants were irregular in their responses. A total of 240 (23.76 %) tobacco users followed the instructed tobacco cessation modality for period of one year and were included in the stastical analysis. Out of 240, 198 participants had symptomatic or asymptomatic, clinically visible tobacco induced lesions or conditions. This study exclusively analysed the effects of different types of

196 Results communicational and behavioural guided interventions for tobacco cessation; tobacco users who opted for NRTs (n=22) were provided with same however these were excluded from final statistical analysis.

Age wise distribution [Table 1& Graph 1]: These 240 participants were aged between 20- 55 years with the mean age 32.5 years.

Gender wise distribution [Table 2& Graph 2]: A total of 240 individuals; 56(23.33%) females and 184 (76.67 %) males consented for 3 different modalities of tobacco cessation.

Socioeconomic Status [Table 3 & Graph 3]:32(13.33 %) participants belonged to SES III. 176 (73 .33%) to middle and 32 (13.33 %) had higher SES 32.

Habit [Table 4 & Graph 4]: Out of 240 participants, 85 (35.42 %) were smokeless tobacco users, 123 (51.25 %) were smokers and 32 (13.33 %) participants consumed both smokeless and smoking tobacco products.

Previous tobacco cessation attempts [Table 5 & Graph 5]: Out of 240 participants, 83 (34.58%) had attempted tobacco cessation previously, while 157 (65.42%) had not. Among those who attempted tobacco cessation, 36 attempted due to advice from others, while 25 on advice from health care workers.

Compliance with suggested tobacco cessation plan [Table 6 & Graph 6]: Within first week, compliance with suggested tobacco cessation plan was 100%, in all the 3 groups. However, the compliance gradually reduced. At the end of 12 months in Group I 21(26.25%) participants adhered to instructions given, in Group II 35 (43.75%) and in Group III (60 (75%) complied with the instructions and were able to either reduce or cease their tobacco use. This was also indicative of participant‟s willingness to continue with the tobacco cessation.

Habit cessation according to interventional modality [Table 7a -7b & Graph 7a – 7b ]: In Group I ; 6 (7.5%) participants ceased tobacco usage. In Group II, 14 (17.5%) participants ceased tobacco usage. In Group III, 23 (28.75%) ceased tobacco usage. None of the participant‟s tobacco consumption increased.

197 Results

Up to day 30, in all the three groups, there were no cases of ceased habit in three groups. On day 45, 6 (7.5%) participants from Group I reported to have ceased their habit, while none of the participants in the other two groups were able to. After 3 months, in Group I, the number were same as that of day 45, but in Group II and Group III also, there were 14 (17.5%) and 23 (28.75%) participants respectively. This scenario continued till the end of 12 months in all the three groups. Participants in Group I although only 7.5 % were the earliest to cease their habit and majority of Group III

Reduction in tobacco consumption [Table 8 & Graph 8]: At 7th day, participants in all 3 cessation modalities had decreased tobacco consumption. Alterations were noticed during the course of 1 year due to withdrawal symptoms and craving at different time intervals for different participants and at the end of one year; 49 (61.25%) participants from Group, 21 (26.25%) participants from Group II and 37 (46.25%) participants from Group III had reduced their tobacco consumption.

Relapse to the original tobacco habit [ Table 9 a -9 b & Graph 9 a - 9 b] : In Group I 25 (31.25%) participants had relapsed to their former tobacco habit without any alterations ; in Group II, 45 (56.25%) participants had relapsed habit; while in Group III, 20 (25%) participants tobacco usage relapsed.

On day 7, none of the participants from three groups had relapse. On day 15, there were 15 (18.75%) cases of relapse, while in the leaflet group, 16 (20%) cases had relapse. In counselling group, there was no case of relapse. Similarly, on day 30, in warning and leaflet groups, there were cases of relapse, while in counselling group, there was no case of relapse. On day 45 and after three months, along with relapse cases in warning and leaflet groups, even counselling group also had 4 (5%) cases of relapse. Same was the scenario after 3 months. After 6 months, in warning group, there was no case of relapse, while in leaflet and counselling groups, there were 57 (71.25%) and 20 (25%) cases of relapse, showing an increasing trend compared to 3 months. Further, the scenario was much the same after 9 months. At the end of 12 months, in warning group there were 25 (31.25%) cases, in leaflet there were 45 (56.25%) cases and in counselling group, there were 20 (25%) cases.

198 Results

Withdrawal Symptoms [Table 10 a- b- c & Graph 10 a- b-c]: Withdrawal symptoms were experienced as – on Day 7, 74 (92.5%) participants in Group I, 62 (77.5%) in Group II &58 (72.5%) in Group III. The number of participants experiencing withdrawal symptoms decreased gradually over the period of one year till participants of Group II & III were better able to manage their with drawl symptoms compared to Group I. At the end of 3 months 30 (37.5 %) participants of Group I, 22 (27.5 %) participants of Group II and 11 (13.75 %) participants of group III experienced withdrawal symptoms. At six months none of the participants reported withdrawal symptoms. Withdrawal symptoms varied according to modification of tobacco intake at different point of time by participants.

Off the total 240, 63 (26.25 %) participants experienced withdrawal symptoms; of these 6 smokeless tobacco users, 40 were smokers and 17 were users of both smokeless and smoking products.

Weight gain, oral ulcerations, constipation, irritability, distractions and mood swings were the most commonly reported withdrawal symptoms reported by the subjects. 13 smokers reported weight gain and remaining 56 reported experiencing distractions and irritability occasionally accompanied by craving for tobacco. Constipation by 32 and Oral ulcerations were reported by 21 participants initially but by none after 3 months.

Cravings [Table 11 & Graph 11]: On day 7, all participants in all 3 groups experienced craving for tobacco consumption. The craving gradually decreased but persisted till end of one year intervention period. At 12 months 53 (66.25 %) of Group I, 49 (61.25 %) of Group II and 32 (40 %) Group III experienced craving for tobacco consumption.

Association between intervention and type of product [Table 12 & Graph 12]: Statistically the association between intervention and type of product was significant as indicated by p-value < 0.0001.

Final status of habit according to interventional modality [Table 13 & Graph 13]: In Group I, 49 (61.25%) participants showed reduction in habit, 25 (31.25%)

199 Results relapsed; while 6 (7.5%) participant totally quit tobacco usage. In Group II, out of 80 , 45 (56.25%) relapsed, 21 (26.25%) had reduced habit; while 14 (17.5%) ceased using tobacco . In Group III, 37 (46.25%) participants had reduced, 23 (28.75%) had quit the habit and remaining 20 (25%) relapsed. The association between treatment modality and cessation attempt was highly significant with p-value < 0.0001. Tobacco cessation was maximum in Group III.

Table 14: Univariate Analysis - Factors and their association with intention to quit tobacco Cessation attempt Univariate Analysis Yes /Total Variables p-value* in the category (%) OR 95% CI Lower Upper Age (in years) 41-60 (27/28)96.43 1

21-40 (123/212)58.01 0.0585 0.0224 0.2814 0.0001(HS) Gender

Female (35/56)62.50 1

Male (115/184) 62.50 1.0022 0.5324 1.853 0.9999(NS) Socio economic status Low (18/32) 56.25 1

Middle (111/176) 63.07 1.3289 0.6074 2.8590 0.4647(NS) Higher (21/32) 65.63 1.4722 0.5319 4.1583 0.4421(NS) Smoking Smokeless (45/85) 52.94 1

Smoke (84/123) 68.29 1.9069 1.0773 3.3954 0.0249(S) Both (21/32) 65.63 1.6809 0.7279 4.0534 0.2175(NS) Attempts of quitting before No (93/157) 59.24 1

Yes (57/83) 68.67 1.5030 0.8603 2.6705 0.1508(NS) *Obtained using chi-square test; S: Significant; HS: Highly Significant; NS: Not Significant

Table 1 provides the factors and their association with intension to quit. Factor age was categorized into two i.e. <= 40 and > 41 years. The percentage of subjects intending to quit in > 41 years category was 96.43 as against 58.01% in the age range of 21-40 years. The odds of quitting tobacco for the age group 21-40 years was 0.0585 [95% CI: 0.0224 – 0.2814] with p-value < 0.0001.

200 Results

As regards gender, the proportion of females intending to quit was 62.5%, and equally same number of males showed intention to quit. Thus, the odds for intention to quit were same for both males and females.

Socio-economic status was categorized into Low, Middle and High. There were 56.25% cases intending to quit in Low status group, while 63.07% in the middle and 65.63% in the higher status group, who were intending to quit. The odds for middle group for cessation as compare to Low group was 1.3289 [95% CI: 0.6074 – 2.8590], while odds for higher group was 1.4722 [95% CI: 0.5319 – 4.1583]; although the effects were statistically insignificant.

There were 52.94% subjects who consumed smokeless tobacco and were intending to quit, while 68.29% who smoked were willing to quit and 65.63% who consumed both showed intention to quit. The odds in favour of cessation for smoke category was 1.9069 [95% CI: 1.0773 – 3.3954] with associated P-value of 0.0249 (P < 0.05). The odds associated with Both was 1.6809 [95% CI: 0.7279 – 4.0534] with P-value of 0.2175 (P > 0.05).

As regards attempt to quitting before, there were 59.24% subjects who never attempted to quit before, while 68.67% had attempts to quit before. The odds associated with attempts to quit before was 1.503 [95% CI: 0.8603 – 2.6705] with P- value of 0.1508 (P > 0.05).

Table 15: Relevance of different factors on cessation attempt using multivariate logistic regression Cessation attempt Multivariate Analysis Variables Yes/Total 95% CI p-value* in the category (%) OR Lower Upper Age (in years) 41-60 (27/28) 96.43 1.000

21-40 (123/212) 58.01 0.040 0.005 0.314 0.002(S) Gender Female (35/56) 62.50 1.000

Male (115/184) 62.50 0.826 0.405 1.686 0.600(NS)

201 Results

Socio economic status Low (18/32) 56.25 1.000

Middle (111/176) 63.07 1.729 0.732 4.084 0.212(NS) Higher (21/32) 65.63 1.168 0.380 3.593 0.787(NS) Tobacco use Smokeless (45/85) 52.94 1.000

Smoke (84/123) 68.29 1.539 0.570 4.150 0.395(NS) Both (21/32) 65.63 2.540 1.332 4.845 0.005(S) Attempts of quitting before No (93/157) 59.24 1.000

Yes (57/83) 68.67 0.835 0.447 1.559 0.571(NS) Table 2 provides different factors and their relevance to intention to quit tobacco products in presence of other factors. Multivariate logistic regression was used with factors as independent variables and intention to quit (quit / reduced / relapse) as dichotomous dependent variable. Accordingly, the adjusted odds ratios were obtained for the levels of different factors as shown in the table.

As regards age, the adjusted OR associated with age level 21-40 years is 0.04 [95% CI: 0.005 – 0.314] compared to reference level in presence of other factors, indicating that the intention to quit tobacco usage in older groups is reduced as compared to elder groups. The effect of age level is significant with P-value of 0.002 (P < 0.05).

The adjusted OR associated with Males is 0.826 [95% CI: 0.405 – 1.686] indicating that the likelihood of males going for cessation of tobacco usage is marginally smaller as compared females; however, the gender effect is statistically insignificant with P- value of 0.6 (P > 0.05).

As regards socio-economic status, the adjusted OR associated with middle and higher socio-economic strata are 1.729 [95% CI: 0.732 – 4.084] and 1.168 [95% CI: 0.38 – 3.593] respectively as compared to reference level (low). In other words, the likelihood of tobacco cessation in middle and higher strata is more as compared to lower strata; however, the effect is statistically insignificant with p-value > 0.05.

The adjusted OR associated with smoking and both (smokeless and smoking) are 1.539 [95% CI: 0.57 – 4.15] and 2.54 [95% CI: 1.332 – 4.845] respectively, indicating that with reference to smokeless tobacco consumption, the likelihood of cessation in

202 Results smoking and those using both is higher; and the effect is significant in those consuming both type of products, as indicated by P-value of 0.005 (p < 0.05).

As regards attempt for quitting tobacco before, the adjusted OR associated for positive reply (yes) is 0.835 [95% CI: 0.447 – 1.559] indicating marginal likelihood of intention of tobacco cessation as compared to those who never attempted for quitting. The effect of the factor was statistically insignificant with p-value of 0.571 (P > 0.05).

Final outcome of behavioural interventional [Table 14]: 60 participants from Group III , 55 from Group I and 35 from Group II were able to positively alter their behaviour in the form of reduction or cessation of tobacco use. Communication of the clinician appears to be the major motivator for this apparent change.

203 Tables

Table 1: Age distribution

Age Groups No. of participants Percentage 10-20 3 1.52 21-30 88 36.67 31-40 121 50.42 41-50 25 10.42 51-60 3 1.25 Total 240 100 Mean Age 32.5 S.D. 6.62 Minimum age 20 Maximum age 55

Table 2: Gender distribution

Gender No. of participants Percentage (%) Male 184 76.67 Female 56 23.33 Total 240 100

Table 3: Socio economic status

Socioeconomic background Score* No. of participants Percentage

Upper I 32 13.33 Upper middle/ Lower Middle II 176 73 .33 Upper Lower / Lower III 32 13.33 Total 240 100 *Kuppuswamy‟s Socio-Economic Status Scale 2014

Table 4: Distribution of tobacco products used

Tobacco products No. of participants Percentage Smokeless 85 35.42 Smoking 123 51.25 Both 32 13.33 Total 240 100

204 Tables

Table 5: Previous tobacco cessation attempts

Attempted tobacco cessation before No. of participants Percentage a) Yes 83 34.58 b) No 157 65.42 If yes

On own 22

Health care worker’s advice 25

Advice of others 36

Total 240 100

Table 6: Compliance with different tobacco cessation modalities

Tobacco cessation Number of participants complying at a Time Point [No. (%)] as suggested Treatment modality 7 15 30 45 3 6 9 12 Day Day Day Day Months Months Months Months Group I 80 40 37 32 30 26 23 21 (n=80) (100) (50) (46.25) (40) (37.50) (32.5) (28.75) (26.25) Group II 80 64 52 47 42 40 37 35 (n=80) (100) (80) (65) (58.75) (52.5) (50) (46.25) (43.75) Group III 80 72 69 68 65 62 61 60 (n=80) (100) (90) (86.25) (85) (81.25) (77.5) (76.25) (75)

Table 7a: Habit Cessation according to interventional modality

Final status Habit [No. (%)] Treatment Ceased Reduced Relapse Group I [Warning (n=80)] 6 (7.5) 49(61.25) 25 (31.25) Group II [Leaflet (n=80)] 14 (17.5) 21 (26.25) 45 (56.25) Group III [Counselling (n=80) ] 23 (28.75) 37 (46.25) 20 (25.00)

Table 7b: Habit Cessation according to interventional modality

Tobacco cessation Habit Cessation [No. (%)] as suggested 7 15 30 45 3 6 9 12 Treatment modality Day Day Day Day Months Months Months Months Group I 0 0 0 6 6 6 6 6 (n=80) (0) (0) (0) (7.5) (7.5) (7.5) (7.5) (7.5) Group II 0 0 0 0 14 14 14 14 (n=80) (0) (0) (0) (0) (17.5) (17.5) (17.5) (17.5) Group III 0 0 0 0 23 23 23 23 (n=80) (0) (0) (0) (0) (28.75) (28.75) (28.75) (28.75)

205 Tables

Table 8: Reduction in amount of tobacco consumption

Groups No. of participants Percentage Group I [Warning (n=80)] 49 61.25 Group II [Leaflet (n=80)] 21 26.25 Group III [Counselling (n=80) ] 37 46.25 Total 240 100

Table 9a: Relapse to the original tobacco habit

Groups No. of participants Percentage Group I [Warning (n=80)] 25 31.25 Group II [Leaflet (n=80)] 45 56.25 Group III [Counselling (n=80) ] 20 25 Total 240 100

Table 9b: Relapse to the original tobacco habit

Tobacco cessation Relapse [No. (%)] as suggested

7 15 30 45 3 6 9 12 Treatment modality Day Day Day Day Months Months Months Months

Group I 0 25 0 0 25 15 (18.75) 29 (36.25) 29 (36.25) (n=80) (0) (31.25) (0) (0) (31.25) Group II 0 16 28 28 28 57 45 45 (n=80) (100) (20) (35) (35) (35) (71.25) (56.25) (56.25) Group III 0 0 0 4 4 20 20 20 (n=80) (0) (0) (0) (5) (5) (25) (25) (25)

Table 10a: Withdrawal Symptoms

Tobacco cessation as suggested Withdrawal Symptoms [No. (%)]

7 15 30 45 3 6 Treatment modality Day Day Day Day Months Months

Group I 74 69 51 49 30 0 (n=80) (92.5) Group II 62 57 45 34 22 0 (n=80) (77.5) Group III 58 46 32 18 11 0 (n=80) (72.5)

206 Tables

Table 10b: Withdrawal Symptoms (At 3months)

Tobacco No. of Group I Group II Group III Percentage products participants Smokeless 6 9.52 4 2 0 Smoking 40 63.49 32 6 2 Both 17 26.98 9 6 2 Total 63 100

Table 10c: Withdrawal Symptoms

Withdrawal Symptoms No. of participants Habit Weight Gain 6 Smoking Irritation / Distraction 56 30 smokers 16 SLT 10 S+ SLT Oral Ulcerations 22 34.92 Constipation 24 38.09 Total 63 100 *A participant can experience more than one withdrawal symptom

Table 11: Cravings

Cravings Time Point [No. (%)]

Treatment modality 7 15 30 45 3 6 9 12 Day Day Day Day Months Months Months Months

Group I 80 78 71 67 63 55 53 53 (n=80) (100) (97.5) (88.75) (83.75) (78.75) (68.75) (66.25) (66.25)

Group II 80 (100) 76 70 68 63 51 51 49 (n=80) (95) (87.5) (85) (78.75) (63.75) (63.75) (61.25)

Group III 74 (92.5) 70 (87.5) 64 60 52 46 40 32 (n=80) (80) (81.25) (65) (57.5) (50) (40)

207 Tables

Table 12: Association between intervention and type of product

Smokeless Smoke Intervention (n=85) (n=123) Both (n=32) p-value* Warning 45 27 8 Leaflet 24 40 16 <0.0001(HS) Counselling 16 56 8

Table 13: Final status of habit according to interventional modality

Final status Habit Status [No. (%)] Treatment Ceased Reduced Relapse p-value* Group I (n=80) 6 (7.5) 49 (61.25) 25 (31.25) Group II (n=80) 14 (17.5) 21 (26.25) 45 (56.25) < 0.0001 Group III (n=80) 23 (28.75) 37 (46.25) 20 (25.00) *Obtained using Chi-square test

Table 14: Final outcome of behavioural interventional

Positive behavioural Relapse Sr. modification p - No. value* Group I Group II Group III Group Group II Group I III p <0.0001 1. 55 35 60 25 45 20 *Obtained using Chi-square test

208 Graphs

Graph 1: Age Distribution

Age

140 121 120 10 to 20 100 88 21-30 80 31-40 60 41-50 40 25 51-60 20 3 3 0 10 to 20 21-30 31-40 41-50 51-60

Graph 2: Distribution of Gender

Gender Distribution

56 Male (26.08 %)

184 Female ( 76.92%)

209 Graphs

Table 3: Socio economic status

I 32 32 II

III 176

Table 4: Tobacco Product Used

Smoking 32 85 Smokeless

123 Both

Table 5: Previous tobacco cessation attempts

Yes 83

157 No

210 Graphs

Graph 6: Compliance with different tobacco cessation modalities

80

70 7 Day 60 15 Day 50 30 Day

40 45 Day 3 Months 30 6 Months 20 9 Months 10 12 Months

0 Warning Leaflet Counselling

Graph 7a: Habit Cessation according to interventional modality

Group I Group II Group III 49 50 45

45

40 37 35 30 25 23 25 21 20 20 14 15 6 No. of participants of No. 10 5 0 Ceased Reduced Relapse

Final staus of habit

211 Graphs

Graph 7b: Habit Cessation according to interventional modality

Habit status: Ceased

Group I Group II Group III

25 23 23 23 23

20

15 14 14 14 14

10 6 6 6 6 6

No. of participants of No. 5 0 0 0 0 0 0 0 0 0 0 0 0 Day 7 Day 15 Day 30 Day 45 3 6 9 12 months months months months

Graph 8: Reduction in tobacco consumption

Reduced tobacco consumption at the end of one year 49 50 45 37 40 35 30 21 25 20 15 10 5 0 Group I Group II Group III

212 Graphs

Graph 9a : Relapse

Relapse 45

45 40 35 30 25 25 20 20 15 10 5 0 Group I Group II Group III

Graph 9b : Relapse

Habit status: Relapsed Group I Group II Group III

60 57

50 45 45

40

2928 2928 28 30 25 25 20 20 20

20 1516 No. of participants of No. 10 4 4 0 0 0 0 0 0 0 0 Day 7 Day 15 Day 30 Day 45 3 6 9 12 months months months months

213 Graphs

Graph 10 a: Withdrawal Symptoms (At 3months)

80 70 60 7 Days 15 Days 50 30 Days 40 45 Days 30 3 Months 20 6 Months 10 0 Group I Group II Group III

Graph 10 b: Withdrawal Symptoms (At 3months) SLT 10% Both 27%

Smoking 63%

Graph 10 c: Withdrawal Symptoms (Types)

Weight gain 6% Oral Ulceration 22%

Constipation Irritation / 20% Distraction 52%

214 Graphs

Graph 11: Cravings

80

70 7 Day 60 15 Day 50 30 Day 45 Day 40 3 Months 30 6 Months

20 9 Months 12 Months 10

0 Group I Group II Group III

Graph 12: Association between intervention and type of product

60 56 Group I 50 45 40 Group II 40 Group III 27 30 24

20 16 16 8 8 10

0 Smokeless Smoking Both

215 Graphs

Graph 13: Final status of habit according to interventional modality

49 50 45 45 40 37 35 Group I 30 23 25 Group II 25 21 20 20 Group III 14 15 10 6 5 0 Ceased Reduced Relapse

216 Discussion

5.4 Discussion

The tobacco crisis in India requires urgent efforts due to the enormity of the burdening morbidity and mortality resulting from its use. Dental health care workers are a largely untapped resource for providing advice and counselling to tobacco users for their habit cessation. Tobacco cessation interventions are cost- effective disease prevention and intervention methods.

The approach adopted by a health professional to help patients for quitting tobacco is termed as counseling.155 Very limited literature exists comparing the effectiveness of interventions aiming at behavioural modifications. This study analyses the responses of tobacco users to the delivery of three types of tobacco cessation interventions:

I. By verbal instructions (brief cessation intervention) II. By providing information about cessation process via a leaflet (self help) III. Planned tobacco cessation counselling according to the manual

217 Discussion

Out of 1010 tobacco users, 841 participants showed positive attitude towards discontinuing tobacco use. 455 participants initially agreed to participate in the tobacco cessation program, however only 296 actually participated. This study included comparative evaluation of 3 different types of tobacco cessation interventions. 2, participants dropped out, remaining 294 participants were divided in to 3 equal groups of 98 each. 28 participants were lost to follow up over the course of one year and 22 (16 smokers, 4 both smoker and SLT users and 2 kharra chewers) were able to alter (19 tobacco cessations & 3 reductions) their habit with help of NRT (Nicotine chewing gums) and 6 participants were irregular in their responses. A total of 240 tobacco users followed the instructed tobacco cessation modality for period of one year. Out of 240, 198 participants had symptomatic or asymptomatic, clinically visible tobacco induced lesions or conditions. This study exclusively analyzed the effects of different types of communicational and behavioural guided interventions for tobacco cessation; tobacco users who opted for NRTs (n=22, all) were provided with same however these were excluded from final statistical analysis. Similar to our findings Sinusas K et al (1993) 126, also concurred with the observation of the present study that nicotine chewing gum as an adjunct to SLT cessation had limited effectiveness.

A total of 240 individuals; 56(23.33%) females and 184 (76.67 %) males consented to participate in the study. 198 participants had symptomatic or asymptomatic, clinically visible tobacco induced lesions or conditions ; which is similar to findings by Nagpal R et al (2014) 84 that tobacco users quit the habit only if they personally experience any health problem due to the habit. 32(13.33 %) participants belonged to SES III. 176 (73 .33%) to SES II and 32 (13.33 %) to SES I 32. SES II participants were keener on tobacco cessation. Unawareness among SES III and unconcerned attitude among SES I could be cited as reason for less enthusiasm among these groups. The commonly observed attitude among participants was that “Cancer is the disease among the neighbours and will not affect them” which rendered it impossible for them to imagine the possibility of any harmful effects from tobacco use.

Carr AB et al (2006)106, described the following in Cochrane review; in addition to the well-known harmful effects of smoking on respiratory and cardiovascular

218 Discussion systems, tobacco use has significant adverse effects on oral health (Warnakulasuriya 2010). Cigarette smoking is associated with an increased risk for oral disease (Gelskey 1999; Mecklenburg 1998; Salvi 2000). Tobacco exposes the oral cavity to toxic carcinogens that may have a role in initiation and promotion of cancer (Mirbod 2000). Tobacco is the major inducer of oral squamous cell carcinoma (SCC) and is considered to be responsible for 50% to 90% of oral cancer cases worldwide (Epstein 1992; Holleb 1996). The incidence of oral SCC is 4 to 7 times greater in smokers than non-smokers (Piyathilake 1995). Oral cancer and pre-cancer occurs more frequently in smokers and quitting smoking decreases the risk for oral cancer within 5 to 10 years (EU Working Group 1998). Tobacco exposure is also harmful to periodontal health and smoking status is an important factor in the prognosis for periodontal therapy, oral wound healing, implant therapy and cosmetic dentistry (Mecklenburg 1998). Smoking results in discoloration of both teeth and dental restorations and is associated with halitosis, diminished taste and an increased prevalence and severity of periodontal disease (EU Working Group 1998). Cigarette smoking is causally associated with an increased prevalence and severity of periodontitis (Gelskey 1999), even when adequate oral hygiene is practiced (Kerdvongbundit 2002). Cessation of smoking may halt disease progression and improve outcomes of periodontal therapy (EU Working Group 1998). SLT use has been reported to cause tooth decay (Tomar 1999) and discoloration of dental restorations (Walsh 2000). Chewing tobacco, in particular, is associated with an increased risk for dental caries due to high sugar content and increased gingival recession. Abrasive particles in chewing tobacco may contribute to significant dental attrition which may require dental restorations in advanced cases (Bowles 1995; Carr and Ebbert Page 2 Cochrane Database Syst Rev. 2014). Cross-sectional studies have suggested that smokeless tobacco users with co- existing gingivitis have high rates of gingival recession, mucosal pathology and dental caries (Offenbacher 1985). Smokeless SLT use has also been associated with irreversible gingival attachment loss resulting in root exposure (Ernster 1990). Effects of SLT use are typically observed at anatomical locations where the tobacco contacts the mucosa, such as the labial vestibule and adjacent periodontium. Both the prevalence and severity of tobacco-related oral lesions demonstrate a dose-response relationship with the amount, frequency and duration of smokeless tobacco exposure

219 Discussion

(Little 1992a). Chronic exposure can lead to leukoplakia (Hirsch 1982), a premalignant condition (Silverman 1984; Silverman 1976). SLT use in the United States has been associated with an increased risk for oral cancer in a dose-response fashion (Stockwell 1986; Williams 1977; Winn 1981). Risk may vary depending upon the type of SLT used, as the highest rates of oral cancer are observed in countries where SLT is consumed with additives (e.g., areca nut) (Critchley 2003). The dental practice setting provides a unique opportunity to assist tobacco users in achieving tobacco abstinence (Christen 1990; Needleman 2010; Ramseier 2010).

Widespread acceptance of tobacco use interventions in the dental setting have been lacking and limitations in primary care resources have curtailed further efforts (Warnakulasuriya 2002). Compared to other health care providers, dentists more accurately estimate patient tobacco use (Block 1999). However, dental practitioners are less consistent with and supportive of intervention, less likely to report having strong knowledge or skill levels regarding tobacco cessation, and more likely to perceive barriers to tobacco intervention (Block 1999). More than 40% of dentists do not routinely ask about tobacco use and 60% do not routinely advise tobacco users to quit (Tomar 2001). While 61.5% of dentists believe their patients do not expect tobacco cessation services, 58.5% of their patients felt such services should be provided (Campbell 1999). Barriers to providing tobacco cessation service include concern for patient resistance (Campbell 1994), lack of knowledge, lack of time (Dolan 1997), lack of financial reimbursement (Fried 1992), and a concern for poor co-ordination of care between dentistry and tobacco cessation services (Campbell 1994).

West R et al (2004) 107 suggest that dentists should advice and ensure that SLT users know the potential health risks and advise them to stop and keep a record of the outcome. Dental professionals should also examine the oral cavity of SLT users for lesions when the opportunity arises. Stevens VJ et al (1995) 111 also reported that 78 % of participants from their interventional program had oral tobacco induced lesions.

Need for Tobacco Cessation Counselling Manual: According to Jha P et al (2008)141 only 2% of smokers had spontaneously quit; in order for a downward shift

220 Discussion in tobacco use to occur, it is imperative that health professionals be at the forefront of tobacco cessation efforts. Several studies in the West have shown that tobacco cessation advice provided by health professionals enhances the quit rate among their patients 123. Lack of cessation advice and support arising from lack of trained health professionals is a major barrier among others in tobacco cessation process 142. A guide directing about the steps of cessation counselling can be immensely helpful for this cause. In 2002, tobacco cessation clinics (TCCs) were set up in India to provide the first formal tobacco cessation intervention. 13 clinics supported by the WHO and the Ministry of Health and Family Welfare, Government of India were set up in oncology, cardiology, psychiatry, surgery and in NGO settings and later expanded to 19. The objectives of this initiative were to evolve treatment approaches for the management of smoking and SLT dependence, to generate experience in the implementation of these interventions and to study the feasibility of implementing these interventions on a large scale. In the first 5 years of the clinics, 34,741 cases were registered and baseline information recorded for 23,320 cases. Only behavioural strategies were employed in 69% of the cases and pharmacotherapy, primarily bupropion, and nicotine gums were used in 31% along with behavioural counselling. At 6 weeks, 14% had completely quit and 22% had reduced their tobacco intake by 50% or more. Younger male patients, users of SLT and those receiving a combination of pharmacotherapy and behavioural counselling had relatively better outcomes at 3, 6, and 9 months. The longer the patients retained in follow-up, the greater was the movement from “not improved” to “improved” categories. Encouraging results have been published from the TCC at Delhi, comparing the effect of counselling alone with counselling and medication (bupropion).146 Most smoking cessation trials, however, have been conducted in developed countries and various strategies need to be explored in India, given the differences in educational, cultural and economic factors and greater use of SLT preparations where NRT use is somewhat questionable. Most meta-analytical studies evaluating tobacco cessation interventions recommend a combination of pharmacotherapy with behavioural interventions. Pharmacotherapy with NRTs has been shown to double or triple quit rates. NRTs are the most widely used therapy for smoking cessation and comprises a range of products with passive (transdermal patch) and instantaneous nicotine delivery (eg, gum, nasal spray, inhaler)

221 Discussion with the rationale of providing a slow and steady supply of nicotine to achieve constant concentration levels of nicotine in order to relieve craving and withdrawal symptoms. A combination of NRTs appears to work better than a single NRT for smokers. Non-NRT medications commonly used for treatment include varenicline, bupropion and nortryptiline. Varenicline is a novel orally administered alpha4beta2- nicotinic acetylcholine (ACh) receptor partial agonist developed specifically for smoking cessation having both short-term and long-term efficacy. It is been reported to be well tolerated and appears to attenuate the urge to smoke. Bupropion is an antidepressant drug; it is believed to act as an antagonist by blocking nicotine receptors in the brain and affecting the brain‟s reward/pleasure system. Nortryptiline, a second-generation tricyclic antidepressant and clonidine, an alpha-agonist antihypertensive are recommended as second-line medications. These drugs have not been evaluated as extensively as the other drugs, but their lower costs may make them potential pharmacotherapies in low-income countries. 143 Most studies of behavioural interventions worldwide reported moderate success in quitting tobacco at 6 months. Group counselling has shown to be effective. Behavioural interventions in adolescents and pregnancy seem more effective than pharmacotherapy. Technology-driven interventions, such as telephone counselling, dedicated quit lines, and mobile- and web-based technologies have recently gained popularity. Combining interventions shows promising results compared with a single intervention 143

Rationale for using behavioural therapy was mainly to observe its effectiveness as proved in previous studies for ceasing tobacco dependence & withdrawal management and thus contribute substantially to improved health by enabling cessation of tobacco use. Even among persons who might ultimately achieve tobacco abstinence without therapy, the benefits can be profound if treatments help people to achieve tobacco abstinence earlier, because the risk of disease is strongly related to the duration of tobacco use.

Dhumal GG et al (2014) 94 stated that doctor‟s advice along with education and anti- tobacco messages were positively associated with higher intention to quit tobacco. Doctors specially dentist‟s advice and guidance for tobacco cessations have been positively associated with higher intention to quit tobacco and culminating in tobacco

222 Discussion cessation as well. However dentists often feel there is lack of training and various other barriers such as time constraints and possibility of loss of patients on advice of tobacco cessation counselling 5, 7, 8.9, 59, 94, and 98. Previous studies have cited positive uptake of such counselling by tobacco users and highlighted their willingness for the same. Nagler RH et al (2014) 147, state that health information engagement is low among individuals who smoke, particularly active seeking of health information online. Population subgroups differ in their media use patterns; some of these differences reflect communication inequalities, which have the potential to exacerbate health disparities. Clinicians have an opportunity to guide tobacco users towards useful and reliable information sources. This guidance could help tobacco users fulfil their unmet information and support needs and may be particularly important for less educated and other underserved populations. Results in the previous section of this project also showed that; the willingness to cease the tobacco habit was significantly higher in participants knowing about the ill effects of tobacco (p-value < 0.0032). Out of 1010 participants 467 (46.24%) participants said that guidance about cessation process will help them quit, while 209 (20.69%) wanted NRTs. Medications for other minor ailments; for which tobacco was used a home remedy were expected by 174 (17.23%) participants; while 166 (16.44%) participants opted for tobacco cessation counselling. The dental set ups and dental fraternity are one of the important centres for providing such desired aids for tobacco cessation. . The manual created as a part of this project will help in dentists in overcoming some commonly identified barriers and encourage them to participate in cessation counselling. Different approaches, practical solutions and steps of cessation are highlighted in the manual (Annexure 2).

Habit: Out of 240 participants, 85 (35.42 %) were SLT users, 123 (51.25 %) were smokers and 32 (13.33 %) participants consumed both SLT and smoking tobacco (mixed) products. Smokers were keener on cessation intervention; this could be attributed to the fact that promotion and thus resulting awareness about consequences of smoking on health are more propagated than other forms. Frequently circulated message includes

“Smoking causes cancer. Smoking Kills”

223 Discussion

Previous tobacco cessation attempts: Out of 240 participants, 83 (34.58%) had attempted tobacco cessation previously, while 157 (65.42%) had not. Among those who attempted tobacco cessation, 36 attempted due to advice from others, while 25 on advice from health care workers. As observed in the present study, about 2/3rd of tobacco users were welcome to the idea of tobacco cessation intervention however about 1/3rd participantswere reluctant and did not want to discuss about their tobacco habit. Patil et al 3 stated that the response of the subject to the question - should the dentists ask about tobacco usage were statically significant. 73.63% of the subjects agreed, 20.45% were not sure and 5.9% disagreed that dentist should routinely ask about tobacco usage. 3 Similar results were also reported by Campbell et al., (1999)135 that 59.7% tobacco users agreed that the dentist should offer quit assistance and services and in the TCP survey4, rates of tobacco users who received advice to quit from doctors or health professionals were found to be encouraging, [ MP (52%) and Maharashtra (34%)]. The vast majority (85%) who received this advice said it made them think about quitting. However Rikard-Bell et al., (2003) 109 and Davis et al., (2005) 3 found that 23% and 66 % of the tobacco users did not agree that dentist should provide smoking advice. Awojobi O et al (2012) 110 state that patients seem generally unaware of oral cancer screening by their dentist but are happy to participate, patients would like to be informed and welcome the support of their dentist to reduce their risk of developing oral cancer.

Saud M et al (2014) 7 reported that almost 95% of physicians asked their patients about smoking status and 94% advise them to quit smoking, but only 50% assist the patient to quit smoking and only 28% arrange follow-up visits. Thus, regular assistance to patients for tobacco cessation was not being provided. Medical education system in India is failing to impart the necessary skills to doctors, which is needed to help patients quit smoking and suggested reforms in educational curriculum. Tomar SL (2001) 101 (US) reported that > 40 % of dentists do not routinely ask about tobacco use and 60 % do not routinely advise tobacco users to quit. Meanwhile, < 1/2 of dental schools and dental hygiene programs provide clinical tobacco intervention services. Amit S et al (2011)99 reported as a result of a study conducted that 97% of the dentists agreed that it is the duty of every dentist to advice patients about tobacco cessation. A total of 58% strongly agree that formal training will be an effective tool

224 Discussion to provide the guidelines to dentists in tobacco cessation and counselling. Parakh et al (2013) 100 state that dental professionals must expand their armamentarium to include TCC strategies in their clinical practice. The dental institutions should include TCC in the curriculum and the dental professionals at the primary and the community health care level should also be trained in TCC to treat tobacco dependence. Awojobi O et al (2016) 108, evaluated the effect of a training session on the use of an oral cancer communication guide on dentists' and reported that training dentists in the use of the guide showed positive impact by reducing perceived barriers and increasing self-efficacy.

Johnson NW et al (2006) 103, Ibrahim H et al (2008) 105 and Gansky SA et al (2002) 137 state that most dentists feel that promotion of tobacco cessation is an important part of the duty of a dentist but they feel inadequately prepared to deliver such advice. Commonly cited barriers in delivering successful tobacco cessation campaigns are the amount of time required, lack of reimbursement, lack of training, lack of patient education materials and lack of knowledge of available referral resources. The majority of dentists have received no training in TCC strategies. They feel that staff training and free availability of more patient education materials (leaflets, posters, etc.) would help promote the success of such a campaign.

Smith SE et al (1998) 102 report that motivated dentists with access to information on smoking counselling are able to contribute to tobacco control measures in the community. Shaik SS (2016) 10, suggested that leaflets, brochures, continuing patient education materials regarding tobacco cessation should be made available. Martin LM (1996) 104 reported that cancer screening and tobacco cessation advice are underutilized in the dental practice. Increased patient awareness and implementation of screening and tobacco cessation interventions could decrease oral cancer incidence and have a public health benefit for other tobacco-related morbidity and mortality as well. Carr AB et al (2006)106, suggests that behavioural interventions dealing with tobacco use, conducted by oral health professionals, including oral examination, in the dental office and community setting, may increase tobacco abstinence rates in both smokers and SLT users. Mehta A et al (2012) 113, state in favour of a guided tobacco cessation intervention by stating that interventions by dentists are effective in helping people to quit tobacco consumption. A step-wise approach and patience must be adopted while dealing with such patients as adopted in the presented study an

225 Discussion intervention was implemented for a period of over 1 year. Literature on such similar interventions is very limited.

The present study was conducted in dental college set up which is also advocated by many studies. Salman K et al (2014) 117 , Murugaboopathy V et al (2013)120 and Kuruvilla J (2008)115, say that to effectuate a breakthrough in the existing tobacco situation, the work force of dental schools could be capitalized on (1) as the colleges transcend wide geographical regions including rural areas, they can cover a large number of population (2) negligible need of further infrastructure makes its cost effective (3) In case of detection of treatment can be initiated without further delay (4) all modalities for oral cancer care like prevention, treatment and rehabilitation can be provided in dental colleges (5) both community-based and hospital-based oral screening can be carried out (6) with a standardized approach, surveillance of oral cancer , estimate the frequency, type, location, study of aetiology, age distribution and prognosis of the condition can all be studied at dental college (7) Ready availability of man power of dentists , interns and students. Rajasundaram P et al (2011) 116 in a study found that only 47 % dental students said they had been taught antismoking advice for patients. , 95 % planned to advise patients about tobacco use in their professional careers but only 66 % indicated that such counselling would help patients to quit. Hatsukami DK et al (1997) 128 report that majority of SLT users want advice and help from their dentists and a significant number indicate that discussion of the negative oral effects from the use of SLT has an impact on their desire to quit.

Cornuz J et al (2008) 123, state that healthcare professionals are in a unique position to advise smokers to quit by their ability to integrate the various aspects of an effective counselling. Similar to present study, non pharmacological interventions were suggested for smokers presenting in a clinical setting. Strategies used for cessation counselling may differ according to the patient‟s readiness to quit. For tobacco users who do not intend to quit smoking, physicians should inform and sensitise about tobacco use and cessation. For dissonant patients, motivational strategies, such as discussing barriers to cessation and their solutions can be opted for. For tobacco users ready to quit, the physician should show strong support and help set a cessation date. Healthcare professionals counselling for smoking cessation is among the most cost-effective clinical interventions.

226 Discussion

Members from same house hold, peer group, professional group and acquaintances were welcomed in the intervention program. 148 participants (61.66 %) out of 240 were familiar with someone in the program highlighting the underlying need of peer group support. Hatsukami DK et al (1997) 128 also deduced that intervention in the dental office can be effective and that group behavioural treatment may also improve cessation rates as compared to minimal contact.

Compliance with suggested tobacco cessation plan: Within 1st week, compliance with suggested tobacco cessation plan was 100%, in all the 3 groups. This gradually reduced and at the end of 12 months in Group I 21(26.25%) participants adhered to instructions given, in Group II 35 (43.75%) and in Group III 60 (75%) complied with the instructions and were able to either reduce or cease their tobacco use. This was also indicative of participant‟s willingness to continue with the tobacco cessation.

Habit cessation according to interventional modality: A total of 43 participants were able to cease their habit as a result of interventions of this study. In Group I; 6 (7.5%), in Group II, 14 (17.5%) in Group III, 23 (28.75%) ceased tobacco usage. None of the participant‟s tobacco consumption increased. Stevens VJ et al (1995) 111 state that tobacco cessation intervention is acceptable to vast majority of patients and takes from 30 seconds to 4 minutes of time from the members of dental team during routine visits. About 10 -15 minutes were spent in the present study during brief cessation counselling. Hatsukami DK et al (1997) 128 deduced that intervention in the dental office can be effective and may also improve cessation rates compared to limited effectiveness of minimal contact.

Similar to our intervention for Group II; Lancaster T et al (2005)136 reported that self-help materials may increase quit rates compared to no intervention but not to a remarkable extent. Advice and behavioural counselling can help in tobacco cessation.

Giving the same type of support via written materials or other media has only been moderately helpful, although beneficial for people with no other support. Tailoring materials to provide individualized support is more effective. Comparisons between different types of standard materials have generally failed to show differences between them. Garvey AJ et al (1997) 125, observed that cigarette smoking has a major impact both on oral and general health as well ; as up to 70 % of smokers see their dentists each year, the dentist is in a very powerful position to intervene with the

227 Discussion smokers to help them stop smoking. A 4-step program was suggested for assisting patients to quit, based on the National Cancer Institute's protocol for the dental office. It involves identifying smokers, advising them to quit, providing assistance to patients trying to quit and following-up on patients as a means of enhancing success rates. Dentists who implement an effective cessation program in their practices can expect to achieve quit rates up to 10 to 15 %. Such a rate of success, if established nationwide and continued over a period of years, would markedly reduce the prevalence of tobacco use.

Reduction in tobacco consumption: At 7th day, participants in all 3 cessation modalities had decreased tobacco consumption. Alterations were noticed during the course of 1 year due to withdrawal symptoms and craving and at the end of one year; 49 (61.25%) participants from Group I, 21 (26.25%) participants from Group II and 37 (46.25%) participants from Group III had reduced their tobacco consumption. A relatively consistent pattern of reduction of tobacco use, regardless of intervention group was seen in the study similar to findings by Richmond RL et al (1993) 139. Habit reduction is one of the popular harm reduction strategies which is effective in reducing harm caused by continued tobacco/nicotine use, such as reducing the number of cigarettes smoked, or switching to different brands or products

Relapse to the original tobacco habit : In Group I 25 (31.25%) participants had relapsed to their former tobacco habit without any alterations ; in Group II, 45 (56.25%) participants had relapsed habit; while in Group III, 20 (25%) participants tobacco usage relapsed. Cornuz J et al (2008) 123 define tobacco use as a „„chronic condition that often requires repeated intervention‟‟ and reported better management of relapse for tobacco users seeking guidance and support form trained health care professional.

Participants were encouraged to visit the dental college at specified time point and also provided with the alternative of telephonic contact. After 30 days, personal reporting were highest by participants of Group III, followed by Group II and then Group I. This is similar to trend observed by Stevens VJ et al (1995) 111, telephone contacts were made approximately 1 to 2 weeks after. Of these subjects, 39% reported no tobacco at the time of the call. 60% reported that the intervention had helped them to cut down or stop their use of smokeless tobacco. Of those who were still using

228 Discussion tobacco at the time of the call, 71% reported that they were seriously considering quitting in the next 6 months and 42% set a specific quit date at the end of the call.

Withdrawal Symptoms: Jiloha RC (2010) 2 and Benowitz NL (2008) 138, describe that nicotine sustains addictive tobacco use, which in turn may lead to premature disability and death. The essence of drug addiction is loss of control of drug use. Molecular biology studies indicate that the alpha (4) beta (2) nicotinic acetylcholine receptor subtype is the main receptor mediating nicotine dependence. Nicotine acts on these brain nicotinic cholinergic receptors to facilitate neurotransmitter release (dopamine and others), producing pleasure, stimulation and mood modulation. Neuroadaptation develops with repeated exposure, resulting in tolerance to many of the effects of nicotine eg nausea.

When nicotine consumption stops - nicotine withdrawal syndrome ensues, characterized by irritability, anxiety, increased eating, dysphoria, and hedonic dysregulation, among other symptoms. Tobacco use specially smoking is also reinforced by conditioning, such that specific stimuli that are psychologically associated with tobacco use become cues for an urge to smoke. These include the taste and smell of tobacco, particular moods, situations and environmental cues. Pharmacotherapies to aid smoking cessation should ideally reduce nicotine withdrawal symptoms and block the reinforcing effects of nicotine obtained from smoking without causing excessive adverse effects. Further, given the important role of sensory effects of smoking and psychoactive effects of nicotine, counselling and behavioral therapies are important adjuncts to and substantially augment the benefits of pharmacotherapy. Russell (1986)8 demonstrated the persistent nature of nicotine by the fact that 48% of smokers in a UK study had been unable to abstain from smoking for any period in excess of 1 week in the previous 5 years. In the same study, craving was reported in 47% of smokers following attempts to stop. Similar to this study numerous studies also show a clear withdrawal syndrome (Benowitz, 1988). The symptoms include irritability, poor concentration, anxiety, restlessness, increased hunger, depressed mood and craving for tobacco (Hughes, 1992). Symptoms develop within 12 hours and can persist for 3 weeks, although appetite is increased for over 10 weeks (Benowitz, 1988). These symptoms also occur to some degree after withdrawal of nicotine replacement therapy (NRT) or smokeless tobacco suggesting that symptoms represent a physiological withdrawal from nicotine rather than a

229 Discussion behavioural response to the process of smoking cigarettes. Stolerman IP et al (1995)9 reported that over 50% of smokers said they wished to give up but only 13% thought they were likely to succeed. Only about 2% of smokers quit per year without professional advice or help. Furthermore, less than 20% of those embarking on an intensive treatment aimed at abstinence succeed for over 1 year. To put these facts into perspective, among smokers who suffered a heart attack, 40% return to smoking while still in hospital and 50% of those who have undergone surgery for lung cancer resume the habit. These facts clearly indicate a compulsion (an irresistible urge) to smoke.

Withdrawal symptoms were experienced as – on Day 7, 74 (92.5%) participants in Group I, 62 (77.5%) in Group II & 58 (72.5%) in Group III. The number of participants experiencing withdrawal symptoms decreased gradually over the period of 1 year till participants of Group II & III were better able to manage their withdrawal symptoms compared to Group I. At the end of 3 months 30 (37.5 %) participants of Group I, 22 (27.5 %) participants of Group II and 11 (13.75 %) participants of group III experienced withdrawal symptoms. At 6 months none of the participants reported withdrawal symptoms. Withdrawal symptoms varied according to modification of tobacco intake at different point of time by participants.

Off the total 240, 63 (26.25 %) participants experienced withdrawal symptoms; of these 6 SLT users, 40 were smokers and 17 were users of both SLT and smoking products. Weight gain, oral ulcerations, constipation, irritability, distractions and mood swings were the most commonly reported withdrawal symptoms reported by the subjects. 13 smokers reported weight gain and remaining 56 reported experiencing distractions and irritability occasionally accompanied by craving for tobacco. Constipation by 32 and Oral ulcerations were reported by 21 participants initially but by none after 3 months.

Cravings: On day 7, all participants in all 3 groups experienced craving for tobacco consumption. The craving gradually decreased but persisted till end of one year intervention period. At 12 months 53 (66.25 %) of Group I, 49 (61.25 %) of Group II and 32 (40 %) Group III experienced craving for tobacco consumption.

230 Discussion

Although NRTs usage was not analyzed as a part of current study; it was observed that withdrawal symptoms, cravings and relapse were better managed and less troublesome for those tobacco users who opted for cessation with the aid of NRTs.

Pradeepkumar AS (2008) 140 observed that although brief advice resulted in a quit rate of 55%, the relapse rate was 23%. Hatsukami D et al (1996) 127, as a part of their study noticed withdrawal symptoms through follow-up assessments made at 1, 6, and 12 months post treatment. Results showed that behavioural therapy or placebo gums were equally effective and superior to the minimal contact plus 2 mg of nicotine gum treatment in terms of abstinence. On the other hand, withdrawal symptoms were significantly reduced by nicotine gum, compared with placebo during the initial phases of cessation. The ineffectiveness of nicotine gum on treatment outcome may be attributed to its similarity with smokeless tobacco. Hatsukami DK et al (1997) 128 also reported limited effectiveness of primarily 2 mg nicotine gum only. Smith KD et al (2005) 129, state that NRTs, decreases cravings and short-term abstinence rates, but does not improve long-term abstinence. Behavioural interventions increase abstinence rates for smokeless tobacco users.

Association between intervention and type of product: Statistically the association between intervention and type of product was significant as indicated by p-value < 0.0001. Counselling according to the manual as seen in group III was most effective; 17 smokers and 6 SLT users were able to cease their tobacco use according to cessation manual designed as part of this study. The leaflet offered as a part of Group II was helpful for 7 smokers, 5 SLT users and 2 users of both smoking and smokeless products. Intervention in group I helped 6 SLT users to quit their tobacco use.

Final status of habit according to interventional modality: In Group I, 49 (61.25%) participants showed reduction in habit, 25 (31.25%) relapsed; while 6 (7.5%) participants totally quit tobacco usage. In Group II, out of 80, 45 (56.25%) relapsed, 21 (26.25%) had reduced habit; while 14 (17.5%) ceased using tobacco. In Group III, 37 (46.25%) participants had reduced, 23 (28.75%) had quit the habit and remaining 20 (25%) relapsed. The association between treatment modality and cessation attempt was highly significant with p-value < 0.0001; proving that guided cessation counseling was more helpful for tobacco cessation than other modalities. Tobacco cessation was maximum in Group III.

231 Discussion

Comparison of three modalities: Lancaster T et al (2005) 136 stated that self-help materials may increase quit rates compared to no intervention, but the effect is likely to be small. There is no evidence of additional benefit when used alongside other interventions such as advice from a health care professional or NRTs. Evidence favours that tailored materials for individuals are more although the absolute size of effect is still small. Advice and behavioural counselling can help smokers to quit. Giving the same type of support via written materials or other media has been marginally helpful, although there is likely to be a small benefit for people given no other support. Tailoring materials to provide individualized support is more effective. Gansky SA et al (2002) 137, reviewed studies where the cessation treatments shared 4 common components: oral cancer screening with feedback about SLT-related oral problems, tobacco cessation advice, self-help materials and a single session of cessation - Oral Screening/Brief Counselling It was concluded that tobacco users with interventions were twice as likely to quit. Collaboration between dental professionals and community partners such as school and college authorities was suggested. Ransing RS et al (2016) 144 recommend behavioural counselling however in the workplace rather than clinical setting where it has superior outcome in tobacco cessation and harm reduction than clinical setting. In addition, it is associated with low dropout rate and the cessation effect is maintained over a period of 6 months. Carr AB et al (2006)106 compared 14 clinical trials of dental interventions to usual care, no contact or less treatment intensive controls (all tobacco users), statistically significant increase in the odds of tobacco abstinence at 6 to 24 months is observed in patients receiving TCC. Raja M et al (2014) 149 stated that any intervention given to tobacco users from either cognitive behavioural therapy or basic health education, helped the patients in quitting habit of tobacco.

Cornuz J et al (2008) 123 highlight the non pharmacological interventions and state that medical advice to quit tobacco produces 1 year abstinence rates up to 5-10 % however this happens < 50 % of the time and one of the reasons for hesitation of health care professional is because they see very few of their patients follow their advice. Such advice may not be effective immediately but encourage future cessation attempt. Similar to our study the authors here suggested that tailored counselling methods should be preferred 150Recommended attitude is advising tobacco stoppage for every tobacco using patient. Tobacco cessation attempted on own, without

232 Discussion guidance such as cold turkey method leads to continuous craving, prolonged withdrawal symptoms and compensatory mechanisms such as more or deeper puffs per cigarettes. The 5 As method should be adopted and tobacco use for every patient should be documented in every visit which require only a few minutes of clinicians time. Cessation interventions provided to smokers during clinician–patient contacts have the aggregate potential to produce a dramatic enhancement of health. For the non pharmacological interventions suggested; Self-help interventions, such as written, generic materials, videos and audio material and, provided without personal support, have only a small effect on smoking cessation rates but are better compared with no intervention. Materials that are tailored to the tobacco users personal profile have better success.

Telephone-based access to counselling and smoking cessation resources increases cessation rates. The majority of help-lines provide access to individual counselling; the greatest amount of counsellor contact, the greater the likelihood of successful cessation.151 Patients often express interest in smoking cessation by hypnosis. Its popularity is understandable, because it implies smoking cessation without effort or distress but reviews of the literature have found insufficient evidence that hypnosis offers any additional treatment advantage above and beyond the behavioural and pharmacotherapeutic interventions that may be bundled together with it or recommended similar is the opinion for acupuncture 152, 153,154. Counselling is the most cost effective clinical intervention. Follow up and reassurance along with pharmotherapy is suggested for relapse. Motivation using 5 Rs i.e – relevance, risks, rewards, road blocks is suggested for tobacco users unwilling to quit. Combination of counselling & pharmacotherapy is essentially recommended as both pharmacologic and non pharmacologic component of nicotine dependence is managed. NRTs are the main stay of tobacco cessation pharmacotherapy. The chemical addiction of tobacco products is due to nicotine; NRTs provide this nicotine in controlled and safe form so the body doesn't have to endure nicotine withdrawal. This can be gradually tapered and eventually eliminated and also are devoid of many other harmful additives preset in tobacco products . Nicotine dependence treatments are effective in reducing relapses, increasing abstinence and increasing quit rates. NRTs are available as; Nicotine gum , Nicotine patch, Nicotine lozenges , Nicotine spray / inhaler and e cigarette s. However NRTs efficacy for SLT cessation yet remains to be proven.

233 Discussion

Interventions have shown to increase possibility of cessation many folds. However any intervention efforts will not be successful without sufficient motivation or „„readiness‟‟ to quit on the part of the tobacco user. Healthcare fraternity often explicitly expresses lack of training and resulting lack of confidence in conducting communication for tobacco cessation. Thus the rationale behind forming a manual for tobacco cessation stressing more upon the aspect of behavioural counselling 113 ,155.

234 Conclusion

5.5 Conclusion

240 tobacco users were administered three different types of tobacco cessation interventions.

Group I: By verbal instructions (Brief cessation intervention)

Group II: By providing information about cessation process via self help leaflet

Group III: Planned tobacco cessation counseling according to manual designed as part of this project

Following conclusions can be drawn from the present study;

1. Tobacco users from 3rd to 6th decade participated in the intervention program with the mean age of 32.5 years. It can be concluded that participants < 20 years and > 60 years were less keen on tobacco cessation.

235 Conclusion

2. More males 184 (76.67 %) than females 56 (23.33%) consented for the tobacco cessation intervention.

3. Participants from SES II (73.33%) participated more in cessation interventions. Relatively less participants from SES I and SES III (13.33% each) consented for the tobacco cessation intervention.

4. Smokers (51.25%) were keener for tobacco cessation than SLT users (35.42%), users of both Smoking and SLT products (13.33 %) showed least enthusiasm for participation in cessation programs. This may be attributed to greater awareness among smokers, which is a result of more stress of the awareness programs on smoking hazards. Reluctance among users of both types of tobacco products may be because of their greater dependency on nicotine and resulting lower confidence in cessation attempt.

5. 83 (34.58%) had attempted tobacco cessation previously while 157 (65.42%) had not. Among those who had attempted cessation previously 36 attempted due to advice from others while 25 on advice of health care workers.

6. During the initial days of the cessation intervention tobacco users fully comply with the cessation plan as advised however compliance gradually decreases due to withdrawal symptoms and cravings. Greater compliance is noted among Group III that is counselling participants and among older participants.

7. One on one counselling is more helpful for habit cessation (Group III 28.75%) compared to self help material (Group II 17.5%) and brief cessation counselling (Group I 7.5%).

8. At 7th day participants in all 3 cessation modalities had decreased tobacco consumption. Alterations were noticed during the course of 1 year due to withdrawal symptoms and cravings at different times for different participants. At the end of one year 49 (61.25 %) participants from Group II and 37 (46.25%) participants from Group III had reduced their tobacco consumption. Habit reduction is considered as positive development as it is an harm reduction alternative and motivating factor for future cessation attempts.

236 Conclusion

9. Possibility of relapse decrease substantially for tobacco users undergoing guided TCC (Group III - 25 %) than self help material (Group II - 56.25%) and brief cessation counselling (Group I - 31.25%). Relapses were maximum in first 15- 45 days of cessation attempt and were noted up to 3 months. It can be deduced that heightened withdrawal symptoms during initial period of cessation attempt can lead to more relapses during this period.

10. Support from structured TCC sessions (Group III) and self help material provided in (Group II) are more helpful in managing withdrawal symptoms which were reported on Day 7 by 74 (Group I) , 62 ( Group II) and 58 (Group III). This decreased and at the end of three months withdrawal symptoms were reported by 30 (Group I), 22 (Group II) and 11 (Group III). At six months none of the participants reported withdrawal symptoms.

11. Smokers experience more withdrawal symptoms. At the end of 3 months 63 (26.25 %) participants experienced withdrawal symptoms – SLT users.

12. As seen in the literature withdrawal symptoms occurred up to 10 –12 weeks of cessation intervention and subsided gradually. Weight gain (13 smokers), oral ulceration (21), constipation (32), irritability and distractions (56) and mood swings were most commonly reported withdrawal symptoms.

13. Cravings differ from withdrawal as craving is merely an urge whereas withdrawal is a reaction. Previous literature does not comment on craving; however cravings may persist longer than withdrawal and may be an important factor for possible relapses. On day 7 all participants across all 3 groups experienced cravings for tobacco consumption. The cravings gradually decreased, at the end of 1 year cravings were reported by 53 (Group I), 49 (Group II) and 32 (Group III).

14. Guided counselling as per manual (Group III) proved to be more helpful for smokers and users of mixed tobacco. Warnings were most effective for SLT users. Self help materials (Group II) effectiveness depended largely upon participant‟s compliance and could not be co related with product. Statistically

237 Conclusion

the association between intervention and type of product was significant (p <0.0001)

15. Structured TCC as per the manual designed as a part of this study, Group III - lead to maximum cessations 23 (28.75 %), least relapses 20 (25 %) and considerable habit reductions 37 (46.25 %). In Group I - cessations 6 (75 %), relapses 25 (31.25 %) and habit reductions 49 (61.25 %). Group II - cessations 14 (17.5 %), relapses 45 (56.25 %), and habit reductions 21 (26.25 %). The association between treatment modality and cessation attempt was highly significant ( p < 0.0001)

16. Among the participants of this study it can be concluded that better compliance was noted among older individuals > 41 years , SES II and equal among males and females.

17. 198 participants had symptomatic or asymptomatic clinically visible tobacco induced lesions or conditions thus confirming findings in the literature that unless a tobacco users experiences a health issue resulting from the habit he /she will not consider alteration of the habit.

18. NRTs (2 mg and 4 mg nicotine gums) combined with cessation counselling helped 22 tobacco users with their cessation attempt ( 19 cessations & 3 reductions ) ; which is in agreement of previous literature that NRT along with TCC has better chance for habit cessation .

19. This study conclusively proves the effectiveness of TCC in dental set ups. Guided counselling is statistically proven to be more effective than self-help or brief counselling but these two are still more effective than no intervention at all. TCC should be integrated in dental curriculums.

238 Scope, Limitation & Implications

Scope, Limitation & Implications

The doctoral study “Evaluation of the effectiveness and impact of tobacco de- addiction tool in the context of present anti-tobacco campaigns” was a hospital based cross sectional study that aimed to;

1. To assess the knowledge, attitude and practices of tobacco users and to evaluate their responses towards current anti-tobacco measures.

2. To study whether on-going anti-tobacco measures increased the awareness level amongst the population about the hazards of tobacco consumption and encouraged tobacco cessation.

3. To develop a tobacco cessation counselling manual (to be used by dentists, primarily) for assisting tobacco users in habit cessation.

4. To evaluate the effectiveness of tobacco cessation manual.

239 Scope, Limitation & Implications

Scope:

1. Tobacco industry is a highly profitable lobby offering many with livelihood on one hand and hazardous, carcinogenic addictive substance on the other. So far legislations banning tobacco in India have not been implemented. However numerous anti-tobacco measures aligning with WHO and other international bodies have been implemented here.

2. Tobacco addiction produces neurobiological and behavioural changes, and optimal approaches combining behavioural methods and pharmacotherapy need to be developed

3. Given the high global morbidity and mortality from tobacco use in India, there is a need to develop evidence-based, cost-effective interventions for both smoking and smokeless tobacco studies.

4. Literature suggest that India is one of the proactive and leading nations in initiating tobacco cessation measures however these measures are not meeting expectations in controlling the tobacco habit and bringing about cessation.

5. The scope of this study was firstly to study knowledge, attitude and perception of tobacco users about their habit.

6. Studying the awareness among general population about harmful effects of tobacco and different anti-tobacco measures reflect on the success of such efforts comprising of legislations, regulations and campaigns.

7. Attitude about tobacco consumption, reason for initiation and continuation of habit, sensitivity to anti-tobacco messages highlight participants understanding of the gravity of the situation and intention to quit the habit.

8. Practices observed and inquired as a part of this study were helpful in understanding the need and habit of tobacco and in formulating practical solutions to be offered to tobacco users while attempting cessation.

240 Scope, Limitation & Implications

9. India does not fit into global model of tobacco use due to very high consumption of tobacco here that to as many different preparations. Studies such as these will help in understanding the mind-set of tobacco using population and the barriers in thematerialisation of such campaigns in bringing about tobacco cessation.

10. The main purpose of the study is to assess the contributions of community- based interventions to public health, with an overall goal of providing insight into the nature of community change, as both a process and an outcome of health promotion efforts.

11. Results from this population-based study that screening and tobacco cessation advice are underutilized in the dental practice. Increased patient awareness and implementation of screening and tobacco cessation interventions could reduce oral cancer incidence and mortality and have a public health benefit for other tobacco-related morbidity as well.

12. A structured tobacco cessation guide is more helpful in guiding tobacco users for attempting cessation and encountering withdrawals and cravings.

13. Manual and self-help leaf let used in this study have the scope to be developed for clinical utility.

14. Oral health care professionals are aware of their responsibility to advise patients to stop using tobacco. However, they do not feel sufficiently prepared to help their patients to quit, and consequently are not confident in providing these preventive measures. This fact reflects the lack of emphasis on tobacco cessation in both dental undergraduate education. It may therefore be assumed that improvement of dental education in tobacco use cessation counselling may result in increased self-confidence and frequency of its provision. The importance of making space in the curriculum for tobacco use prevention and cessation has to be emphasized.

241 Scope, Limitation & Implications

15. Dental schools have to be reminded of the key role the dental profession has in tobacco control. Next to the public health aspect of tobacco control, such involvement may be both an ethical and a legal responsibility.

16. The implementation of effective tobacco use prevention and cessation in a dental educational setting requires a multidisciplinary approach involving teaching personnel and external experts. In general, a knowledge base attained through lecture, Problem-Based Learning (PBL), or E-Learning, and clinical skills attained through clinical instructions and practices is required. It is suggested that curriculum content should include (1) the biological effects of tobacco use, (2) the history of tobacco culture and psychosocial aspects of tobacco use, (3) prevention and treatment of tobacco use and dependence, and (4) development of clinical skills for tobacco use prevention and cessation.

Limitations:

1. Larger sample size would further corroborate findings of this study.

2. A disadvantage of the questionnaire method, especially when the instrument is administered by personal interview, is that a respondent may give what is perceived as a socially desirable response because a truthful response would

be socially embarrassing. To minimize this tendency, respondents were informed before each interview of the confidentiality of the study. Every effort was made to ensure that the respondents understood that no information that they gave would be used against them.

3. The present study also contained a potential for gender-bias by considering majority of male participants. Still a similar gender ration is observed in existing literature. This was due to high non-response rate amongst women. Reliability of obtaining genuine responses from 12 to 17 years old was also doubtful because of fear being humiliated or being caught in the situation although attempts were made to develop trust before proceeding.

4. Due to unavailability of similar types of studies in which solely tobacco addictions were considered, this prevalence rate could not be compared. Most

242 Scope, Limitation & Implications

of the similar type of studies either considered tobacco or alcohol or areca nut consumption together.

5. Socioeconomic differences in tobacco use have been reported, but there is a lack of evidence on how they vary according to types of tobacco products used thus limiting the comparison of socio economic findings of the present study.

6. Even with the limitations of this design, significant differences between the intervention, in form of counselling, self-help materials and routinely adopted methods of brief cessation counselling were found however studies having similar comparisons were not available.

7. A major public health challenge of this century is finding a way to harness the powerful influence of the media to curtail tobacco use. This study highlights the important process of understanding the full extent of this influence, among most vulnerable populations. However evaluation of outcomes to date has been limited. Only a few studies have examined how high smoking prevalence groups respond to these warnings thus limiting comparison of our results.

8. During pilot phase of this study hesitant responses were obtained for factors of perceptions based on religious, racial, ethnic back grounds; factors of alcoholism, substance abuse and tobacco use combined, tobacco price and effect on family life hence these factors were not considered.

9. While questioning the impact of movies, media and celebrities’ popular sequences and actors were not short listed like international studies.

10. Nicotine replacement therapy was not considered with the rationale of its limited impact on SLT users and lack of communication skills among clinicians for designing a custom cessation program for which a protocol needed to be designed.

Implications: Although studies assessing the barriers in implementing tobacco cessation in dental practices and self-perceived barriers were reported earlier, studies assessing oral perception of patient’s receptivity for the same were limited. To the

243 Scope, Limitation & Implications best of our knowledge, this is the first of its kind reporting from India where the burden of diseases due to tobacco is high.

1. Studies like these, where in depth analysis of tobacco use habit and mind set of tobacco users are analysed should be conducted on larger scale as these offer insight regarding barriers to overcome for success of anti-tobacco cessation measures.

2. In recently times many countries have issued guidelines on treating tobacco use and dependence providing evidence-based, practical methods for dentists and other health care providers to incorporate into their practice.

3. Because dentists and clinicians can be effective in treating tobacco use and dependence, the identification, documentation and treatment of every tobacco user they see need to become a routine practice in every dental office and clinic.

4. It is highly recommended that tobacco control content should be integrated in health science curriculum and that dental professionals must expand their armamentarium to include TCC strategies in their clinical practice.

5. The dental institutions should include TCC in the curriculum and the dental professionals at the primary and the community health care level should also be trained in TCC to treat tobacco dependence.

6. The manual designed as part of this study can be referred by clinicians and health science education students alike to learn about basics of tobacco cessation.

Further studies are required to identify the reasons for the modest impact of many community-based prevention programs. To determine the extent to which such programs target change in the social environment as well as at the individual level. To determine magnitude of effects can be expected from community health promotion programs and if community participation increases the overall effectiveness of a program. Additional studies are needed on the various factors that can influence a

244 Scope, Limitation & Implications policy’s effectiveness and feasibility such as cost, local context, political barriers and implementation strategies.

Tobacco use prevention (TUC) guidelines need to be designed form undergraduate education to practising clinicians as well. Most practising dental professionals have not been trained in TUC and so current and future guidelines need to be adapted for continuing education. It is important to motivate dental professionals to be involved in TUC. Brief advice and enhanced interventions can be incorporated into routine practice. It is recommended that TUC continuing education on these interventions should be provided by a team of dental and trans- disciplinary experts. The international dental professional organisations can provide important 'benchmarks' for minimum clinical standards and for the involvement of both national dental organisations and individual dental health professionals in TUC continuing education

Further studies are also recommended on population groups to motivate tobacco users towards the habit cessation to improve their oral and general health. However, this study is of importance since provides information on the attitude of patients towards tobacco cessation counselling by dentist.

245 Possible Contributions & Translatory Component

Possible Contributions & Translatory Component

Translatory Component:

1. In recently times many countries have issued guidelines on treating tobacco use and dependence providing evidence-based, practical methods for dentists and other health care providers to incorporate into their practice.

2. Because dentists and clinicians can be effective in treating tobacco use and dependence, the identification, documentation and treatment of every tobacco user they see need to become a routine practice in every dental office and clinic.

3. It is highly recommended that tobacco control content should be integrated in health science curriculum and that dental professionals must expand their armamentarium to include TCC strategies in their clinical practice.

246 Possible Contributions & Translatory Component

4. The dental institutions should include TCC in the curriculum and the dental professionals at the primary and the community health care level should also be trained in TCC to treat tobacco dependence.

5. Tailor made cessation advice keeping in mind socio cultural variables have proven to be more effective.

6. The manual designed as part of this study can be used : i. To disseminate the Oral Screening/Brief Counselling to dental practitioners via workshops that provide skills training, including actual or simulated counselling and modelling by dental professionals.

ii. To prepare dental students to be proficient in this evidence-based model so that it can become part of routine oral healthcare.

iii. Update surveys of oral healthcare practitioners to document current oral cancer screening and tobacco prevention and cessation activities.

iv. Conduct surveys of dental educational programs to determine oral cancer screening and tobacco-related curriculum content.

v. Develop and implement guidelines for dental insurance coverage of tobacco use assessment and treatment.

vi. Involve dental professionals in applying the Oral Screening/Brief Counselling Model in community settings, especially in youth athletic programs in order to contribute to oral health beyond the dental office.

7. Studies like these, where in depth analysis of tobacco use habit and mind set of tobacco users are analysed should be conducted on larger scale as these offer insight regarding barriers to overcome for success of anti-tobacco cessation measures.

8. Similarly more researches should be conducted to identify the habit pattern of tobacco users in order to identify barriers in cessation process and offer practical solutions to them with reference to their socio economic, cultural and demographic context.

247 References

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119. Elango J K, Sundaram KR, Gangadharan P, Subhash P, Peter S, Pulayath C and Kuriakose MA. Factors affecting oral cancer awareness in a high-risk population in India. Asian Pacific J Cancer Prev.2009; 10: 627-630.

120. Murugaboopathy V, Ankola AV, Hebbal M and Sharma R. Indian Dental Students’ Attitudes and Practices Regarding Tobacco Cessation Counseling. Journal of Dental Education. 2013; 77 (4): 510- 517.

121. Ajagannanavar SL, Alshahrani OA, Jhugroo C, Tashery HM, Mathews J and Chavan K. Knowledge and perceptions regarding nicotine replacement therapy among dental students in Karnataka. J Int Oral Health 2015; 7(7):98- 101.

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123. Cornuz J and Willi C. Nonpharmacological smoking cessation interventions in clinical practice. Eur Respir Rev. 2008; 17: 187-191.

124. Fiore MC, Jaen CR and Baker TB et al. Treating tobacco use and dependence: 2008 update. Rockville, US Dept of Health and Human Services, 2008. Available fromwww.ahrq.gov/path/tobacco.htm

125. Garvey AJ. Dental office interventions are essential for smoking cessation. J Mass Dent Soc. 1997; 46(1):16-9.

126. Sinusas K and Coroso JG. Smokeless tobacco cessation: report of a preliminary trial using nicotine chewing gum. J Fam Pract. 1993 Sep; 37(3):264-7.

127. Hatsukami D, Jensen J , Sharon A, Grillo M and Bliss R. Effects of behavioral and pharmacological treatment on smokeless tobacco users. Journal of Consulting and Clinical Psychology. 1996; 64 (1):153 161.

128. Hatsukami DK and Boyle RG. Prevention and treatment of smokeless tobacco use. Adv Dent Res. 1997; 11(3):342-9.

129. Smith KD, Scott MA, Ketterman E and Smith PO. Clinical inquiries. What interventions can help patients stop using chewing tobacco? J Fam Pract. 2005; 5 4 (4):368-9.

130. Frieden TR and Blakeman DE. The Dirty Dozen: 12 Myths That Undermine Tobacco Control. Am J Public Health.2005; 95:1500 – 1505.

131. Bhargava S. Need of Oral Pre Cancer Awareness Initiatives in India. The Open Dentistry Journal. 2016; 10: 417-419.

132. Gururaj and Maheshwaran. Kuppuswamy’s Socio-Economic Status Scale – A Revision of Income Parameter For 2014. International Journal of Recent Trends in Science and Technology. 2014; 11(1): 1-2.

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134. Vijayan VK, Kumar R. Tobacco cessation in India. Indian J Chest Dis Allied Sci 2005; 47 (7): 5-8.

135. Campbell HS, Mona S, Trey P. Patients perception of tobacco cessation services in tobacco cessation services in dental offices. J Am Dent Assoc 1999; 130(1):219-25.

136. Lancaster T and Stead LF. Self-help interventions for smoking cessation. Cochrane Database of Systematic Reviews 2005 (3).

137. Gansky SA, Ellison JA, Kavanagh C, Hilton JF and Walsh MM. Oral Screening and Brief Spit Tobacco Cessation Counseling: A Review and Findings. JDE 2002; 66(9):1088-98.

138. Benowitz NL. Neurobiology of nicotine addiction: implications for smoking cessation treatment. Am J Med 2008; 121(4 Suppl 1): S3-1.

139. Richmond RL, Makinson RJ, Kehoe LA, Giugni AA and Webster IW. One- year evaluation of three smoking cessation interventions administered by general practitioners. Addictive Behaviors 1993; 18: 187- 199.

140. Pradeepkumar AS, Thankappan KR, Nichter M. Smoking among tuberculosis patients in Kerala, India: Proactive cessation efforts are urgently needed. Int J Tuberc Lung Dis 2008; 12:1139-45.

141. Jha P, Jacob B, Gajalakshmi V, Gupta PC, Dhingra N, Kumar R, et al. A nationally representative case-control study of smoking and death in India. N Engl J Med 2008; 358:1137-47.

142. Murthy P and Saddichha S. Tobacco cessation services in India: Recent developments and the need for expansion. Indian Journal of Cancer 2010 ; 47 (Suppl 1) : S69 -S74.

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143. Tobacco Cessation Services in the South-East Asia Region. TFI Newsletter (WHO SEARO) 2009; 2:1-6.

144. Ransing RS, Patil DB, Desai MB, Modak A. Outcome of tobacco cessation in workplace and clinic settings: A comparative study. J IntSoc Prevent Communit Dent 2016;6:487-92

145. Callum C. The Smoking Epidemic. London: Health Education Authority.1998

146. Benowitz NL. Pharmacologic aspects of cigarette smoking and nicotine addiction. New England Journal of Medicine.1988 ; 319 : 1318–1330

147. Nagler RH, Puleo E, Sprunck-Harrild K, Viswanath K, Emmons KM. Health media use among childhood and young adult cancer survivors who smoke. Support Care Cancer. 2014 Sep; 22(9):2497-507.

148. Parrott S, Godfrey C, Raw M et al. Guidance for commissioners on the cost effectiveness of smoking cessation interventions. Thorax .1998 ; 53 (suppl. 5), S2–S37

149. Raja M, Saha S, Mohd S, Narang R, Reddy LVK and Kumari M. Cognitive Behavioural Therapy versus Basic Health Education for Tobacco Cessation among Tobacco Users: A Randomized Clinical Trail. JCDR 2014; 8(4): ZC47-ZC49.

150. Prochaska JO, Di Clemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol 1983; 51: 390–395.

151. Ossip-Klein DJ, McIntosh S. Quitlines in North America: evidence base and applications. Am J Med Sci 2003; 326: 201–205

152. Fiore MC, Jaen CR, Baker TB, et al. Treating tobacco use and dependence: 2008 update. Rockville, US Dept of Health and Human Services, 2008. Available from www.ahrq.gov/path/tobacco.htm#Clinic Last updated: May 2008.

153. Abbot NC, Stead LF, White AR, Barnes J, Ernst E. Hypnotherapy for smoking cessation. Cochrane Database Syst Rev 2000; 2: CD001008. 20

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154. White AR, Rampes H, Campbell JL. Acupuncture and related interventions for smoking cessation. Cochrane Database Syst Rev 2006; 1: CD000009.

155. Gonmei D, Shanbhag N, Puranik MP. Strategies for Tobacco Cessation Counseling by Dental Personnel. Int J Adv Health Sci 2015; 2(1):33-41.

156. NIH US National library of medicine. Profiles in Science. The reports of the surgeon general. The 1964 report on smoking and health.

157. Cook TD, Campbell, DT. Quasi-Experimentation; Design and Analysis Issues for Field Settings. Boston, MA: Houghton Mifflin Company, 1979.

158. Damato S, Bonatti C, Frigo V and Pappagallo S et al. Validation of the Clinical COPD questionnaire in Italian language. Health and Quality of Life Outcomes 2005, 3:9.

159. Shimkhada R and Peabody JW. Tobacco control in India. Bulletin of the World Health Organization 2003; 81:48-52.

160. Jandoo T and Mehrotra R. Tobacco Control in India: Present Scenario and Challenges Ahead. Asian Pacific J Cancer Prev 2008; 9, 805-810.

161. Chaly PE, Tobacco control in India. Indian J Dent Res 2007; 18:2-5.

162. Courtesy - Ranade A. Tobacco Intervention Initiative. Lecture I.

163. www.who.int/fctc. WHO Framework Convention on Tobacco Control. World Health Organization. 2003.

164. Soni P and Raut DK. Prevalence and Pattern of Tobacco Consumption in India. Int. Res. J. Social Sci. 2012; 1(4) : 36-43.

165. Tobacco use: A smart guide NCCP.WHO Helping people quit tobacco. 2010.

264 Annexures

Annexure I

KUPPUSWAMY CLASSIFICATION OF SOCIOECONOMIC STATUS – 2014 132

Modified adaptation for present study:

Class according to Scale Classes Clubbed together for easier understanding I Upper (I) II III Middle (II) IV V Lower (III)

i Annexures

Annexure II CONSENT FORM

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eS &&&&&&&&&&&&&fy[kdj nsrk @ nsrh gqWa dh] MkW&&&&&&&&&&&&&}kjk 'kks/k izdYi ds fy, dh tkusokyh tkWap ds fy, lger gqWaA mUgksaus bl ckjs esa iq.kZ :i ls tkudkjh nh gSA eq>s bl tkWap ds fy, fdlh Hkh rjg ls ck/; ugh fd;k x;k gS o eS LosPNk ls blds fy, lger gqWaA eS mUgsa lgdk;Z djus dk opu nsrk @ nsrh gqWA

I ………………………………………………..……….. hereby consent to Dr.Stuti Bhargava perform procedure related to the study (tobacco cessation counselling) as previously explained to me. I have carefully understood the study & agree to it as my own free will & in my complete consciousness, without any undue influence. I also agree to co-operate fully with her.

Date:

Place: Signature of Patient

Name- ………………………………..

ii Annexures

Annexure III INTERVIEW QUESTIONNAIRE

Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti tobacco campaigns

Principal Investigator: Dr. Stuti S.Bhargava Guide: Dr. Rahul Bhowate

Vital Information:

1. Name: 2.Age /sex: 3. Education: 4. Occupation:

5. Accommodation: a. alone b. with friend’s c. with spouse d. with spouse & children e. with parent’s f. joint family g. home h .hostel i. others

6. Socioeconomic background: a. Low b. Middle c. High

Questionnaire:

1. Do you use tobacco /tobacco product: a. Yes b.No

2. Age of start of tobacco use: ______

3. Duration: ______

4. Frequency: ______

5. Why did you start consuming tobacco product: a. experimentation b. adventure c. imitating celebrities d. imitating family members e. peer pressure f. influence of friend circle g. it looks cool h. was advised for __

5.h . 1. Constipation 2. Exertion / exhaustion 3. Night shifts 4. Body pain 5. Dental pain 6. Acidity 7. Quit smoking 8. Energy 9.concentrataion 10. Dentrifrice

6. What type of tobacco product do you use: a .bidi b. Cigarettes c. Cigar d. Pipe e. Hooka f. Pan Quid g. Kharra h. hand rolled i. khaini j. gutkha k. Jarda l. tobacco pouch m. snuff n. other

7. Using same tobacco product from beginning: a. Yes b. No c. Change if any ______

7.c. 1. More products 2. Lesser products 3. Concentrated forms 4. Less concentrated product

8. From your initial days of tobacco use has your consumption: a. increased b. decreased c. remained the same d. increased and decreased intermittently

9. Awareness of harmful effects of tobacco when the habit started: a. Yes b. No c. Misconceptions ______

iii Annexures

9c. 1.Remedy/ health benefits 2. Less concentration -no harm 3. Can be easily given up 4. Preparation not harmful

10. Reason for continued habit: a. professional stress b. personal stress c. Feels good after tobacco use d. as a remedy e. wasn’t aware of harmful effect f. Habituated g. unable to quit h. other ______

11. How do you get the tobacco product: a. buy the product b. friends’ c. Family d. work colleagues

12. How soon after waking up, you consume tobacco: a.15 mins b. 30 mins c. 60 mins d. Later ______

13. Company during tobacco use: a. alone b. friend’s c. colleague’s d. family member’s ______

13.d. 1. Brother 2. Mother 3. Mother in law 4. Sister in law 4.sister 5. Aunt 6. Uncle 7. Children 8.many

14. Do you consume tobacco in presence of non tobacco users in the family: a. Yes b. No

15. Do you consume tobacco in presence of children & younger family members: a. Yes b. No

16. When do you consume tobacco products: a. at home b. While commuting c. working d. during breaks

17. Where is your usual place of tobacco consumption: a. home /hostel b. Work c. Restaurant d .pan kiosk e. friends place f. place of hang out g. others ______

18. Who know about your habit: a. Parents b. spouse c. siblings d. Children e. Friends f. colleagues’ g. None h. Others ______

19. How do you feel after tobacco consumption? a. Relaxed b. alert c. increased concentration d.high e. depressed f. performance enhanced g. Good h. Bad i. nothing specific j. Energetic k. Awake l. other

20. How do you feel if you do not consume tobacco? a. Irritated b. anxious c. headache d. breathlessness e. decreased concentration f. Nauseous g. Distracted h. nothing specific i. Good j. other ___ k. tired

21. Are you aware about different tobacco preparations eg. kharra / jarada /gutka etc: a. Yes b. No

22. Are you aware of ill effects of tobacco: a. Yes b.No

23. Are you aware that tobacco containing preparations are also harmful: a. Yes b. No c. Misconceptions

23. c 1. Not small amounts 2. Preparations have small amounts 3. Very less intake to cause harm 4. Harms only older individuals 5. Only smoking is harmful

24. Are you aware of tobacco on various organs: a. yes b. no

iv Annexures

25. If yes, which effects are you aware off: a. Oral cavity b. lungs c. male fertility d. on foetus e. others f. none 26. Have you ever tried to stop tobacco use: a. Yes b. No Why? ______26.c 1.misconceptions 2. Unawareness 3. Dependency 4. Staining of teeth 5 . Nothing specific 6. Awareness 7. Was advised in camp 27. How long have you stayed without consuming tobacco: a.____ days b. ______wks c. ______mnths d._____ yrs e. don’t remember 28. Did you restart the habit: a. Yes b. No c. Never discontinued If yes why ______28.a. 1. Craving 2. Stress 3. Withdrawal symptoms 4. Peer pressure 29. Have you seen ads mentioning harmful effects & statutory warnings about tobacco: a. Yes b. No

30. Medium of information: a. print b.TV c. camps d. hoardings e. movie halls f. public places g. public transport h. work place i . Packaging j. internet k. others l. none 31. What did you note about tobacco cessation infomercials: a. Patients images b. patients stories c. warning d. advice e. help line number f. treatment center g. other ______h. Nothing i. developed misconceptions ______31. i. 1. only smoking is harmful 32. How do you react to such information: a. noticed it b. ignored it c. felt uncomfortable d. want to quit tobacco e. scared of tobacco induced cancer f. quit habit g. reduced habit h. no reaction i. noticed but did not alter the habit 33. Are you willing to quit tobacco use? a. Yes b. No

34. Are you aware of NRTs: a. Yes b. No

35. What do you require to quit the habit: a. NRT b. Other Medication ______c. Information d. Guidance for habit stoppage e. counselling for habit stoppage f. nothing

35 b. 1. Constipation 2.stress relief 3. Energy 4. Pain relief

36. Despite the ban are you able to accesses tobacco products? a. Yes b. No

37. What are your inputs for improving the no tobacco campaign?

37 . 1. more camps 2. NRT availability 3. Awareness about smokeless 4. Ban sale near schools /collg /hostel 5. Tips for cessation 6. More one on one facility 7. none 8. Satisfied 9. Cheap NRT 10. NRT in curriculum

Clinical Examination: Lesions if any :

I willingly &consciously consented to answer the above questionnaire: ______

v Annexures

Annexure IV

INTERVENTION RECORD SHEET

Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti tobacco campaigns

Principal Investigator: Dr. Stuti S. Bhargava Guide: Dr. Rahul Bhowate

1. Do you consume tobacco products now: a. Yes b. No

2. Have you attempted tobacco cessation before: a. Yes b. No

2 (i). If yes attempted: a. on own b. Health care workers advice c. Advice of others

3. Are you willing for tobacco cessation: a. Yes b. No

4. What do you prefer for cessation -

a. Verbal instructions about harmful effects of tobacco and habit cessation b. Written Information about harmful effects of tobacco and habit cessation c. Cessation Counselling Sessions over period of 45 days

Cessation Attempt:

5. Day 1:

(i) Did you find the session helpful l: a. Yes b. No (ii) Have you decided to attempt tobacco cessation as explained: a. Yes b . No

6. Day 7: A Observation i. Subject ii. Availability iii. Response Available Yes No In person Telephonically Positive Negative Reluctant

vi Annexures

B. Subjects Response:

i) Have you attempted the tobacco use cessation as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same iib) If Decreased how ______iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No . Nature ______v) Craving: a. Yes b. No 7 . Day 15: A Observation i. Subject ii. Availability iii. Response Available a. b. a. b. a. b. c. Yes No In person Telephonically Positive Negative Reluctant

B. Subjects Response:

i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same ii b) If Decreased how ______-_ iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No . Nature ______v) Craving: a. Yes b. No

8 . Day 30: A Observation

i. Subject ii. Availability iii. Response Available a. b. a. In b. a. b. c. Yes No person Telephonically Positive Negative Reluctant

vii Annexures

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______iii) Willing to continue cessation attempt: a. Yes B. No iv) Withdrawal symptoms: a. Yes B. No . Nature ______v) Craving: a. Yes B. No

9 . Day 45: A Observation i. Subject ii. Availability iii. Response Available a. b. a. In b. a. b. c. Yes No person Telephonically Positive Negative Reluctant

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______-_ iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No. Nature ______v) Craving: a. Yes b. No

10. After 3 months: A Observation

i. Subject ii. Availability iii. Response Available a. b. a. b. a. b. c. Yes No In person Telephonically Positive Negative Reluctant

viii Annexures

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No. Nature ______v) Craving: a. Yes bs. No

11. After 6 months: A Observation

i. Subject ii. Availability iii. Response Available a. b.No a. b. a. b. c. Yes In person Telephonically Positive Negative Reluctant

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______-_ iii) Willing to continue cessation attempt: a. Yes b. No. Nature ______iv) Withdrawal symptoms: a. Yes b. No v) Craving: a. Yes b. No

12. After 9 months: A. Observation

i. Subject ii. Availability iii. Response Available a. b. a. b. a. b. c. Yes No In person Telephonically Positive Negative Reluctant

ix Annexures

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______-_ iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No v) Craving: a. Yes b. No

13. After 12 months: A Observation i. Subject ii. Availability iii. Response Available a. b. a. In b. a. b. c. Yes No person Telephonically Positive Negative Reluctant

B. Subjects Response: i) Have you attempted the tobacco use cessation plan as suggested: a. Yes b. No ii) Habit status: a. increased b. Decreased c. Relapsed d. ceased e. Same II b. If Decreased how ______-_ iii) Willing to continue cessation attempt: a. Yes b. No iv) Withdrawal symptoms: a. Yes b. No Type : v) Craving: a. Yes b. No

14. Final status:

a. Ceased the habit b. Reduced the habit c. Relapse

15. Since: ______

x Annexure - V You can delay tobacco craving by:

Tobacco Cessation Information Leaflet 1. Drink water / citrus fruit juices slowly

Say No to Tobacco 2. Deep breathe / meditate

3. Do something else (exercise) / distract 4. Delay the urge to smoke

5. Avoid people /places of tobacco use

You can stop the tobacco use by:

 Quit cold turkey – Suddenly

Dr. Stuti Sharad Bhargava Dr. Rahul Bhowate OR Contact: 9096843907  Quit one day at a time by deciding a Quit date

You are a tobacco user if you: Keep yourself well hydrated & Practice the delay approach 1. Smoke - cigarettes, bidi , hooka , cigar , chillum 2. Consume - tobacco, kharra , gutkha , kahini jarda , You are 4 times likely to quit with the help of a health care specialist.

pan quid with tobacco , snuff or nass

Tobacco & its preparations may be smoked, chewed or sniffed. Quit tobacco for improvement of your health & improvement of your

& your family s quality of life Tobacco can severely damage your overall health. Be proud that you are ceasing tobacco use Tobacco cessation has several benefits & improves quality of life..... Contact: 9096843907 Stop tobacco & save your life!!!!

Benefits of Tobacco contains nicotine an addictive substance. Tobacco cessation: Both Smoking & smokeless form of tobacco has contain various cancer

causing agents

Potential health risks from tobacco include:

1. Increased risk of diseases of heart, vessels & stroke 2. Cancer – lungs, mouth, tongue, larynx, nose & sinuses, throat,

oesophagus, stomach, bladder, kidney, pancreas, cervix, colon & rectum Benefits from smoking cessation: 3 Problems with reproductive system & congenital problems in new born It is never too late to stop smoking; the benefits begin as soon as you stop. 4. Tooth loss, bad breath, staining & gum problems 5. Ageing & poor wound healing Within 20 minutes - BP, pulse rate return to normal 6. Health risk from second hand smoke to your near & dear ones. Within 8 hrs - the oxygen level in blood will be normal Within 24 hrs - chances of heart attack & stroke reduce Tobacco cessation will eliminate these risks Within 48 hrs - lungs clear & ability to smell & taste improve Within72 hrs - breathing becomes easier & energy levels increase. Within 2 -12 wks – circulation improves , less chances of clot Within 5 yrs - the risk of a heart attack falls to about half Within 10 yrs - risk of heart & lung disease is same as someone who has never smoked.

There are many more benefits including increased energy & freedom from the worry that you are damaging your health as well as that of your family and friends.

Nicotine replacement Therapy (NRTs) helps in tobacco cessation, use NRTs under practioners guidance.

Inquire about Nicotine gums, Nicotine patch, Lozenges, sprays & NRT medications to help you give up tobacco Annexures

Annexure VI

Tobacco Cessation Counselling Manual

Say No to Tobacco

Developed as a part of doctoral project

"Evaluation of the effectiveness and impact of tobacco de-addiction tool in the context of present anti-tobacco campaigns".

Dr. Stuti Sharad Bhargava Dr. Rahul Bhowate Assistant Professor, Prof & HOD Dept of OMR, VSPM DCRC Dept of Oral Medicine & Radiology Nagpur Sharad Pawar Dental College & Hospital PhD Scholar, SPDC Sawangi (Meghe) Sawangi (Meghe),Wardha

(i) Annexures

This manual is a resource which can be used by dentists and clinicians and health science students who can provide brief as well as detailed counselling sessions to tobacco users for quitting their tobacco consumption habits.

This manual uses a combination of motivational interviewing and behavioural therapeutic approaches along with suggestions which may be offered as practical solutions to tobacco users to give up their habit.

This resource may not be relevant or helpful to all tobacco users but –it employs frequently used approaches to healing and recovery from commercial tobacco use; i.e. tobacco cessation.

Tobacco cessation proper, attempt to cease tobacco use , reduction in amount of tobacco consumed or increased desire to cease tobacco use among tobacco users can all be considered as successful outcome of this manual.

P.S.: The term clinician is used throughout the manual; it encompasses health care providers such as dentists, physicians, ENT specialists , oncologists and students of medical , dental and nursing fields ; all of whom can refer to this manual for conducting tobacco cessation counselling (TCC).

(ii) Annexures

Index:

1. Need for Tobacco Cessation Counselling

2. Terminology

3. Understanding Nicotine addiction

4. Tobacco products and preparations

5. Harmful effects of tobacco

6. Basic Skills of Counselling – Behavioural intervention

7. Introduction to Pharmacotherapy for Tobacco cessation

(iii) Annexures

1. NEED FOR TOBACCO CESSATION COUNSELLING

It is a commonly known fact that tobacco use is a leading cause preventable death. Numerous research studies in the past have consistently revealed detrimental effects of smokeless and smoked tobacco on oral as well as general health. However tobacco use and resulting morbidity and mortality still continue to haunt the civilized society. Efforts constituting anti-tobacco measures at present are directed mostly towards anti- tobacco mass media campaigns and legislations; intending towards creating awareness and curtailing its use. Though it is evidenced that awareness campaigns have limited reach and modest impact on the vulnerable population sub groups (such as adolescents, individual from lower socio economic or rural backgrounds).Also the laws and regulations curtailing tobacco use and availability are more often than not – poorly enforced. Thus leaving the population susceptible to tobacco use and impending after effects. Population subgroups differ in their media use patterns; some of these differences reflect communication inequalities, which have the potential to exacerbate health disparities. Clinicians have an opportunity to guide tobacco users towards useful and reliable information sources. This guidance could help survivors fulfil their unmet information and support needs and may be particularly important for less educated survivors and other underserved populations.

Many tobacco users , have attempted to stop their habit previously or wish to stop the habit however they are unsuccessful in their attempts due to lack of structured information about tobacco cessation. For a tobacco user psychological dependence along with lack of proper information regarding how give up the habit are the biggest challenges in tobacco cessation process. The impact of proper de-addiction counselling as a part of the anti-tobacco measures taken is under-explored. An effective protocol for counselling and guiding the users about the de-addiction process will help in reducing the number of tobacco users. Considering the immensity of the problem, a greater involvement of health care professionals is required in tobacco control measures such as prevention, cessation and reduction of exposure to second- hand smoke. Training health care professionals and students about these issues can have a profound impact on public health.

(iv) Annexures

Dentists and other healthcare professionals are in a unique position to advice smokers to quit by their ability to integrate the various aspects of an effective counselling. Counselling for tobacco cessation is among the most cost-effective interventions. This manual provides an overview of non-pharmacological (behavioural) and pharmacological interventions for tobacco users presenting in a clinical setting.

Most of the literature available on tobacco cessation methods comes from developed countries. This may not be completely suitable in the Indian context given the differences in socio demographic, cultural setting and a major difference of products being used; as wide range of regionally specific tobacco products and preparations are available both in smokeless as well as smoking forms in India. This furthermore stresses upon the need for tailored tobacco cessation modality which is accommodative of the socio cultural diversities here. Strategies used for cessation counselling differ according to the patient‘s readiness to quit. An effective counselling attempt comprises of tailor made combination of information, sensitisation, use of motivational strategies and practical solutions.

Tobacco use consists of both psychological dependence and physical addiction to nicotine contained in tobacco. Ideal approach to tobacco use cessation should include both support for behavioural modification and pharmacotherapy to assist in overcoming withdrawal symptoms.

With almost 60 % of the population consuming tobacco, chances of dentists dealing with tobacco users is very high. Dentists deal very often with visible dental complaints like staining .Patients may have tobacco use associated problems, oral lesions or other complaints aggravated due to tobacco. These noticed or unnoticed tobacco associated oral lesions may also require treatment. Habit stoppage is an important part of treatment to such patients and so the need to understand the concept of ―tobacco addiction‖. Longer appointments with the patients more time to attempt counselling compared to other specialist‘s Timely intervention may prove beneficial for not only oral health but overall health of and individual and even help in management of other yet undiagnosed tobacco induced disease.

(v) Annexures

2. TERMINOLOGY

1. Addiction : Compulsive physiological use of a substance (habit forming substance eg. nicotine , cocaine ) characterised by tolerance and well defined physiological symptoms upon withdrawal 2. Abstinence : A period of stopping the use of cigarettes or other tobacco products 3. Cessation : Also called ‗quitting‘ The goal of treatment to help people achieve abstinence from smoking or other tobacco use 4. Cold Turkey: Quitting abruptly or quitting without behavioral or pharmaceutical support 5. Craving: Intense urge or desire for (here) consumption of tobacco. 6. Efficacy: effectiveness of treatment 7. Nicotine: An alkaloid derived from tobacco, responsible for the psychoactive and addictive effects of tobacco. 8. Nicotine Replacement Therapy (NRT): A smoking cessation treatment in which nicotine from tobacco is replaced for a limited period by pharmaceutical nicotine. This reduces the craving and withdrawal experienced during the initial period of abstinence while users are learning to be tobacco-free. The nicotine dose can be taken through the skin, using patches, by inhaling a spray, or by mouth using gum or lozenges. 9. Relapse: Return to regular tobacco use after a period of abstinence. 10. Second hand smoke / Passive smoke: Tobacco smoke exhaled by a smoker or environmental tobacco smoke generated side stream from burning end of a tobacco preparation. 11. SLT : Smokeless tobacco (tobacco that is not burned before or at the time of use as opposed to cigarettes or bidis that are burned to liberate smoke but instead used in preparations for chewing , snuffing or chewed and spat out) . 12. Third hand smoke:Fine smoke particles settled on surface and ingested/inhaled by non-smokers. 13. Withdrawal: A variety of behavioral, affective, cognitive and physiological symptoms, usually transient, which occur after use of an addictive drug is reduced or stopped. Nicotine Withdrawal occurs in the first few days to weeks upon the abrupt discontinuation or decrease in intake of nicotine; it is characterised by set of distressing symptoms.

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3. UNDERSTANDING NICOTINE ADDICTION

Tobacco is an agricultural product processed from the leaves of plants of the same name. and in its leaves an alkaloid called nicotine. After harvesting and curing, tobacco leaves are manufactured into consumable products, which may be used for chewing, snuffing or smoking. Several products containing tobacco are available legally despite possible harm to human health. Smokeless preparations like kharra, jarada, gutkha, nass etc are used for chewing, snuffing and local application, while smoking of tobacco is in the form of cigarettes, cigars, hookah, chillum, bidis etc. Tobacco is responsible not only for several pathophysiological changes in the body but also develops tolerance to its own action with repeated use. In short tobacco has psychoactive properties and its consumption on one hand causes development of psychological dependence amongst users.

Tobacco contains nicotine and nicotine dependency is true chemical addiction, captivating the same brain dopamine reward pathways as alcoholism, cocaine or heroin addiction. The 1988 US Surgeon General‘s report states that nicotine is as addictive as heroin and cocaine. This landmark conclusion represents the culmination from viewing smoking as a bad habit to seeing it as a behavioural form of habituation and ultimately, a formal addiction. The ICD–10 criteria for addiction regard the nicotine in tobacco smoke as addictive (World Health Organization, 1992). These criteria include compulsive use, tolerance, development of withdrawal symptoms and tendency to relapse after stopping. Furthermore, nicotine in tobacco smoke activates brain reward areas in a way comparable to that of other addictive drugs. The essence of drug addiction is loss of control of drug use.

Studies suggest that the alpha-4 beta-2 nicotine acetylcholine receptor subtype is the main receptor that mediates nicotine dependence. Nicotine acts on these receptors to facilitate release of neurotransmitters such as dopamine, nor epinephrine, serotonin, acetylcholine, glutamate and beta endorphins. These neurotransmitters cause pleasure, stimulation and mood modulation. A person consuming tobacco may experience range positive emotions courtesy of nicotine which stimulates release of dopamine. Once the nicotine level in the blood falls the brain generates crave and the tobacco

(vii) Annexures user is tempted to consume tobacco again. Repeated exposure to nicotine develops neuro-adaptation of the receptors resulting in tolerance to many of the effects of nicotine. Once the addiction is established it cannot be eliminated or cured but only arrested and regardless of how long one has remained nicotine free, it is possible that only one hit of nicotine will create a high degree of probability of a full relapse. Nicotine crosses the Blood Brain Barrier in 7 secs and has a half-life of 1/ 2 hours. An average cigarette yields about 1 mg of absorbed nicotine it is metabolized in the liver. In short nicotine is highly addictive psychoactive chemical which stimulates adrenaline, increases BMR, BP, heart rate, blood sugar level, free fatty acids and has a role in acute episodes of some diseases (stroke and heart disease).

Neurotransmitters released by nicotine and their effect Dopamine Pleasure , Appetite Suppression Nor epineprine Arousal , Appetite Suppression Acetylcholine Arousal , Cognitive enhancement Vasopressin Memory Improvement Serotonin Mood Modulation, Appetite Suppression Beta –Endorphin Reduction of Anxiety , Tension

When nicotine consumption stops-nicotine withdrawal syndrome ensues, characterized by irritability, anxiety, increased eating, dysphoria, and hedonic dysregulation, among other symptoms. Tobacco use specially smoking is also reinforced by conditioning, such that specific stimuli that are psychologically associated with tobacco use become cues for an urge to smoke. These include the taste and smell of tobacco, particular moods, situations and environmental cues.

In a nutshell tobacco causes its user to experience a range of positive emotions due to psychoactive properties of nicotine and causes development of addiction. Tobacco use causes no intoxication and thus no behavioural disturbances, no damage to others in the society except to its user and it is legally available despite its evident adverse effects. Not only tobacco proper but other products used in combination for preparing various products eg. lime, beetle nut etc. are also potentially harmful to human health.

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Behavioural and pharmacotherapies to aid tobacco cessation should ideally reduce nicotine withdrawal symptoms and block the reinforcing effects of nicotine obtained from tobacco without causing excessive adverse effects. Further, given the important role of sensory effects of smoking and psychoactive effects of nicotine, behavioural therapies and pharmacotherapy should be practised as important adjuncts to substantially augment the benefits of tobacco cessation counselling.

4. TOBACCO PRODUCTS

Tobacco has been used in India for centuries. Tobacco Most common ways of tobacco consumption are in the forms of smoking, chewing, snuffing, dipping tobacco and as dentifrice. Effects of tobacco use on the public health (both general and oral) are alarming. Common forms of tobacco use are:

Sr . No Product Type 1. Cigarette , cigar chillum , pipe, hand rolled Smoking 2. Bidi (sun dried tobacco leaves ) Smoking 3. Snuff (finely ground flavored tobacco) Insufflated Nicotine nasal Spray 4. Tobacco quid (tobacco & lime) SLT - Chew / Spit 5. Paan (betel leaf quid- betel nut, catechu, lime, SLT - Chew / Spit tobacco) 6. Kharra (tobacco , betel nut & lime ) SLT - Chew / Spit 7. Gutkha ( tobacco, crushed areca nut , catechu , slaked SLT - Chew / Spit lime , paraffin wax , sweet or savory flavorings) 8. Kahini ( tobacco and slaked lime) SLT - Chew

9. Zarda (mixture of tobacco, lime, spices, occasionally, SLT - Chew silver flakes is also added to pan ) 10. Khiwam (tobacco extract, spices and additives is a SLT - Chew paste-like preparation that may be added to pan or chewed as it is)

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11. Nicotine gum SLT - Chew / Spit 12. Nicotine patch, nicogel or topical tobacco paste SLT - Transdermal 13. Dipping tobacco, snuffs, dissolvable tobacco or Intrabuccal creamy snuff 14. Electronic (e) cigarette Vaporized 15. Nicotine inhaler Directly inhaled 16. Hookha (Also called as water pipe or Sheesha , It is a Smoking single or multi-stemmed (often glass-based) instrument for smoking tobacco in which the smoke is cooled and filtered by passing through water. 17. Mainpuri (tobacco, slaked lime, areca nut, camphor SLT - Chew and cloves ) 18. Mawa(thin shavings of areca nut, SLT - Chew tobacco, and slaked lime) 19. Gudakhu (paste) or gul (dry) (prepared from Dentifrice powdered tobacco & molasses. It is applied to the gums& teeth with a finger). 20. Masheri, /mishri ( homemade- roasted tobacco flakes Dentifrice on a hot griddle until it turns brown or black) 21. Bajjar(dry snuff) Dentifrice 22. Lal dantamanjan ( tobacco , catechu - tooth powder) Dentifrice 23. Creamy snuff (tobacco-containing tooth paste) Dentifrice 24. Tibur (water through which tobacco smoke is passed) Sipping / Gargling 25. Chutta (coarse tobacco cigars commonly used for Smoking reverse smoking as well ) 26. Paan masala (areca nut, slaked lime, SLT - Chew catechu, and condiments, with or without powdered tobacco)

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5. HARMFUL EFFECTS OF TOBACCO

Tobacco consumption has a deleterious effect on nearly every organ of our body .It is the primary risk factor for oral cancer, pre cancer, periodontal diseases halitosis, stained teeth, exposed roots, loss of taste and numerous systemic diseases cardiovascular, pulmonary disorders delayed wound healing. Smokeless tobacco increases the risk for pharyngeal and esophageal cancers as well. Cigarette smoking significantly contributes to several other nasopharyngeal and upper gastrointestinal carcinomas. Tobacco affects the diagnosis and therapy in clinical practice as it alters the immune system, interferes with medication efficacy and increases the risk of medical crisis, so tobacco users become vulnerable to a wide range of debilitating diseases. There is emerging evidence relating maternal smoking with the development of cleft lip in the child, development of primary caries in children. Children exposed to environmental tobacco smoke are at increased risk of sudden infant death syndrome, asthma, otitis media and chest infections in the first years of life.Fetal exposure to maternal smoking increases the risk of miscarriage, premature birth, low birth weight and stillbirth. Smoking in pregnancy may also affect the child's physical growth and academic attainment may be reduced.

Smoking is a major risk factor for at least 20 diseases, including coronary and peripheral vascular disease, chronic bronchitis and at least 80% of lung cancers. Blood coagulates in smokers more easily than in non-smokers, fibrinogen levels are higher and platelets are more likely to aggregate. These effects all contribute to thromboembolic diseases. Although nicotine itself is not carcinogenic, tobacco smoke contains over 200 other compounds that are potential carcinogens and smoking itself is the greatest single risk factor for lung cancer. After tobacco use cessation, the harmful effects on oral and systemic health gradually subside over time. Tobacco users can be informed about harmful effects of tobacco and benefits of stopping its use in order to motivate them for habit cessation.

Harmful substances contained in tobacco smoke:

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Oral cancer not only accounts for significant mortality, but is also responsible for extensive disfigurement, loss of function, behavioural changes, financial and social hardship. Tobacco addiction and related disorders causes approximately 1.5 million deaths annually and more users will fall prey to this destructive addiction if users are not persuaded to quit the habit. There are 7,000 known chemicals in cigarette smoke. At least 69 are known to cause cancer in humans. For information of clinicians and to guide the smoker‘s here‘s is a list of chemicals present in cigarettes:

Acetone Used to make fingernail polish remover Ammonia Found in urine and used in fertilizer Arsenic An effective rat poison and weed killer Beryllium A toxic metal used for X-ray tubes, nuclear weapons, aircraft brakes and rocket fuel additives Butane Cigarette lighter fluid Cadmium Used in paint and to make batteries and plastic Carbon monoxide Found in car exhaust fumes Ethylene oxide Used to make antifreeze and pesticides Formaldehyde Used to preserve dead people Hydrogen cyanide Gas chamber poison Naphthalene Used for mothballs Nitrobenzene A gasoline additive Stearic acid Candle wax Toluene Used to make gasoline, paint, paint thinner, fingernail polish, glue, and rubber Vinyl chloride Used to make plastics

Every time a cigarette is smoked, those around them are also exposed to second-hand smoke and these harmful chemicals enter their bodies. Some cigarettes claim to be ―natural‖ or ―light‖ however these too contain chemicals known to cause cancer and other diseases.

Informational images such as one given here can be highlighted in clinical sitting and in self-help material provided to tobacco users.

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Contents in cigarette :

Inform tobacco users about possible debilitating effects on overall health due to smoking :  Getting very tired in a short time  Oral ulcerations, stale breath  Voice deepening or becoming gravelly  Frequent coughing or heavy chest colds, pneumonia, COPD , TB , asthma Emphysema, chronic bronchitis  Wheezing, trouble breathing, or shortness of breath  Tingling in hands and feet, bad circulation  Heart disease or heart attack , High blood pressure , Pain or tightness in the chest  Having difficulty sleeping  Cataracts  Stomach ulcers  Diabetes complications  Bone density loss  Worsening of existing condition or causing conditions which did not exist earlier

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Warn about second hand smoke: Children who breathe in second-hand smoke get sick more often with ear infections, bronchitis and pneumonia. 1. Children‘s allergies and asthma get worse if they live with a smoker. 2. Breathing in second-hand smoke at home or work increases the chances of dying from lung cancer or heart disease. 3. Passive smoking: exposure to environmental tobacco smoke causes an increased risk of smoking related diseases, especially lung cancer and heart disease.

Similarly advantages of giving up tobacco can also be highlighted for the tobacco user which includes:

Health Benefits After Quitting Tobacco …… In 20 minutes Heart rate drops to more normal levels. In 12 hours The carbon monoxide level in blood returns to normal In 2 wks to 3 mths Risk of heart attack drops and lung function begins to improve In 1 to 9 months Coughing and shortness of breath decrease 1 year after quitting Risk of coronary heart disease decrease to half of smokers 5 years after quitting Risk of stroke begins to decrease In 5–15 years Stroke risk decreases to that of a non-smoker

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6. BASIC SKILLS OF COUNSELLING – BEHAVIOURAL INTERVENTION

The approach in helping patients quit tobacco and guiding them toward habit cessation by any health professional is termed as counseling. Tobacco dependence can be a challenging topic to raise with people, particularly when they are seeking help for some other issue. Even opening a conversation about commercial tobacco use can be a challenge if the person has been accustomed to being ―lectured‖ by health practitioners, family, friends and the media. Adopting an understanding and motivational stance while maintaining patient doctor confidentiality is important in raising the issue in a non-confrontational, matter-of-fact way. The most common reasons for tobacco use are and failed cessation attempts are:

1. Experimentation / Adventure 2. Peer pressure / influence of friend circle 3. Imitating family members 4. Imitating celebrities 5. Stress relief / Tobacco is relaxing 6. Performance enhancement / increased concentration 7. Misconceptions of tobacco being a home remedy for minor health issues 8. Previous unsuccessful attempts 9. Withdrawal symptoms : - weight gain , restlessness 10. Unawareness

Some of the common justifications offered by tobacco users are:

 Assumed health benefits - Pain relief , relaxed, regular bowel movements  When I quit smoking, I felt worse – withdrawal  I consume very less tobacco – self perceived small amounts  Grandfather took tobacco till 70 yrsof age & never had any problems neither will I  I am able to stay awake for my night shifts , tobacco helps me  I am too young to have any diseases from tobacco

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Tobacco Cessation in Dental Clinic:

Tobacco users encountered during practice will fall into any of these sub groups:

 Not thinking about quitting  Weighing pros and cons of quitting tobacco use  Planning to quit  Made a cessation attempt

The Clinician / Dentist should:

 Determine the presence o tobacco use  Motivation for tobacco cessation  Behavioral Counseling & Pharmacotherapy for habit cessation  Follow up and continuous support

Dentists are in best place to ascertain presence of tobacco habit in a individual. To broach the topic of tobacco use cessation; ask the patient  First, does he/she use tobacco currently?  Inquire and document about tobacco habit from all patients.  History of tobacco use/frequency, type of tobacco, alcohol use, family history, past quit attempts, past medical history  Patient‘s views on tobacco use, as well as the likely association between such use and current health condition

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Clinicians can ace retain the need of tobacco cessation using the following patterns: 1. Modified CAGE questionnaire:  C-Have you ever felt the need to Cut down or control your smoking/ tobacco use but had difficulty in doing so.  A-Do you ever get Annoyed or angry with people who criticize your smoking/tobacco use or tell you that you ought to control smoking  G-Have you ever felt Guilty about your tobacco use  E- Have you ever used tobacco/ smoked within half an hour of waking up (Eye opener)

Any two responses as – Yes constitute a positive screening test and confirm the need of intervention. The CAGE questionnaire takes less than one minute to administer, has a non threatening approach and can be used in primary care or other general settings as a quick screening tool. There is no intended population and is meant to find those who consume tobacco excessively and are in need of treatment. Examples of CAGE questionnaire responses:-

Cut down: I wanted to quit smoking so I opted for smokeless chew tobacco instead. Or - I switched to low tar cigarette Or – I consume tobacco for stress relief, now i use it only during stressful working hours and not at home in front of children.

Annoyed: My wife keeps on nagging me to stop chewing paan, but it never affected my grandfather or father so it won‘t affect my health.

Guilty: I should have stopped using tobacco earlier, now I have developed this problem ______(any tobacco associated disorder)

Eye opener: I cannot work night shifts without chewing kharra or I smoke within half hour of waking up

2. The “Four C‟s” test : Psychiatrists, psychotherapist and clinicians rely on this criterion to determine substance dependence and can be used to determine nicotine dependence. Clinicians who feel comfortable discussing psychological issues with their patients may only

(xvii) Annexures prefer this approach or may refer tobacco user for specialized counseling. Following communication can help in determining the behavior of tobacco user and their dependence on tobacco;

The Four C‟s are: 1. Compulsion : Intensity with which the desire to use a chemical overwhelms a patients thoughts, feelings and judgment  Do you ever smoke / consume tobacco more than you intend?  Have you ever neglected a responsibility because you were smoking / chewing tobacco or so you could smoke? 2. Control : The degree to which patient can (or cannot) control their chemical use once they have started  Have you felt the need to control tobacco use/ how much you smoke but were unable to do so easily?  Have you ever decided to quit tobacco but bought/ procured tobacco on the same day. 3. Cutting down : Effects of reducing intake , withdrawal symptoms  Have you ever tried to stop tobacco? How many times? How long?  Have you ever had any of the following symptoms when you went without tobacco for a while; agitation, difficulty concentrating, irritability, mood swings? If so did the symptoms go away after you consumed tobacco / smoked? 4. Consequences : Denial or acceptance of the damages caused by addiction  How long have you known that tobacco use / smoking was hurting your body?  If you continue to smoke / use tobacco how long do you expect to live ? If you were able to quit today how long do you think.

The Four Cs may not be very practically adapted in dental clinics but the questions exemplified above may help in broaching a dialogue about tobacco cessation.

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3. Fagerstrom Test for Nicotine Dependence

Not only is it important to know whether or not patients smoke, it‘s also important to know how addicted to nicotine they actually are. Fagerstrom‘s Test for Nicotine Dependence is an easy way to assess patient‘s addiction. Have patients answer the questions; each answer gets a set amount of points. Add up the points and check out the score indicator below:

Questions Answers Points Within 5 minutes 3 1. How soon after you wake up do you smoke / use 6 to 30 minutes 2 tobacco your first cigarette? 31-60 minutes 1 After 60 minutes 0 2. Do you find it difficult to refrain from smoking / Yes 1 tobacco use in places where it is forbidden such as No 0 church, the library, or movie theatres? The first one in the 3. Which cigarette / time of tobacco use would you 1 morning hate most to give up? 0 All others 10 or less 0 4. How many cigarettes do you smoke? / Frequency of 11-20 1 SLT (20 cigarettes are in a pack) 21-30 2 31 or more 3

5. Do you smoke / use tobacco more frequently during Yes 1 the first hours after waking than the rest of the day? No 0

6. Do you smoke / use tobacco if you are so ill that Yes 1 you are in bed most of the day? No 0

Score: 0-2 Very Low Addiction ; 3-4 Low Addiction; 5 Medium Addictions 6-7 High Addiction; 8-10 Very High Addiction Usually, people who score 6 or greater need additional assistance in quitting smoking. This may mean NRTs or one-on-one counselling to problem solve ways to overcome barriers and cope with withdrawal symptoms.

Additional questions can also be used to determine patient‘s attitude towards tobacco use readiness to quit tobacco.

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Behavioural intervention through counselling:

What is counselling: 1. Counselling ≠ advice giving 2. Counselling ≠ eliciting information with lot of questioning 3. Counselling ≠ imposing our values on the patient because WE think they are wrong 4. Counselling ≠ getting the patient to change the way WE want

Behavioural Counselling involves: Giving psychological support, enabling someone to identify and explore their reactions, feelings & emotions. Help someone to make realistic decisions and to find ways to adjust to change, by drawing conclusions on their own. Avoiding arguing, express empathy and stress on the point that tobacco cessation is vital for good health. Counselling differs from advice .

Advise: Offering suggestions about the best course of action

Counselling: The provision of professional assistance & guidance in resolving personal or psychological problems, Tobacco Counselling aims to enable a person to cope better with stress & find realistic ways to solve problems and make informed decisions on quitting tobacco

Attitude during Counselling: Listen & ask relevant questions, to provide relevant information, practical suggestions and emotional support. A counsellor must take precaution not to impose his/her own values, prejudices assumptions and internal ‗rules‘.Non-Judgmental attitude, good listening skills, common language and understanding patient‘s emotions are helpful traits for clinicians to adopt while attempting counselling. Genuine empathy, unconditional positive acceptance and confidentiality are essential.

The core communication skills can be summarised as: OARS O – Asking skilful open-ended questions A – Making well-timed affirmation R–Making frequent and skilful reflective listening statements S – Using summaries to communicate understanding

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The dialogues elaborating these skills are detailed further in the manual Brief cessation Intervention: In case tobacco use and nicotine dependency is assessed the clinician must perform brief cessation intervention. This can last from 2 - 10 minutes depending on tobacco users willingness to indulge in further communication about habit cessation .This dialogue should touch on the following aspects in a non-threatening albeit motivating manner and should include; 1. Screening and feedback about oral condition 2. Cessation Advice 3. Assess readiness to quit 4. Providing awareness about health hazards of tobacco & benefits of tobacco cessation 5. Information about cessation methods 6. Information about any harmful effects of tobacco patient appears to be affected with 7. Dispelling any misconceptions about tobacco use 8. Welcoming further interaction and possible help for habit cessation

Intervention in patient‟s cessation attempt should comprise of the following steps:

1. Helping the patient with a cessation plan – Setting a quit date 2. Providing practical solutions (problem solving) – tips to control craving 3. Providing social support and encouragement to overcome craving 4. Recommending the use of approved pharmacotherapy 5. Providing supplementary materials.

The 5 Model is recommended for clinicians in initiating assessment and intervention for tobacco cessation.

The 5 A‟s Ask Ask about tobacco use if , No – congratulate , if yes proceed further Assess Assess the willing to make cessation attempt Advice Advice to quit Assist Assist in cessation attempt using counselling and pharmacotherapy Arrange Arrange follow up and monitor preferably within first week after cessation date

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The 5As - Ask, Advise, Assess, Assist and Arrange Protocol:

Ask: All patients should be asked about tobacco use at every visit. Systematically identify and document tobacco use when possible.

 Have you used any form of tobacco product in the last six months?  Have you used tobacco in the last two weeks?  Do you regularly use tobacco product? Type?

How the question is asked influences the level of detail in the response. In addition, people may not want to disclose their tobacco use status for fear of reproach. People are increasingly sensitive to the stigma associated with smoking as tobacco use becomes less ―normal.‖ A non- judgmental approach will enhance rapport and provide a safe environment for people to consider the possibility of change.

Advice: Advise clients to quit in a strong, clear and personalized manner. Strongly urge all tobacco users to consider quitting. Whenever possible, tailor the advice by adding detail relevant to the client‘s personal circumstances.  As your clinician, the most important advice I can give you is to quit tobacco.  In light of (Condition), it is extremely important that you quit. How can I help?  Quitting is the best thing you can do for your health and well-being.

Following two approaches can be used

 Fear Approach :- ill-effects of tobacco on body  Reward Approach: - Benefits of quitting (Health, financial savings, social)

Assess: Assess the willingness to quit and nicotine dependency. Assessment will highlight the status of the tobacco users and is important in tailoring the intervention according to patients need. Sometimes intentions emerges part of the conversation or are quite obvious. If not, a simple question will often elicit the readiness for tobacco cessation. Motivational methods can be used to increase motivation to quit.  Are you thinking about quitting?  Have you considered quitting?  Are you ready to make a quit attempt?

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The assessment will highlight that a patient is not a tobacco user or a tobacco user who is in either of the stages of pre contemplation, contemplation, determination, action, maintenance or relapse.

Assist: The type of intervention and counseling provided during the ASSIST component will vary depending on the ASSESS component, as well as the clinical setting and time available. The Stages of Change Model provides assistance identifying appropriate strategies for support based on the tobacco user‘s readiness to make a quit attempt.

Options for people willing to make a quit attempt include: using motivational methods to strengthen commitment to change; providing information about tobacco use, health effects and medication. Providing practical counselling to help the client recognize potential challenges and develop coping skills to address them; helping with the development of a quit plan and providing supplementary materials & information about community resources for quitting.

Tobacco user Pre contempletation

Relapse Contempletion

Stages

Quit Of

Change

Maintainence Prepartaion

Action

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Goals and Interventions in different stages:

Stage Goals Interventions  Ask about his or her feelings about Pre- Help to think seriously tobacco use Contemplation about tobacco cessation  Discuss the pros & cons of tobacco in next 6 months use  Assist by assuring that cessation will not be forced , no push to stop  Offer quitting information To help a decision to stop • Discuss the pros &cons of tobacco Contemplation tobacco use in near future use To help tobacco user feel • Assist by reinforcing the reasons comfortable and for change and exploring new ones confident about cessation • Suggest to cut back or stop for a day suggest a future visit and offer information  Ask about concerns, preparations Preparation To help patient prepare and lessons learned from previous for change and begin to attempts use quitting skills  Advise by identifying barriers to stopping and eliciting solutions  Assist by providing material (booklet / leaflet) & help regarding action plan, date for quitting and NRT  Ask how patient is doing (relapses, Action To help stay off tobacco temptations, successes, NRT use) products & recover from  Advise for relapse prevention, relapses weight gain, triggers, etc.  Assist by focusing on successes; encourage self-rewards & increased support; elicit solutions to problems

Tips of Quitting: Set a quit date and ….

 Quit cold turkey.  Quit one day at a time  Be proud that you are not smoking  Make a list of all the reasons you want to quit smoking

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 Keep yourself well hydrated  Don‘t rationalize  Practice 4 D approach  Delay, Drink water, Deep breath, Distract

Practical counselling:

• Teach problem-solving skills • Identify danger situations for smoker • Suggest coping skills to use with danger situations and how to avoid temptation • Provide basic information about withdrawal symptoms

Triggers Plan of Action Soon After waking up in the morning Brush your teeth/meditation Going to office , on my way, a Try going another route tobacco vendor After Lunch Read a book, talk with a non tobacco user , chew gum While returning home Talk with your family member After having Dinner Keep yourself busy/distract/recollect Smoking with friends / colleagues Tell them about quit plan or avoid tobacco using company Stress at work /family Take a break , walk , meditate when stress gets high

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Arrange: Arrange for continued support for the tobacco user. Schedule a follow-up appointment and welcome for further help if and when required.

Let‘s set up another meeting to talk about this again?  Arrange for a follow up within 1 week.  Follow –up again within first month if possible  Set additional follow- up as necessary  Congratulate success during all contacts  If relapse occurs ,review circumstances and encourage another try  Motivational Messages to the patients These recommendations for counselling patients can be summarized as ‗‗STAR‘‘ 124: 1) Set a cessation date 2) Tell family, friends, co-workers about quitting and request understanding and support 3) Anticipate challenges to the cessation attempt (withdrawal symptoms), particularly during the critical first few weeks and discuss practical situations for the same 4) Remove tobacco products from environment, avoid smoking in places where a lot of time will be spent (e.g. work, home and car).

Contact time increases the abstinence rates:

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5A summary:

Once cessation is attained emphasis on never to start or use tobacco again.

For tobacco users unwilling to quit: Intervention efforts will not be successful without sufficient motivation or ‗‗readiness‘‘ to quit smoking on the part of the tobacco user.

One time brief cessation counselling should be still performed med and they should be encouraged to think about tobacco cessation.

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Recommendations to enhance motivation to quit tobacco: the „„5 Rs‟‟

Relevance Encourage the patient to identify why cessation is relevant. Motivational information has the greatest impact if it is relevant to a patient‘s disease, family or social status (having children), health concerns, age, sex and other important characteristics (prior cessation experience and personal barriers to cessation). Risks Identify the potential negative consequences of tobacco use, highlighting those which are most relevant to the patient (e.g. exacerbation of cough; long-term risk of cardiovascular problems and cancer; risks of children of breathing second-hand smoke; increased probability that children will become smokers themselves). The clinician should emphasize that smoking low-tar and/or low-nicotine cigarettes or use of other forms of tobacco (smokeless tobacco, cigars and pipes) will not eliminate these risks. Rewards Identify rewards associated with cessation (improved sense of taste , smell; clothes, house and car will smell better; financial savings) Roadblocks Identify roadblocks or barriers to cessation and note treatment elements that could address them (withdrawal symptoms, such as irritability; appetite increase and risk of depression, which could be attenuated by pharmacotherapy; lack of social support for cessation could be remedied by joining a cessation clinic or support group) Repetition Repeat this information for the patient.

Self help material such as leaflets / booklets should be freely accessible for tobacco users to take voluntarily. Clinical setup could also have self assessment quizzes and sections available which can be used by tobacco users and act as motivational tool for inculcating willingness to quit. These materials should highlight possible hazards, advantages of cessation and practical tips for cessation.

Motivation: To motivate the tobacco user the communications and self help material should include the following:

1. Have information material ready at your centres, which highlights hazards of tobacco use, advantages of habit cessation and methods of cessation.

2. Let the matter communicate - Are you definitely planning to quit tobacco use? If you are not ready to quit yet, we understand. For now, consider looking over the rest of the guide for ideas for when you are ready. Think and talk some

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more (with friend who are former tobacco users and your doctor) about quitting.

3. Inform about second hand smoke and its possible effects on smokers loved ones

4. Inform about possibility of other family members picking up the habit due to influence

5. Advice the patients to consult the said material , then inquire :

 What do you think about quitting?

 Are you concerned about your health and wonder if you should quit? If you have no health problems that‘s great! This is a good time to quit, before you do.

 If you do have health problems, then many of your symptoms, your quality of life, and your future health will improve almost immediately if you quit now.

6. Encourage: Have you tried to quit before and are ready to try again? You can quit for good. You can learn from your past attempts and plan for new challenges. You know what to expect. You are the expert in your ―re- quitting.‖

7. Positive reinforcement : Are you ready to quit tobacco? Congratulations! This guide will help you prepare for your Quit Date and the days, weeks, and months after. The best time to quit is NOW. But regardless of where you are in your decision to quit, this guide will give you a great deal of information, and support, and strategies that have been proven to help smokers quit. The fact that you are reading this guide is a good start.It is never too late to quit. Quitting has benefits at all ages

8. Experiences of former tobacco users : Quote examples: Meet Others like You: You are not alone... You can learn a lot about quitting from real people who have quit smoking. They will tell you why they quit and how they made it.

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eg. NarendraSinha, 42, is a successful city engineer, married, and the father of two grown children. His youngest son just finished college. He is beginning to think about retiring from his job and doing some part-time work. He quit smoking last year.

Reasons for quitting: ―I wanted to quit for 20 years. But dealing with something else always came first—job pressures, getting the kids through school. I finally decided to put myself first and take the time I deserve to give quitting a try. I was tired of smoking and of all the ways it tied me down. I was tired of late night trips to the store for emergency cigarettes. I was tired of having to cut out for a cigarette every time intermission rolled around. I was tired of promising myself that I‘d quit someday. After 40 years of smoking, I wanted to find out what life was like without cigarettes.‖

How he changed his patterns to help him quit:―I did my best to avoid temptation. The first few weeks, I really tried to stay away from smokers and places where people were smoking. I found I didn‘t miss cigarettes as much when no one was smoking around me.‖

Battling withdrawal and cravings:―Sure, it was tough at first… I‘d get tingle in my hands and feet. I just told myself that I wasn‘t itching for a cigarette, but that more blood was reaching my fingers. When I felt restless, I took a walk, drank water or distracted myself.

Final outcome: ―It was 8 months of struggle but I made it through. I‘ve never looked back.‖

Smoker‘s Helpline are often free, confidential and evidence-based service that provides non-judgmental and personalized support to help people quit. Refer people to such sources.

• Are you interested in trying Smoker‘s Helpline? They provide support on the telephone, online or via text messaging.

• Would you like some materials you can review at home? We can meet again to discuss what you‘ve learned.

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If a client is not ready or willing to consider continued support, respect their perspective. Encourage clients to seek support when they are ready.

Nicotine Withdrawal Symptoms: Withdrawal syndrome is a collection of signs and symptoms caused by abstinence of nicotine. Symptoms usually begin within a few hours, increase over 3-4 days, gradually decrease over 1-3 weeks. Hunger and craving can last for 6 months even more. Cravings are strongest in the 1st week. Generally last 30-90 seconds.

Commonly experienced withdrawal symptoms are; Dysphonic or depressed mood, insomnia, irritability, frustration or anger, anxiety difficulty concentrating restlessness, decreased heart rate, increased appetite or weight gain and oral ulceration.

Time line of withdrawal symptoms:

2 Lightheadedness

1 Sleep disturbance

2 Poor concentration Craving for nicotine

4 Irritability or aggression Depression Restlessness

10 Increased appetite

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Relapse Prevention: The majority of patients who attempt to quit will relapse. Generally many attempts are required to quit tobacco specially smoking. Relapse is often a natural part of the quitting process. Patients should be encouraged to learn from relapses and to develop strategies to avoid them in future attempts. Patients should be encouraged by statements like, ―Now you know that you can quit you have already been tobacco-free for 3 weeks.‖ Patients should be advised to abstain from consuming alcohol, to avoid stressful and emotional situations, and to avoid attending social functions or gatherings where others may be smoking/ using tobacco. Socializing in the workplace, where there may be other tobacco user, is hard to avoid. The link between environmental stimuli and the quick and pleasurable effect of tobacco use makes quitting very difficult. The clinician must address the patient‘s fear of withdrawal symptoms. Psychological and emotional triggers are very much connected with the tobacco habit and therefore patients must be counselled to cope with moments of temptation through the development of alternative strategies. The patient‘s self-image and socialization behaviour must be changed to accommodate the new self-awareness of a smoke-free person.

To manage Relapse:

Tobacco addiction has a non pharmacologic component, which must be addressed primarily by counselling. For tobacco users with a high degree of tobacco dependence and withdrawal or relapse pharmacotherapy can be very helpful. Pharmacotherapy is an adjunct to counselling & behaviour management. Nicotine Replacement Therapy – NRTs are the mainstay of pharmacotherapy for tobacco cessation

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7. INTRODUCTION TO PHARMACOTHERAPY FOR TOBACCO CESSATION

Combination of counselling & pharmacotherapy is essentially recommended as both pharmacologic and non pharmacologic component of nicotine dependence is managed. NRTs are the main stay of tobacco cessation pharmacotherapy. The chemical addiction of tobacco products is due to nicotine; NRTs provide this nicotine in controlled and safe form so the body doesn't have to endure nicotine withdrawal.This can be gradually tapered and eventually eliminated and also are devoid of many harmful additives present in tobacco products . Nicotine dependence treatments are effective in reducing relapses, increasing abstinence and increasing quit rates. NRTs are available as; Nicotine gum Nicotine patch Nicotine lozenges Nicotine spray / inhaler, E cigarette.

Nicotine plasma level achieved l: 1 Cigarette = 50 mg/ml (range 10 -80) 1 x2 mg nicotine gum = 7ng/ml 1x 4mg nicotine gum = 15ng/ml 1x 10 mg nicotine inhaler = 7ng/ml 1x21mg nicotine patch = 10ng/ml I. Nicotine Gums: Available in 2mg & 4 mg chewing gums with added flavors. Maximum 8- 12 pieces / day can be consumed for 4mg gum and maximum 25 for 2 mg ones. Acidic beverage should be avoided 15 mins prior to chewing the gum as it is absorbed in a basic environment (avoid coffee, soda, juice). No definite benefit beyond 8 weeks

Smoking a pack or 20 cigarettes getting 20-40 mg per day of nicotine ; 2 mg dose delivers 1 mg nicotine - 10 pieces only 10 mg ; taper suggestions to 1 / 4 hrs 3 wks, 1/8 hrs 3 weeks.

Price: Nu life chewing gum approx. Rs. 2 / piece; Nicotex gum Rs.4 /2 mg & Rs.5 /4mg

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Side effects:

 Nicotine related : Gastrointestinal discomfort, hiccups, nausea, vomiting  Chewing related: TMJ problems  Oral : Mouth Soreness , taste alteration

Administration instruction: Chew and park method; Continue for 30 minutes

Contraindications:

 Hypersensitivity to nicotine or any components of the chewing gum  During pregnancy and lactation,  Acute myocardial infarction,  Unstable angina pectoris, severe cardiac arrhythmias,  Recent cerebrovascular accident.

Special Precautions for Use: Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis or peptic ulcer.

Use with caution in patients with: Hyperthyroidism, pheochromocytoma, diabetes mellitus, and renal or hepatic impairment.

Both amount & timing of the dose can be adjusted; should be taken as soon as urge for tobacco consumption arises. These products are particularly useful to counter strong cravings & threats to abstinence. Under dosing is more common problem than overdose and is the single greatest challenge for successful use of these products. 50% Absorbed rough buccal mucosa

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II. Nicotine patch: Available for 24 hour in doses of : 7,14,21 mg(/24 hours)

> 10 cigarettes/day: can start with 21mg. Nicotine levels are typically half those obtained by smoking. Patch to be applied on non-hairy skin, to be rotated on different areas of body.

Side effects: skin reaction, sleep disturbances

III. Nicotine Lozenge: Similar to gum, but 25% more nicotine than gum . Allow to dissolve 30 min. Not to drink or eat 15 minutes before using 6 week success rate 46%.

IV. Nicotine inhaler: Cartridge and mouth piece - Mimics hand to mouth ritual. Each cartridge contains 10 mg of nicotine, only 4mg delivered and 2 mg absorbed. 6- 16 cartridges / day for 12 weeks, then tapering for 6-12 months.

V. Nicotine nasal spray: One spray into each nostril equals one dose. Each spray contains 0.5mg of nicotine. Blood nicotine levels peaking within 5–10 minutes .Initial dosing should be 1 to 2 doses per hour, increasing as needed up to 6-8 weeks and then taper. Highly dependent smokers benefit more from the spray than patch. 6 month success rate 31% .

Non Nicotine Medication: 2 of most commonly use Non – NRT drugs are discussed here

I. Bupropion (Zyban™): Bupropion hydrochloride is one of two non nicotine-based medications used to help people quit smoking, and was originally developed as an antidepressant. Recent data suggest that when it is metabolized, it acts as a competitive antagonist of nicotine at the nicotine receptors in the brain.. Use of Buproprion can lead to a doubling of quit rates compared with unaided quit attempts. It should not be used for clients with seizure disorders, or those with a current or prior diagnosis of bulimia or anorexia nervosa. In combination with NRT, it was more efficacious than NRT alone.

Administration: Start 150mg per day.

 Increase by day 3-4 to 150mg twice a day  Quit date be 7-14 days after starting bupropion

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 Continue for 7-12 weeks after quit date. Maintenance – up to 6 months.  If no significant improvement by 7th week, to discontinue.  Side effects: dry mouth and insomnia, risk of seizure  Caution :History of eating disorders & seizures  Alone or combination with patch significantly increase long term cessation rate compared to patch .

II. Varenicline (Champix®): Derived from natural chemical cytisine, found in the plant ―false tobacco‖ Varenicline is the newest non nicotine-based medication. It acts on the receptors in the brain, which is also responsive to nicotine and blocks nicotine from attaching to receptors in the brain. It acts as a partial agonist stimulating the sufficient release of dopamine to reduce craving and withdrawal, while simultaneously acting as a partial antagonist to block the effect of nicotine. People who continue to smoke while taking varenicline will not experience the nicotine pleasure they experienced in the past, as that action has been blocked. 2- to 3 fold increase in quit rates with use of Varenicline

However careful monitoring is warranted due to neuropsychiatric symptoms include depressed mood, agitation, aggression, hostility, changes in behavior, suicide related events and worsening of pre-existing psychiatric disorder in patients treated with varenicline. It was noted that neuropsychiatric side-effects have occurred in patients taking varenicline with or without a history of psychiatric disorder. Hypersensitivity reactions such as swelling of the face, trouble breathing and skin reactions have also been noted.

Administration: 0.5 mg every morning for 3 days  0.5 mg twice daily for day 4 to day 7  1 mg twice daily (morning and evening) for a total of 12 weeks Tab.Champix approx.Rs.1500 / 2 weeks Varenicline is available exclusively as a prescription medication. Not recommended for use in combination with NRT because of its nicotine antagonist properties. Efficacy more than doubles the chance of quitting at six months.

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E cigarettes: Electronic cigarettes are an alternative to tobacco smoking, although no tobacco is consumed. It is a battery-powered device that provides inhaled doses of nicotine by delivering a vaporized propylene glycol/nicotine solution. Many legislation and public health investigations are currently pending in many countries due to its relatively recent emergence.

Pharmacotherapy It can double or triple the likelihood of successful smoking cessation but is not a magic bullet! Also India has more number of SLT users where effectiveness of NRT remains to be proven; however this information can be abundantly helpful in guiding smokers. NRTs reduces smoking urge by sustaining tolerance, may maintain mood, attentiveness and stress handling and prevent relapse.

Overcoming Barriers cited by clinicians for tobacco cessation:

Following are the barriers commonly cited by the clinicians in tobacco cessation and some suggestions to overcome these

Barrier Suggested Solution Brief cessation counselling is suggested to last for only 2-10 Too little time minutes. Advanced counselling can be allotted scheduled appointments Financial TCC can be charged as a specialized service by in house Consideration staff , consultants , specialists etc Lack of interest and Motivation and brief counselling for tobacco cessation can reluctance on part of inculcate a willingness to quit and lead to positive results in patients future Respect for Tobacco despite its potential harmful effect; its legally individuals choice available ; still unawareness about potential harm resulting from tobacco persists and users must be, warned , screened and advised to quit Lack of experience Material such as this manual , workshops and continuing and training education programs should be opted for training of TCC Fear of losing patients Keep the conversation non threatening while maintaining at the same time that it is for patients benefit and there are no impositions. With practice of broaching this subject clinicians can overcome this barrier

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Many myths surround use of tobacco; these can either encourage people to begin or continue or deter them from quitting. Besides behavioural and pharmacological assistance dentists can play a major role in dispelling myths such as; (a) tobacco, consumed regularly but in self perceived, small quantities is not harmful; rather it may be helpful in improving digestion, increasing concentration and even in pain relief (b) only smoking is harmful and chewable forms do not posses any threat (c) tobacco products may be harmful only in the old age and not the young (d) quantity of tobacco in preparations less to cause any potential harm (e ) tobacco with beetle nut/areca nut and beetle leaf (pan) are used in many Hindu religious customs, so a great part of the population does not envision any probable disadvantages from consumption of these products (f) tobacco use can be stopped when desired or once started tobacco use cannot be controlled (g) ―light‖ cigarettes are less harmful (h) environmental tobacco smoke may be nuisance but is not harmful (i) cessation medications are infective (j) with all the restrictions tobacco industry no longer indulges in promotion or marketing to newer potential customers (i) everyone knows tobacco is harmful, tobacco problem has been solved and tobacco use is no longer a threat.

It is recommended that self examination techniques and mass media use for awareness should also highlight visuals of initial developments as a result of tobacco habit. Increased awareness of precancerous developments and its potential consequences will further encourage tobacco users to timely notice any changes and encourage tobacco cessation before development of life threatening ailments such as cancers, cardiac or pulmonary disorders etc.

Tobacco dependence is jot not a habit but a disease. It‘s complex, multifaceted problem involving human brain, human nature, socioeconomics, individual coping power and the addictive power of nicotine. Instead of blaming the user need to patient and have sympathy. Behavioural and pharmacological approach (combination works better) can help in attaining the desired result. Continue education for relapse prevention. The majority of patients who make an initial attempt to quit will continue to use tobacco and to cycle through periods of relapse and remission.

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Finally addiction is a cunning disease you can treat it but not necessary you can cure! There is no other psychoactive drug that affects brain chemistry as much as nicotine. Reducing or quitting tobacco may be one of the hardest challenges for a tobacco user. Compassionate and positive support will greatly enhance the tobacco user‘s chances of success.

Additional Sources:

1. Treatment at www.can-adaptt.net and Appendix 4 ―Stop Smoking Medications Compared‖.

2. Foulds (2006) The neurobiological basis for partial agonist treatment of nicotine dependence: varenicline. J Clin Pract 60: 571–576.

3. http://www.camh.net/education/Online_co urses_webinars/index.html

4. http://www.motivationalinterviewing.info/

5. http://www.cancercare.on.ca/cms/one.aspx?pageId=9322

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