“Efficacy of Auriculotherapy for Stage 1 and Stage 2

A Dissertation On

“EFFICACY OF AURICULOTHERAPY FOR STAGE 1 AND STAGE

2 HYPERTNSION – A RANDAMIZED CONTROL TRAIL”

Submitted By

Dr.N.LILLY B.N.Y.S (Reg. No.461613002 )

Under the Guidance of

Prof. Dr. N. MANGAIARKARASI, B.N.Y.S, M Sc (PSY),PGDHAN.

Submitted to

The Tamil Nadu Dr. M. G. R. Medical University, Chennai

In partial fulfilment of the requirements for the award of degree of

DOCTOR OF MEDICINE

BRANCH – III: ACUPUNCTURE & ENERGY MEDICINE

POST GRADUATE STUDIES-DEPARTMENT OF AEM

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE & HOSPITAL, CHENNAI – 600106

OCTOBER-2019

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU.

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “EFFICACY

AURICULOTHERAPY IN STAGE I AND STAGE II HYPERTENSION

-- RANDOMIZED CONTROL TRIAL” is a bonafide research work done by the post graduate Dr. N.LILLY, Department of Acupuncture & Energy

Medicine, Government Yoga & Naturopathy Medical College & Hospital,

Chennai – 600 106 under my guidance and supervision in partial fulfilment of regulations of The Tamilnadu Dr. M.G.R. Medical University, Chennai for the award of M.D. (Acupuncture & Energy Medicine) Branch –III during the academic period from 2016 to 2019.

Date: SIGNATURE OF THE GUIDE

Place: Chennai Dr.N.MANGAIARKARASI,

B.N.Y.S,Msc (Psy),PGDHAN Head of the Department, Department of Acupuncture & Energy Medicine, Government Yoga & Naturopathy Medical College & Hospital, Arumbakkam, Chennai – 600 106.

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU.

ENDORSEMENT BY THE HEAD OF THE DEPARTMENT

I certify that the dissertation entitled “EFFICACY AURICULOTHERAPY IN

STAGE I AND STAGE II HYPERTENSION” -- RANDOMIZED CONTROL TRIAL” is the record of original research work carried out by Dr. N.LILLY, in the

Department of Acupuncture & Energy Medicine, Government Yoga &

Naturopathy Medical College & Hospital, Chennai – 600 106 submitted for the degree of DOCTOR OF MEDICINE (M.D) in Yoga and Naturopathy under my guidance and supervision, and that this work has not formed the basis for the award of any degree, associate ship, fellowship or other titles in this University or any other University or Institution of higher learning.

Date: SIGNATURE OF THE H.O.D Place: Chennai Dr.N.MANGAIARKARASI,

B.N.Y.S,Msc (Psy),PGDHAN Head of the Department, Department of Acupuncture & Energy Medicine, Government Yoga & Naturopathy Medical College & Hospital, Arumbakkam, Chennai – 600 106.

GOVRNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, ARUMBAKKAM, CHENNAI – 600106

ENDORSEMENT BY THE PRINCIPAL

I certify that the dissertation entitled “EFFICACY OF

AURICULOTHERAPY FOR STAGE 1 AND STAGE 2 HYPERTNSION

– A RANDAMIZED CONTROL TRAIL” is the record of original research work carried out Dr.N.LILLY, in the Department of Acupuncture & Energy

Medicine Government Yoga & Naturopathy Medical College & Hospital,

Chennai – 600 106 submitted for the degree of DOCTOR OF MEDICINE

(M.D) in Yoga and Naturopathy under my guidance and supervision, and that this work has not formed the basis for the award of any degree, associateship, fellowship or other titles in this University or any other University or Institution of higher learning.

Date: SIGNATURE OF THE PRINCIPAL

Place: Chennai Dr. N. MANAVALAN,

N.D.(OSM),M.A(G.T),M.Sc(Y&N), M. Phil,

P.G.D.Y,P.G.D.H.M,P.G.D.H.H,

Government Yoga & Naturopathy Medical College & Hospital,

Arumbakkam,Chennai-600106.

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND HOSPITAL, CHENNAI, TAMILNADU.

DECLARATION BY THE CANDIDATE

I, Dr.N.LILLY solemnly declare that dissertation titled “EFFICACY OF

AURICULOTHERAPY FOR STAGE 1 AND STAGE 2 HYPERTNSION

– A RANDAMIZED CONTROL TRAIL ” is a bonafide and genuine

research work carried out by me at Government Yoga & Naturopathy Medical

College & Hospital, Chennai from June 2018 – May 2019 under the guidance

and supervision of Dr.N.MANGAIARKARASI, Head of the Department,

Department of Acupuncture and Energy Medicine, Govt. Yoga & Naturopathy

Medical College & Hospital, Chennai. This dissertation is submitted to The

Tamilnadu Dr. M.G.R. Medical University towards partial fulfilment of

requirement for the award of M.D. Degree (Branch – III) in Acupuncture &

Energy Medicine.

Date: Signature of the Candidate

Place: Chennai (Dr.N.LILLY)

INSTITUTIONAL ETHICAL COMMITTEE

GOVERNMENT YOGA AND NATUROPATHY MEDICAL COLLEGE

AND

HOSPITAL, CHENNAI – 600 106.

CERTIFICATE OF APPROVAL

The Institution Ethical Committee of Government Yoga & Naturopathy

Medical College Hospital, Chennai reviewed and discussed the application for approval of “EFFICACY OF AURICULOTHERAPY FOR STAGE 1 AND

STAGE 2 HYPERTNSION – A RANDAMIZED CONTROL TRAIL” for project work submitted by Dr.N.LILLY,3rd Year M.D. Acupuncture & Energy

Medicine, Post Graduate, Government Yoga & Naturopathy Medical College

& Hospital, Chennai – 600 106.

The proposal is APPROVED.

The Institutional Ethical Committee expects to be informed about the progress of the study and adverse drug reaction during the course of the study and any change in the protocol and patient information / informed consent and asks to be provided a copy of the final report.

COPY RIGHT

DECLARATION BY THE CANDIDATE

I hereby declare that the Tamilnadu Dr. M. G. R. Medical University, Chennai,

Tamilnadu shall have the rights to preserve, use and disseminate this

Dissertation / Thesis in print or electronic format for academic / research purpose.

Date: Signature of the Candidate

Place: Chennai (Dr.N.LILLY)

ACKNOWLEDGEMENT

Firstly I thank the Almighty for all that I am gifted with.

I thank Dr. N. Manavalan N.D.(Osm), Principal, Govt. Yoga and Naturopathy

Medical College, Chennai for creating an opportunity to pursue M.D in Yoga and Naturopathy.

It is a great pleasure to express my deep sense of thanks and gratitude to my mentor, philosopher and guide(Late)Dr.R.S.Himeshwari N.D.(Osm),H.O.D,

Dept. of Acupuncture and Energy Medicine, GYNMC, Chennai, for her constant guidance and tireless motivation all the way.

I extend my sincere gratitude to guide Dr.N.Mangaiarkarasi B.N.Y.S,

M.Sc(PSY),PGDHAN, H.O.D, Department of Acupuncture and Energy

Medicine, Government Yoga and Naturopathy Medical College, Arumbakkam for her support for the completion of this dissertation.

I also extend my gratitude towards them for their constant support and encouragement.

I thank Dr.R.Jainraj B.N.Y.S,MPH. Assistant medical officer in Yoga

Naturopathy Department, District Government hospital of Ramanathapuram for helping me throughout the statistical analysis and its interpretations needed for this study.

I thank Dr.P.Prabu B.N.Y.S, MD (yoga), Assistant medical officer and

Incharge for the Department of Acupuncture and Energy Medicine in

Government Yoga and Naturopathy Medical college and Hospital,

Arumbakkam, Chennai.

I also thank my mother Mrs.N.Malarvizhi and my father Mr.M.Newton for their immense support in my life.

I also thank friends for extending their support at all times. I also acknowledge the subjects co-operation and support who participated in the study.

Date:

Place: DR.N.LILLY

ABSTRACT

Background: Hypertension is not only a well-known risk factor for cardiovascular disease but also a public health challenge worldwide. Some auricular acupuncture treatment research papers shows reduction in blood pressure in patients with hypertension and helps as preventive aspect in pre- hypertensive patients.

Objective: The aim of the study to determine the efficacy of auriculotherapy in stage 1 and stage 2 hypertensive patients.

Methodology: Through RCT method 82 patients only fulfilling inclusion and exclusion criteria with age ranges from 30 to 60 years old and they were selected for this research project. From that by simple randomization method

41 patients participated in intervention group and 41 patients participated in control group. They were given auriculotherapy daily 30 minutes for 5 days in a week for a month and blood pressure and pulse rate monitored an assessed pre and post intervention.

Result: There was significant improvement in auriculotherapy intervention group with P<0.0001 when compared to control medicine group.

Conclusion: Giving auriculotherapy separately in shenmen and heart point reduces high blood pressure in stage 1 and stage 2 hypertensive patients due to vagal parasympathetic activation capacity.

Key words: Auriculotherapy, shenmen point, heart point, Blood pressure.

SL.NO CONTENT

1 INTRODUCTION

2 AIM AND OBJECTIVES

3 REVIEW OF LITERATURE

4 MATERIALS AND METHODS

5 RESULTS

6 DISCUSSION

7 CONCLUSION

8 SUMMARY

9 REFERENCE

10 ANNEXURE

LIST OF TABLES

SL NO INDEX PAGENO

1. Descriptive statistics values for auriculotherapy 57

intervention group

2. Descriptive statistics values for anti-hypertensive drug 58

control group

3. Tests of within-subjects effects-for case group 59

4. Tests of within -subjects effects -for control group 60

5. Pairwise comparisons 61

LIST OF FIGURES

SL NO INDEX PAGENO

1 Risk Factors Of Hypertension 8

2 Measuring Normal Blood Pressure 11

3 Stages Of Blood Pressure 12

4 Regulation Of Blood Pressure By Baroreceptors 14

5 Renin Angiotensin Aldosterone- Function In HTN 15

6 ANP-Regulation Of Blood Pressure 18

7 Pathophysiology Of Hypertension 23

8 Management Of Hypertension 26

9 Classification Of Anti-Hypertensive Drugs 27

10 Allopathic Treatment For Hypertension 33

11 Complications Of Hypertension 34

12 Vagus Nerve Activation On Heart And Blood 36

Pressure

13 Auriculotherapy Divisions And Points 41

14 Study Plan 47

15 Automatic Omron Blood Pressure Monitor 49

16 Measuring Bp Using Omron Machine 51

17 Bp Values Noted In Study Plan Sheet 52

18 Heart & Shenmen Point Stimulated With Sujok 53

Needles

19 Patient In Auriculotherapy Intervention 54

20 Patients Distribution In Control Group 56

21 Patients Distribution In Auriculotherapy Group 56

22 SBP Reduction In Auriculotherapy Group 62

23 DBP Reduction In Auriculotherapy Group 63

24 PR Variation In Auriculotherapy Group 64

25 SBP Variation In Control Group 65

26 DBP Variation In Control Group 66

27 PR Variation In Control Group 67

LIST OF ABBREVATIONS

CVD CARDIO VASCULAR DISEASE

BP BLOOD PRESSURE

EH ESSENTIL HYPERTENSION

JNC 7 SEVENTH REPORT OF JOINT NATIONAL COMMITTE

SBP SYSTOLIC BLOOD PRESSURE

DBP DIASTOLIC BLOOD PRESSURE

VAI VISERAL ADIPOSE INDEX

BFD BODY FAT PERCENTAGE

BMI BODY MASS INDEX

HR HEART RATE

AT ANGIOTENSIN

ACE ANGIOTENSIN CONVERTING ENZYME

ANP ATRIAL NATRIURETIC PEPTIDE (ANP)

NO NITRIC OXIDE

TOD TARGET ORGAN DAMAGE

ECG ELECTROCARDIOGRAM

BHS BRITISH HYPERTENSION SOCIETY

DASH DIETARY APPROACHES TO HYPERTENSION

CHD CORONARY HEART DISEASE

AA AURICULAR ACUPUNCTURE

OPD OUT PATIENT DEPARTMENT

ABP AMBULATORY BLOOD PRESSURE

ANOVA ANALYSIS OF VARIANCE

1. INTRODUCTION

Non-communicable cardio vascular diseases (CVDs) are predicted to be the leading cause of death and disability globally by 2020 [1]. The number of hypertensive adults will reach 1.5 billion approximately 30%of the world population—by 2025[2].

Arterial hypertension is one of the top leading risk factors for global disease burden and 16.5% of all mortality can be attributed to high blood pressure (BP) [2]. The World Health Organization defines hypertension as a systolic/diastolic pressure that is persistently greater than 140/90 mm Hg [2].

Essential hypertension (EH) is a common chronic disease, which affects up to one billion individuals worldwide and is attributable each year to more than 7 million deaths and loss of 64million disability-adjusted life years [3].

In The Seventh Report of the Joint National Committee on Prevention,

Detection, Evaluation and Treatment of High Blood Pressure (JNC7) defined prehypertension as SBP of 120 to 139 mmHg and DBP of 80 to 89 mmHg to identify individuals who were associated with a risk of developing hypertension and decrease blood pressure (BP), inhibit the progression of BP to hypertensive levels with age and prevent hypertension through early intervention .Raised blood pressure is a major risk factor for chronic heart disease, stroke, and coronary heart disease [4].

Elevated BP is positively correlated to the risk of stroke and coronary heart disease. Other than coronary heart disease and stroke, its complications include heart failure, peripheral vascular disease, renal impairment, retinal haemorrhage, and visual impairment [5].

India is a developing country and like other developing countries, it also going through a rapid demographic and epidemiological transition. In that nutritional transition is the key ingredient and plays important role. One of the cross-sectional community based study identified a high prevalence of prehypertension and hypertension in urban areas of Varanasi, which was

41.7% and 32.96%, respectively. Only a quarter of subjects were in the normal category, which highlights the escalating burden of this silent killer hypertension

[6].

2. AIM AND OBJECTIVES

Aim

The study is aimed to determine the efficacy of Auriculotherapy in stage 1 and

stage 2 Hypertensive patients.

Objectives of the study:

 To understand the effect of Auriculotherapy on cardiovascular functions such as

Blood pressure and in pulse rate.

 To find out the effect of minimum 2 points such as heart and shenmen point in

Auriculotherapy stimulated with sujok needles how reducing the high blood

pressure scientifically.

3. REVIEW OF LITERATURE

HYPERTENSION:

DEFINITIONS:

Hypertension is not only a well-known risk factor for cardiovascular disease but also a public health challenge worldwide [6].BP classification was based on the

JNC7 guidelines [7]. Normotension was defined as subjects with SBP <120 mm

Hg and DBP <80 mm Hg without antihypertensive drugs. Prehypertension was defined as not being on antihypertensive drugs and having an SBP of 120–139 mm Hg and/or DBP of 80–89 mm Hg [7].

Hypertension was defined as SBP140 mm Hg and/or DBP90 mm Hg, and also if the individual was on antihypertensive drugs for 2 weeks. Awareness of hypertension was defined as self-report of any previous diagnosis of hypertension by a health care professional. Treatment of hypertension was defined as self- reported use of antihypertensive medications in the previous 2 weeks among hypertensive participants, as well as among hypertensive participants who were aware of being hypertensive. [8].

PREVALENCE:

There has been a wide range of prevalence of hypertension around the world, with the lowest prevalence in rural India (3.4% in men and 6.8% in women) and the highest prevalence (78%) for South Africa and Poland (68.9% in men and

72.5% in women). Similarly the prevalence of hypertension is rising among older adults in Sub-Saharan Africa [9].

The relationship between increasing age and rise in systolic blood pressure is suspected to emulate from the length of time people are exposed to these modifiable risk factors. Generally, both hypertension and pre-hypertension are significantly more prevalent in males than females and this is possibly due to the differences in hormonal activity between males and females in early life [10].

According to World Health Organization (2015), the overall prevalence of hypertension in India was 23.5% and gender specific prevalence was 24.2% and

22.7% among the men and women, respectively [11].

The prevalence of prehypertension in the present study was 41.7%

(male: 45.9% and female: 38.05%). The prevalence estimated in the present study was much higher than that estimated by Nellore (22.3%) and Bihar

(37.95%) The difference of prevalence observed between the present study and other studies with respect to hypertension and prehypertension could be due to social and cultural differences, dietary and lifestyle factors, and also the age span as well as the research methodology used [12].

The prevalence of prehypertension and hypertension increased with increasing body mass index (BMI). The prevalence of prehypertension decreased, in parallel to an increase in the prevalence of hypertension, with increasing waist circumference (WC). A combination of WC and BMI was superior to individual indices in identifying hypertension. A multivariate logistic regression analysis indicated that increasing age, high BMI, high visceral adipose index and high heart rate were risk factors for prehypertension and hypertension. The high body fat percentage was significantly associated with prehypertension. Living in an urban area, male sex, abdominal obesity and menopause were correlated with hypertension [13].

There are several risk factors that Contribute to hypertension, the main ones being obesity, alcohol consumption, sedentary lifestyle and smoking.

Habits, lifestyle and adherence to treatment have strong influence in disease control. Hypertension is both preventable and treatable, early detection is key, and with aggressive treatment and long term management as well. Many complementary and alternative therapies are available for treating and preventing hypertension; auricular stimulation is one of the popular Chinese methods. It involves stimulating points on the ears that correspond to different organ systems of the body. Moreover, no large-scale surveys have been conducted on the prevalence of prehypertension and correlate of prehypertension and hypertension in southern China, especially Jiangxi Province [14].

Few studies discussed the relationship between visceral adipose index

(VAI), body fat percentage (BFP), and BP. Therefore, the present study aimed to estimate the prevalence and correlates of prehypertension and hypertension.

Also, the determinants for prehypertension and hypertension were compared.

Moreover, scientific references on the primary prevention and intervention strategies for treating prehypertension and hypertension were provided [14].

The Global Burden of Disease study estimates 62% of stroke, 49% ischemicheartdisease,and14%ofothercardiovasculardiseasecanbeattributableto mean systolic blood pressure levels >115mmHg worldwide. Blood pressure can be lowered by several classes of drugs and by such lifestyle changes as weight loss, salt intake restriction, and exercises [14].

Figure1: Risk factors of hypertension.

Risk factors associated with prehypertension and hypertension:

A multivariate logistic regression analysis was performed using SPSS to assess significant determinants of prehypertension (vs. Normotension), hypertension (vs

Normotension), and hypertension (vs prehypertension).One of the research said

People aged 45–54, 55– 64, 65–74, and75 years had a greater correlation of developing prehypertension compared with participants aged 15–24 years [odds ratio (OR) = 2.290, 2.875, 3.526, and 5.241, respectively [15].

The probability of having prehypertension and hypertension increased with an increase in BMI and VAI. Moreover, patients with a high HR were more likely to develop prehypertension and hypertension (P< 0.001). Interestingly, the multivariate logistic regression analysis showed a significant increase in ORs

8 with an increase in BFP in the prehypertension group (P< 0.01), not in the hypertension group. In contrast, gender, location, smoking, drinking, menopause, abdominal obesity, and low BFP were not significantly associated with prehypertension. Also, a higher correlation of hypertension with increasing age was observed. Compared with females, males were positively associated with hypertension (OR = 2.408). People living in urban areas were also associated with hypertension (OR = 1.317). Smoking and drinking were not significantly associated with hypertension. Unlike prehypertension, menopause, and abdominal obesity were associated with a greater likelihood of having hypertension [15].

Normal Blood pressure at different age groups

The arterial blood pressure of the first day of the new born after the birth is measured to be 70/50 mm Hg. This systolic and diastolic pressure tends to increase gradually, after the next several months of child’s development, which appears to be in ranges of about 90/60 mm Hg. After the subsequent years of development the percentile rise in the blood pressure is very much slow, until the individual reaches adulthood, where the normalized blood pressure was 115/70 mm Hg (adolescence), whereas normal blood pressure for adults is 110 to 140

9 mm Hg in the case of systolic pressure and 60-90 mm Hg in the case of diastolic pressure [16].

Figure 2: Measuring normal blood pressure.

Stages of Hypertension:

Figure 3: Stages of Hypertension.

Regulation of blood pressure

The control of blood pressure is complex and will be reviewed only briefly.

Neurogenic control

The vasomotor centre includes the nucleus tractus solitarius in the dorsal medulla

(baroreceptors integration), the rostral part of the ventral medulla (pressor region), and other centres in the pons and midbrain. The arterial baroreceptors respond to vessel wall distension by increasing the afferent impulse activity. This in turn decreases the efferent sympathetic activity and augments vagal tone. The net effect is bradycardia and vasodilatation [17].

Figure 4: Regulation of Blood pressure by baroreceptors.

Renin-angiotensin system:

Figure 5: Renin angiotensin aldosterone -function in hypertension.

The renin-angiotensin system may be the most important of the endocrine systems that affect the control of blood pressure. Renin is secreted from the juxtaglomerular apparatus of the kidney in response to glomerular under perfusion or a reduced salt intake. It is also released in response to stimulation from the sympathetic nervous system [18].

Renin is responsible for converting renin substrate (angiotensinogen) to angiotensin I, a physiologically inactive substance which is rapidly converted to angiotensin II in the lungs by angiotensin converting enzyme (ACE).

Angiotensin II is a potent vasoconstrictor and thus causes a rise in blood pressure. In addition it stimulates the release of aldosterone from the zona glomerulosa of the adrenal gland, which results in a further rise in blood pressure related to sodium and water retention [18].

The circulating renin-angiotensin system is not thought to be directly responsible for the rise in blood pressure in essential hypertension. In particular, many hypertensive patients have low levels of renin and angiotensin II

(especially elderly and black people), and drugs that block the renin-angiotensin system are not particularly effective. There is, however, increasing evidence that there are important non-circulating ―local‖ renin-angiotensin epicrine or paracrine systems, which also control blood pressure. Local renin systems have been reported in the kidney, the heart, and the arterial tree. They may have important roles in regulating regional blood flow [18].

Newer antihypertensive agents such as ACE inhibitors and angiotensin II receptor antagonists are effective, but not more than diuretics and b-blockers converted into an active octapeptide, angiotensin II by the angiotensin-converting enzyme (ACE). Though the renin– angiotensin system is widespread in the body,

In addition, renin release is stimulated by b- and decreased by a-adrenoceptor stimulation [19].

High angiotensin II concentrations suppress renin secretion via a negative feedback loop. Angiotensin II acts on specific angiotensin AT1 and AT2 receptors causing smooth muscle contraction and the release of aldosterone, prostacyclin, and catecholamines [19].

The renin–angiotensin–aldosterone system plays an important role in the control of arterial pressure including the sodium balance [19].

Atrial natriuretic peptide

Atrial natriuretic peptide (ANP) is released from atrial granules. It produces natriuretic, diuresis and a modest decrease in blood pressure, while decreasing plasma renin and aldosterone. Natriuretic peptides also alter synaptic transmission from the osmoreceptors. ANP is released as a result of the stimulation of atrial stretch receptors. ANP concentrations are increased by raised

17 filling pressures and in patients with arterial hypertension and left ventricular hypertrophy as the wall of the left ventricle participates in the secretion of ANP

[20].

Figure6: ANP Regulation of Blood pressure.

Eicosanoids

Arachidonic acid metabolites alter blood pressure through direct effects on vascular smooth muscle tone and interactions with other vaso-regulatory systems: autonomic nervous system, renin– angiotensin–aldosterone system, and other humoral pathways. In hypertensive patients, vascular endothelial cell dysfunction could lead to reduction in endothelium-derived relaxing factors such as nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor, or increased production of contracting factors such as endothelin-1 and thromboxane A2[21].

Kallikrein-kinin systems

Tissue kallikreins act on kininogen to form vasoactive peptides. The most important is the vasodilator bradykinin. Kinins play a role in the regulation of renal blood flow and water and sodium excretion. ACE inhibitors decrease the breakdown of bradykinin into inactive peptides [21].

Endothelial mechanisms

Nitric oxide (NO) mediates the vasodilatation produced by acetylcholine, bradykinin, sodium nitroprusside and nitrates. In hypertensive patients, endothelial-derived relaxation is inhibited. The endothelium synthesizes endothelins, the most powerful vasoconstrictors. The generation of, or sensitivity

19 to, endothelin-1 is no greater in hypertensive than it is in normotensive subjects.

Nonetheless, the deleterious vascular effects of endogenous

Endothelin-1 may be accentuated by reduced generation of nitric oxide caused by hypertensive endothelial dysfunction [22].

Adrenal steroids

Mineralo and glucocorticoids increase blood pressure. This effect is mediated by sodium and water retention (mineralocorticoids)or increased vascular reactivity

(glucocorticoids). In addition, glucocorticoids and mineralocorticoids increase vascular tone by up regulating the receptors of pressor hormones such as angiotensin II [23].

Reno-medullary vasodepressor

Reno-medullary interstitial cells, located mainly in the renal papilla, secrete an inactive substance medullipin I. This lipid is transformed in the liver into medullipin II. This substance exerts a prolonged hypotensive effect, possibly by direct vasodilatation, inhibition of sympathetic drive in response to hypotension, and a diuretic action. It is hypothesized that the activity of the reno-medullary system is controlled by renal medullary blood flow [24].

Sodium and water excretion

Sodium and water retention are associated with an increase in blood pressure. It is postulated that sodium, via the sodium–calcium exchange mechanism, causes an increase in intracellular calcium in vascular smooth muscle resulting in increased vascular tone. The primary cause of sodium and water retention may be an abnormal relationship between pressure and sodium excretion resulting from reduced renal blood flow, reduced nephron mass, and increased angiotensin or mineralocorticoids [25].

Insulin sensitivity:

Epidemiologically there is a clustering of several risk factors, including obesity, hypertension, glucose intolerance, diabetes mellitus, and hyperlipidaemia. This has led to the suggestion that these represent a single syndrome (metabolic syndrome X or Reaven's syndrome), with a final common pathway to cause raised blood pressure and vascular damage. Indeed some hypertensive patients who are not obese display resistance to insulin. There are many objections to this hypothesis, but it may explain why the hazards of cardiovascular risk are synergistic or multiplicative rather than just additive [26].

Pathophysiology of Hypertension:

Hypertension is a chronic elevation of blood pressure that, in the long term, causes end-organ damage and results in increased morbidity and mortality.

Blood pressure is the product of cardiac output and systemic vascular resistance. It follows that patients with arterial hypertension may have an increase in cardiac output, an increase in systemic vascular resistance, or both.

In the younger age group, the cardiac output is often elevated, while in older patients increased systemic vascular resistance and increased stiffness of the vasculature play a dominant role [27].

Figure 7: Pathophysiology of Hypertension.

Vascular tone may be elevated because of increased adrenoceptor stimulation or increased release of peptides such as angiotensin or endothelins. The final pathway is an increase in cytosolic calcium in vascular smooth muscle causing vasoconstriction. Several growth factors, including angiotensin and endothelins, cause an increase in vascular smooth muscle mass termed vascular remodelling.

Both an increase in systemic vascular resistance and an increase in vascular stiffness augment the load imposed on the left ventricle; this induces left ventricular hypertrophy and left ventricular diastolic dysfunction. In youth, the pulse pressure generated by the left ventricle is relatively low and the waves reflected by the peripheral vasculature occur mainly after the end of systole, thus increasing pressure during the early part of diastole and improving coronary perfusion. With ageing, stiffening of the aorta and elastic arteries increases the pulse pressure. Reflected waves move from early diastole to late-systole. This results in an increase in left ventricular afterload, and contributes to left ventricular hypertrophy [27].

The widening of the pulse pressure with ageing is a strong predictor of coronary heart disease. The autonomic nervous system plays an important role in the control of blood-pressure in hypertensive patients, release of, and enhanced peripheral sensitivity to, norepinephrine can be found. In addition, there is increased responsiveness to stressful stimuli. Another feature of arterial hypertension is a resetting of the baroreflexes and decreased baroreceptor

sensitivity. The renin–angiotensin system is involved at least in some forms of

hypertension (e.g. reno- vascular hypertension) and is suppressed in the presence

of primary hyperaldosteronism. Elderly or black patients tend to have low-renin

hypertension [27].

DIAGNOSIS OF HYPERTENSION:

Hypertension is a silent disease64% of cases remain undiagnosed. Therefore, BP

should be measured at every chance encounter. Evaluation of newly diagnosed

hypertensive patients has three main objectives includes,

1. To exclude secondary causes of Hypertension.

2. To ascertain the presence or absence of target organ damage (TOD).

3. To assess lifestyle and identify other cardiovascular risk factors and/or

concomitant disorders that affect treatment and prognosis.

The baseline investigations should include the following:

 Full blood count (FBC)

 Fasting lipid profile

 Urine albumin excretion or albumin/creatinine ratio

 o Fasting blood sugar (FBS)

 Urinalysis

 Electrocardiogram (ECG)

 Renal profile and serum uric acid

 Chest x-ray (if clinically indicated)

MANAGEMENT OF HYPERTENSION:

Figure 8: Management of Hypertension.

All patients should be managed with non-pharmacologic interventions/therapeutic lifestyle modifications to lower BP. Patients with prehypertension should be followed up yearly to detect and treat Hypertension as early as possible. Decisions regarding pharmacological treatment should be based on the individual patient’s global cardiovascular risk. In subjects with medium risk or higher, the threshold for commencing hypertension treatment should be lower [27].

Figure 9: classification of Anti-hypertensive drugs.

Anti-hypertensive drug management:

The names of all antihypertensive drugs were collected and coded using the

Anatomical Therapeutic Chemical (ATC) classification system. In both baseline and follow-up, antihypertensive drugs were classified into six different categories: 1) Diuretics (isolated or associated with other drugs), 2) Calcium channel blockers (CCBs), 3) Beta-blockers (BBs), 4) Angiotensin-converting enzyme inhibitors (ACEIs), 5) Angiotensin receptor blockers (ARB) and 6)

Other (reserpine) [26].

Combinations were split into the drug classes they contained; for example ATC code C08GA01, corresponding to nifedipine and diuretics, was split into

―diuretics associated with other drugs‖ and ―calcium channel blockers‖. As a single medicine can be a combination of up to three antihypertensive drug classes, two further classifications were used according to the number of antihypertensive drug classes or of antihypertensive pills: monotherapy (i.e. taking a single drug class)/combination therapy and single medicated (i.e. taking a single pill, which can eventually be a combination of drugs)/polymedicated

[26].

According to the evolution of their antihypertensive treatment, participants were assigned into 4 different groups determined by drugs brought to visit at baseline and approximately 5 years later as suggested in a previous study .1) Continuers: participants continuing the initial treatment (including combinations) without

28 changes; 2) Switchers: treatment from one class to another class of antihypertensive therapy (for example a CCB for an ARB); 3) Combiners: participants treated with an additional type of antihypertensive class but continuing the initial medication (for example adding a diuretic to an ARB) and

4) Discontinuers: participants stopping the therapy without having another antihypertensive drug prescription added [27].

The BHS (British hypertension society) also advocates maintenance of normal body weight, consumption of a diet rich in fruit and vegetables, and reduced total and saturated fat. They make the point that these interventions can reduce the need for drug therapy, enhance the effect of antihypertensive drugs, reduce the need for multiple drug regimens, and favourably influence overall cardiovascular risk. The international guidelines advocate diet/behavioural modification at every stage, both before drug therapy in pre-hypertension or uncomplicated stage-1 hypertension, as well as for high-risk patients and those on medication. They also specifically recommend adoption of the Dietary Approaches to Stop

Hypertension (DASH) eating plan [27].

Therapeutic lifestyle changes should be recommended for all individuals with hypertension and pre-hypertension. It may be the only treatment necessary in

Stage 1 hypertension. A high degree of motivation is also needed to sustain the benefits of non-pharmacological treatment. It is also important to remember that

29 lifestyle modification requires a concerted effort and reinforcement on behalf of the practitioner. Lifestyle modification works better with concurrent behavioral intervention than just passive advice. This non-pharmacological management includes weight reduction, sodium restriction and avoidance of alcohol intake, regular physical exercise, healthy eating and cessation of smoking [27].

It must be emphasized that the decision to commence pharmacological treatment should be based on global cardiovascular risks and not on the level of BP [27].

The DASH diet is low in total and saturated fat, red meat, sugar, sugary drinks, and refined carbohydrates, but high in fruits, vegetables, whole grains, fish, poultry, and low-fat dairy products. The DASH diet has been found to lower weight, heart rate, risk of type 2 diabetes, C-reactive protein, apolipoprotein B, and homocysteine and is associated with a lower incidence of heart failure, all- cause mortality, and stroke [27].

Treatment of Hypertension:

Dozens of high blood pressure medications (anti-hypertensive) are available, each with pros and cons. Your doctor might prescribe more than one high blood pressure medication to treat your condition [27].

Diuretics (water pills). Your doctor might first suggest diuretics, which remove excess water and sodium from your body. That decreases the amount of fluid flowing through your blood vessels, which reduces pressure on your vessel walls

[27].

There are three types of diuretics: thiazide, loop and potassium-sparing. The Joint

National Committee on Prevention, Detection, Evaluation, and Treatment of

High Blood Pressure recommends that most people try thiazide diuretics first to treat high blood pressure and heart problems related to high blood pressure [27].

Angiotensin-converting enzyme (ACE) inhibitors. These help relax blood vessels by preventing the formation of a hormone called angiotensin, a substance in your body that narrows blood vessels. Frequently prescribed ACE inhibitors include enalapril (Vasotec), lisinopril (Prinivil, Zestril) and ramipril (Altace)

[27].

Angiotensin II receptor blockers (ARBs). These help relax blood vessels by blocking the action, not the formation, of angiotensin, a chemical in your body that narrows blood vessels. ARBs include valsartan (Diovan), losartan (Cozaar) and others [27].

Calcium channel blockers. These medications prevent calcium from entering heart and blood vessel muscle cells, thus causing the cells to relax [27].

Frequently prescribed calcium channel blockers include amlodipine (Norvasc), diltiazem (Cardizem, Tiazac, others) and nifedipine (Adalat CC, Afeditab CR,

Procardia) [27].

Beta blockers. Also known as beta-adrenergic blocking agents, these work by blocking the effects of the hormone epinephrine, also known as adrenaline. They cause your heart to beat slower and with less force [27].

Frequently prescribed beta blockers include metoprolol (Lopressor, Toprol-XL), nadolol (Corgard) and atenolol (Tenormin) [27].

Renin inhibitors. Renin is an enzyme produced by your kidneys that starts a chain of chemical steps that increases blood pressure [27].

Figure 10: Allopathic treatment for Hypertension.

Complications of Hypertension:

Figure 11: Shows complications of Hypertension.

Hypertension also increases the risk to development of Cardio Vascular

Disease. The increased health risk of obesity is most marked when excess fat is mainly in abdomen rather than on hips or thighs. Asians are more prone to metabolic Syndrome with high risk of developing Diabetes and subsequently hypertension, heart disease or stroke. A waist measurement of 90cms or above for (Asian) men and 80 cm or above for Asian (Women) is a significant health risk [27].

AURICULOTHERAPY:-

The ear was originally mentioned in the earliest Chinese medical book Yellow

Emperor's Classics of Internal Medicine that was published more than 2,000 years ago. The book states that the ear is related to all parts of the human body, particularly internal organs, and that all meridians converge at the ear [28]. The

Chinese Association of Acupuncture and Moxibustion was tasked by the World

Health Organization (WHO) to standardize acu-point locations to have a common language in the study and exchange of ideas [28].

Acupuncture has been widely used to treat various conditions, including cardiovascular disease and hypertension. Several articles have evaluated the effect of auricular acupuncture on controlling BP [19-22]. Some studies also

35 reported that the electroacupuncture treatment of auricular acu-points decreased

BP in patients with hypertension [28].

Figure 12: Vagus nerve activation on Heart and blood pressure.

The first document was accomplished in 1992 (GB/T 13734-1992) but was published in 1993 [29].

It has a very rich innervation and blood supply. Embryologically, the auricle is only derived from the ectoderm and mesoderm. The four mixed cranial nerves

(motor and sensitive roots with ganglions) controlling the four visceral arches give the ear more than half of its innervation by the trigeminal (V), facial (VII), glossopharyngeal (IX), and vagal nerves (X), and also the cervical plexus

(C2/C3). This composition of nerves allows one to consider this organ as a specific neurovascular origin. The latest nomenclature and location of auricular points announced by the China Standardization Organizing Committee in 2008

(GB/T 13734-2008) are more comprehensive because the committee has added additional information about the anatomical classification and location of the various parts of the auricle [29].

The mechanism of French Auriculotherapy can be alluded to the impedance change after acupressure so that its influence will be propagated to the correlated area or region of the body [30].

The reflexive property of the ear can cause various physical attributes to appear on the auricle in the presence of bodily disorders. These attributes include variations in shape, colour, size, and sensation; the appearance of papules,

37 creases, and oedema and increased tenderness or decreased electrical conductivity [30]. Auricular signals associated with body functions have been reported in previous studies. Kwai-Ping Suen et al [31].one of the study found that participants with coronary heart disease (CHD) exhibit the presence of earlobe crease compared with those without CHD. The ―heart‖ zone of the CHD cases significantly showed higher conductivity and tenderness in both ears than those of the controls. Abnormal hair growth on the ear is a sign of hormonal changes that accompany the decline in kidney qi, which occurs with age [32].

Though the ears are innervated by different nervous system/nerve endings, such as cervical nerves, temporal nerve, vagus nerve, and sympathetic nervous system, the principle for selecting the acu-points in the current study was not affected by their nature of parasympathetic and sympathetic dominance [33].

Auricular interventions also known as Auriculotherapy, auricular medicine and ear acupuncture depending on practice local has gained the attention of the wider medical community in recent years. Although the World Health

Organisation has, since 1997, accepted that Auriculotherapy (AT) has a place in clinical care, it has mostly been utilized in Europe, China and the USA. Until recently, many countries were often not aware of the place of Auriculotherapy in clinical diagnosis and therapeutics [33].

The Vagus and Trigeminal Nerves are represented on the ear and their links to psycho-neuro-endocrino-immuno interactions (PNEI) are now better understood. This connectivity has been shown to be integral to this highly effective approach in clinical care [34]

Auricular acupuncture (AA) is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear [35]. Ear stimulation involves the neurological reflex, neurotransmitters, cytokines, the immune system, and inflammation [36]. AA has been employed for approximately 2500 years, for which the oldest record is Huang Di Nei

Jing (The Yellow Emperor’s Classic of Internal Medicine), written in Chinese, and a report by Hippocrates is the oldest Western record [37].

In Traditional Chinese Medicine (TCM), the ear is directly or indirectly connected with 12 meridians, and stimulating the ear can restore the balance between Qi and blood [38]. TCM regards the ears as an important body part for clinical diagnosis and treatment, stimulating the points on them can achieve general or local effects. The way to stimulate the ear points can be needling, electricity, injection, blood-letting, pressing or moxa heating [38].

Auricular stimulation is indicated for a variety of conditions, and is relatively easy and simple to apply. For hypertension, the commonly selected points include: heart, liver, kidney, shenmen, sympathetic, adrenal gland, and lowering BP notch [39].

Normal needling method in Auriculotherapy:

Select points like adrenal gland, shenmen, lowering BP notch, & heart. Sterilize ear and stimulate with 25mm or 13mm needles or sujok needles. Insert a needle into the cartilage and then twirl rapidly for 30 seconds, be careful not to penetrate through the ear, retain the needle for 20 to 30 minutes to enhance stimulation or to facilitate further manipulation. After finished, press the point with a cotton ball for a while, so as to prevent bleeding, then sterilized again. Stimulating on one side or both sides, do this every day or every two days, ten times as one course

[40].

Figure 13: Auriculotherapy division and points.

1. HEART POINT 4.SHENMEN POINT.

MECHANISM OF ACTION OF AURICULOTHERAPY:

The stimulus from AA raises the vagal tone and regulates the cardiovascular, respiratory, gastrointestinal, and endocrine systems [41]. Some research papers regarding the cardiovascular system, AA can lower the heart rate and blood pressure and accelerate blood flow and heart rate variability (HRV) [42].

Moreover, stimulating the heart acu-point of the ear in rats was found to lower arterial pressure and the heart rate significantly compared with the use of Zusnali

(ST36) and Neiguan (PC6) [43].

In a randomized trial of a 6-week acupuncture treatment on patients with essential arterial hypertension, it was found that the mean 24-hour ambulatory BP in the experimental group was significantly lowered when compared to the sham group [44].

Auriculotherapy is to treat pathological conditions based on a neurophysiological pattern. It acts on the neural networks, eliciting action potentials, urging and rebalancing hormone and neurotransmitters secretion. The fastest and the best results are obtained in treating painful syndromes of whatever origin [44].

It has been acquired acupuncture to elicit synthesis of endorphin, encephalin, dynorphin, serotonergic, noradrenergic, and non-opioid neurotransmitters. According to some research articles, it is conceivable the central-mediated effects of acupuncture to be involved in suppression of neuropathic pain, too [45].

The results of auricular acupuncture study suggest that the tenderness and electrical conductivity of a number of auricular points, including pancreas and gallbladder, endocrine, kidney, lower tragus and heart point related to hypertension [45].

4. METHODOLOGY

MATERIALS AND METHODS:

Source of data:

The patients will be selected from the Out-patient department of both undergraduate and postgraduate block in Government Yoga and Naturopathy

Medical College, Arumbakkam, Chennai.

Inclusion criteria:

. Age group : between 30 to 60 years

. Both male and female subjects

. Patients were diagnosed with hypertension, according to a systolic blood

pressure (SBP) ≥140mmHg and/or a diastolic blood pressure (DBP)

≥90mmHg, or use antihypertensive drugs.

. Willingness to participate in the study.

Exclusion criteria:

. Secondary hypertension with pathologic conditions

. Grade 3 hypertension

. local infection at the ear

. Immunodeficiency and bleeding disorders

. any allergies

. intake of antipsychotic or antidepressant drugs

. Participation in another clinical trial.

Study Design: Randomized control trial.

Randomization:

The participants were selected by General Flux banner advertisement contain special treatment Auriculotherapy for hypertension at OPD in Government yoga naturopathy medical college and hospital, Arumbakkam,Chennai.102 hypertension patients participated in research study. From them 82 patients only fulfilling inclusion and exclusion criteria and they were selected for this research project. From that by simple randomization method 41 patients participated in intervention group and 41 patients participated in control group.

Ethical Considerations:

Ethical clearance was sought from the Institutional Ethics Committee prior to the start of the study and the approval for the same was granted.

Written informed consent:

Subjects who fulfilled inclusion criteria were apprised about the purpose of the study and their rights as research subjects. Informed consent form was administered in English. As all the subjects cannot understand English, so I translated to their native language (i.e., Tamil and Telugu), before participating

45 in this research study. Adequate time was given to each patient to go through the information sheet and their queries were answered. Their right to withdraw anytime from the study and the need for willingness to participate voluntarily in the study was explained. All the subjects expressed their willingness to participate in the study by giving a signed (A sample information sheet and consent form is enclosed as Annexure 1).

Study Setting:

The study was conducted in OPD of Government Yoga &Naturopathy medical college and hospital with duration of one month (4 weeks), Blood pressure and pulse rate monitored before starting the Auriculotherapy treatment for intervention group and then sujok needles was used for hypertensive patients.

Study Plan

Subjects will be screened

Randomization

(n =82)

Group 1(n = 41) Group 2(n = 41)

Pre -Assessment Pre-Assessment

Standard drug treatment Auriculotherapy treatment andand

Dropout 5 patients Dropout 7 patients

Post-Assessment Post-Assessment

Statistical Analysis & result

Figure 14: Study plan

INTERVENTION PROCEDURE:

DATA COLLECTION METHODS:

ASSESSMENTS:

All the parameters were recorded by Digital sphygmomanometer before and after the Auriculotherapy treatment for every week for the period of one month.

MEASUREMENT OF BLOOD PRESSURE AND PULSE RATE:-

BP and pulse rate was measured using the automatic blood pressure monitor

Omron HEM-8712 Professional Portable Blood Pressure Monitor (Kyoto, Japan) one time on the right arm supported at the heart level after the participants were allowed to rest for 5 min, SBP or DBP readings, along with that pulse rate was measured for single time is considered as main vale. Data’s entered in the excel sheet in HP laptop The subjects were advised to avoid cigarette smoking, and consumption of coffee, tea, and alcohol for at least 30 min before BP measurements.

Figure 15: Automatic OMRON blood pressure monitor.

Method of collection of data:

. Screening in first visit according to a Systolic blood pressure (SBP)

≥140mmHg and/or a diastolic blood pressure (DBP) ≥90mmHg, or use

antihypertensive drugs.

. The selected participants would be subjected to Auriculotherapy each sitting

with 30minutes 5 days in a week for 4 weeks with a break of 2days in

between each week.

. Blood pressure and pulse rate will be checked before and after treatment of

every sitting of Auriculotherapy treatments and in control waiting list group

in every 5 days once.

. After the period of 4 weeks, Blood pressure readings every week will be used

to assess the effectiveness of the interventions and subjects will be in follow

up treatments upto2 months.

DATA MANAGEMENT:

Data expressed Mean ±SD. Comparison of Mean in between the pre and post intervention was analysed by ANOVA with a Greenhouse-Geisser correction determined that mean systolic blood pressure differed statistically between the time points (F (2.343, 77.322) = 217.610, p<0.0005).

Figure 16: Measuring the Blood pressure using Automatic OMRON BP monitor.

Figure17: Blood pressure readings noted in treatment plan sheet.

Figure 18: Heart point and Shenmen point stimulated with Sujok needle.

Figure 19: Patient underwent Auriculotherapy treatment.

5. RESULTS

The following chapter represents the overall results of the current study that determines the effectiveness of Auriculotherapy for hypertensive patients. The resultant outcomes from the interventional studies were monitored from the cardiovascular parameters (BP and Pulse rate), which were further subjected to statistical analysis.

Statistical Analysis

The results for the following studies were statistically determined for

Cardiovascular parameters (BP & Pulse rate) and the results were analysed in

SPSS Software in 16.0 version by Repeated measures ANOVA test method.

The following data for each subsets were expressed Mean± SD. In this study 82 hypertensive patients consisting of 41 patients participated in Auriculotherapy study group and 41 patients were participated in control Medicine group for the period of one month research study.

Series1, Control group M, 15, Series1, Control 42% group F, 21, 58%

Figure 20: Patients Distribution in Control Group.

Series1, Case group F, 17, Series1, Case 50% group M, 17, 50%

Figure 21: Patients Distribution in Auriculotherapy Group.

TABLE 1: DESCRIPTIVE STATISTICS FOR CASE GROUP

Sys BP DBP PR Std. Std. Std. Deviati Deviati Mean Deviation N Mean on N Mean on N Pre 174.38 9.795 34 104.47 4.974 34 60.00 4.849 34 post7 162.03 9.731 34 96.71 6.088 34 63.91 5.282 34 post14 152.91 10.428 34 90.21 6.275 34 68.71 5.823 34 post21 140.68 12.579 34 84.15 6.320 34 77.74 9.153 34 post30 119.59 10.139 34 73.21 6.732 34 74.85 5.985 34

Table 1 explains about descriptive statistics for Auriculotherapy intervention group Systolic blood pressure, Diastolic blood pressure and Pulse rate variation in every week, first reading shows the Mean value is high in SBP and DBP gradually reduced in every week, but in PR gradually it increased in every week, because PR is inversely proportion to BP. this itself explaining that Auriculotherapy has more significant result in this study.

TABLE 2: DESCRIPTIVE STATISTICS FOR CONTROL GROUP SBP, DBP AND PR.

Descriptive Statistics for control group

SBP DBP PR

Std. Std. Deviatio Std. Mean Deviation N Mean n N Mean Deviation N

Pre 166.11 15.950 36 94.08 12.852 36 62.92 5.500 36 post7 days 159.61 14.100 36 88.50 12.493 36 65.97 4.663 36 post14 days 155.06 14.160 36 84.03 10.924 36 69.00 6.320 36 post21 days 145.86 13.451 36 78.28 8.464 36 70.86 5.128 36 post31 days 135.19 14.126 36 73.75 9.857 36 72.83 3.140 36

Table 2 explains about descriptive statistics for control group shows mild reduction in SBP, DBP and mild increased in PR for 4 weeks.

TABLE 3: Tests of within- Subjects effects for Auriculotherapy group

Tests of Within-Subjects Effects-For case group

Type III Sum of Mean Partial Eta Source Squares df Square F Sig. Squared Time Sphericity 217.61 59821.435 4 14955.359 .000 .868 For SBP Assumed 0 Greenhouse- 217.61 59821.435 2.343 25530.954 .000 .868 Geisser 0 Huynh-Feldt 217.61 59821.435 2.533 23613.405 .000 .868 0 Lower-bound 217.61 59821.435 1.000 59821.435 .000 .868 0 Error(tim Sphericity 9071.765 132 68.725 e) Assumed Greenhouse- 9071.765 77.322 117.324 Geisser Huynh-Feldt 9071.765 83.601 108.512 Lower-bound 9071.765 33.000 274.902

191.81 For DBP Greenhouse- 19393.212 3.103 6250.102 .000 .853 7 Geisser

For PR Greenhouse- 7396.035 2.423 3052.284 58.841 .000 .641 Geisser

Table 3 explains that with Greenhouse-Geisser test method shows significant values in SBP, DBP and PR for Auriculotherapy intervention group with P<0.001.

TABLE 4: Tests of within- Subjects effects for control group.

Type III Sum of Mean Partial Eta Source Squares Df Square F Sig. Squared Time For Sphericity 21089.856 4 5272.464 87.848 .000 .715 SBP Assumed Greenhous 21089.856 1.948 10823.956 87.848 .000 .715 e-Geisser Huynh- 21089.856 2.062 10229.123 87.848 .000 .715 Feldt Lower- 21089.856 1.000 21089.856 87.848 .000 .715 bound Error(f Sphericity 8402.544 140 60.018 actor1ti Assumed me) Greenhous 8402.544 68.195 123.213 e-Geisser Huynh- 8402.544 72.161 116.441 Feldt Lower- 8402.544 35.000 240.073 bound

For Greenhous 9336.967 2.036 4586.537 75.093 .000 .682 DBP e-Geisser

Table 4 explains that with Greenhouse-Geisser test analyses method SBP, DBP

and PR show significant effect in control medicine group.

TABLE 5: PAIRWISE COMPARISONS

Pairwise Comparisons

95% Confidence Interval for Mean a (I) (J) Difference (I- Difference time time J) Std. Error Sig.a Lower Bound Upper Bound 1 2 12.353* 1.134 .000 8.941 15.765 3 21.471* 2.165 .000 14.958 27.983 4 33.706* 2.719 .000 25.525 41.886 5 54.794* 2.452 .000 47.419 62.169 2 1 -12.353* 1.134 .000 -15.765 -8.941 3 9.118* 1.523 .000 4.537 13.698 4 21.353* 2.108 .000 15.013 27.693 5 42.441* 2.182 .000 35.876 49.007 3 1 -21.471* 2.165 .000 -27.983 -14.958 2 -9.118* 1.523 .000 -13.698 -4.537 4 12.235* 1.417 .000 7.973 16.497 5 33.324* 1.936 .000 27.501 39.146 4 1 -33.706* 2.719 .000 -41.886 -25.525 2 -21.353* 2.108 .000 -27.693 -15.013 3 -12.235* 1.417 .000 -16.497 -7.973 5 21.088* 1.942 .000 15.247 26.930 5 1 -54.794* 2.452 .000 -62.169 -47.419 2 -42.441* 2.182 .000 -49.007 -35.876 3 -33.324* 1.936 .000 -39.146 -27.501 4 -21.088* 1.942 .000 -26.930 -15.247 Based on estimated marginal means *. The mean difference is significant at the .05 level. a. Adjustment for multiple comparisons: Bonferroni.

Table 5 pairwise comparisons for SBP every week, that first week values compared with 2nd week value, then 1st week compared with 3rd week values, same like that all weekly values were measured and compared with this method and shows significant result in every week in Auriculotherapy intervention group.

Figure 22: SBP reduction in Auriculotherapy- group gradually in every week.

Figure 23: Shows DBP reduction in Auriculotherapy- group gradually in every week.

DBP reduces from 1st day 108mm HG to 74 mm HG at the end of 30th day.

Figure 24: Shows PR variation in Intervention group for one month.

Pulse rate gradually increased from low level to normal range in Auriculotherapy intervention group.

Figure 25: Shows variation in SBP in control group.

Systolic blood pressure in anti-hypertensive drug intake control group shows mild and gradual reduction from 1st day 166 mm HG to 120 mm HG at 30th day.

Figure 26: Shows variation in DBP in control group.

Diastolic blood pressure in anti-hypertensive drug intake control group shows mild and gradual reduction from 1st day 96 mm HG to 74 mm HG at 30th day.

Figure 27: Shows variation in PR in control group.

Pulse rate also gradually increased in anti-hypertensive drug intake control group.

The data obtained following the study is analysed by a repeated measures

ANOVA with a Greenhouse-Geisser correction determined that mean systolic blood pressure differed statistically between the time points (F (2.343, 77.322)=

217.610, p<0.0005). Post hoc test using the Bonferroni correction revealed that the Auriculotherapy elicited a reduction in systolic blood pressure from pre- treatment to all the time points.

There was significant improvement seen systolic blood pressure, diastolic blood pressure and pulse rate in Auriculotherapy intervention group compared to antihypertensive drug intake group.

6. DISCUSSION

The initial management of hypertension begins with a diagnosis based on several blood pressure measurements made in the Hospital. Ambulatory blood pressure

(ABP) is a more accurate measure of BP compared with clinical BP and shows better correlation with cardiovascular outcomes [46, 47&48]. Some studies also suggest that adopting ABP monitoring as the reference standard for the diagnosis of hypertension would lead to more appropriately targeted treatment, and this would be particularly important for patients near the threshold for diagnosis

[49&50].

But here we cannot provide ABP equipment for all the 82 patients, so the clinical blood pressure and Pulse rate will be assessed as a primary outcome measurement. Blood pressure is a surrogate end point, and the relationship between blood pressure and the risk of morbid cardiovascular events is well established [51].

Since acupuncture is a diagnostic and treatment system based on normalizing the body’s dysfunction, acupuncture has been applied in order to provide pain relief, relaxation, and the other effects [52].

Auriculotherapy at tranquilizing points had induced the activation of parasympathetic nerve tone [53].

Decreased nitric oxide levels and increased endothelin-1 play both a functional regulatory role for arterial stiffness and endothelial dysfunction [54].

It has been reported that the influence of acupuncture on hypertension might be related to its regulatory effects on serum nitrogen monoxide level [55] or on renin secretion [56].

The role of supraoptic (so) nucleus and paraventricular nucleus of the hypothalamus was secreting vasopressin, which could interact with neurons of cardiovascular activity as well as influencing the body’s baroreflex sensitivity

[57].

Cardiovascular depressant effects of electroacupuncture in an animal model have been reported and attributed to afferent nerves stimulation [58].

From Chinese medicine point of view, hypertension is believed to be caused by the hyperactivity of the Liver Yang due to the excess of Yang Qi, or malnutrition of the ―Liver‖ resulting from the deficiency of the Kidney Yin.

Thus, the ―Liver‖ suppresses the Liver Yang and abates the wind[59], the

―Kidney‖ nourishes the yin and benefits the blood of the ―Kidney‖ [60].

The ―Ear apex‖ tranquilizes the mind and lowers BP,6 and the ―Heart‖ calms the state of mind and clears away the heart-fire, part from control of BP, it is possible that the simultaneous application of this holistic treatment approach may help a person achieve balance, as the selected acu-points regulate the functions of the body in a preferred direction. The traditional Chinese medical theory therefore appears to have a valid physiological basis in acu-point selection in this study [61].

A case reported resection cerebellar vermis and right cerebellum hemisphere in a cerebellum haemorrhage patient could cause transient or thostatic hypotension, indicating that the cerebellum was involved in blood pressure regulation. In our study, the connectivity between the cerebellum and seed points may reveal that the cerebellum has a role in blood pressure regulation [62].

The present RCT study will provide data on the effectiveness of auricular acupuncture for reducing blood pressure and the duration of therapy through a follow-up period of 2 months after the completion of the treatment.

Life style and diet modification is the essential step to reduce the hypertension generally before starting medication or any other alternate therapies.

In this 100 patients were selected for RCT study, from this 82 patients only fulfilling the inclusion criteria of this study, from that through simple randomization method that 82 patients were distributed 41 patients participated in Auriculotherapy study group and 41 patients participated in Medicine control group. Control group patients underwent only medication daily in this one month study.

Before starting Auriculotherapy treatments, Blood pressure and Pulse rate was monitored in all the 82 patients who participated in this RCT. In study group

17 Male and 17 Female totally 34 hypertensive patients underwent

Auriculotherapy treatment for 5 days in a week, like that one month(4weeks), between each week 2 days treatment was not employed. Major blood pressure reduction point in Auriculotherapy study group is shenmen and heart point present in the Ear were stimulated with sujok needle with each sitting duration of

30 minutes.

Every week before and after blood pressure and Pulse rate was measured using automatic blood pressure monitor Omron HEM-8712 Professional

Portable Blood Pressure Monitor (Kyoto, Japan) one times on the right arm supported at the heart level after the participants were allowed to rest for 5 min. the values are noted in excel sheet.

Same like the study group, the control group has 21 Female and 15 Male patients, totally 36 hypertensive patients participated in control group underwent treatment anti-hypertensive medications only and they were in waiting list.

The Auriculotherapy was given for one month duration .The values were analysed by SPSS software with 16.0 by repeated measures ANOVA method.

End results shows that P<0.0001, this shows significantly Auriculotherapy for stage 1and stage 2 hypertensive patients compared to control Medicine group.

The purpose of this study to find out the efficacy of Auriculotherapy in hypertension and to see whether it is really working on advanced stages of hypertension.

7. CONCLUSION

 The present study showed that there is a more significant change on systolic

and diastolic blood pressure and pulse rate among stage 1 and stage 2

hypertensive patients after following one month Auriculotherapy intervention

with P<0.0001 compared to Medicine group.

 The significant reduction of systolic blood pressure reflected the status of

Parasympathetic domination immediately after Auriculotherapy intervention.

 There are currently only few trials of Auriculotherapy for the management of

hypertension that have been published.

LIMITATION OF THE STUDY

 The main limitation of the study was control group was in waiting list.

 The sample size is relatively smaller.

 Sample size is not calculated by statistical method.

 Study focused only on the stage 1and stage 2 hypertensive patients.

STRENGTH OF THE STUDY

 This is the first study in Tamilnadu especially in Chennai documented the

immediate effect of Auriculotherapy for hypertension using Blood pressure

and Pulse rate as parameters.

 There was no adverse effect reported during or after the Intervention.

DIRECTION FOR THE FUTURE RESEARCH:

 The study can be performed with large sample size.

 Study can be conducted on stage 3 hypertensive patients

 Study can be performed with large study design like cohort which is a gold

standard method for any kind of research and to validate the effect of

Auriculotherapy.

 Study can be performed with more outcome variable.

8. SUMMARY

Raised blood pressure is a major risk factor for chronic heart disease, stroke and coronary heart disease. Elevated BP is positively correlated to the risk of stroke and coronary heart disease. Other than coronary heart disease and stroke, it complications include heart failure, peripheral vascular disease, renal impairment, retinal haemorrhage and visual impairment.

The stimulus from AA raises the vagal tone and regulates the cardiovascular, respiratory, gastrointestinal and endocrine systems and so the heart point and shenmen point in Auriculotherapy used to reduce high blood pressure.

The participants were selected from OPD in Government yoga & naturopathy medical college and hospital, Arumbakkam, Chennai. In that 102 hypertensive patients came for this research project, from that 82 patients fulfilling only inclusion and exclusion criteria and they were selected for this project. From that trough simple coin toss randomization method, 41 patients participated in Auriculotherapy intervention group and 41 patients participated in control group. Intervention group underwent Auriculotherapy treatment specially on shenmen and heart point in ear treated with sujok needles for 30 minutes each sitting for 5 days in a week with 2 days interval between each week practised for the period of one month (4weeks). Later on they were kept under follow up

76 treatment for 2 months. Same like that control group participants took only antihypertensive drug for the period of one month and they were in waiting list.

This research project was statistically determined for cardiovascular parameters (BP & Pulse rate) and the results were analysed in SPSS software in

16.0 version by Repeated measures ANOVA test method.

Results shows that Auriculotherapy intervention group has got more significant result compared to control anti-hypertensive medicine group with

P<0.0001. Auriculotherapy is a convenient approach for treating diseases in areas lacking medical resources. The mechanism of Auriculotherapy warrants further study.

The significant reduction of systolic blood pressure reflected the status of parasympathetic domination immediately after Auriculotherapy intervention.

9. REFERENCE

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Mar 8;153(5):598-615.

[2] Suen KP, Thompson DR, Yu CM, Lin ZX, Lee PW, Chu TS. Traditional auriculotherapy for hypertension: a pilot randomized trial. Journal of cardiovascular disease. 2014.

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10. ANNEXURE

INFORMATION SHEET

We are conducting a study “EFFICACY OF AURICULOTHERAPY IN STAGE I AND

STAGE II HYPERTENSION” -- RANDOMIZED CONTROL TRIAL, in Government

Yoga & Naturopathy Medical College, Chennai- 106. The purpose of this study is to evaluate the effectiveness of Auriculotherapy in Hypertension. We need your participation in this study. Here we are assessing the Blood pressure and pulse rate variations before and after Auriculotherapy sitting.

The privacy of the patients in the research will be maintained throughout the study. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared. Taking part in this study is voluntary. You are free to decide whether to participate in this study or to withdraw at any time; your decision will not result in any loss of Benefit to which you are otherwise entitled. The results of the special study may be intimated to you at the end of the study period or during the study if anything is found abnormal which may aid in the management or treatment.

Signature of investigator Signature of participant

Date:

INFORMED CONSENT FORM

Title of the study: “EFFICACY AURICULOTHERAPY IN STAGE I AND STAGE II

HYPERTENSION” -- RANDOMIZED CONTROL TRIAL.

Name of the Participant:

Name of the Principal Investigator: Dr.N.Lilly

Name of the Institution: Government Yoga and Naturopathy Medical College,

Arumbakkam, Chennai – 600 106.

Documentation of the informed consent

I ______have read the information in this form (or it has been read to me). I was free to ask any questions and they have been answered. I am over 18 years of age and, exercising my free power of choice, hereby give my consent to be included as a participant.

“EFFICACY AURICULOTHERAPY IN STAGE I AND STAGE II HYPERTENSION” --

RANDOMIZED CONTROL TRIAL.

1. I have read and understood this consent form and the information provided to me.

2. I have had the consent document explained to me.

3. I have been explained about the nature of the study.

4. I have been explained about my rights and responsibilities by the investigator.

5. I have been informed the investigator of all the treatments I am taking or have taken in the past ______months including any native (alternative) treatment.

6. I have been advised about the risks associated with my participation in this study.

7. I agree to cooperate with the investigator and I will inform him/her immediately if I suffer unusual symptoms.

8. I have not participated in any research study within the past

______month(s).

9. I am aware of the fact that I can opt out of the study at any time without having to give any reason and this will not affect my future treatment in this hospital.

10. I am also aware that the investigator may terminate my participation in the study at any time, for any reason, without my consent.

12. I hereby give permission to the investigators to release the information obtained from me as result of participation in this study to the sponsors, regulatory authorities, Govt. agencies, and IEC. I understand that they are publicly presented.

13. I have understood that my identity will be kept confidential if my data are publicly presented.

14. I have had my questions answered to my satisfaction.

15. I have decided to be in the research study.

I am aware that if I have any question during this study, I should contact the investigator. By signing this consent form I attest that the information given in this document has been clearly explained to me and understood by me, I will be given a copy of this consent document.

For adult participants:

Name and signature / thumb impression of the participant (or legal representative if participant incompetent)

Name______Signature______

Date______

Name and Signature of impartial witness (required for illiterate patients):

Name ______Signature______

Date ______

Address and contact number of the impartial witness:

Name and Signature of the investigator or his representative obtaining consent:

Name ______Signature______

Date ______

INFORMATION TO PARTICIPANTS

Investigator: Dr.N.Lilly, B.N.Y.S.

Name of Participant:

Title: “EFFICACY AURICULOTHERAPY IN STAGE I AND STAGE II

HYPERTENSION” -- RANDOMIZED CONTROL TRIAL.

You are invited to take part in this research/ study /procedures. The information in this document is meant to help you decide whether or not to take part.

Please feel free to ask if you have any queries or concerns.

You are being asked to participate in this study being conducted in

Government Yoga and Naturopathy Medical College,

Arumbakkam,

Chennai -– 600 106.

What is the Purpose of the Research?

The abnormal blood pressure is the most common sign of hypertension that is recognized as the main risk factor for cardiovascular morbidity and mortality.

To determine whether the Auriculotherapy effect on Hypertension

The Study Design

Thirty Male and female patients with hypertension of age group between 30-

60yrs will participate in the study.

Study Procedures

The study involves assessment of Blood pressure and pulse rate.

You will be required to visit the hospital during the study.

You may have to come to the hospital (study site) for examination and investigations apart from your scheduled visits, if required.

Possible Risks to you – Nil

Possible benefits to other people

The result of the research may provide benefits to the society in terms of advancement of medical knowledge and/or therapeutic benefits to future patients.

Confidentiality of the information obtained from you

You have the right to confidentiality regarding the privacy of your medical information (personal details, results of physical examinations, investigations, and your medical history). By signing this document, you will be allowing the

96 research team investigators, other study personnel, sponsors, IEC and any person or agency required by law like the Drug Controller General of India to view your data, if required.

The information from this study, if published in scientific journals or presented at scientific meetings, will not reveal your identity.

How will your decision to not participate in the study affect you?

Your decisions to not to participate in this research study will not affect your medical care or your relationship with investigator or the institution. Your doctor will still take care of you and you will not lose any benefits to which you are entitled.

Can you decide to stop participating in the study once you start?

The participation in this research is purely voluntary and you have the right to withdraw from this study at any time during course of the study without giving any reasons.

However, it is advisable that you talk to the research team prior to stopping the treatment.

ANNEXURE ANNEXURE 1: ACUPUNCTURE CLINICAL CASE SHEET

Date ………………………

Name ………………………………………. IP/OP No……………………….

Age ……………….. Sex ……………… Marital Status ……………………

Address ………………………………………………………………………..

………………………………………………………………………………….

Present Complaints:

History of Present Complaints:

Past History:

Medical / Drug History:

Menstrual History:

Personal History:

Diet: Appetite: Digestion:

Sleep: Micturition: Bowel Movements:

Addiction: Exercise: Thirst:

Vital Data

Blood Pressure: mm/Hg Pulse Rate : beats/min

Respiratory Rate: cycles/min Temperature:

Anthropometric Measures

Height: CM Weight: KGS BMI:

Provisional Diagnosis:

Treatment Chart (Pre & Post):

DAY PRE VALUE POST VALUE

SBP DBP PR SBP DBP PR

DAY 1

DAY 7

DAY 14

DAY 21

DAY 30