The efficacy of Cat hair 9cH and Histaminum 9cH in treating the symptoms of cat allergy

A research dissertation presented to the

Faculty of Health Sciences, University of Johannesburg, as partial fulfillment for the Masters Degree in Technology: Homoeopathy by

Dalen Alexander (Student number: 802029124)

______Supervisor: Dr. J. Pellow M.Tech Hom (TWR) Date

______Co-supervisor: Dr. R. Kohler M.Tech Hom (TWR) Date

DECLARATION

I, Dalen Alexander declare that this dissertation is my own, unaided work. It is being submitted for the degree of Master of Technology at the University of Johannesburg, Gauteng. It has not been submitted before for any degree or examination in any other University.

______Signature of Candidate

______day of ______

2

ABSTRACT

Cat allergy is the allergic reaction of a person’s body when exposed to allergens borne in the cat’s dander (shed skin cells), saliva or urine. The major cat allergen, called Fel d 1, is found in cat saliva, dander from sebaceous glands in the skin, fur and anal sebaceous glands. Symptoms of cat allergies may include sneezing, itchy and watery eyes, coughing and wheezing and in rare circumstances anaphylaxis occurs.

The aim of this study was to determine the efficacy of the homoeopathic complex Cat hair 9cH and Histaminum 9cH in treating the symptoms of cat allergy using the skin prick test and a symptom score card which rates the severity, frequency and duration of symptoms experienced.

This was a four-week double blind, placebo-controlled study in which thirty participants, male and female between the ages of 18 and 45 were randomly divided into two groups. Advertisements was placed at the University of Johannesburg Doornfontein campus and at the Weleda pharmacy (Fourways). Potential participants that meet the inclusion criteria were requested to sign the Participant Information and Consent Form. This study had to form part of a group study related to cat allergy analysis. Participants were requested to report to Ampath laboratories to undergo a skin prick test to establish the presence of a cat allergy. Those participants that tested positive for cat allergies were to undergo an initial consultation involving a case history and a focused physical examination. Participants were given a score card each week to evaluate their severity, frequency and duration of their symptoms to be completed at the end of each week. Participants were given a 25ml bottle of either the homoeopathic complex of Cat hair 9cH and Histaminum 9cH or the placebo in tablet form, and each participant was instructed to take two tablets twice daily throughout the four week study. At the second consultation the physical exam was repeated and a second bottle of medication were given. At the end of week four, participants had to report to Ampath laboratories for the final skin prick test. This was to be followed by the third and final consultation, where the physical examination was done and all score cards collected. All data will be analysed using the Shapiro Wilk test, Mann-Whitney test, Friedman test and Wilcoxon test. With the aid of results from each participant the researcher arrived at the conclusion that the homoeopathic complex Histaminum 9cH and Cat Hair 9cH was effective on alleviating the symptoms of cat allergy.

3 DEDICATION

This dissertation is dedicated to the participants of this study who shared their views and experiences due to cat allergy. It is also dedicated to my family who supported me through my educational career.

4 ACKNOWLEDGEMENTS

The researcher would like to thank the following individuals for their contribution in the realization of this project:

I would firstly like to thank God for giving me the strength and knowledge to complete my thesis.

My supervisor, Dr Janice Pellow for her patience and academic input. Your advice, knowledge and guidance are greatly appreciated.

My friend and colleague, Prenitha Naidoo for always giving me a helping hand when needed.

My Parents, Freda and Lawrence Alexander: for giving me the opportunity to study and for their constant emotional and financial support.

My friends and colleagues: their loyal friendship and determination inspired me throughout the seven years we studied together.

My girlfriend, Helen Gough: for always been there for me and assisting me. You always urged me to believe in myself. You are the rock on which I stand.

5 TABLE OF CONTENTS Page

DECLARATION ii ABSTRACT iii DEDICATION v ACKNOWLEDGEMENTS vi TABLE OF CONTENTS vii LIST OF APPENDICES xv LIST OF FIGURES xvi LIST OF TABLES xvii

CHAPTER ONE Page

INTRODUCTION 1.1 PROBLEM STATEMENT 1 1.2 PURPOSE OF STUDY 2 1.3 HYPOTHESIS 2 1.4 NULL HYPOTHESIS 2 1.5 IMPORTANCE OF THE PROBLEM 2 1.6 ASSUMPTIONS 3 1.7 CRITERIA GOVERNING ADMISSIBILITY OF DATA 3

CHAPTER TWO Page LITERATURE REVIEW 2.1 ALLERGY 2.1.1 Cat allergy 2.1.2 Potential causes of cat allergies 2.2 Contributing factors in allergy 2.2.1 Hygiene Hypothesis 2.2.2 Heredity

6 2.2.3 Biochemical Individuality 2.2.4 Toxic Load 2.2.5 Drugs 2.2.6 Infant Formula 2.2.7 Illness 2.2.8 Stress 2.2.9 Dental Filings 2.2.10 Food 2.3 Classification and history of allergy 2.3.1 Hypersensitivity reactions 2.3.2 Type I (Immediate hypersensitivity) 2.3.3 Type II (Antibody to cell-bound antigen) 2.3.4 Type III (Immune complex hypersensitivity) 2.3.5 Type IV (Delayed-type hypersensitivity) 2.4 Components of an IgE-mediated hypersensitivity reaction 2.4.1 Allergen 2.4.2 Mast cells 2.4.3 Basophils 2.4.4 IgE antibodies 2.5 Pathophysiology 2.5.1 Initial sensitization 2.5.2 Late-phase reaction 2.6 The chemical mediators of acute inflammation 2.6.1 Histamine 2.6.2 Histamine intolerance 2.6.3 Prostaglandins 2.6.4 Cytokines 2.7 Anaphylaxis 2.7.1 Prevention and treatment of anaphylaxis 2.8 Signs and symptoms of cat allergy

7 2.9 Diagnosis 2.10 Conventional treatment 2.10.1 Pharmacotherapy 2.11 Homoeopathy 2.11.1 History of Homoeopathy 2.11.2 Law of similar 2.12 Isotherapy 2.12.1 History of isotherapy 2.13 Nosodes 2.14 Homoeopathic treatment of cat allergy 2.15 Supportive measures in allergy 2.15.1 Zinc 2.15.2 Calcium 2.15.3 Copper 2.15.4 Sodium bicarbonate 2.15.5 Vitamin B6 2.15.6 Vitamin C 2.15.7 Vitamin F Chapter 3 Methodology 4.1 Research sample 4.2 Research design and procedure 4.3 Medication administration 4.4 Data collection and analysis 4.5 Reliability and validity 5 Ethics Chapter 4 Results 4.1 Introduction 4.2 Skin prick test results

8 4.3 Statistical tests of significance Chapter 5 Discussion 5.1 Introduction 5.2 Skin prick test 5.3 Symptom score card 5.4 Participant compliance 5.5 Participant subjectivity 5.6 Skin prick test (positive control) 5.7 Skin prick test results (cat allergens) 5.8 Severity of symptoms 5.9 Frequency of symptoms 5.10 Duration of symptoms Chapter 6 Conclusion and recommendation 6.1 Conclusion 6.2 Recommendations

References

Appendices Appendix A: Letter of permission Appendix B: Cat allergy advertisement poster Appendix C: Consent form Appendix D: Skin prick test results Appendix E: Case taking form Appendix F: Scorecard Appendix G: Information leaflet Appendix H: One-sample kolmogorov-Smimov test Appendix I: One-sample kolmogorov-Smimov test

Appendix J: One-sample kolmogorov-Smimov test 9

Appendix K: One-sample kolmogorov-Smimov test

Appendix L: One-sample kolmogorov-Smimov test

LIST OF FIGURES 2.1 Immediate (type I) hypersensitivity mediated by IgE antibody bound to mast cells 2.2 Mechanism of type I IgE-mediated reactions 4.2.1 Skin prick test: positive control as measured in the experimental group 4.2.2 Skin prick test: positive control as measured in the control group 4.2.3 Flare reaction: positive control as measured in the experimental group 4.2.4 Flare reaction: positive control as measured in the control group

4.2.5 Degree of itchiness: positive control as measured in the experimental group

4.2.6 Degree of itchiness: positive control as measured in the control group

4.2.7 Skin prick test for sensitivity to cat allergen as measured in the experimental group 4.2.8 Skin prick test: for sensitivity to cat allergen as measured in the control group 4.2.9 Flare reaction: for sensitivity to cat allergen as measured in the experimental group 4.2.10 Flare reaction: for sensitivity to cat allergen as measured in the control group 4.2.11 Degree of itchiness: for sensitivity to cat allergens in the experimental group

4.2.12 Degree of itchiness: for sensitivity to cat allergens in the control 4.3.1 Severity of the symptom red itchy eyes 4.3.2 Severity of the symptom runny itchy stuffy nose 4.3.3 Severity of the symptom skin rash 4.3.4 Severity of the symptom redness of skin where a cat has scratched, licked or bitten 4.3.5 Severity of the symptom sneezing 4.3.6 Severity of the symptom scratchy throat

4.3.7 Severity of the symptom wheezing 4.3.8 Frequency of the symptom red itchy eyes 4.3.9 Frequency of the symptom runny itchy stuffy nose

10 4.3.10 Frequency of the symptom skin rash 4.3.11 Frequency of the symptom redness of skin where a cat has scratched, licked or bitten 4.3.12 Frequency of the symptom sneezing 4.3.13 Frequency of the symptom scratchy throat 4.3.14 Frequency of the symptom wheezing 4.3.15 Duration of the symptom red itchy eyes

4.3.16 Duration of the symptom runny itchy stuffy nose 4.3.17 Duration of the symptom skin rash 4.3.18 Duration of the symptom redness of skin where a cat has scratched, licked or bitten 4.3.19 Duration of the symptom sneezing 4.3.20 Duration of the symptom scratchy throat 4.3.21 Duration of the symptom wheezing

LIST OF TABLES

Table 2.1 Pharmacologic alterations of immediate hypersensitivity reactions Table 4.1 Comparison of the positive skin prick test results between experimental and control groups Table 4.2 Comparison of the positive skin prick test results between week 1 and week 4 in the experimental group Table 4.3 Comparison of the positive skin prick test results between week 1 and week 4 in the control group Table 4.4 Comparison of the cat skin prick test results between experimental and control groups Table 4.5 Comparison of the cat skin prick test results between week 1 and week 4 in the experimental group Table 4.6 Comparison of the cat skin prick test results between week 1 and week 4 in the control group Table 4.7 Comparison of the severity of symptoms across the weeks of study in the experimental group Table 4.8 Comparison of the severity of symptoms across the weeks of study in the control group

11 Table 4.9 Comparison of the frequency of symptoms across the weeks of study in the experimental group

Table 4.10 Comparison of the frequency of symptoms across the weeks of study in the control group Table 4.11 Comparison of the duration of symptoms across the weeks of study in the experimental group

Table 4.12 Comparison of the duration of symptoms across the weeks of study in the control group

12 CHAPTER ONE

1. INTRODUCTION

1.1 Problem statement The prevalence of allergic diseases appears to have been on the increase over the last 25 years, particularly in children and young adults (Burr, 1993). It is estimated that at least one half of the entire world population suffers from some type of mild or serious allergy. It appears that many people are allergic to some sort of allergy but simply do not know it (Davies, 2007). Cat allergy is common and occurs in almost 25% of individuals with allergies (Gelfand, 2008).

Allergy can be defined as a response, within the body, to a substance, which is not necessarily harmful itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed individual (Allergy, 2003). Allergy is an exaggerated response by the immune system to an external substance (Kay, 2000). The immune process of allergy, relies on the production of IgE antibodies specific to common allergens. Allergic diseases are common and increasing in prevalence, resulting in mortality and morbidity in all age groups (Douglass & O’ Hehir, 2006).

Cat allergy is a histamine-mediated response by the body, triggered by exposure to allergens within the cat’s saliva, dander (shed skin cells) or urine (Josephson, 2006). About one-tenth of the population of South Africa has some sort of pet allergy, with twice as many of them having cat allergies (Middleton, 1994). The major cat allergen, called Fel d 1, is found in cat dander, and saliva from sebaceous glands in the urine, fur and skin (Kay, 1997). Allergy is one of the most common ailments of the modern world. Allergy not only constitutes a relentless bother throughout one’s life, but may result in asthma and unnatural death. Symptoms of cat allergies may include itchy and watery eyes, sneezing, wheezing and coughing and in rare circumstances anaphylaxis occurs. Conventional treatment for cat allergies includes antihistamines and decongestants which can be costly and may have numerous adverse effects (Dreyer, 2004). Immunotherapy is used for desensitization for cat allergies; however, this can take many years and may not be effective for all allergy sufferers (Kay, 1997). In this study Histaminum and Cat hair was prepared Homoeopathically and prescribed using Isopathic principles. A related study using Cat hair and Histaminum has shown desensitization effects of cat allergy, however no research has been done on Cat hair and Histaminum.

13 1.2 Purpose of study The purpose of this study was to determine the efficacy of Cat hair 9cH and Histaminum 9cH in treating the symptoms of cat allergy. This was evaluated using the skin prick test and a symptom score card which rated the severity, frequency and duration of symptoms experienced.

1.3 Hypothesis It was hypothesized that Cat hair 9cH and Histaminum 9cH would have an ameliorating effect on the symptoms of cat allergy.

1.4 Null Hypothesis It was hypothesized that Cat hair 9cH and Histaminum 9cH would not ameliorate the symptoms of cat allergy.

1.5 Importance of the problem The results of the study determined: • The efficacy of Cat hair 9cH and Histaminum 9cH on alleviating the allergic symptoms of cat allergy sufferers. • The desensitizing effect of Cat hair 9cH and Histaminum 9cH on cat allergy sufferers.

1.6 Assumptions It is assumed that: • Participants in this study have taken the homoeopathic medication in the manner prescribed • Participants have correctly and truthfully reported and recorded all symptoms and changes that occurred • Participants did not change their normal lifestyle, exercise or dietary habits immediately prior to or during the study • Participants have not made use of herbal medicines and other homoeopathic medicines for allergies

1.7 Criteria governing admissibility of data The following variables were considered • The participants co-operation in: relating their symptoms truthfully, taking the medication as prescribed and reporting all observable changes accurately

14 • The study sample size required the participation of thirty subjects only. This sample size was accepted at the research proposal level as the research is quantitative, thereby involving thorough analysis of not only the statistical data recorded by the participants but also the reported changes noted by the researcher at each consultation.

15 CHAPTER TWO

2. LITERATURE REVIEW

2.1 Allergy Allergy can be broadly defined as an abnormal, adverse, physical reaction of the body to a certain substance known as allergens; these reactions are rapid, predictable and acquired. Allergic reactions are reffered to as a hypersensitive state because those who suffer from an allergy, react to quantities of the allergen which results in an inflammatory response. The process of how an allergen can cause a problem in the body involves the immune system. Allergic individuals will develop an excess of the antibody IgE when exposed to an allergen. The IgE antibodies then attach to mast cells and basophils which are certain white blood cells and causes an allergic reaction.

2.1.1 Cat allergy A cat allergy is an adverse reaction by the body’s immune system to cats. According to the American Academy of Allergy, Asthma and Immunology (AAAAI) nearly 10 million pet owners are allergic to their pets (Kay, 1997). The allergy is triggered by proteins in the cat’s dander (dried flakes of shed skin) as well as proteins in dried saliva, blood and urine. The main cat allergen, called Fel d 1, is found in cat saliva and dander from sebaceous glands in the skin, fur and anas (Kayne and Jepson, 2004). Cat allergen is one of the most common indoor allergens, second only to dust mite as a cause of asthma among children. Exposure to cat allergen causes sensitization in 15% to 60% of atopic individuals and is responsible for acute asthma attacks, as well as prolonged bronchial hyperresponsiveness (Douglass & O’ Hehir, 2006). The cat allergen protein enters the body on exposure and starts a cascade of events that triggers the immune system and eventually leads to an allergic reaction. While many animals have proteins in their saliva that can trigger allergies, cat allergies are the most common. This is because cats groom themselves continually, which results in a great deal of saliva on the animal and in the animal’s environment (Cooper & Noble, 2006).

Cat allergies may not develop quickly, sometimes appearing after more than two years after first exposure (Morgan, 2005). Kittens produce less dander than adult cats which is why people with cat allergies, especially children, may be able to tolerate kittens but not adult cats (Kay, 1997).

16 2.1.2 Potential causes of cat allergies Cat allergies are caused by the protein namely Fe d1 found in the dander, saliva, blood and urine of the cats. Dander (tiny flakes of dead skin) is continually shed by animals (Gelfand, 2008). Dander and dried saliva are also carried by air currents, even into areas the cat has not been (e.g., air ducts, walls) (Kayne & Jepson, 2004). The proteins in dried urine tend to stay indoors because many cats use indoor litter boxes. In contained areas, such as a home, the overall accumulation of dander, urine, blood and saliva proteins is often enough to trigger an allergic reaction in people with cat allergies (Cooper & Noble, 2006).

Saliva, urine, blood and dander allergens are present in all cats, even breeds labeled as non- allergenic. There is no such animal as a hypo-allergenic cat (Gelfand, 2008). Regardless of breed, size and hair, all cats may cause allergic reactions. Hairless cats have dander and release that dander by grooming themselves as often as haired cats (Delbert et al, 2007). Male cats may produce more of the proteins that trigger allergic reactions than females or neutered male cats (Kayne & Jepson, 2004).

Direct contact with a cat is not needed to develop or trigger an allergy. Flakes from dander, saliva and urine proteins are extremely lightweight and easily become attached to larger particles, which can then become airborne or stick to surfaces or objects. These allergen particles remain in an environment for weeks or months after a cat has departed (Choron & Moore, 2007). In addition, cat saliva proteins dry on the cat’s hair and become airborne when the cat is stroked. Cat allergens can be airborne for extended periods of time, even for several months (Middleton, 1994).

Allergy is the result of the over stimulation of the immune system, together with a person’s unique hereditary background and individual metabolic state. Certain body patterns and metabolic states have been associated with the production of allergic symptoms. The fact that allergy is polycausal which means ‘has many causes’, has led to medical confusion. Doctors usually only look for one cause, then try to find a drug to heal or subdue the symptoms. Since no single cause can be found, allergic symptoms are often ignored or attributed to mental or emotional stress.

Allergies are not only a reaction to external substances in genetically predisposed individuals; they also develop as a result of our lifestyle and habits. A major contributor to the development of allergies is the environment, which contains many chemical and physically harmful pollutants

17 and irritants. Other contributing factors include our nutritional situation, imbalances in the types of food we eat and a general lack of healthy eating habits.

2.2 Contributing Factors in Allergy

2.2.1 Hygiene hypothesis The hygiene hypothesis states that allergic diseases are due to inappropriate immunological responses to harmless antigens driven by TH2-mediated (T-helper 2 lymphocyte) immune response that down-regulates TH1 responses. The first mechanism state that insufficient stimulation of the TH1 (T- helper 1 lymphocyte) arm of the immune system leads to an overactive TH2 arm, which leads to allergic disease. TH1 arm is stimulated by the presence of pathogens. This means that individuals living in a sterile an environment are not exposed to enough pathogens to keep the TH1 arm of the immune system active. Both TH1 and TH2 are produced by TH0 cells. Our bodies have evolved to deal with a certain level of such pathogens, when our immune system is not exposed to this level of pathogens it will attack harmless antigens and in so doing trigger an allergic immune response (Loops, 2009).

The hygiene hypothesis was originally established to explain the increase in allergic disease in modern urban society where people had clean houses. This theory has evolved at such a rate that it has expanded to include exposure to symbiotic bacteria and parasites as important modulators of immune system development, together with infectious agents (Loops, 2009).

2.2.2 Heredity It is believed that a person inherits their predisposition to allergy, rather than the specific allergy, therefore it is the tendency to become allergic to a foreign substance that is inherited. The greater the incidence of allergy in a family, the greater the tendency for the offspring to develop allergy (Bateson-Koch, 2000). If one parent is allergic, the chances of the children being allergic are fifty to fifty-eight percent. If both parents are allergic the likelihood of this children being allergic is sixty-seven to one hundred percent (Cooper & Noble, 2007).

Research confirms that a developing foetus in the uterus can demonstrate the hallmark of allergy, i.e. IgE antibody formation in the liver and lungs, by the eleventh week of gestation. IgE has also been found in the amniotic fluid (the fluid surrounding the foetus) at thirteen weeks. No IgE has been found in the arterial blood of the umbilical cord, which leads to the belief that the placenta

18 does not allow direct transfer of maternal blood containing IgE to the foetus. Therefore allergens transferred placentally can lead to intra-uterine sensitization (Bateson-Koch, 2000).

2.2.3 Biochemical Individuality Each individual has a metabolic pattern or state that is unique to that person. In some people the genetic requirements for nutrients can be much higher than “normal” to prevent disease. In others, metabolic individuality can cause them to react very differently to various substances (Thomas, 1998).

Allergy appears to increase with advancing age. As a person ages, he tends to have weakened resistance due to a weakened immune system; various stages of organ degeneration; and having had more time to accumulate toxic substances which leads to metabolic overload (Choron, Moore, 2007). Nutritional deficiencies often increase as a person ages, which accumulate over time from the person’s eating patterns (Bateson-Koch, 2000).

Emotionally stressful situations can lead to diminished immune system function. Physical stress can increase nutrient requirements, leading to nutrient deficiency which further stresses the immune system (Thomas, 1998). Poor diet affects the body’s ability to fight disease and leaves the body unprotected. Therefore if an individual does not eat correctly it will have a negative impact on their immune system, making them more susceptible to allergic disease. As one organ or body system loses its ability to function at peak performance, it affects other organs and systems (Gelfand, 2008). These other organs and systems must now do more work to compensate for the one that is stressed. As malnutrition continues, these accommodating organs and systems become stressed and lose their ability to function optimally (Bateson-Koch, 2000).

2.2.4 Toxic Load Frequency and extent of exposure to various substances plays a large role in allergy. Increasing exposure to a substance causes toxic load to build faster in the body. People are increasingly exposed to a variety of industrial pollutants, pesticides and chemicals. The air, food and water have all been altered in recent years leading to varying degrees of toxic load. Therefore an increase in toxic substances within the body, increases the chances of experiencing an allergic reaction increases as well. (Cooper & Noble, 2006).

19 2.2.5 Drugs The vast quantity of prescription and over the counter drugs available today is indeed astounding. Allergic reactions to drugs have been well documented, although the information has not been well distributed. The drug that most commonly causes allergic reactions is penicillin, and the second most allergenic drug is aspirin (Bateson-Koch, 2000). Drugs contribute directly to allergy by decreasing liver function, increasing chemical overload and destroying enzyme systems. Other drugs frequently associated with allergic reactions include: sulfonamides, sedative-hypnotics (barbiturates), anti-tuberculosis drugs, anti-malarial drugs, anti-convulsants, ant-psychotic tranquilizers, blood pressure drugs, anti-serum and vaccines, heavy metals (including gold) and anti-arrhythmics (heart agents) and in most cases might increase the toxic load (Choron, et al 2007).

2.2.6 Infant Formula Feeding infant formula to babies increases the frequency of allergy. The highest incidence of lifetime milk allergy is found in this iatrogenically conditioned group, as most infant formula’s are cow’s milk based (Bateson-Koch, 2000).

Breastfeeding is essential to the strengthening of the infant’s immune system, to its natural immunity, and to proper body growth and development as a whole. It has many distinct advantages over other types of nourishment, for both infant and mother. Mother’s milk contains a smaller percentage of minerals than cow’s milk, which is why dairy eaters tend to develop a heavier bone structure and grow quickly (Sherwood, 2001). Therefore young children are now outgrowing their parents before completing adolescence. Human milk contains less protein than cow’s milk, but this protein exists primarily in the form of soluble lactalbumin which is more digestable than the casein found in cow’s milk. Casein is relatively insoluble in the human digestive system, it often coagulates in the stomach and produces diarrhea and other digestive disorders (Gelfand, 2008). The fat contained in human milk is easier to digest and contains less fatty acid than cow’s milk. Due to the unique chemical composition of human milk, the alkaline condition of the body is maintained without the action of buffers. By contrast, regular intake of cow’s milk, which is more acid-forming, requires the mobilization of minerals from the bones and teeth to serve as buffers in maintaining an alkaline blood condition. The composition of mother’s milk varies during the first few months in order to meet the changing and essential needs of the infant (Parham, 2000).

20 Recent research has indicated significant benefits of breastfeeding with regard to the prevention of allergy. Babies who breastfeed from mothers who reduce their consumption of cow’s milk will experience a much lower incidence of all allergies than other breastfed babies. This shows how the mother’s food selection has a direct effect on the infant even after birth, when the infant is still directly dependant on nutrition from the mother (Sherwood, 2001). The food ingested by the mother is absorbed into her blood, and this blood is transformed into milk in the mammary glands. The composition and quality of this milk is a result of what the mother has eaten. Even with breastfeeding, unless the mother is eating in a macrobiotic way, the milk produced will be less than ideal for the infant’s consumption. This can lead to either an immediate reaction, such as food or chemical allergy or make the baby susceptible to other allergies and various illnesses in later life (Mark, 2001).

2.2.7 Illness After infectious illness changes can take place in the body that allow allergy to emerge. The body will react more readily to allergic stimuli. For example infection of the intestine can make its lining more permeable to undigested food particles, producing allergic symptoms (leaky gout syndrome) (Gelfand, 2008). Biochemical changes take place in the body during prolonged illness, leading to decreased resistance to allergic stimuli (Bateson-Koch, 2000). Toxins produced by the yeast Candida albicans also play a major part in allergy. These toxins include acetaldehyde, carbon monoxide, alcohol, steroid substances and up to one hundred other substances not completely identified. The more frequent the exposure the greater the incidence of allergy (Morgan, 2005).

2.2.8 Stress Stress in any form, whether it is emotional, chemical or environmental can contribute to allergic symptoms. Any stress that is beyond a person’s ability to cope leads to adaptive changes physically and mentally. However, much “mental stress” has now been identified as being due to chemicals in the environment, Candida infections, toxins in food and electromagnetic disharmonies previously unperceived by the individual (Cooper & Noble, 2006). Therefore when one’s stress levels increase it weakens the immune system making an individual more susceptible to any form of allergy (Morgan, 2005).

2.2.9 Dental Fillings Mercury is a component of the silver amalgam used in dental fillings. Mercury is highly toxic to the nerves and immune system (Bateson-Koch, 2000). This toxicity has historically been

21 illustrated by the “mad hatter” syndrome, whereby hat makers became mentally ill after using mercury in the production of hats. Mercury in fillings of the teeth leeches out over the years. It also produces toxic mercury vapour in the mouth (Morgan, 2005). Bacteria and fungi found in the mouth are capable of converting mercury into an even more toxic product called methyl mercury. Mercury is one of many toxins capable of contributing to chemical overload in the body, blocking enzymes and leading to degenerative diseases, including allergies (Gelfand, 2008).

2.2.10 Food Repeated consumption of a specific food plays a part in allergy by depleting enzymes systems. Most people eat only a few foods which are ones they like best. Daily overeating of a few specific foods has the effect of stressing the enzyme systems to handle that food. If the food is also an allergenic food, the body’s capacity to deal with it is greatly diminished. Food is man’s primary potential allergen and addictant. This is because everybody eats every day. As a result of the quantity eaten, food provides the greatest consistent stimulation to the body (Cooper & Noble, 2006).

2.3 Classification and history of allergy The most commonly accepted classification of immunopathologic or allergic reactions was brought upon by Gell and Coombs, who assigned numerical designations to refer to four different mechanisms or reactions. These have been labeled Type I, the immediate hypersensitivity or anaphylactic reaction, Type II, the cytotoxic reaction, Type III, the immune complex or Arthus reaction and Type IV, the cell-mediated or delayed hypersensitivity. There are other immunopathologic reactions which do not fit into these four groups. These include cutaneous basophil hypersensitivity and the granulomatous reaction, which is an extension of the Type IV reaction (Underwood, 2004).

This classification is superficial and seldom is a particular disease associated with a single mechanism only. The four mechanisms are interrelated and in most hypersensitivity reactions, several mechanisms are at work simultaneously. Some of them are secondary to disease, whereas others are pathognomonic and the primary cause of tissue destruction (Sodeman & Sodeman, 2000).

22 2.3.1 Hypersensitivity reactions The inappropriate responses of allergy (immune-mediated inflammatory response to common environmental allergens), autoimmunity (abnormal state in which the body’s immune system reacts against its own tissues or constituents) and alloimmunity (can be collectively classified as hypersensitivity). Hypersensitivity is an altered immunologic reactivity to an antigen that results in a pathologic immune response after re-exposure (Underwood, 2004). Allergy is differentiated by the source of the antigen against which the hypersensitivity response is directed. The term allergy was originally derived from both aspects of the immune response, which are immunity, which is beneficial and hypersensitivity, which is harmful. Allergy has come to mean the deleterious effects of hypersensitivity to environmental antigens and immunity the protective responses to antigens expressed by disease-causing agents (Sodeman & Sodeman, 2000).

The pathogenesis of hypersensitivity, whether it consists of allergy, autoimmunity or alloimmunity is not completely understood. It is generally accepted that genetic, infectious and environmental factors contribute to hypersensitivity. Most diseases caused by hypersensitivity evolve because of the interactions of at least three variables which are an original insult, which alters immunologic homeostasis; secondly the individuals genetic makeup, which determines susceptibility to the effects of the insult; and thirdly an immunologic process that amplifies the insult (Kay, 1997).

Hypersensitivity reactions are distinguished by the recognition of foreign antigens by the immune system which can cause incidental tissue damage as well as the intended destruction of the antigen. Hypersensitivity reactions are immediate or delayed, depending on the time required to elicit the secondary immune response. Reactions that occur within minutes are termed immediate hypersensitivity reactions. Delayed hypersensitivity reactions may take several hours to appear and are at maximum severity days after re-exposure to the antigen (Sodeman & Sodeman, 2000).

2.3.2 Type I (Immediate hypersensitivity) Type I reactions are those in which an antigen interacts with IgE bound to tissue mast cells or basophils as illustrated in figure 2.1. IgE is embedded in the membranes of mast cells, exposing the antigen-binding sites of the molecule to the micro-environment of the cell. Exposure to specific antigens bridges two adjacent IgE molecules and this bridging effect triggers the mast cell to release its mediators. There are two groups of mediators: those which are preformed and those which are newly synthesized. The preformed mediators include histamine, lysosomal

23 enzymes, chemokines and heparin. As they are preformed mediators, type I reactions are rapid: clinically the effects begin within 5-10 minutes and peak around 30 minutes (Underwood, 2004).

Figure 2.1

2.3.3 Type II (Antibody to cell-bound antigen) Type II hypersensitivity reactions are triggered by antibodies reacting with antigenic determinants which form part of the cell membrane. The consequences of the reaction depend on whether or not complement or accessory cells are involved and whether the metabolism of the cell is affected. IgM or IgG antibodies are typically implicated. Many examples of type II hypersensitivity involve drugs or metabolites which have bound to the surface of red blood cells or platelets to form highly immunogenic epitopes. Antibodies formed against the drug or its metabolite inadvertently destroy the cell as well as the bystander lysis resulting in haemolytic anaemia or thrombocytopenic reaction. The same mechanism is responsible for certain autoimmune disorders where the target antigen is intrinsic (i.e. self) antigen rather than extrinsic (Underwood, 2004).

24 2.3.4 Type III (Immune complex hypersensitivity) Type III reactions result from the deposition or formation of large number of antibody-antigen complexes accumulate. Localisation of immune complexes depends on their size, their electrostatic charge and the nature of the antigen. If they accumulate in the tissues in large quantities, they may activate complement and accessory cells and produce extensive tissue damage. A classic example is the Arthus reaction, an experimental model where an antigen is injected into the skin of an animal that has been previously sensitised. The reaction of preformed antibody with this antigen results in high concentrations of local immune complexes; these cause complement activation and neutrophil attraction and result in local inflammation 6-24 hours after the injection (Kay, 1997).

2.3.5 Type IV (Delayed-type hypersensitivity) Type IV reactions occurs when an antigen interacts with antigen-specific lymphocytes that release interleukin-2, interferon y and other cytokines. Once T-cells have been sensitized by primary exposure, secondary challenge is followed by a delayed-type hypersensitivity reaction (DTH), a local inflammatory response which takes 2-3 days to develop clinically. Histologically these reactions consist of infiltrating T-lymphocytes, macrophages and occasional eosinophils. Experimentally, DTH can be transferred by T-lymphocytes but not by serum, i.e. antibodies are not involved (Underwood, 2004).

2.4 Components of an IgE-mediated hypersensitivity reaction. Components of type I hypersensitivity reactions include the causative allergen, mast cells, basophils and IgE antibodies (Underwood, 2004).

2.4.1 Allergen An allergen which is generally preferred to the term antigen (antibody generator), is a substance that can produce a hypersensitive reaction in the body (Hendry & Farley, 2001). Examples of allergens include pollens, animal proteins, food proteins and mites (Leech, 2002). Allergens can gain entry to the body by ingestion, injection, inhalation or absorption through the skin (Henderson, 1998).

The allergen itself is normally harmless. It is the immune system itself and not the allergen that causes the adverse effects on the body (Waugh & Grant, 2001). The way people respond to allergens varies and is probably genetically determined (Leech, 2002).

25 A particular allergen will result in the production of IgE antibodies that are specific to that allergen and no other. Following the initial exposure to the allergen, the individual becomes sensitized and elicits an IgE response; then, on the second or subsequent exposures the immune system mounts a response which is entirely out of proportion to the perceived threat which is an exaggerated version of normal immune function (Waugh & Grant, 2001). The severity of the reaction increases with repeated exposure to the allergen (Staines et al, 1993)

2.4.2 Mast cells Mast cells are located just under the skin, along blood vessels, in the connective tissue of all organs excluding the brain and in the mucosa of the gastrointestinal and respiratory tracts (Leech, 2002). They are most plentiful in regions that come into contact with the external environment, e.g. the skin, outer surface of the eyes, the linings of the respiratory tract and the digestive tract (Sherwood, 2001).

Although the exact function of mast cells is unknown, they do play an important role in the body’s inflammatory response which is vital for recovery (Jones, 2002). The cytoplasm of a resting mast cell is filled with large granules that contain chemical mediators of inflammation, including histamine, heparin and tryptase (Waugh & Grant, 2001).

During an IgE-mediated hypersensitivity reaction, mast cells are activated. They then degranulate, causing the release of the chemical mediators into the surrounding tissues, collectively resulting in increased vascular permeability and vasodilation (Zull, 1999). Following degranulation, the mast cells synthesise and produce a new set of granules (Parham, 2000).

2.4.3 Basophils Basophils (basophils polymorphonuclear leucocytes) contain similar granules to, and have a similar function to mast cells (Staines et al., 1993). They act as circulating mast cells and mediate systemic allergic reactions and migrate to the tissues to partake in local allergic reactions (Leech, 2002). As with mast cells, during an IgE-mediated hypersensitivity reaction activated basophils release chemical mediators.

2.4.4 IgE antibodies Immunoglobulins are proteins that are sometimes referred to as antibodies. There are five different classes of immunoglobulins, each having the prefix Ig.

26 IgE antibodies are responsible for most allergic responses (Parham, 2000). They are normally found in very small quantities in serum (<0,002% of all immunoglobulins) (Hendry & Farley, 2001).

In allergic patients, levels can increase by as much as 2-10 times (Leech, 2002). Interaction between the allergen and the allergen-specific IgE antibodies on the surfaces of mast cells and basophils triggers a hypersensitivity reaction as seen in figure 2.2, which can lead to anaphylaxis (Underwood, 2005).

Figure 2.2

2.5 Pathophysiology The pathophysiology of allergic responses can be divided into two phases. The first is an acute response that occurs immediately after exposure to an allergen. This phase can either subside or

27 progress into a late phase reaction which can substantially prolong the symptoms of a response, and result in tissue damage (Allergy, 2009)

2.5.1Initial sensitization After the first exposure to the allergen the body produces allergen-specific IgE antibodies, which adhere to the surfaces of mast cells and basophils (Staines et al., 1993). At this point, the person is said to be sensitized (Hendry & Farley, 2001)

2.5.2Late-phase reaction The initial reaction is then followed by a late-phase reaction, which usually begins after 2-4 hours, peaks between 6 and 12 hours and resolves within 24-48 hours (Leech, 2002). This late- phase reaction can be even more profound than the first (Rusznak & Peebles, 2002).

2.6 The chemical mediators of acute inflammation The preformed mediators include histamine, chemokines and prostaglandins (Underwood, 2004).

2.6.1 Histamine Histamine is the best-known chemical mediator in acute inflammation and the most potent mediator of IgE-mediated hypersensivity, which affects all the target cells. It acts through certain histamine receptors (H1 receptors) on target cells in the host tissue. Histamine contracts bronchial smooth muscles, causing bronchial constriction, increases vascular permeability causing oedema, and causes vasodilation which increases blood flow into the infected area (Leech, 2002). The interaction of histamine with H2 receptors are due to re-exposure to the antigen on the mast cells and basophils which therefore results in the antigen binding to and cross-linking the bound IgE antibodies on target cells, which results in increased gastric secretion and a decrease of histamine released from mast cells and basophils (Sodeman & Sodeman, 2000).

2.6.2 Histamine Intolerance Histamine intolerance is an imbalance between the level of histamine present and the rate the body is able to break it down (Leech, 2002). Histamine is heat resistant and cannot be destroyed through heating, boiling, frying, baking, microwaving or freezing. Allergic reactions to foods or allergens depends not only on how much histamine a food contains, but also on our individual threshold and our ability to break down histamine (Davies, 2007).

28 Histamine is a highly active biological substance, and is normally broken down immediately when its level is too high. The breakdown of histamine involves specific enzymes, namely diamine oxidase (DAO) ((Sodeman & Sodeman, 2000). Insufficient breakdown capacity results in an imbalance and therefore histamine intolerance. The cause for insufficient breakdown capacity can include: • Congenital enzyme deficiencies • Side effects of inflammatory gastro-intestinal disorders • DAO enzyme suppression by various substances • Vitamin and mineral deficiencies • Overload of breakdown capacity caused by the presence of other substances (biogenic amines) that are broken down by the same enzyme (DAO)(Davies, 2007).

2.6.3 Prostaglandins These are a group of long-chain fatty acids derived from arachidonic acid and synthesized by many cell types. Some prostaglandins potentiate the increase in vascular permeability caused by other compounds. (Underwood, 2004).

2.6.4 Cytokines This large family of 8-10 kD proteins selectively attracts various types of leukocytes to the site of inflammation. Some chemokines such as IL-8 are mainly specific for neutrophil polymorphs and to a lesser extent lymphocytes, whereas other types of chemokines are chemotactic for monocytes, natural killer cells, basophils and eosinophils. The IL-4 stimulates and maintains TH2 cell proliferation and changes B cells to IgE synthesis. Another cytokine that is involved in allergy is IL-5 which primes basophils for histamine and leukotriene release (Routes, 2010). The various chemokines bind to extracellular matrix components such as heparin and heparin sulphate glycosaminoglycans, setting up a gradient of chemotactic molecules fixed to the extracellular fluid (Underwood, 2004).

2.7 Anaphylaxis The most life-threatening and dramatic of all allergic reactions is anaphylaxis. It occurs so rapidly that often therapy cannot be applied before death occurs. Anaphylaxis involves the whole body, causing similar shock symptoms to those one might see in car accident victim. Symptoms begin within minutes of exposure to the allergen. Since the symptoms involve the whole body, the reaction is immediate and explosive. One may experience in rapid succession a constricted

29 feeling in the chest, dizziness, wheezing, nausea, vomiting or diarrhea, weakness, hoarseness, abdominal pain, skin manifestations, swelling and cyanosis. Blood pressure can fall rapidly, and unconsciousness and death follows (Jones, 2002).

The number one cause of anaphylaxis is drugs, especially injected drugs. Injecting a substance bypasses the normal defense system of the body. Penicillin is the most common drug involved in anaphylaxis, with aspirin running a close second. Dyes used in X-ray diagnosis have also caused anaphylaxis, as have some anaesthetics used in surgery (Jones, 2002). Peanuts and other nuts, eggs, fish and shelfish are the most common foods involved in anaphylaxis. Sulfites added to fruits, vegetables and processed foods are another frequent cause. Less common but also important are the stinging insects. Insects such as bees and wasps cause deaths every year due to anaphylaxis (Zull, 1999).

2.7.1Prevention and treatment of anaphlaxis The life-threatening nature of anaphylaxis makes prevention the corner stone of therapy. If prevention techniques are routinely followed, it will provide significant degrees of protection against its occurrence. The following steps should be followed by a healthcare practitioner to prevent anaphylaxis in their patients: • Avoid agents that are known to have a high incidence of anaphylaxis • Test for agents that are known to have a high incidence of anaphylaxis • Educate the patient to avoid exposure • Administer drugs by an oral route if feasible • Require a clear indication for drug use • Observe patients after injections • Premedicate selected patients before using certain agents • Desensitize patients to any drug known to have caused anaphylaxis if it is urgently required to treat a life-threatening disease (Hendry & Farley, 2001)

2.8 Signs and symptoms of cat allergy The signs and symptoms of cat allergies are similar to those of other allergic conditions and may include: sneezing, coughing, wheezing, breathing problems, stuffy nose, itchy and watery eyes and skin rash (Davies, 2007). The severity of allergic reactions to cats varies between patients. Highly sensitive individuals may begin experiencing symptoms within 15 to 30 minutes of exposure to cat allergens. People who are less sensitive may only develop symptoms several

30 days after contact with the allergens. The level of cat allergens in an environment also plays a role in the timing of a patient’s symptoms. In rare circumstances, a person with a cat allergy experiences anaphylaxis. Symptoms of anaphylaxis include: shortness of breath, tightness in the chest, swelling of lips, face, throat or tongue and lowered blood pressure (Davies, 2007).

2.9 Diagnosis Due to the widely varying manifestations of allergy in many tissues of the body, developing valid tests for allergy has been a challenge. All of the diagnostic tests have their own strengths and weaknesses. A good patient history is still considered to be the best indicator of an allergic condition. As with most diagnostic tests, the value of tests for allergy depends on the knowledge of their interpreter. Some of the more common tests used to detect allergy are described below. • Skin testing – A skin prick test involves the introduction of a very small amount of allergen extract into the epidermis (skin) using a standardized method to ensure reproducibility and comparability of results. The results of a skin prick test are read at 10 minutes for the positive control and 15 minutes for the allergen, and the diameter of the resulting weal is recorded in two dimensions (Douglass and O’Hehir, 2006). A positive test is one in which the mean of the wheal diameter of the positive control (histamine) is at least 3 mm greater than the negative control (saline). Where a positive reaction is to develop, the patient will notice itching within 2-3 minutes of testing, followed by erythema and then a weal which expands progressively between 5 and 15 minutes after testing. The size of the skin weal should be recorded after 15 minutes by measuring the largest diameter of the weal. A negative control must be included to make sure that the patient does not react to the diluent. A positive control is included to exclude unsuspected antihistamine activity and to validate the negative results. Adverse effects of this test may include a rash, urticaria (hives) or rarely anaphylaxis. The skin prick test is a fast, accurate and cost effective method of testing (Kay, 1997). • RAST (Radioallergosorbent Test) - The RAST test method uses IgE-binding (anti-IgE) antibodies labeled with radioactive isotopes for quantifying the levels of IgE antibody in the blood (Kay, 1997). This test is more expensive to administer than skin testing and still requires an additional blood sample to be taken. • Cytotoxic Test – In this test white blood cells are mixed with a food extract. When subsequent changes to the white blood cells are observed, the test is positive. This test is used for food allergies.

31 • Elimination Provocation – This test is the most widely accepted by the medical community. The patient is either fasted on water only or given a hypoallergenic diet for five days to one week. Then foods are reintroduced one at a time and the patient is observed for reactions or symptoms. The main disadvantage to this test is the time involved. It can take days or weeks. This test is used for food allergies (Kay, 1997). • Sublingual Provocation – This test is preformed by placing a test substance under the tongue. Then a major muscle is tested for a change in muscle strength. Weakening of the muscle when challenged with the test substance is an indication of sensitivity to that substance. This test is used for food allergies (Gelfand, 2008).

2.10 Conventional treatment

2.10.1Pharmacotherapy The main form of prevention of cat allergies is complete avoidance of cats (Holgate et al., 2004). Antihistamines are the most common allergy medication, and are sometimes combined with decongestants, to help treat the nasal symptoms. Antihistamines may cause the following adverse effects: sedation, hypotension, increase in appetite which can lead to weight gain, dry mouth and thickening of secretions in the lungs, sinuses, and middle ear, which hampers drainage (Dreyer,

2004). Antihistamines act by binding to histamine receptors of the H1 type, therefore the binding of the antagonists to the receptor does not elicit a tissue response. The anticholinergic activity of antihistamines will exacerbate prostatic hypertrophy and glaucoma (Dreyer, 2004). Sympathomimetic nasal decongestants should be restricted to a maximum of two weeks, because prolonged use often leads to rebound congestion when they are stopped and they should be prescribed with caution in patients with heart disease and an overactive thyroid gland (Kay, 1997).

Corticosteroids may be subdivided into two general classes which are mineralocorticoids and glucocorticoids. These drugs work by reducing inflammation and opening the nasal passages so more air can be taken in through the nose. These drugs will inhibit the inflammatory pathways, immune system cells and chemicals such as histamines, mast cells, basophils, eosinophils, leukotrienes and cytokines. Steroidal nasal sprays appear to be most complete conventional treatment for allergies because they work against all the symptoms, including congestion, sneezing, itching and nasal discharge (Hendry & Farley, 2001).

32 Another form of treatment is immunotherapy which involves the administration of increasing doses of the cat allergen to a patient to achieve clinical and immunological tolerance over time (Douglass and O’Hehir, 2006). Immunotherapy must be given under the supervision of a physician. A series of allergen injections are administered to the patient, in which the dose is initially very small and then gradually increased (Parham, 2000). It is usually taken over a period years. This results in a reduction of inflammatory cells and mediators in the affected tissues; the production of blocking antibodies; and the suppression of IgE.This is shown in Table 2.1 below. Symptom severity can be reduced; however prolonged treatment may be necessary to provide relief. Immunotherapy is not effective for all allergy sufferers and may cause local or systemic adverse effects (Kay, 1997).

Table 2.1 Pharmacologic alterations of immediate hypersensitivity reactions (Gelfand, 2008) Methods of alteration Potential therapeutic approaches Inhibit IgE antibody production, alter IgE/IgG Immunosuppressive drugs ratio or immunologically desensitize mast cells Immunotherapy and basophils Immunologic manipulations

Deplete inflammatory cells (basophils) Corticosteriods

Inhibit mediator synthesis Corticosteriods (may inhibit synthesis of histamine and prostaglandins) Nonsteroidal anti-inflammatory agents (NSAID) (aspirin, indomethacin, etc) inhibit prostaglandin synthesis

Inhibit mediator secretion Cyclic AMP-active drugs (theophylline, beta- adrenergic agents, prostaglandins, others) Corticosteroids Cromolyn Flavonoids ETYA, ETI Bromphenacetyl bromide, mepacrine Others (DFP, cytochalasins, colchine, calcium chelators)

33 (Cyclic GMP, D2O, PGD2, NSAID, 5-HPETE, 5-HETE, alpha-adrenergic agents and depressed cyclic AMP enhance mediator secretion)

Block mediator effects on end organs Antihistamines (i.e., principally histamine-type 1 antagonists) Antiserotonin agents Anti-SRS-A agents

Reverse or counteract mediator on end organs Beta-adrenergic agents Prostaglandins Corticosteroids (synergistic with beta- adrenergic agents and/or prostaglandins)

2.11 Homoeopathy

2.11.1 History of Homoeopathy Homoeopathy was founded in the early 1800’s by a German physician Samuel Hahnemann. While Hahnemann was translating a book by a leading physiologist of the time, he disagreed with the author’s claim that the bitter and astringent qualities of Peruvian bark or quinine accounted for its effectiveness in treating malaria, as there were substances with even more bitter and astringent qualities that were useless against Malaria. Hahnemann decided to test the physiological effects of Peruvian bark and noticed that ingestion of Peruvian bark presented with similar symptoms to the disease picture (Cummings & Ullman, 1997).

2.11.2 Law of Similars Homoeopathy was founded on the principle of “Like Cures Like”, i.e. the principle that a substance which produces certain symptoms in healthy people can cure the same symptoms in the sick (De Schepper, 2006). Hahnemann (1983) stated that the medicine capable of producing symptoms upon the healthy human body similar to the disease being treated is the only one that will cure. The Latin phrase Similia similibus curentur, meaning “let likes be cured by likes”,

34 expresses the homoeopathic Law of Similar, the doctrine that any drug capable of producing morbid symptoms in the healthy will remove similar symptoms occurring in a disease state (Pugh and Werner, 2000). Hahnemann termed the medical system based on this principle homoeopathy, from the Greek words homoios, for “similar”, and pathos, for “suffering” (Cummings and Ullman, 1997).

2.12. Isotherapy Isopathy, or isotherapy refers to a therapeutic method based on the principle of sameness, “Aequalia aequalibus curentur,” whereby an infectious substance or allergen, diluted and dynamised according to homoeopathic practice, is capable of healing the same contagious disease (or allergy) that it causes (Bellavite and Signorini, 2002). An isopathic remedy is prepared from minute amounts of an allergen to which the person is allergic to establish desensitization (Morgan, 2005). In allergies the hyperimmune reaction is reduced by isotherapy. Isotherapy is often used as an adjunctive therapy in addition to standard homoeopathic medication for allergies (Morgan, 2005). Isopathy can be seen as a loose application of the law of similar but in this case no proving has been conducted on the remedy and therefore no remedy picture exists.

2.12.1 History of Isotherapy The history of isopathy was dominated by three homoeopaths, namely Constantine Hering, Wilhelm Lux and Denys Collet. Hering played a major role in homoeopathy, in particular with regards to drug provings and the preparation of homoeopathic remedies from pathological excretions and secretions, which he termed “nosodes”. He also used products from the human in a healthy state which had a healing action to the related diseased parts, and initiated the use of diluted and dynamized homologous organs (iso-organotherapy) (Loop, 2009).

Joseph Wilhelm Lux was a veterinarian and played a major role in the history of veterinary medicine. In 1831 he was asked to prescribe a remedy for distemper and anthrax and he came up with the idea to replace the homoeopathic “similar” with a 30c dilution of a drop of nasal mucus from an animal with distemper and 30c dilution of a drop of blood of an animal with anthrax. Lux published a booklet Isopathic der Contagionen where he concluded that all pathological phenomena contain’s products that can assist in the healing process (Loop, 2009).

Father Denys Collet was the third isopath that rediscovered the principle of isopthy. He witnessed a homoeopathic healing process using isopathic methods and therefore he started to

35 invest his time in this new method of healing. He published a book entitled Isopathie, Methode, Pasteur par Voie Interine at the age of 74. Collet believed there were three ways of healing, which was allopathy, homoeopathy and isopathy. During his time as an isopath, he differentiated between three types of isopathy. Firstly, Pure isopathy, is when you take the same product from the patient to heal the exact same disease. Secondly, Organic isopathy, is when a diseased organ is cured through the process of dynamization of products from healthy organs. Thirdly, was the Serotherapeutic isopathy or ‘serotherapy’ (dilutions of hyperimmune serum). The rediscovering of this new method was brought upon his book “Isopathie, Methode Pasteur par Vio Interne” which contained 42 personal observations and rules of isopathic pharmacopraxis (Loop, 2009).

2.13. Nosodes Nosodes are homoeopathic preparations obtained from a sick animal or person, a virus, a secretion or excretion. Therefore nosodes are homoeopathic remedies made from products containing the organisms. Nosodes are prepared in the same way as other homoeopathic remedies and can be diluted and potentized. Nosodes are much more effective when given near or at the time of exposure to the unhealthy organism. Nosodes are diluted and dynamized according to homoeopathic methodology. In 1965 the French Pharmacopoea replaced the term “nosode” with “biotherapeutic” (Loop, 2009). In the 1970’s O.A. Julian proposed another name change from biotherapeutic and isotherapeutic substances to “Dynamized Micro- Immunotherapy” to keep up with modern terminology. Due to the outside world not accepting the name change as there was much debate about dynamization the word nosode is still used today (Schepper, 2006).

2.14 Homoeopathic treatment of cat allergy Homoeopathic preparations are believed to keep the body free of allergic reactions for a longer period (Kayne and Jepson, 2004). Cat hair is indicated for the treatment of cat allergies based on the principles of Isotherapy. Histaminum is a nosode which is made from histamine (De Schepper, 2006). Histaminum is helpful following exposure to allergens, and is indicated for treating symptoms of bronchial asthma, nasal congestion, hayfever, eczema and hives (Thomas, 1998).

Homoeopathic medicines are useful for alleviating the symptoms of cat allergy. They are useful in calming runny eyes with a burning or gritty feeling, facial flushing, watery nose, and short,

36 hard, tickling cough. If used immediately during onset of allergic symptoms (De Schepper, 2006).

Desensitization and neutralization of allergy is frequently assisted by the use of homoeopathic preparations which are minute dilutions of specific substances. These preparations, in liquid or tablet form, are generally taken under the tongue. In the case of allergy, the diluted substance would be an allergen. The allergen has been diluted over and over during preparation. The remedy is completely safe and easy to administer (Cummings & Ulman, 1997).

Homoeopathic remedies work well on all types of allergy. They are helpful with food allergens as well as with airborne allergens such as dust, pollen, grass and mould, and with allergies to dogs, cats and horses. The action appears to be increased after the allergic individual is detoxified. For this reason, they are useful for allergies which are still active after parasites are under control and the digestive tract has had time to heal (Hendry & Farley, 2001).

2.15 Supportive Measures in allergy One will find deficiencies of minerals, trace elements and vitamins with many, if not all forms of allergy and intolerance. A definite improvement in symptoms will be noticed by administering the correct substance. The following substances are important in the case of allergies:

2.15.1 Zinc Zinc is found as a central mineral in many enzyme systems and influences the effect of the thymus gland as an immune-competent organ. Zinc influences acid–base balance, supports hormone production of the adrenal glands (cortisone, progesterone) and is important in all skin disorders, including its attributes (skin, nails). Zinc is used for candidiasis, neutralizes heavy metals, and is almost always absent in cases of fructose intolerance. The daily requirements of zinc are 15mg and the therapeutic dosage are approximately 30-60mg (Douglas & O’ Heir, 2006).

2.15.2 Calcium Calcium is one of the most important mineral substances in cases of allergies. It reduces the effect of histamine. Calcium is a component of bones and teeth, where it is responsible for strength and firmness. It is also involved in the transfer of information to the cell walls of a living cell and there is an increased tendency to cramp with calcium defiency. The daily requirements are 1g and the therapeutic dose are approximately 1g (Hendry & Farley, 2001).

37 2.15.3 Copper Copper is stored in the liver and is one of our most important anti-inflammatory minerals. It is important in cases of histamine intolerance because breakdown of histamine is carried out through an enzyme containing copper (diamine oxidase). Copper deficiency or the increased requirement of copper due to inflammation intensify allergy symptoms. The daily requirement for copper is 2mg and the therapeutic dosage are 4-8mg. Copper is not to be taken simultaneously with zinc (Hendry & Farley, 2001).

2.15.4 Sodium Bicarbonate Sodium bicarbonate is the most important substance with inflammation. All inflammation involves local excess acidity. Sodium bicarbonate balances acidity, reduces excess acidity in the stomach, reduces pain and has anti-inflammatory properties in cases of allergies. Taking sodium bicarbonate as a base powder between meals has proven to be worthwhile. In acute cases, sodium bicarbonate can be administered by intravenous infusion, which can quickly control symptoms. The daily requirement is approximately 200g and the therapeutic dose are 2-20g (Douglas & O’ Heir, 2006).

2.15.5 Vitamin B6 Vitamin B6 is important for the nerves and for the breakdown of protein. A rich protein diet frequently leads to B6 deficiency. B6 acts as a co-factor in the breakdown of histamine. The therapeutic dose per day are 50mg (Davies, 2007).

2.15.6 Vitamin C Vitamin C is well known as being very effective with colds, minor infection or vital inflammation. These all involve the immune system. In allergies, vitamin C lowers histamine levels, with quantities of about 2-10g or more required to achieve this result. It is administered partially as an intravenous infusion, when supplied via digestive system. High doses results in soft stool or even diarrhea. The correct therapeutic dosage falls just short of causing diarrhea. Vitamin C should be taken with a buffer, pH-neutral form to avoid local acidic effects, and as a powder dissolved in water, possibly mixed with base powder. To buffer pure vitamin C, it can be mixed with base powder at a 1:1 ratio (Hendry & Farley, 2001).

2.15.7 Vitamin F Vitamin F means unsaturated fatty acids. These are of particular significance, especially in the case of allergies. They are important in all skin disorders, neurodermatitis, allergy eczema and

38 dry skin. Highly unsaturated fatty acids are preliminary stages for synthesis of the hormones cortisone and progesterone in the adrenal glands (Douglas & O’ Heir, 2006). The thymus gland depends on unsaturated fatty acids to provide information to specialized immune cells. Fatty acids also have many metabolic functions without which healthy life is not possible. The daily requirements are about 5-10g (2 tablespoons) of cold-pressed vegetable oil. Highly unsaturated fatty acids require vitamin E as protection to prevent rancidity. Therefore intake of 200 IU of vitamin E is necessary daily. Light, air and heat destroy highly saturated fatty acids; therefore cold-pressed vegetable oil should be stored in dark bottles, well sealed, in the refrigerator (Davies, 2007).

39 4. METHODOLOGY

4.1 Research sample Thirty males and females between the ages 18 and 45, was recruited by means of purpose sampling for the study. Advertisements were placed at the University of Johannesburg Doornfontein campus and at Weleda pharmacy (Fourways) with permission from the owner of the pharmacy (Appendix A, B).

Inclusion criteria • Male and female between the ages 18 and 45

• Participants should have been living with a cat for a period of six months or more

• Participants suffering from allergy-like symptoms when in the presence of a cat or when exposed to cat dander (sneezing, coughing, wheezing, breathing problems, stuffy nose, itchy and watery eyes and skin rash).

Exclusion criteria • Individuals that were being treated with allopathic medicines for allergies i.e. corticosteroids, antihistamines and decongestants

• Pregnant or lactating women

• Immuno-compromised individuals

• Individuals immunized against pet allergies

Participant’s were kindly advised not to take any conventional, homoeopathic or herbal medication for allergies during the course of the study.

4.2 Research design and procedure This was a double-blind placebo-controlled study which took place over a period of four weeks. On the first day of the study participants were given a full explanation of the research procedures. Potential participants who met the inclusion and exclusion criteria were requested to sign the Participant Information and Consent Form (Appendix C). This study was part of a group study related to cat allergy analysis. Participants was asked to report to Ampath laboratories to undergo a skin prick test and results were recorded by the researcher (Appendix D). Those participants that tested positive for cat allergies did undergo an initial consultation at the health

40 centre located at the UJ Doornfontein campus, involving a medical history, vital signs and physical examination of their ears, nose and throat (Appendix E). Medication was randomized by an external administrator (Pharma Natura). Each participant received a 25ml bottle of either the medication or the placebo in tablet form and instructed to take two tablets in the morning and two tablets at night for the four weeks. Each participant was given a score card (Appendix F) to take home and rate the severity / intensity of their symptoms at the end of each week for four consecutive weeks. The second consultation occurred two weeks later which involved a brief follow-up consultation, related physical examination, and then a second bottle of medication was given. At the end of week four, participants reported to Ampath laboratories for their final skin prick test. This was followed by the third and final consultation, where the physical examination was done, and score cards collected.

4.3 Medication administration The homoeopathic complex contained Cat hair 9cH and Histaminum 9cH and was manufactured, packaged and randomised by Pharma Natura a registered homoeopathic manufacturer. Each medication bottle was coded and packaged in a 25ml amber glass bottle containing 52 tablets and neither the researcher nor the participant did know which bottle was the medicated complex or the placebo. The placebo was manufactured to be identical in taste and appearance and were unmedicated lactose tablets. Participants received their medication at the first and second consultations. Participants were required to take two tablets twice a day throughout the four week study period, one dose in the morning and the second dose in the evening. Included with the medication bottle was an information leaflet (Appendix G) explaining the dosage and storage conditions required.

4.4 Data collection and analysis On completion of the study, all data received from the skin prick test and the score cards (Appendix F) were analyzed with descriptive statistics and frequencies that were graphically displayed. The tests for normality were done using the Shapiro Wilk test. Comparisons between the two groups (the experimental and placebo group) were analysed using non-parametric tests i.e. the Mann-Whitney Test, the Friedman Test and the Wilcoxon Signed Ranks Test (Smith, 2010).

4.5 Reliability and validity The medication was manufactured and packaged by Pharma Natura, according to good manufacturing practice to ensure quality assurance and control. The placebo was manufactured

41 to be identical in taste and appearance to the homoeopathic complex and both packaged identically. The skin prick test is a valid tool for measuring the level of allergic reaction and was standardized and conducted by qualified nurses at Ampath laboratories a pathology laboratory (Kay, 1997). All consultations and physical examinations were done by the researcher. The score card rating the severity, frequency and duration of symptoms was based on use in previous similar studies, on allergy and enhanced data quality and reliability by monitoring the participants’ subjective allergic experience (Du Plessis et al., 2001; Smith, 2010).

5. ETHICS Participation in the research study was on a purely voluntary basis, and participants did have the right to withdraw from the study or refuse treatment at any stage. Participants were fully informed of the research procedure and requirements of the study. Confidentiality was ensured throughout the study with files being kept under lock and key. Anonymity was maintained and no identifying data was included in the research results. Privacy was ensured and all consultations took place in a private consultation room. Homoeopathic medication is considered safe and free from side effects; therefore there were no anticipated risks. If however, any participant experienced any adverse symptoms, they were requested to contact the researcher immediately, and if necessary were referred to heir healthcare practitioner. The researcher was available to answer any questions and/or concerns that may have arisen during the study. All participants did have full access to the research results and its conclusions on request. My ethical clearance number is AEC41/02-2010.

42 4. RESULTS

4.1 Introduction The aim of this study was to determine the efficacy of Cat Hair 9cH and Histaminum 9cH on treating the symptoms of cat allergy using a skin prick test and a symptom score card. Thirty participants was required to participate in the study over a period of four weeks. Each participant did experience a positive reaction to cat allergen in the skin prick test and experienced symptoms of cat allergy at the start of the study. All data was analysed using the SPSS (Statistical Package for Social Sciences) version 13. Therefore the results of the effectiveness of Cat Hair 9cH and Histaminum 9cH in treating the symptoms of allergy to cats are represented in the form of bar graphs and tables in this section.

4.2 Skin prick test results The skin prick test were conducted by a qualified health professional at Ampath laboratories. Each participant’s skin prick test was performed at the start (week 1) and at the end of the study (week 4). Three test serums were used in the process which consisted of a positive control, negative control and the cat allergen (which was a mixture of cat hair and cat saliva). The wheal diameters of each participant were recorded fifteen minutes after every individualized skin prick test. The positive control contains histamine and each individual did react to this. The negative control contains saline and no participants reacted to this.

The results of the skin prick test was analysed by comparing the wheal diameter, flare reaction and the intensity of itchiness. The wheal diameter measures the elevation of the skin after test has been performed. The flare reaction measures the intensity of the red colour of the skin after the skin tissue has been pierced with the needle. The intensity of itchiness was analysed by each individual based on their own perception on a scale rating of one to five, were one is little itching and five was intense itching experienced over the area that was pricked. The data obtained was compared and analysed between the placebo group and the experimental group which was measured at the start of week one and the end of week four for both the positive skin prick test results and the cat skin prick test results.

43 4.3 Statistical tests of significance

Kolmogorov-Smirnov Test Kolmogorov-Smirnov Test is used to tests for the equality of continuous one dimensional probability distribution. This test is used to compare a sample or two sample groups to a reference probability distribution.

Mann Whitney Test The Mann Whitney Test is a non-parametric statistical hypothesis test for assessing whether two independent samples have equally large values.

Friedman Test The Friedman Test is a non-parametric test used for testing the difference between several related samples when the same parameters are being measured under different conditions in the same subjects.

The Wilcoxon Signed Ranks Test The Wilcoxon Signed Ranks Test is a non-parametric test used to compare to related variables. It test the hypothesis that the two variables have the same distribution, however makes no assumptions bout the shapes of the distributions of the variables. This test considers the magnitude of the differences within pairs, and weighs pairs that show more differences higher than those that show less of a difference.

The p-value A 0,05 p-value indicates a ninety five percent confidence level. If the p-value is less than 0,05 this indicates that the mean of the control group and the mean of the experimental group were different at the beginning of the study, this would than imply a rejection of the null hypothesis. If the p-value is equal or greater than 0,05 this indicates that the mean of the control group and the mean of the experimental group were equally at the beginning of the study, therefore accepting the null hypothesis.

In this section we test whether the treatment used was effective, that is, we test whether the results of the experimental (medication) group differed significantly from those of the control (placebo) group; also we check whether the results of the skin prick test and symptom score card were significantly different from week 1 to week 4. We test the null hypothesis of no difference

44 against the alternative hypothesis of difference between groups or within groups (week 1 to week 4).

First, we carried out the Kolmogorov Smirnov test of normality to decide whether a parametric or non-parametric test should be used. The result of this test (Appendices J to K ), showed that some variables related to symptoms were normally distributed as the p-values were not less than 0.05 and others are not normally distributed as the p-values are less than 0.05 . Same trend is also observed for the variables related to cat and positive skin prick test results (Appendix H and Appendix I). Hence, parametric tests were used for the normal variables score card results and non-parametric tests for the non normal ones.

For the between groups test, Mann Whitney test is carried out for the non-parametric, and two samples t test for the parametric. For the within groups test, Friedman K related samples was used for the difference between week 1 to week 4; Wilcoxon signed rank test was used for the difference between week 1 and week 4 for the non-parametric, and two related samples t test for the parametric one.

The following graphs and tables represent the frequency distribution of the positive skin prick and cat skin prick tests.

45 4. RESULTS

4.2.1 Skin prick test: positive control as measured in the experimental group Graph 4.1 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the wheal diameter of the skin prick test for the positive control measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.1 Frequency of wheal diameter in positive skin prick for experimental group

Graph 4.1 shows that there was a significant change in the wheal diameter, experienced in the experimental group, between the test conducted at the start of the study (week 1) and at the completion of the study (week 4). We see that the wheal diameter dropped for all the patients, except two whose results remained unchanged.

46 4.2.2 Skin prick test: positive control as measured in the control group Graph 4.2 depicts the group of participants that were given the placebo (control group). This graph illustrates the wheal diameter of the skin prick test for the positive control measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.2 Frequency of wheal diameter in positive skin prick for control group

Graph 4.2 shows that there was no significant change in the wheal diameter, experienced in the control group as there is a mix pattern of increase, decrease and status quo, between the test conducted at the start of the study (week 1) and at the completion of the study (week 4).

47 4.2.3 Flare reaction: positive control as measured in the experimental group Graph 4.3 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the extent of the flare reaction measured in centimeters for the positive control, measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.3 Frequency of flare reaction in positive skin prick for experimental group

Graph 4.3 shows that there is a significant change (decrease) in the diameter of the flare reaction with only one patient (Patient number 9) displaying an unchanged result.

48 4.2.4 Flare reaction: positive control as measured in the control group

Graph 4.4 depicts the group of participants that were given the placebo (control group). This graph illustrates the extent of the flare reaction measured in centimeters for the positive control, measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.4 Frequency of flare reaction in positive skin prick for control group

There is no drop, in the control group, in the flare reaction for the positive skin prick from week 1 to week 4, Graph 4.4. The flare reaction remains unchanged for 9 participants and increased for 6 participants.

49 4.2.5 Degree of itchiness: positive control as measured in the experimental group

Graph 4.5 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the degree of itchiness measured by each participant on a scale of 0 to 10 (0 represents no itching and 10 represents intense itching), for the positive control measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.5 Frequency of the degree of itchiness in positive skin prick for experimental group Two of the patients experienced unchanged degree of itchiness from week 1 to week 4 while the majority experienced a significant drop, Graph 4.5. The improvement in the degree of itching was more pronounced in most participants, who experienced a drop of more than two units from week 1 to week 4.

50

4.2.6 Degree of itchiness: positive control as measured in the control group

Graph 4.6 depicts the group of participants that were given the placebo (control group). This graph illustrates the degree of itchiness measured by each participant on a scale of 0 to 10 (0 represents no itching and 10 represents intense itching), for the positive control measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.6 Frequency of the degree of itchiness in positive skin prick for control group

Graph 4.6 indicates that the degree of itchiness in the control group shows a mixed pattern of increased, unchanged and decreased; therefore there is no significant change in the level of itchiness in the positive skin prick test as experienced by the control group participants.

51 Table 4.1 Comparison of the positive skin prick test results between experimental and control groups Positive skin Standard Group Mean P-value prick deviation Wheal diameter Experimental 5.23 1.65 0.009 scale Placebo 5.93 1.53 Flare reaction Experimental 2.40 1.00 0.003 scale Placebo 3.13 0.68 Level of Experimental 2.90 1.52 0.010 Itchiness Placebo 3.57 1.01

Table 4.1 shows the mean, standard deviation and p-values for the positive skin prick test as measured in the experimental and control groups respectively. The p-values were all less than 0,05 for the experimental group as opposed to those in the control group therefore the results from the positive skin control measured in the experimental group are statistically significant.

Table 4.2 Comparison of the positive skin prick test results between week 1 and week 4 in the experimental group Positive skin Standard Week Mean P-value prick deviation Wheal diameter 1 6.40 0.99 0.001 scale 4 4.07 1.34 Flare reaction 1 3.07 0.88 0.001 scale 4 1.73 0.59 Level of 1 4.00 1.25 0.001 Itchiness 4 1.80 0.78

Tables 4.2 shows the means, standard deviation and p-values of the positive skin prick test results at week 1 and week 4, in experimental. It can be seen that, on average, the positive skin prick test results decreased significantly from week 1 to week 4 in the experimental group all with p-values of less than 0.05.

52 Table 4.3 Comparison of the positive skin prick test results between week 1 and week 4 in the control group Positive skin Standard Week Mean P-value prick deviation Wheal diameter 1 6.00 1.65 0.810 scale 4 5.87 1.46 Flare reaction 1 3.00 0.66 0.410 scale 4 3.27 0.70 Level of 1 4.07 0.96 0.002 Itchiness 4 3.07 0.80

Table 4.3 shows the means, standard deviation and p-values of the positive skin prick test results at week 1 and week 4, in control group. The skin prick test results as measured in the control group show that the wheal diameter and flare reaction scale results are not statistically significant as the p-value were greater than 0.05, but the results for the level of itchiness are statistically significant with p-values of less than 0,05.

53 4.2.7 Skin prick test for sensitivity to cat allergen as measured in the experimental group

Graph 4.7 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the wheal diameter for the skin prick test conducted for cat allergen measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.7 Frequency of wheal diameter in cat skin prick for experimental group

Graph 4.7 shows that there was a significant change in the wheal diameter, experienced in the experimental group, between the test conducted at the start of the study (week 1) and at the completion of the study (week 4). The wheal diameters of seven participants dropped to zero while for the rest, the change was between 30 to 80%.

54 4.2.8 Skin prick test: for sensitivity to cat allergen as measured in the control group

Graph 4.8 depicts the group of participants that were given the placebo (control group). This graph illustrates the wheal diameter for the skin prick test conducted for cat allergen measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.8 Frequency of wheal diameter in cat skin prick for control group

It can be seen, Graph 4.8, that most of the participants had their wheal diameters increased or had slight improvement, from week 1 to week 4, except for patients 6 and 15 who experienced a decrease in their wheal diameters. There is no significant drop in the wheal diameter from week 1 to week 2.

55

4.2.9 Flare reaction: for sensitivity to cat allergen as measured in the experimental group

Graph 4.9 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the extent of the flare reaction measured in centimeters to the cat allergen, which was measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.9 Frequency of flare reaction in cat skin prick for experimental group

Graph 4.9 depicts a significant decrease in the flare diameter for most of the participants, except for three participants whose flare reactions display a status quo.

56

4.2.10 Flare reaction: for sensitivity to cat allergen as measured in the control group

Graph 4.10 depicts the group of participants that were given the placebo (control group). This graph illustrates the extent of the flare reaction measured in centimeters to the cat allergen, which was measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.10 Frequency of flare reaction in cat skin prick for control group

Two participants had their flare reaction unchanged from week 1 to week 4, Graph 4.10. Nine increased and only four of the fifteen decreased. This suggests that there is no significant change in the flare diameters, from week 1 to week 4, in the control group.

57 4.2.11 Degree of itchiness: for sensitivity to cat allergens in the experimental group

Graph 4.11 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group). This graph illustrates the degree of itchiness measured by each participant on a scale of 0 to 10 (0 represents no itching and 10 represents intense itching), to the cat allergen measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.11 Frequency of the degree of itchiness for sensitivity to cat allergen in the experimental group Graph 4.11 shows a significant change (drop) in the level of itchiness experienced by all participants in this group, although one participant experienced a statu quo in his level of itchiness from week 1 to week 4. Seven of them had a drop of three units from week 1 to week 3.

58 4.2.12 Degree of itchiness: for sensitivity to cat allergens in the control group

Graph 4.12 depicts the group of participants that were given the placebo (control group). This graph illustrates the degree of itchiness measured by each participant on a scale of 0 to 10 (0 represents no itching and 10 represents intense itching), to the cat allergen measured at the beginning of the study (week 1) and at the completion of the study (week 4).

Graph 4.12 Frequency of the degree of itchiness for sensitivity to cat allergen in the control group

Graph 4.12 indicates that the level of itchiness in the control group has a mixed pattern. Some increased, remained unchanged and decreased; therefore there is no significant change in the level of itchiness to the cat allergen experienced by the control group participants.

59 Table 4.4 Comparison of the cat skin prick test results between experimental and control groups Standard Cat skin prick Group Mean P-value deviation Wheal diameter Experimental 4.30 2.29 0.012 scale Placebo 5.87 2.10 Flare reaction Experimental 2.20 0.89 0.003 scale Placebo 3.00 1.05 Level of Experimental 2.53 1.50 0.020 Itchiness Placebo 3.30 1.06

The difference of cat skin prick test results observed between the experimental and control groups are statistically significant as shown in Table 4.4 above. This shows that the cat skin prick tests worked better in the experimental group than the control group.

Table 4.5 Comparison of the cat skin prick test results between week 1 and week 4 in the experimental group Standard Cat skin prick Week Mean P-value deviation Wheal diameter 1 5.53 2.03 0.002 scale 4 3.07 1.87 Flare reaction 1 2.73 0.80 0.001 scale 4 1.67 0.62 Level of 1 3.67 1.29 0.001 Itchiness 4 1.40 0.51

Table 4.5 confirms that the homoeopathic treatment was effective in the experimental group, as the p-values were all less then 0,05 therefore the results are statistically significant.

60 Table 4.6 Comparison of the cat skin prick test results between week 1 and week 4 in the control group Standard Cat skin prick Week Mean P-value deviation Wheal diameter 1 5.40 2.06 0.036 scale 4 6.33 2.09 Flare reaction 1 2.93 1.16 0.480 scale 4 3.07 0.96 Level of 1 3.33 1.55 0.229 Itchiness 4 3.17 0.70

The placebo group (control group) shows no statistically significant results as all the p-values were all higher than 0,05 (Table 4.6), except for the wheal diameter.

61 4.3 Symptom score card results Participants were asked to complete a score card which rated the severity, frequency and duration of symptoms experienced at the end of each of the four weeks. Symptoms that were rated by each participant included the following:

• Red itchy eyes • Runny itchy stuffy nose • Skin rash • Redness of skin where a cat has scratched, licked or bitten • Sneezing • Scratchy throat • Wheezing

The scales used to rate these symptoms were as follows

Severity 1. Improved 2. Mild improvement 3. Unchanged 4. Fairly severe 5. Very severe

Frequency 1. Never 2. Rarely 3. Sometimes 4. Often 5. Always

Duration 1. 0-10 min 2. 11-20 min 3. 21-30 min 4. 31-40 min 5. 41-50 min

62 Refer to appendix F (score card rating the severity, frequency and duration of symptoms).

The data obtained from these symptom score cards were compared between the experimental group and the placebo group in week one, week two, week three and week four, using the four related samples test. To decide whether parametric tests or non parametric tests would be carried out, normality of all the variables were tested first using the Kolmogorov Smirnov test of normality.

The follow graphs represent the frequency distribution of the severity, frequency and duration of symptoms.

63 4.3.1 Severity of the symptom red itchy eyes

Graph 4.13 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “red itchy eyes” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.13 Severity of red itchy eyes

The severity of red itchy eyes symptom in the experimental group was dominated by unchanged and fairly severe at the end of week 1, Graph 4.13. However, at the end of week 4 the symptom was rated by majority of the participants as improved. In the control group the rating of the symptom “red itchy eyes” showed very little improvement from week 1 to week 4.

64

4.3.2 Severity of the symptom runny itchy stuffy nose

Graph 4.14 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “runny itchy stuffy nose” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.14 Severity of runny itchy stuffy nose

Graph 4.14 indicates that, in the experimental group the severity of the symptom “runny itchy stuffy nose” was either unchanged, mild improved or fairly serve for majority of the participants at the end of week 1, however at the end of week 4 the symptom was rated mostly as either improved or mildly improved. In the control group the rating of the symptom “runny itchy stuffy nose” remained unchanged from week 1 to week 4 for majority of the participants. The number of unchanged cases even increased from week 1 to week 4.

65 4.3.3 Severity of the symptom skin rash

Graph 4.15 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “skin rash” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.15 Severity of the presentation of a skin rash

In the experimental (medication) group, 11 participants had their skin rash symptom, in week 1, either improved, mildly improved or unchanged, Graph 4.15. However, at the end of week 4 the symptom was rated as improved by 10 participants, mildly improved by 4 participants and unchanged by 1 participant only. In the control group the symptom “skin rash” was rated either as mild improvement or unchanged at the end of week 1; however by the end of week 4, 3 participants showed some improvement and 11 reported no change.

66 4.3.4 Severity of the symptom redness of skin where a cat has scratched, licked or bitten

Graph 4.16 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “redness of skin where a cat has scratched, licked or bitten” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.16 Severity of redness of skin where a cat has scratched, licked or bitten

Graph 4.16 indicates that in the experimental group the severity of the symptom “redness of skin where a cat has scratched, licked or bitten” was either unchanged or mildly severe for most participants at the end of week 1; however at the end of week 4 the symptom was rated as improved by 11 participants and mildly improved by 3 participants. In the control group the rating of the symptom “redness of skin where a cat has scratched, licked or bitten” was rated by 13 participants as either unchanged, fairly severe or very severe at the end of week 1 ; however by the end of week 4 it was rated as unchanged by 5 participants, mild improvement by 5 participants and improved by 4 participants.

67 4.3.5 Severity of the symptom sneezing

Graph 4.17 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “sneezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.17 Severity of sneezing

Graph 4.17 illustrates that in the experimental group the severity of the symptom “sneezing” was rated as unchanged, mild improvement or fairly severe by a total of 13 participants at the end of week 1, however at the end of week 4 the symptom was rated as improved by 10 participants and mildly improved by 4 participants. In the control group the rating of the symptom “sneezing” remained unchanged from week 1 to week 4 for majority of the participants.

68 4.3.6 Severity of the symptom scratchy throat

Graph 4.18 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “scratchy throat” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.18 Severity of scratchy throat

In the experimental group the severity of the symptom “scratchy throat” was rated improved or mildly improved by a total of 7 participants and the remaining 8 participants rated it as unchanged, fairly severe or very severe, at the end of week 1, Graph 4.18. However at the end of week 4 the symptom was rated as improved by 9 the participants and mildly improved by 5 participants. In the control group the rating of the symptom “scratchy throat” was only rated mostly as unchanged or mildly improved at the end of week 1, while at the end of week 4, most of them rated it as unchanged.

69

4.3.7 Severity of the symptom wheezing

Graph 4.19 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the severity of “wheezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.19 Severity of wheezing

Graph 4.19 illustrates that in the experimental group the severity of the symptom “wheezing” was rated as either unchanged or improved by majority of the participants, with 2 participants rating this symptom as fairly severe and 1 as very severe at the end of week 1; however at the end of week 4 the symptom was rated as improved by 8 participants and mildly improved by 5 participants. In the control group the rating of the symptom “wheezing” displays a mixed pattern of unchanged, improved, mildly improved, fairly severe and very severe at the end of week 1; however at the end of week 4 the symptom almost the same trend was observed.

70 Table 4.7 Comparison of the severity of symptoms across the weeks of study in the experimental group Symptoms Week Mean SD P-value

1 3.20 1.01 2 2.40 0.74 Red itchy eyes 0.006 3 1.80 0.56 4 1.33 0.62 1 3.27 0.96 2 2.27 0.88 Runny itchy stuffy nose 0.004 3 1.60 0.63 4 1.73 0.80 1 2.73 1.22 2 2.27 0.96 Skin rash 0.001 3 2.00 0.93 4 1.40 0.63 1 2.93 1.10 Redness of skin where a cat has 2 2.33 0.98 0.000 scratched, licked or bitten 3 1.87 0.74 4 1.33 0.62 1 3.00 1.07 2 2.53 0.64 Sneezing 0.000 3 2.13 0.92 4 1.40 0.63 1 2.67 1.23 2 2.33 0.72 Scratchy throat 0.001 3 2.00 0.76 4 1.53 0.83 1 2.67 1.23 2 2.33 0.90 Wheezing 0.040 3 2.00 1.00 4 1.73 1.03

Table 4.7 compared the severity of all symptoms across the 4 weeks as measured in the experimental group. Table 4.7 shows that all the p-values for the severity of symptoms experienced by the participants as measured in the experimental group were less than 0,05 which

71 is statistically significant, therefore it can be deduced that participants had an improvement in the severity of all symptoms experienced from the end of week 1 to the end of week 4.

72 Table 4.8 Comparison of the severity of symptoms across the weeks of study in the control group Symptoms Week Mean SD P-value

1 2.47 1.60 2 2.27 1.49 Red itchy eyes 0.136 3 1.87 1.13 4 1.93 1.28 1 3.07 1.63 2 2.60 0.99 Runny itchy stuffy nose 0.035 3 2.13 0.83 4 2.33 0.98 1 2.40 1.24 2 2.07 1.03 Skin rash 0.209 3 1.87 1.01 4 2.07 1.10 1 3.00 1.20 Redness of skin where a cat 2 2.07 1.39 0.004 has scratched, licked or bitten 3 2.07 1.22 4 1.93 0.96 1 2.47 1.36 2 2.13 1.19 Sneezing 0.505 3 2.07 0.88 4 2.20 1.08 1 2.27 1.39 2 1.93 1.28 Scratchy throat 0.425 3 1.93 0.88 4 2.20 1.08 1 2.33 1.54 2 2.07 1.53 Wheezing 0.666 3 2.20 1.61 4 1.80 1.52

Table 4.8 compared the severity of all symptoms across the 4 weeks as measured in the control group. Table 4.8 shows that in the control group the p-valves for the severity of symptoms red itchy eyes, skin rash, sneezing, scratchy throat and wheezing were all greater than 0.05 and are

73 therefore not statistically significant. The p-values for the symptoms “runny itchy stuffy nose” and “redness of skin where a cat has scratched, licked or bitten” were less than 0.05 therefore statistically significant.

74 4.3.8 Frequency of the symptom red itchy eyes Graph 4.20 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “red itchy eyes” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.20 Frequency of red itchy eyes The frequency of the symptom “red itchy eyes”, in the experimental group, was rated mostly as sometimes at the end of week 1,Graph 4.20. However at the end of week 4 the symptom was rated by majority of the participants as either experienced rarely or never. In the control group the rating of the symptom “red itchy eyes” went from being often at the end of week 1 to sometimes or rarely at the end of week 4.

75 4.3.9 Frequency of the symptom runny itchy stuffy nose Graph 4.21 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “runny itchy stuffy nose” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.21 Frequency of runny itchy stuffy nose Graph 4.21 indicates that in the experimental group the frequency of the symptom “runny itchy stuffy nose” was rated as either being often or sometimes for the majority of participants at the end of week 1; however at the end of week 4 the symptom was mostly rated as rarely. In the control group the rating of the symptom “runny itchy stuffy nose” remained as sometimes from week 1 to week 4 for the majority of the participants.

76 4.3.10 Frequency of the symptom skin rash Graph 4.22 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “skin rash” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.22 Frequency of the presentation of a skin rash Graph 4.22 illustrates that in the experimental group the frequency of the symptom “skin rash” was rated as either sometimes or often for most participants at the end of week 1; however at the end of week 4 the symptom was rated as either rarely by 8 participants or never by 5 participants. In the control group the rating of the symptom “skin rash” displays a slight improvement from week 1 to week 4, where the symptom was rated as either being rarely or sometimes for majority of the participants at the end of week 1, to being rated as never by 5 participants, rarely by 4 participants and sometimes by 4 participants at the end of week 4.

77 4.3.11 Frequency of the symptom redness of skin where a cat has scratched, licked or bitten Graph 4.23 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “redness of skin where a cat has scratched, licked or bitten” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.23 Frequency of redness of skin where a cat has scratched, licked or bitten Graph 4.23 illustrates that in the experimental group the frequency of the symptom “redness of skin where a cat has scratched, licked or bitten” was either often or sometimes for most participants (10) at the end of week 1, however at the end of week 4 the symptom was rated as either rarely or never by majority (12) of the participants. In the control group the rating of the symptom “redness of skin where a cat has scratched, licked or bitten”, was either always or often for the majority (8) of the participants, however at the end of week 4 it was mostly rated as occurring sometimes.

78 4.3.12 Frequency of the symptom sneezing Graph 4.24 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “sneezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.23 Frequency of sneezing Graph 4.23 illustrates that in the experimental group the frequency of the symptom “sneezing” was rated as sometimes or often by most of the participants at the end of week 1, however at the end of week 4 the symptom was rated as rarely or never by the majority of participants, with few of them remaining never. In the control group the rating of the symptom “sneezing” was sometimes or often by the majority at the end of week 1. At the end of week 4, 7 participants rated it as sometimes, 4 participants as rarely, 2 as often and 1 as never. While the sometimes increased by 1 from week 1 to week 4, there was a slight improvement as the often changed mostly to rarely.

79 4.3.13 Frequency of the symptom scratchy throat Graph 4.25 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “scratchy throat” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.25 Frequency of scratchy throat Graph 4.25 indicates that in the experimental group the frequency of the symptom “scratchy throat” was rated as either often or never by 10 participants at the end of week 1; however at the end of week 4 the symptom was rated as either rarely or never by 14 of the participants. In the control group the rating of the symptom “scratchy throat” was sometimes or rarely, for the majority, at the end of week 1 and remained unchanged at the end of week 4.

80 4.3.14 Frequency of the symptom wheezing Graph 4.26 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the frequency of “wheezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.26 Frequency of wheezing

Graph 4.26 illustrates that in the experimental group the frequency of the symptom “wheezing” was rated as either never, sometimes or often by most participants at the end of week 1; however at the end of week 4 the symptom was rated as either rarely or never by majority of the participants. In the control group the symptom “wheezing” was rated as often or never by 9 participants at the end of week 1 and either rarely or never at the end of week 4 by 10 participants.

81 Table 4.9 Comparison of the frequency of symptoms across the weeks of study in the experimental group Symptoms Week Mean SD P-value

1 3.10 1.51 2 2.37 0.98 Red itchy eyes 0.004 3 2.13 0.81 4 1.80 0.68 1 3.27 1.03 2 2.40 0.66 Runny itchy stuffy nose 0.003 3 2.61 0.91 4 2.07 0.70 1 3.00 0.93 2 2.33 0.82 Skin rash 0.001 3 1.93 0.88 4 1.60 0.68 1 3.07 1.63 Redness of skin where a cat has 2 2.40 0.91 0.000 scratched, licked or bitten 3 2.20 1.01 4 1.80 0.78 1 3.47 0.92 2 2.60 0.91 Sneezing 0.000 3 2.20 0.78 4 2.00 0.76 1 2.80 1.42 2 2.07 1.03 Scratchy throat 0.009 3 1.47 0.83 4 1.73 0.64 1 2.73 1.49 2 2.27 1.10 Wheezing 0.022 3 1.87 0.99 4 2.00 0.93 Table 4.9 and 4.10 compared the frequency of all symptoms across the 4 weeks as measured in the experimental and control group respectively

Table 4.9 shows that all the p-values for the frequency of symptoms experienced by the participants as measured in the experimental group were all less than 0,05 which is statistically

82 significant, therefore it can deduced that participants had an improvement in the frequency of all symptoms experienced from the end of week 1 to the end of week 4.

83 Table 4.10 Comparison of the frequency of symptoms across the weeks of study in the control group Symptoms Week Mean SD P-value

1 3.20 0.94 2 2.80 0.78 Red itchy eyes 0.001 3 2.47 0.74 4 2.67 0.98 1 3.27 0.62 2 3.40 0.79 Runny itchy stuffy nose 0.018 3 2.75 0.67 4 2.66 0.84 1 2.87 1.63 2 1.63 1.30 Skin rash 0.051 3 1.60 0.82 4 1.93 1.30 1 3.13 1.73 Redness of skin where a cat has 2 2.87 1.51 0.001 scratched, licked or bitten 3 2.53 1.30 4 2.40 1.18 1 3.33 1.23 2 3.33 1.11 Sneezing 0.002 3 2.53 1.25 4 2.53 1.06 1 2.87 1.34 2 2.73 1.56 Scratchy throat 0.057 3 2.00 1.00 4 2.07 1.88 1 2.40 1.90 2 2.47 1.81 Wheezing 0.059 3 2.70 1.57 4 1.90 1.67

Table 4.10 shows that the p-values for the frequency of symptoms experienced by the participants as measured in the control group were less than 0.05 for all symptoms except for “skin rash” with a p-value of greater than 0.05, therefore all results were statistically significant with the exception of “skin rash”, “scratchy throat” and “wheezing”.

84 4.3.15 Duration of the symptom red itchy eyes

Graph 4.27 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “red itchy eyes” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.27 Duration of red itchy eyes

In the experimental group, the duration of the symptom “red itchy eyes” was almost equally distributed around the 5 scales of rating at the end of week 1, however at the end of week 4 the symptom duration was between 0-10mins for the majority of the participants, indicating a much shorter duration of this symptom, Graph 4.27. In the control group the rating of the symptom “red itchy eyes” was also almost equally distributed around the 5 scales recorded at the end of week 1, at the end of week 4 the rating was slightly improved scoring between 0-10mins or between 11-20mins, for most participants.

85 4.3.16 Duration of the symptom runny itchy stuffy nose Graph 4.28 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “runny itchy stuffy nose” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.28 Duration of runny itchy stuffy nose

Graph 4.28 illustrates that in the experimental group the duration of the symptom “runny itchy stuffy nose” was either between 0-10mins or 41-50mins for most (8) of the participants at the end of week 1, however at the end of week 4 the symptom was rated as being between 0-10mins by the majority (10) of the participants, indicating a noticeable improvement. In the control group the rating of the symptom “runny itchy stuffy nose” was rated as being either between 21- 30mins or 41-50mins, by 9 participants, at the end of week 1, and between either 11-20mins or 21-30mins by 10 participants, at the end of week 4.

86 4.3.17 Duration of the symptom skin rash Graph 4.29 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “skin rash” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.29 Duration of the presentation of a skin rash The duration of the symptom “skin rash”, in the experimental group, was distributed around the 5 scales of rating at the end of week 1; however at the end of week 4 the symptom was rated as being between 0-10mins by most (10) of the participants, showing a marked reduction in the duration of this symptom, Graph 4.29. In the control group the rating of the symptom “skin rash” remained almost unchanged from week 1 to week 4 with most participants rating this symptom between 0-10mins.

87 4.3.18 Duration of the symptom redness of skin where a cat has scratched, licked or bitten Graph 4.30 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “redness of skin where a cat has scratched, licked or bitten” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.30 Duration of the symptom redness of the skin where a cat has scratched, licked or bitten Graph 4.30 indicates that in the experimental group the duration of the symptom “redness of skin where a cat has scratched, licked or bitten” displays a mixed pattern of rating at the end of week 1, however at the end of week 4 the symptom duration was rated between 0-10mins by 13 participants, showing a remarkable improvement from week 1 to week 4. In the control group the rating of the symptom “redness of skin where a cat has scratched, licked or bitten” also displayed a mixed pattern at the end of week 1, and at the end of week 4, the pattern continued without the scale of 31-40mins.

88 4.3.19 Duration of the symptom sneezing Graph 4.31 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “sneezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.31 Duration of sneezing Graph 4.31 illustrates that in the experimental group the duration of the symptom “sneezing” displays a mixed pattern of rating at the end of week 1, however at the end of week 4 the symptom duration was rated between 0-10mins by the majority (12) of the participants, showing a marked improvement from week 1 to week 4. In the control group the rating of the symptom “sneezing” remained unchanged from the end of week 1 to the end of week 4 for majority of participants.

89 4.3.20 Duration of the symptom scratchy throat Graph 4.32 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “scratchy throat” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.32 Duration of scratchy throat Graph 4.32 illustrates that in the experimental group the duration of the symptom “scratchy throat” displayed a mixed pattern of rating at the end of week 1, however at the end of week 4 the symptom duration was rated between 0-10mins for 14 of the 15 participants, showing a remarkable improvement from week 1 to week 4. In the control group the rating of the symptom “scratchy throat” was either 0-10mins or 21-30mins for all the participants at the end of week 1, however, at the end of week 4 some participants shifted their duration of symptom to 11-20mins.

90 4.3.21 Duration of the symptom wheezing Graph 4.33 depicts the group of participants that were given Cat hair 9cH and Histaminum 9cH (experimental group) as well as the group of participants given the placebo (control group). This graph displays the duration of “wheezing” rated by each participant at the end of week 1, week 2, week 3 and week 4.

Graph 4.33 Duration of wheezing In both experimental group and control group, the duration of the symptom “wheezing” showed a mixed pattern of rating at the end of week 1, however at the end of week 4 the symptom duration was rated as being between 0-10mins for 12 of the 15 participants in the experimental group and 10 of the 15 participants in the control group, Graph 4.33. These shows a marked improvement in the reduction of the duration time for the symptom “wheezing” experienced by participants in the experimental group and not in the control group respectively.

91 Table 4.11 Comparison of the duration of symptoms across the weeks of study in the experimental group Symptoms Week Mean SD P-value

1 2.61 1.92 2 1.70 1.27 Red itchy eyes 0.009 3 1.77 0.74 4 1.27 0.46 1 3.00 1.67 2 2.00 1.35 Runny itchy stuffy nose 0.004 3 1.70 0.99 4 1.83 0.49 1 2.93 1.67 2 2.07 1.44 Skin rash 0.000 3 1.67 1.045 4 1.13 0.35 1 2.67 1.63 Redness of skin where a cat has 2 2.20 1.32 0.001 scratched, licked or bitten 3 2.07 1.39 4 1.13 0.35 1 2.27 1.44 2 1.93 1.44 Sneezing 0.006 3 1.33 0.62 4 1.20 0.41 1 2.27 1.28 2 1.73 1.16 Scratchy throat 0.000 3 1.33 0.82 4 1.07 0.26 1 2.13 1.81 2 1.67 1.44 Wheezing 0.041 3 1.80 0.91 4 1.27 0.71 Table 4.11 and 4.12 compared the duration of all symptoms across the 4 weeks as measured in the experimental and control group respectively

Table 4.11 shows that all the p-values for the duration of symptoms experienced by the participants as measured in the experimental group were less than 0,05 which is statistically

92 significant, therefore it can deduced that participants had an improvement in the duration of all symptoms experienced from the end of week 1 to the end of week 4.

93 Table 4.12 Comparison of the duration of symptoms across the weeks of study in the control group Symptoms Week Mean SD P-value

1 2.93 1.66 2 2.56 1.71 Red itchy eyes 0.018 3 2.61 1.56 4 2.45 1.33 1 3.47 1.36 2 3.07 1.28 Runny itchy stuffy nose 0.000 3 2.67 1.18 4 2.21 0.89 1 1.93 1.44 2 1.60 1.18 Skin rash 0.039 3 1.47 0.92 4 1.36 0.84 1 2.87 1.73 Redness of skin where a cat 2 2.33 1.50 0.001 has scratched, licked or bitten 3 2.20 1.32 4 2.14 1.23 1 2.27 2.55 2 2.07 1.44 Sneezing 0.231 3 1.98 1.19 4 1.63 1.20 1 1.40 1.06 2 1.60 1.06 Scratchy throat 0.560 3 1.33 0.98 4 1.36 0.84 1 2.47 2.67 2 1.89 1.66 Wheezing 0.349 3 1.67 2.67 4 1.31 1.54

Table 4.12 shows that in the control group the p-valves for the duration of symptoms “sneezing”, “scratchy throat” and “wheezing” were greater than 0,05 and are therefore not

94 statistically significant. The p-values for the rest of the symptoms were less than 0,05 therefore statistically significant.

95 5. DISCUSSION 5.1 Introduction During the study the results were obtained regarding change in the wheal diameter, flare reaction and the degree of itchiness from the skin prick test, and data was obtained from each participant’s symptom score card for both the experimental and control groups. The positive control and cat allergen skin prick test results were compared, across the three criteria of measurement. The symptom score card rated the severity, frequency and duration of several symptoms which are the most commonly experienced by cat allergy sufferers.

5.2 Skin prick test Each participant required a positive skin prick test for the cat allergen in order to have qualified to participate in this study. The skin prick test was conducted at the beginning of the study at week 1 and at the completion of the study week 4. The results for both the positive control and cat allergen was measured and compared across the three criteria i.e. wheal diameter, flare reaction and degree of itchiness to determine whether the homoeopathic complex of Histaminum 9cH and Cat Hair 9cH had a desensitising effect.

5.3 Symptom score card Each participant in both the experimental and control groups were given a symptom score card to complete at the end of each week for the four week study (Appendix F). This score card measured the severity, frequency and duration of the following symptoms i.e. red itchy eyes, runny itchy stuffy nose, skin rash, redness of skin where a cat has scratched, licked or bitten, sneezing, scratchy throat and wheezing. This score card served as an additional tool in order to measure if the participants noted an improvement in their symptoms over the four week study period.

5.4 Participant compliance The study was conducted outside of a clinical setting and therefore participant compliance was difficult to asses. There is no way to gauge whether allergen exposure remained constant or not during the course of the study. There is a risk that participants did not fill in their symptom score cards honestly and accurately, as each participant knew the researcher personally and therefore irrespectively of whether they were in the experimental or control group rated their symptoms as improving feeling that they were in some way not letting the researcher down. Participants were asked not to make use of any conventionally medications for allergies during the course of this study; however we cannot definitively say that participants complied with this request. The

96 researcher’s medication administration stated that each participant had to take two tablets twice daily for the four weeks, however there is no way to assess if this was upheld and that participants did not forget to take their medication as directed.

5.5 Participant subjectivity One of the tools used to assess whether participants were improving across the four week study was by means of a symptom score card. The symptom score is a subjective tool and is dependant on each of the individuals personal interpretation. Therefore is a discrepancy between what participants considered the severity, frequency and duration of a symptom to be and what they consider to be a significant improvement. Participants where explained at the beginning of the study that they would either be receiving the homoeopathic complex of Histaminum 9cH and Cat Hair 9cH or the placebo, because of knowing they stood a 50% chance of receive the placebo instead of the actually homoeopathic complex this could have influenced the participants mindset, and in turn affecting their possible outcome.

5.6 Skin prick test results (positive control) The results recorded for the skin prick test shows that there was a significant change as measured in the experimental group in the wheal diameter, flare reaction and degree of itchiness between the test conducted at week 1 and compared to the test conducted at week 4 (Graphs 4.1, 4.3 and 4.5). This result can be due to the Histaminum 9cH in the homoeopathic complex being researched, as histamine is used during the positive control skin prick test, therefore the remedy Histaminum 9cH reduces the amount of histamine during an allergic reaction. All the results obtained for the skin prick test positive control as measured in the experimental group were statistically significant (Table 4.2).

In the control group the results recorded for the skin prick test positive control shows that the wheal diameter, flare reaction and degree of itchiness showed a mixed pattern of increase, decrease, unchanged and status quo (Graphs 4.2, 4.4 and 4.6). The results were not statistically significant for the wheal diameter and flare reaction, however, the degree of itchiness were statistically significant (Table 4.3).

When comparing the results from the experimental group to control group it can be concluded that the participants in the experimental group had a much more significant outcome opposed to those in the experimental group (Table 4.1). 5.7 Skin prick test results (Cat allergens)

97 The results recorded for the skin prick test measured for the cat allergen shows that the wheal diameter, flare reaction and degree of itchiness decreased significantly in the experimental group (Graphs 4.7, 4.9 and 4.11). Therefore we can conclude that the homoeopathic complex of Cat Hair 9cH and Histaminum 9cH had a desensitizing effect on the participants in the experimental group. All the results measured for the cat allergen as in the experimental group were statistically significant (Table 4.5).

In the control group the results for the skin prick test measured for cat allergens shows that the wheal diameter, flare reaction and degree of itchiness had a mixed pattern of increased, decreased, unchanged and status quo (Graphs 4.8, 4.10 and 4.12). All the results measured for the cat allergens as in the control group were not statistically significant (Table 4.6).

When comparing the results from experimental group to control group it can be concluded that the participants in the experimental group had a greater significant outcome opposed to those in the control group (Table 4.4).

5.8 Severity of symptoms The severity of the following symptoms was rated by each participant at the end of each week of the four week study: • Red itchy eyes • Runny itchy stuffy nose • Skin rash • Redness of the skin where a cat has scratched, licked or bitten • Sneezing • Scratchy throat • Wheezing

In the experimental group it can be observed that most of the participants had a significant decrease in the severity of their symptoms over the four week period of the study (Graphs 4.13- 4.19). All the results measured for the severity of symptoms in the experimental group are statistically significant (Table 4.7). Therefore we can conclude that the homoeopathic complex of Cat Hair 9cH and Histaminum 9cH reduced the severity of symptoms experienced by participants in the experimental group.

98 In the control group it can be observed that most of the participants in the severity of the symptoms showed a mixed pattern of unchanged, mild improvement or fairly severe (Graphs 4.13-4.19). In the control group the severity of symptoms were not statistically significant, except for “redness of the skin where a cat has scratched, licked or bitten” were statistically significant (Table 4.8).

5.9 Frequency of symptoms The frequency of the following symptoms was rated by each participant at the end of each week of the four week study: • Red itchy eyes • Runny itchy stuffy nose • Skin rash • Redness of the skin where a cat has scratched, licked or bitten • Sneezing • Scratchy throat • Wheezing

In the experimental group it can be observed that majority of the participants had a slight improvement in the frequency of the above mentioned symptoms over the four week period of the study, with most of the participants rated their symptom frequency as “sometimes” (Graph 4.20-4.26). All the results obtained for the frequency of symptoms as measured in the experimental group were all statistically significant (Table 4.9). Therefore we can conclude that the homoeopathic complex of Cat Hair 9cH and Histaminum 9cH decreased the frequency of symptoms experienced by participants in the experimental group.

In the control group it can be observed that the frequency of symptoms had a slight improvement from week 1 to week 4 (Graphs 4.20-4.26). All the results were statistically significant except for the symptom “skin rash”, “scratch throat” and “wheezing” (Table 4.10).

5.10 Duration of symptoms The duration of the following symptoms were rated by each participant at the end of each week of the four week study: • Red itchy eyes • Runny itchy stuffy nose • Skin rash 99 • Redness of the skin where a cat scratched, licked or bitten • Sneezing • Scratchy throat • Wheezing

In the experimental group it can be seen that majority of the participants had a reduction in the duration time of the above mentioned symptoms measured across the 4 weeks of the study. It can be noted that on average the duration time for the symptoms experienced by participants in the experimental group was between 0-10mins at the end of the four weeks compared to the beginning were the duration time was much higher (Graphs 4.27- 4.33). The results obtained for the duration of symptoms as measured in the experimental group were all statistically significant (Table 4.11). We can from this deduce that the homoeopathic complex of Histaminum 9cH and Cat Saliva 9cH reduced the duration of symptoms experienced by participants in the experimental group.

In the control group majority of the participants observed a reduction in the duration time of the symptoms they experienced, however the improvement was not as marked as those seen in the experimental group (Graphs 4.27- 4.33). The results obtained for the duration of symptoms as measured in the control group were all statistically significant except for the symptoms “sneezing”, “scratchy throat” and “wheezing” (Table 4.12).

100 6. CONCLUSION AND RECOMMENDATION

6.1 Conclusion This research study was conducted to determine the efficacy of Histaminum 9cH and Cat Hair 9cH in treating the symptoms of cat allergy by means of a skin prick test and symptom score card. The study period spanned over four weeks.

It was found that the complex of Histaminum 9cH and Cat Hair 9cH prepared according to homoeopathic and isopathic principles had a desensitizing effect on the participants (experimental group) and therefore there was an overall improvement. The participants in both the experimental and control group reported no adverse effects during the treatment.

There is significant data to support the hypothesis that Histaminum 9cH and Cat Hair 9cH did have an overall ameliorating effect on the symptoms experienced by cat allergy sufferers. Therefore this study demonstrates that the complex Histaminum 9cH and Cat Hair 9cH is an effective treatment for cat allergy and therefore it can be recommended, as safe and cost effective alternative to allopathic medicine which often produces adverse effects.

6.2 Recommendations The following recommendations need to be considered when performing a study of this nature:

• During the conduction of the skin prick tests, it would be recommended that the researcher test for a wider variety of allergens to determine whether symptoms experienced by participants are not caused or maintained by other allergens.

• Further studies should be conducted to verify whether the findings of this study are conclusive, employing Histaminum and Cat Hair prepared in other potencies i.e. lower or higher e.g. 6cH or 30Ch

• Administering the remedies less frequently and over a long period e.g. two tablets to be taken three times a week and for three months, this would be the ideal method to desensitize an individual properly to a specific allergen.

101 • Further studies could be conducted on multiple allergens. The researcher can determine the top five allergens that most individuals are allergic to and produce a complex of these allergens and research its effectiveness.

• Including more objective measures in the study to be able to assess efficacy more precisely e.g. RAST test, allergen specific blood test.

• Research should be conducted on larger sample groups which will reflect much more accurately on the statistical value of the study.

• Research should be conducted with a much wider age variety i.e. individuals younger than 18 and those older than 45 as allergies affected anyone and age does not play a role.

• The symptom score card used in this research study should be revised and maybe participants should be asked to rate their own symptoms experienced and on a daily basis then compared to once a week.

• Because the use of a symptom score card is subjective it would be advised that future studies into similar conditions should use a better method for rating an individuals symptoms e.g. instead of participants completing a score card the objective test like blood test or skin prick test should be conducted more frequently over the study period. As to reduce the element of incorrect data beginning obtained.

• A study could be conducted on the ability to desensitise an individual to certain allergens by the use of homoeopathic injectables rather than oral medication, this way the researcher can reduce the degree of error if the participants forgets to take the medication. Therefore streamlining the research process.

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Smith, J. (2010) Statkon, Personal discussion, 26 January, Chisel house, RAU, UJ, (+27 011 559-4407), (email: [email protected])

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Staines N, Brostoff J, James K (1993) Introducing Immunology. Mosby, London.pp78-80, 101- 102

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Underwood, J.C.E (2004) General and Systematic Pathology, Fourth Edition, Edinburgh London, pp 207-209

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Zull D (1999) Principles and Practice of Emergency Medicine, 4th edition. Wilkins & Wilkins, London, pp32-33, 90-92

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APPENDIX A

Letter of permission

To whom it may concern

I Stefan Groeneweld, owner of the Home of Healthy Living health shop give Dalen Alexander student number (802029124) permission to advertise for the study he will be conducting, at my pharmacy.

Kind Regards Stefan Groeneweld B.Pharm (TUT)

CONTACT DETAILS: 011 814-8170 OR 082 569 3462

DATE: / /2010

SIGNATURE: ______

Pharmacy stamp

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APPENDIX B CAT ALLERGIES

Do you experience any of the following symptoms? Sneezing, Itchy throat, Red itchy eyes, Skin rash, Runny itchy nose when in the presence of a cat

If you are between the ages of 18 and 45 years, male or female and suffer from symptoms of cat allergies, YOU may qualify to participate in a Research Study being conducted through the Department of Homeopathy on:

The efficacy of Cat hair 9cH and Histaminum 9cH in treating the symptoms of cat allergy

Ethical Clearance Number: AEC41/02-2010

Participation is voluntary and strictly confidential Consultations and treatment are FREE OF CHARGE

For more information contact:

108 Dalen Alexander 082 823 6465

APPENDIX C

PARTICIPANT INFORMATION AND CONSENT FORM

Dear Prospective Participant

My name is Dalen Alexander. I am a final year homoeopathic student at the University of Johannesburg. I am inviting you to participate in this research study. I am undertaking this research study into the homoeopathic treatment in respect of cat allergy for my M. Tech Homoeopathy qualification.

The purpose of this study is to determine the efficacy of a homoeopathic complex of Cat hair 9cH and Histaminum 9cH in treating the symptoms of cat allergy.

The inclusion and exclusion criteria to participate in this study are as follows:

Inclusion criteria • Male and female between the ages of 18 and 45 • Participants should have been living with a cat for a period of six months or more • Participants must suffer from allergy-like symptoms (i.e. sneezing, red itchy eyes, skin rash, runny itchy stuffy nose, scratchy throat, wheezing and redness of the skin where a cat has scratched, licked or bitten) when in the presence of a cat or when exposed to cat dander.

Exclusion criteria • Individuals that are currently being treated with allopathic medicines for allergies i.e. corticosteroids, antihistamines and decongestants • Pregnant or lactating women • Individuals that have been immunized against pet allergies • Immuno-compromised individuals • Participants on conventional, homeopathic or herbal medication for allergies.

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The research aims to assess your cat allergy symptoms for a period of four weeks. You are requested to carefully monitor and complete a score card rating the severity, frequency and duration of your symptoms every week during the study period. The treatment will be free, and you are requested to attend three consultations for the four weeks of the study. The consultations will take place at the University of Johannesburg at the Doornfontein Homoeopathic health centre.

If you agree to participate in the study, you will be randomly allocated to one of two groups, either the experimental or the placebo group. The experimental group will receive the homoeopathic medication comprised of Cat hair 9cH and Histaminum 9cH and the placebo group will receive unmedicated tablets. The medication will be given at the first and second consultations and will be labeled and coded in such a way that neither you nor I will know who receives the treatment and who receives the placebo.

Once you have signed this consent form and have agreed to participate in this research study I will issue you with an Ampath coding form which will contain the information needed to undergo a skin prick test specifically for cat allergies via Ampath laboratories (any Ampath lab which allows for your convenience). At the back of the coding form is a list of all the Ampath labs in Johannesburg that will conduct the skin prick test for you. There may be slight discomfort experienced on the area being tested during the conduction of the skin prick test, however this should subside in a matter of seconds. In rare cases generalized anaphylaxis may occur which is when there is swelling of the throat coupled with tightness of the chest within thirty minutes of being exposed to an allergen trigger. It is, however, unlikely that you will experience this as you will only be receiving a very small amount of the cat allergen and therefore your symptoms will only be localized to the area being exposed to the allergen. Ampath laboratories are equipped to handle any possible adverse reactions and have the medication on site to treat anaphylaxis if necessary.

If the results from the skin prick test are positive you will then be asked to attend a first consultation with myself, which will entail a detailed explanation of the study, a brief medical history, vital signs, and a physical examination (of ears, nose throat and eyes). Physical examinations will be conducted at each consultation in order to assess your symptoms and note any changes that may occur over the four week period. At the end of the first consultation you

110 will receive a 25mL bottle of medication, and are instructed to take two tablets in the morning and two tablets in the evening for the duration of the study period.

The second consultation will take place two weeks later together with a brief follow-up, physical examination and appropriate medication will be given. The final consultation will take place in the fourth and final week. Prior to this consultation you will be requested to undergo a final skin prick test to establish if any change has been noted. The final consultation will comprise of a brief follow-up, a physical examination and collection of the score cards.

As a participant of this study you are kindly asked not to make use of any homoeopathic treatment other than that issued to you by the researcher. You are also requested not to make use of any herbal or nutritional supplementation for allergies during the study. Should the use of conventional medication be required please inform the researcher.

Your participation in the study is voluntary, and you are free to refuse treatment or withdraw from the study at any time. All information submitted by you will be confidential. Measures in place to ensure this include keeping your file in a secure cabinet and replacing your name with case numbers. Contact details of the researcher and supervisor involved in the study will be made available to you. There are no anticipated risks in this study. If you experience any adverse effects from the medication please discontinue the medication immediately and contact the researcher as soon as possible. A signed copy of this form will be given to you.

Your participation in this study will be much appreciated and will contribute to improving the homoeopathic treatment of cat allergy. The results of this study will be available to you on request.

Thank you.

I, the volunteer, have been fully informed of the procedure of the study, including the risks and benefits expected. In signing this consent form, I agree with the method of treatment and understand that I am free to withdraw my consent and discontinue with the study at any time. I understand that the researcher will answer any queries that I may have at any time.

Date: ______Signature: ______

111 I, the researcher, have fully explained the techniques and purpose of treatment used in this research. Any questions that arise from the participants will be answered to the best of my ability.

Date: ______Signature: ______

CONTACT DETAILS: Researcher: Dalen Alexander Supervisor: Dr Janice Pellow Cell no: 082 823 6465 Office no: 011 559 6828

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APPENDIX D

Skin Prick test results

Patient No. Bottle No.

Consultation One: Date: / /2010

1------2------3------4 mm mm mm mm

Wheal diameter scale

Result:______

1------2------3------4------5 Slight reaction Mild Moderate Fairly Severe Very Severe

Flare reaction scale

Result:______

1------2------3------4------5 Slight reaction Mild Moderate Fairly Severe Very Severe

Itchiness

Result:______

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Skin Prick test results

Consultation Three: Date: / /2010

1------2------3------4 mm mm mm mm

Wheal diameter scale

Result:______

1------2------3------4------5 Slight reaction Mild Moderate Fairly Severe Very Severe

Flare reaction scale

Result:______

1------2------3------4------5 Slight reaction Mild Moderate Fairly Severe Very Severe

Itchiness

Result:______

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APPENDIX E: CASE TAKING FORM

Patient name:______Ms/ Mrs / Mr

Date:______Gender:______

Age:______Patient no:______

DOB:______Bottle no:______

115 PRESENTING CASE:

EAR NOSE THROAT EYE EXAMINATION EXAMINATION EXAMINATION EXAMINATION

116 CURRENT MEDICATION / SUPPLEMENTATION

ADDITIONAL NOTES

APPENDIX F

SCORE CARD RATING THE SEVERITY, FREQUENCY AND DURATION OF SYMPTOMS

Patient No: ______Bottle No: ______

Week No: ______Date: / /2010

SEVERITY OF SYMPTOMS

117 1------2------3------4------5 Improved Mild Unchanged Fairly Very Severe Improvement Severe

SYMPTOMS SCORE Red itchy eyes Runny itchy stuffy nose Skin rash Redness of skin where a cat has scratched, licked or bitten you Sneezing Scratchy throat Wheezing

FREQUENCY OF SYMPTOMS

HOW OFTEN DO YOU EXPERIENCE THE FOLLOWING SYMPTOMS?

1------2------3------4------5 Never Rarely Sometimes Often Always

SYMPTOMS SCORE Red itchy eyes Runny itchy stuffy nose Skin rash Redness of skin where a cat has scratched, licked or bitten you Sneezing Scratchy throat Wheezing

DURATION OF SYMPTOMS

HOW LONG DO YOU EXPERIENCE THE FOLLOWING SYMPTOMS FOR?

1------2------3------4------5 0-10 min 11-20 min 21-30 min 31-40 min 41-50 min

SYMPTOMS SCORE Red itchy eyes Runny itchy stuffy nose Skin rash Redness of skin where a cat has

118 scratched, licked or bitten you Sneezing Scratchy throat Wheezing

APPENDIX G

INFORMATION LEAFLET: MEDICATION ADMINISTRATION

Presentation: 25mL amber glass bottle

Texture: small round, white tablets

Taste: sweetish

119 Dosage: take 2 tablets in the morning and 2 tablets at night

How to take the medication

• Transfer the required dose under the tongue; if you however transfer more than the needed dose please discard the excess. By replacing the excess back into the bottle you may contaminate the medication in the bottle.

• The medication should always be taken with a clean mouth, meaning the mouth should be free of food, drink, smoke, tobacco, toothpaste, mouthwash, breathe fresher at least 15 minutes before ingesting the medication.

• Medicine will be absorbed through the mucous membranes located in the mouth, therefore no water is required.

• Do not ingest or drink anything 15 minutes before or after taking the medication.

• Do not take these medicines at the same time with other medication that you may be on i.e. multivitamins; wait at least 30 minutes afterwards.

Storage instructions for medication

• Do not store medicines in direct sunlight; rather place it in a dark cardboard.

• Keep medicine bottle away from any radiation i.e. near electrical appliances e.g. above microwave etc.

APPENDIX H

One-Sample Kolmogorov-Smirnov Test Normal Most Extreme Differences Parameters(a,b) Kolmogorov- Asymp. Sig. N Negative Std. Smirnov Z (2-tailed) Mean Absolute Positive Deviation

Wheal diameter scale 30 6.20 1.349 .190 .110 -.190 1.041 .229 positive control week 1 Flare reaction scale 30 3.03 .765 .284 .284 -.249 1.556 .016 positive control week 1 Level of itchiness 30 4.03 1.098 .277 .189 -.277 1.519 .020

120 positive control week 1 Wheal diameter scale 30 4.97 1.650 .175 .159 -.175 .957 .319 positive control week 4 Flare reaction scale 30 2.50 1.009 .223 .223 -.157 1.223 .100 positive control week 4 Level of itchiness 30 2.43 1.006 .200 .200 -.180 1.095 .181 positive control week 4 a Test distribution is Normal. b Calculated from data.

APPENDIX I

One-Sample Kolmogorov-Smirnov Test Normal Most Extreme Differences Parameters(a,b) Kolmogorov- Asymp. Sig. N Negative Std. Smirnov Z (2-tailed) Mean Absolute Positive Deviation

Wheal diameter scale 30 5.47 2.013 .158 .158 -.110 .867 .439 cat skin prick week 1 Flare reaction scale cat 30 2.83 .986 .200 .168 -.200 1.098 .179 skin prick week 1 Level of itchiness cat 30 3.60 1.248 .182 .151 -.182 .997 .273 skin prick week 1 Wheal diameter scale 30 4.70 2.562 .113 .113 -.082 .620 .837 cat skin prick week 4 Flare reaction scale cat 30 2.37 1.066 .235 .235 -.137 1.285 .074 skin prick week 4 Level of itchiness cat 30 2.23 1.073 .219 .219 -.129 1.202 .111 skin prick week 4 a Test distribution is Normal. b Calculated from data.

APPENDIX J

One-Sample Kolmogorov-Smirnov Test

Kolmogorov- Asymp. Sig. (2- N Smirnov Z tailed)

Duration of symptoms-red itchy eyes week 1 30 .801 .543 Duration of symptoms-runny itchy stuffy nose week 1 30 1.008 .262 Duration of symptoms-skin rash week 1 30 1.349 .052 Duration of symptoms-redness of skin where a cat has scratched, 30 1.226 .099 licked or bitten week 1 Duration of symptoms-sneezing week 1 30 1.156 .138

121 Duration of symptoms-scratchy throat week 1 30 1.736 .005 Duration of symptoms-wheezing week 1 30 1.475 .026 Duration of symptoms-red itchy eyes week 2 30 1.628 .010 Duration of symptoms-runny itchy stuffy nose week 2 30 1.019 .250 Duration of symptoms-skin rash week 2 30 1.845 .002 Duration of symptoms-redness of skin where a cat has scratched, 30 1.201 .112 licked or bitten week 2 Duration of symptoms-sneezing week 2 30 1.608 .011 Duration of symptoms-scratchy throat week 2 30 1.619 .011 Duration of symptoms-wheezing week 2 30 1.559 .015 Duration of symptoms-red itchy eyes week 3 30 1.240 .092 Duration of symptoms-runny itchy stuffy nose week 3 30 1.433 .033 Duration of symptoms-skin rash week 3 30 2.119 .000 Duration of symptoms-redness of skin where a cat has scratched, 30 1.292 .071 licked or bitten week 3 Duration of symptoms-sneezing week 3 30 1.820 .003 Duration of symptoms-scratchy throat week 3 30 2.265 .000 Duration of symptoms-wheezing week 3 30 2.297 .000 Duration of symptoms-red itchy eyes week 4 29 1.784 .003 Duration of symptoms-runny itchy stuffy nose week 4 29 1.442 .031 Duration of symptoms-skin rash week 4 29 2.375 .000 Duration of symptoms-redness of skin where a cat has scratched, 29 2.072 .000 licked or bitten week 4 Duration of symptoms-sneezing week 4 29 1.882 .002 Duration of symptoms-scratchy throat week 4 29 2.097 .000 Duration of symptoms-wheezing week 4 29 2.380 .000 a Test distribution is Normal. b Calculated from data.

APPENDIX K

One-Sample Kolmogorov-Smirnov Test

Kolmogorov- Asymp. Sig. (2- N Smirnov Z tailed)

Frequency of symptoms-red itchy eyes week 1 30 1.235 .095 Frequency of symptoms-runny itchy stuffy nose week 1 30 1.227 .098 Frequency of symptoms-skin rash week 1 30 1.103 .176 Frequency of symptoms-redness of skin where a cat has scratched, 30 1.094 .183 licked or bitten week 1 Frequency of symptoms-sneezing week 1 30 1.210 .107

122 Frequency of symptoms-scratchy throat week 1 30 1.182 .122 Frequency of symptoms-wheezing week 1 30 1.077 .197 Frequency of symptoms-red itchy eyes week 2 30 1.632 .010 Frequency of symptoms-runny itchy stuffy nose week 2 30 1.385 .043 Frequency of symptoms-skin rash week 2 30 1.029 .240 Frequency of symptoms-redness of skin where a cat has scratched, 30 .999 .271 licked or bitten week 2 Frequency of symptoms-sneezing week 2 30 1.529 .019 Frequency of symptoms-scratchy throat week 2 30 1.350 .052 Frequency of symptoms-wheezing week 2 30 1.024 .246 Frequency of symptoms-red itchy eyes week 3 30 1.703 .006 Frequency of symptoms-runny itchy stuffy nose week 3 30 1.475 .026 Frequency of symptoms-skin rash week 3 30 1.355 .051 Frequency of symptoms-redness of skin where a cat has scratched, 30 1.137 .151 licked or bitten week 3 Frequency of symptoms-sneezing week 3 30 1.442 .031 Frequency of symptoms-scratchy throat week 3 30 1.118 .164 Frequency of symptoms-wheezing week 3 30 1.388 .042 Frequency of symptoms-red itchy eyes week 4 30 1.452 .029 Frequency of symptoms-runny itchy stuffy nose week 4 30 1.363 .049 Frequency of symptoms-skin rash week 4 30 1.138 .150 Frequency of symptoms-redness of skin where a cat has scratched, 30 .963 .312 licked or bitten week 4 Frequency of symptoms-sneezing week 4 30 1.175 .126 Frequency of symptoms-scratchy throat week 4 30 1.268 .080 Frequency of symptoms-wheezing week 4 30 1.272 .079 a Test distribution is Normal. b Calculated from data.

APPENDIX L

One-Sample Kolmogorov-Smirnov Test

Kolmogorov- Asymp. Sig. (2- N Smirnov Z tailed)

Severity of symptoms-red itchy eyes week 1 30 1.179 .124 Severity of symptoms-runny itchy stuffy nose week 1 30 1.017 .253 Severity of symptoms-skin rash week 1 30 .941 .339 Severity of symptoms-redness of skin where a cat has scratched, 30 1.343 .054 licked or bitten week 1 Severity of symptoms-sneezing week 1 30 1.018 .251

123 Severity of symptoms-scratchy throat week 1 30 .868 .438 Severity of symptoms-wheezing week 1 30 1.321 .061 Severity of symptoms-red itchy eyes week 2 30 1.170 .129 Severity of symptoms-runny itchy stuffy nose week 2 30 1.160 .136 Severity of symptoms-skin rash week 2 30 1.101 .177 Severity of symptoms-redness of skin where a cat has scratched, 30 1.097 .180 licked or bitten week 2 Severity of symptoms-sneezing week 2 30 1.110 .170 Severity of symptoms-scratchy throat week 2 30 1.374 .046 Severity of symptoms-wheezing week 2 30 .928 .355 Severity of symptoms-red itchy eyes week 3 30 1.229 .097 Severity of symptoms-runny itchy stuffy nose week 3 30 1.452 .029 Severity of symptoms-skin rash week 3 30 1.257 .085 Severity of symptoms-redness of skin where a cat has scratched, 30 1.095 .182 licked or bitten week 3 Severity of symptoms-sneezing week 3 30 1.707 .006 Severity of symptoms-scratchy throat week 3 30 1.368 .047 Severity of symptoms-wheezing week 3 30 1.261 .083 Severity of symptoms-red itchy eyes week 4 30 1.808 .003 Severity of symptoms-runny itchy stuffy nose week 4 30 1.174 .127 Severity of symptoms-skin rash week 4 30 1.723 .005 Severity of symptoms-redness of skin where a cat has scratched, 30 1.671 .007 licked or bitten week 4 Severity of symptoms-sneezing week 4 30 1.446 .031 Severity of symptoms-scratchy throat week 4 30 1.123 .160 Severity of symptoms-wheezing week 4 30 1.419 .036 a Test distribution is Normal. b Calculated from data.

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