A Comparison of Magnetis Polus Australis 30Ch to 2M on the Symptoms of Onychocryptosis of the Hallux

A comparison of Magnetis Polus Australis 30cH to 2M on the symptoms of Onychocryptosis of the Hallux

A Dissertation presented to the Faculty of Health Sciences, University of Johannesburg, as partial fulfilment for the Masters degree in Technology: Homoeopathy

by

Katri Kruger (Student number: 802001997)

Supervisor: ------Dr E. M. Solomon Date HD. ND. DO. (LIND) BA (UNISA)

Co-supervisor: ------Dr B. Zipfel Date NHD POD, NHDPS ED, BSC HONOURS, PHD

Johannesburg, 2008 Declaration

I declare that this is my own work. This dissertation, to my knowledge, has never before been submitted for any diploma, degree or examination at this institution, or any other. This dissertation is being presented to the University of Johannesburg for the partial fulfilment of the Masters degree of Technology in the programme Homeopathy.

Ethical Clearance No: 52/06 passed 13 October 2006 by the Higher Degrees and Ethical Committees of the University of Johannesburg.

______

(Signature of student)

______

(Date)

ii Abstract

Onychocryptosis is the diagnostic term for an ingrown toenail. It is a common and painful condition that occurs either when the nail grows into the skin on the lateral or medial side of the toe, or if the skin on the side of the toenail grows over the edge of the nail.

Magnetis Polus Australis is a homoeopathic remedy recommended in the Homoeopathic Materia Medica specifically for the treatment of onychocryptosis. In previous studies, Rohl (2003) used the remedy Magnetis Polus Australis in a 7cH and a 30cH potency whereas Khan (2004) used it in a 200cH and a 1M potency. Their studies showed promising results but had sample sizes too small for definitive conclusions. In their respective studies, they recommend using Magnetis Polus Australis 2M in a single dose.

The present study was aimed at determining the efficacy of Magnetis Polus Australis in treating symptoms of onychocryptosis such as pain in the big toe (hallux), tenderness to pressure, infection, erythema and oedema of the lateral nail fold in two different potencies, namely 30cH in repeated doses and 2M in a single dose.

This study was a six week double-blind, placebo controlled study involving forty participants. Pre-diagnosed onychocryptosis participants were recruited and randomly divided into three groups. The first experimental group received a once-off dose of Magnetis Polus Australis 2M powder and a 50ml bottle of placebo liquid. The second experimental group received a once-off placebo powder and a 50ml bottle of 30cH Magnetis Polus Australis liquid. The control group received a once-off placebo powder and a 50ml bottle of placebo liquid. All powders were taken immediately in the presence of the researcher, whereas the 50ml liquids were taken home to be taken as ten drops under the tongue twice daily for the total six week study. After the initial consultation, there were two more follow-up consultations at three weekly intervals. At each follow- up consultation all symptoms of the condition were observed, namely pain in the big toe (hallux), tenderness to pressure, infection, erythema and oedema of the lateral nail fold, and were recorded in respect of each participant (Appendix D and E).

iii At the end of the clinical trial all the recorded data were analyzed and compared using Fisher Exact Tests (FET) according to the symptoms of onychocryptosis. Results showed no significant difference between the experimental and control group and therefore did not confirm the efficacy of Magnetis Polus Australis as a specific treatment for the symptoms of onychocryptosis. The only finding was that the control had a significant improvement in pain as opposed to the experimental group. A possible explanation is that the experimental groups, especially the 2M group, demonstrated a homoeopathic aggravation. Further research on this topic is required with a larger sample group over a longer time period.

iv Acknowledgements

I would like to thank each of the following people for their invaluable contribution to my study:

To my supervisor, Dr Elizabeth Solomon and my co-supervisor, Dr Bernhard Zipfel – thank you for the time and effort you have put into this study. Thank you to Ameesha for preparing the 2M potency and randomising the trial and to Natura Laboratories for preparing the 30cH potency – without your help, the study would not exist. A big thank you goes to Prof H.S. Schoeman – for all the hours of statistical analysis, and for teaching me about statistics. To my dad – thank you for loving me and supporting me, always. To my sister Christa – I want to acknowledge our special bond, because without you, my life would be sadly incomplete. To my shatzi – without your unconditional love, support and encouragement throughout the years, it would have been a very difficult, lonely and boring road to travel. And lastly to my mother, who holds a very special place in my heart. You have always stood by me, and supported me, and helped me make it through the best and worst times of my life. I admire you for your accomplishments in your life and I can only strive to be more like you. Thank you for believing in me when I did not believe in myself, and for being my strength when I had none. You are a truly remarkable woman!

v Table of contents

Declaration ii Abstract iii Acknowledgements v Table of contents vi List of appendices ix List of tables ix List of figures xii

Chapter One – Introduction 1 1.1 Background and contextualisation of the research problem 1 1.2 Aim of the study 1 1.3 Objectives 2 1.4 Hypothesis and null hypothesis 2 1.5 Advantages of this research 2 1.6 Structure of the study 3

Chapter Two – Literature review 4 2.1 The normal toenail 4 2.2 Onychocryptosis 5 2.2.1 Definition 5 2.2.2 Clinical features and diagnosis of onychocryptosis 6 2.2.3 Differential diagnoses of onychocryptosis 6 2.2.4 Causes and predisposing factors of onychocryptosis 8 2.2.5 Pathophysiology of onychocryptosis 9 2.2.6 Types and stages of onychocryptosis 9 2.2.7 Treatment for onychocryptosis 10 2.2.7.1 Surgical treatment 11 2.2.7.2 Non-surgical treatment 13

vi 2.3 Homoeopathy 15 2.3.1 Laws and principles governing the practice of Homoeopathy 15 2.3.1.1 The Law of Similars 16 2.3.1.2 The Single Remedy 16 2.3.1.3 The Minimum Dose 17 2.3.1.4 Potentization 17 2.3.1.5 Homoeopathic aggravation 17 2.3.2 Magnetis Polus Australis in the treatment of onychocryptosis 18 2.4 Magnet therapy 19 2.4.1 History of magnet therapy 20 2.4.2 Function of magnets 21 2.4.3 Preparation of Magnetis Polus Australis 21 2.5 Summary 22

Chapter Three – Materials and methods 23 3.1 Research sample – recruitment of participants / sample selection 23 3.2 Delimitations - inclusion criteria 23 3.3 Delimitations - exclusion criteria 23 3.4 Purchasing and preparation of medication 24 3.5 Administration and randomisation of medication 24 3.6 Research and trial procedure – control and experimental groups 25 3.7 Data collection and analysis 26 3.8 Ethical considerations 27 3.9 Summary 27

Chapter Four – Research results 28 4.1 Gender distribution 28 4.2 Age distribution 29 4.3 Duration of time that participants have been afflicted by onychocryptosis 30 4.4 Number of participants who have previously had treatment for onychocryptosis 31

vii 4.5 Right foot versus Left foot versus Both feet affected by onychocryptosis 32 4.6 Number of ingrown toenails per participant per foot 33 4.7 Side of the hallux affected by onychocryptosis – medial versus lateral 35 4.8 Comparison regarding the percentage improvement in pain 36 4.9 Comparison regarding the percentage improvement in tenderness to pressure 37 4.10 Comparison regarding the percentage improvement in swelling 38 4.11 Comparison regarding the percentage improvement in redness 40 4.12 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails 41 4.13 Percentage of participant compliance regarding taking the medication 42 4.14 Percentage of participant compliance regarding the rules and regulations of the study 44 4.15 Percentage of participant’s perception that the study was beneficial 45 4.16 Summary 46

Chapter Five – Interpretation and discussion of findings 47 5.1 Introduction 47 5.2 Gender 48 5.3 Age 49 5.4 The 2M versus the 30cH potency overall average from zero to six weeks 49 5.5 Limitations of the study 52 5.6 Summary 55

Chapter Six – Concluding remarks and recommendations 56 6.1 Conclusions 56 6.2 Recommendations 57

References 58

viii List of appendices 64 Appendix A – Participant information sheet 64 Appendix B – Consent form 67 Appendix C – Participant profile 68 Appendix D – Initial visit and second follow up questionnaire 69 Appendix E – Final follow up questionnaire 70 Appendix F – Calendar 71 Appendix G – Control numbers corresponding to potencies 72 Appendix H – Grading severity of symptoms of onychocryptosis per participant 74

List of tables Table 4.1 Overall gender distribution in all three groups of the study 28 Table 4.2 Gender distribution in 2M potency group 28 Table 4.3 Gender distribution in 30cH potency group 28 Table 4.4 Gender distribution in the placebo group 29 Table 4.5 Overall age distribution in the three groups 29 Table 4.6 Age distribution in the 2M potency group 29 Table 4.7 Age distribution in the 30cH potency group 29 Table 4.8 Age distribution in the placebo group 29 Table 4.9 Overall duration of time that participants have been afflicted by onychocryptosis in all three groups 30 Table 4.10 Duration of time that participants have been afflicted by onychocryptosis in 2M potency group 30 Table 4.11 Duration of time that participants have been afflicted by onychocryptosis in 30cH potency group 30 Table 4.12 Duration of time that participants have been afflicted by onychocryptosis in the placebo group 31 Table 4.13 Overall number of participants who have previously had treatment for onychocryptosis in all three groups 31 Table 4.14 Number of participants who have previously had treatment in the 2M potency group 31

ix Table 4.15 Number of participants who have previously had treatment in the 30cH potency group 32 Table 4.16 Number of participants who have previously had treatment in the placebo group 32 Table 4.17 Overall results for feet affected by onychocryptosis in all three groups 32 Table 4.18 Results for feet affected by onychocryptosis in the 2M potency group 32 Table 4.19 Results for feet affected by onychocryptosis in the 30cH potency group 33 Table 4.20 Results for feet affected by onychocryptosis in the placebo group 33 Table 4.21 Overall number of ingrown toenails per foot in the three groups 33 Table 4.22 Number of ingrown toenails per foot in the 2M potency group 34 Table 4.23 Number of ingrown toenails per foot in the 30cH potency group 34 Table 4.24 Number of ingrown toenails per foot in the placebo group 35 Table 4.25 Side of the hallux affected in all three groups 35 Table 4.26 Side of the hallux affected in the 2M potency group 35 Table 4.27 Side of the hallux affected in the 30cH group 36 Table 4.28 Side of the hallux affected in the placebo group 36 Table 4.29 Percentage improvement in pain from week 0 - 3 36 Table 4.30 Percentage improvement in pain from week 3 - 6 37 Table 4.31 Percentage improvement in pain from week 0 - 6 37 Table 4.32 Percentage improvement in tenderness to pressure from week 0 – 3 38 Table 4.33 Percentage improvement in tenderness to pressure from week 3 – 6 38 Table 4.34 Percentage improvement in tenderness to pressure from week 0 - 6 38 Table 4.35 Percentage improvement in swelling from week 0 - 3 39 Table 4.36 Percentage improvement in swelling from week 3 - 6 39 Table 4.37 Percentage improvement in swelling from week 0 - 6 39 Table 4.38 Percentage improvement in redness from week 0 - 3 40 Table 4.39 Percentage improvement in redness from week 3 - 6 40 Table 4.40 Percentage improvement in redness from week 0 - 6 40

x Table 4.41 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in all three groups 41 Table 4.42 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the 2M potency group 41 Table 4.43 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the 30cH potency group 42 Table 4.44 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the placebo group 42 Table 4.45 Percentage of participant compliance regarding taking the medication, in all three groups 43 Table 4.46 Percentage of participant compliance regarding taking the medication in the 2M potency group 43 Table 4.47 Percentage of participant compliance regarding taking the medication in the 30cH group 43 Table 4.48 Percentage of participant compliance regarding taking the medication in the placebo group 43 Table 4.49 Percentage of participant compliance regarding the rules and regulations of the study in all three groups 44 Table 4.50 Percentage of participant compliance regarding the rules and regulations of the study in the 2M potency group 44 Table 4.51 Percentage of participant compliance regarding the rules and regulations of the study in the 30cH group 44 Table 4.52 Percentage of participant compliance regarding the rules and regulations of the study in the placebo group 44 Table 4.53 Percentage of participant’s perception that the study was beneficial in the three groups 45 Table 4.54 Percentage of participant’s perception that the study was

xi beneficial in the 2M potency group 45 Table 4.55 Percentage of participant’s perception that the study was beneficial in the 30cH potency group 46 Table 4.56 Percentage of participant’s perception that the study was beneficial in the placebo group 46 Table 5.1 Aggravation caused by potencies over time 53

List of figures Figure 2.1 Cut-away view of the hallux, lateral (side) view 4 Figure 2.2 Hallux, dorsal (top) view 5 Figure 5.1 Percentage improvement in pain from week 0-6 50 Figure 5.2 Percentage improvement in tenderness to pressure from week 0-6 51 Figure 5.3 Percentage improvement in swelling 0-6 51 Figure 5.4 Percentage improvement in redness from week 0-6 52

xii CHAPTER ONE

INTRODUCTION

1.1 Background and contextualisation of the research problem

Onychocryptosis is the diagnostic term for an ingrown toenail. It is a very common, extremely painful and uncomfortable condition that occurs either when the nail penetrates the skin on the lateral or medial side of the toe or if the skin on the side of the toenail grows over the edge of the nail. If the wound is prevented from healing, its natural response is to produce granulation tissue which accumulates around the site of injury. This occurs owing to a variety of factors that may become complicated. It usually affects the hallux, but can occur in any of the toes. It may lead to inflammation, and ultimately infection (Dougans, 2000; Weaver, 2004).

Within the Homoeopathic Materia Medica, the remedy Magnetis Polus Australis is indicated as a specific remedy for onychocryptosis (Vermeulen 2001; Boericke 2004). In two similar previous studies, Rohl (2003) and Khan (2004) showed promising results but had sample sizes too small for definitive conclusions. In their respective studies, they recommend using Magnetis Polus Australis 2M in a single dose. Clarke (2003) claims to have cured numerous cases of onychocryptosis with the 2M potency of Magnetis Polus Australis.

1.2 Aim of the study

This study is aimed at determining the efficacy of the remedy Magnetis Polus Australis 30cH in repeated doses versus 2M in a single dose, in the treatment of onychocryptosis with regard to symptoms such as pain in the great toe (hallux), tenderness to pressure, infection, erythema and oedema of the medial or lateral nail fold.

1 1.3 Objectives

This study is expected to compare the effect of Magnetis Polus Australis 30cH versus Magnetis Polus Australis 2M in treating symptoms of onychocryptosis. This study intends to test previous findings of Magnetis Polus Australis as a specific homoeopathic remedy for onychocryptosis (Rohl, 2003; Khan, 2004), to identify the optimal potency and to increase sample size for greater statistical reliability.

1.4 Hypothesis and null hypothesis

The hypothesis in a research study of this nature, is that treatments affect outcomes. The hypothesis stated in this study derives from the aim of the study as formulated above, i.e. to test previous findings of Magnetis Polus Australis as a specific homoeopathic remedy for onychocryptosis and to identify the optimal potency, using a bigger population group. This hypothesis is formulated as a directional hypothesis as follows:

H1: The remedy, Magnetis Polus Australis, will improve the symptoms of onychocryptosis such as pain, tenderness to pressure, swelling and redness.

The null version of this hypothesis is the opposite, that is, that treatments do not affect outcomes. It proves that the two are not linked – that they are independent. It is formulated as follows:

H0: The remedy, Magnetis Polus Australis, will not improve the symptoms of onychocryptosis such as pain, tenderness to pressure, swelling and redness.

1.5 Advantages of this research

If this remedy is effective, then it will be available as an option to a non-surgical approach to treating onychocryptosis. It is a potentially cost-effective treatment which preserves the cosmetics of the toenail. There is no additional pain involved in this

2 treatment as is the case with surgery, there are no known side effects to the taking of this remedy as is the case with conventional treatment, and no time needs to be allocated towards a recovery period, as is usually the case with surgery. This remedy may also be advantageous to those for which surgery is contra-indicated, as in the case of people with various diseases such as peripheral vascular disease, uncontrolled diabetes mellitus, collagen vascular disease, severe hypertension, heart disease, pheochromocytoma, hyperthyroidism and hemostatic disorders. Patients who present with inflammation or acute infection of the nail itself cannot be considered for surgery until such time as the infection has cleared (Onumah et al., 2006). Surgical removal of the toenail should be avoided or conducted with extreme caution in patients who suffer with a medical history of thrombotic or vasospastic vascular disease, especially when using local anaesthesia involving Epinephrine. The use of this and other vasoconstrictor drugs could lead to complications, because it is associated with poor wound healing and necrosis (Onumah et al., 2006).

1.6 Structure of the study

Following the contextualisation of the research problem addressed in this particular study, its aims, objectives and advantages outlined and the hypothesis stated, the rest of the study is organised as follows:

Chapter 2 provides an overview of the relevant literature on onychocryptosis, information on homoeopathic principles and treatment with magnet therapy. Chapter 3 provides a procedural report of the research methodology followed to obtain the necessary empirical data involved in the clinical trials. Chapter 4 provides the statistical results of this study. Chapter 5 discusses the interpretation of the findings. Chapter 6 concludes with suggestions and recommendations for future studies on this particular topic.

3 CHAPTER 2

LITERATURE REVIEW

2.1 The normal toenail

In order to understand the pathology of an ingrown toenail it is fundamental to understand the anatomy of the normal toenail without pathology.

A nail is an appendage of skin along with hair, glands and their ducts. Nails are the scaly, horny, keratinised parts of the epidermis of the skin (Crocco, 1977). It can be equated to the hoof or claw of an animal. The basic external structure of a nail includes the body, the lateral nail folds, the lunula and the cuticle. In addition to the body of the nail, which is the visible portion, it also has a free edge, and a root matrix. The sides of the nail are covered by nail folds, which are folds of epidermis to enclose the nail in order to prevent infection (Marieb, 2000).

The stratum basale is the part of the epidermis which extends underneath the nail, and is known as the nail bed. The nail matrix is the thickened portion of the nail bed and this is the area responsible for nail growth (Marieb, 2000). See Figure 2.1 below.

Figure 2.1 Cut-away view of the hallux, lateral (side) view (Oster, 2007)

4 Nails are made up of heavily keratinised, non-living cells which is why it is not painful to have them cut. Keratin is a waterproof protein which causes hardening of the nail cells (Mader, 1998). The cells are produced by the nail matrix and die shortly thereafter. Nails are also transparent but tend to have a pinkish colour due to the rich vascular dermis in the nail bed, which is situated in the dermis (Marieb, 2000). The lunula is the “half-moon-shaped” white area at the base of the nail, where the cells grow from. The cells become keratinised as they grow out of this germinal area, then die and are sloughed away (Mader, 1998). See Figure 2.2 below. The normal rate of nail growth is one millimetre per week (Mader, 1998) but some people have nails that grow faster than this.

Figure 2.2 Hallux, dorsal (top) view (Oster, 2007)

2.2 Onychocryptosis

In the next section it is necessary to first define onychocryptosis as the condition of an ingrown toenail is called, and then to discuss its clinical features and various differential diagnoses.

2.2.1 Definition

Onychocryptosis is synonymous with the word onyxis, meaning an ingrown nail

5 (Merriam-Webster, 2002). According to Piraccini et al. (2000), it may also be referred to as an embedded toenail and is also known as unguis incarnatus. It is an acquired condition of the toenails, most commonly the hallux, involving the lateral nail border and sulcus more than the medial, thereby resulting in a painful condition that may become infected.

Weaver et al. (2004) defines the term ‘onychocryptosis’ as being derived from the Greek words onyx, meaning ‘nail’ and krypto, meaning ‘to conceal’. They also mention that it is a condition that is much more prevalent in males than in females, with a ratio of 2:1. It is also much more prevalent in the teenage and young adult age group, ranging from 16- 25 years. However, over the age of 75, it seems that there are more females than males who are afflicted with this condition.

2.2.2 Clinical features and diagnosis of onychocryptosis

There are a few symptoms of this condition which lead to a diagnosis of onychocryptosis to include extreme pain in the hallux and extreme tenderness to pressure on the sulcus. There may also be infection, inflammation and a purulent medial or lateral nail fold. In most cases erythema (redness) and oedema (swelling) of the medial or lateral nail fold are present and there may be crusting of the affected area and sometimes formation of granulation tissue of the affected area (Craig et al., 2004). Usually, the patient’s first complaint is about pain induced by the hard toenail digging into the soft fleshy sulcus. Later on, an infection may be introduced via the overhanging nail fold. Micro-organisms cause the typical signs of inflammation that were mentioned above, mainly a purulent discharge, oedema, erythema and heat (Cox and Jones, 1995).

2.2.3 Differential diagnoses of onychocryptosis

Untreated ingrowing toenails have the potential to be disastrous, particularly in the high risk patient, such as the one who suffers from diabetes mellitus or peripheral vascular

6 disease. There are various disease processes to be excluded before the diagnosis of onychocryptosis is confirmed, such as:

2.2.3.1. Osteomyelitis – defined as inflammation and destruction of bone caused by both aerobic and anaerobic bacteria, mycobacteria and fungi. It can occur in the bones of the feet after the skin has been penetrated (as in the case of an ingrowing toenail). Cancer, diabetes, radiotherapy and other debilitating diseases can cause osteomyelitis. The bone infection is associated with an obstruction of the vascular supply and therefore bone necrosis will set in and the infection will spread through the bone cortex and into the periosteum (Beers et al., 1999).

2.2.3.2. Fracture – a broken toe can result due to heavy, unnatural forces placed on the joints of the toes, or to the bone itself. There is great pain and swelling and much difficulty in walking, and ascending and descending stairs. There will be much heat and redness accompanying the pain and swelling. The swelling may also be vastly out of proportion to the small area that was injured. X-rays will confirm the diagnosis. Treatment involves immobilisation of the foot or toe/s for four to six weeks as necessary (Beers et al., 1999).

2.2.3.3. Paronychial infections – defined as acute or chronic infection of the periungual tissues. The infection is caused by various bacteria, most commonly S. aureus, Pseudomonas or Proteus sp; various fungi, such as Candida sp; or the herpes simplex virus. The organisms enter the body through the break in the skin caused by the ingrowing toenail and lead to infection. If the acute infection is not promptly treated, it leads to chronic infection (Beers et al., 1999).

2.2.3.4. Herpetic whitlow – this is a viral infection, but is often mistaken for a felon. It mostly occurs in the fingers, but the toes cannot be excluded. It is caused

7 by the herpes simplex virus and causes intense, painful cutaneous infection. The diagnostic indicator is many little fluid filled vesicles present all over the affected toe. There may or may not be pain before the breakout of vesicles. It is a self-limiting condition which does not require surgery or any other intervention, other than basic hygiene to prevent spread of the virus (Beers et al., 1999).

2.2.4 Causes and predisposing factors of onychocryptosis

The scientific research available on onychocryptosis states an unknown aetiology. However, there are certain factors that are said to contribute to the condition and thereby aggravate the symptoms. These include:

• Thin, brittle nails and moist skin (Dougans, 2000) • Wearing shoes that have a toe box that is too tight (Craig et al., 2004) • Cutting the nails too short and skew (Craig et al., 2004) • Having the second toe longer than the big toe (Weaver et al., 2006) • Trauma and physical injury caused by stubbing the toe (Craig et al., 2004) • Having bed sheets tucked in too tightly can cause the edge of the nail to be forcefully pushed into the skin and as a result, break the skin (Craig et al., 2004) • Hereditary tendencies (Craig et al., 2004) • Certain kinds of bone pathology (Craig et al., 2004) • Obesity (Craig et al., 2004) • Toes that curl congenitally (Craig et al., 2004) • Toes that curl owing to diseases such as arthritis (Craig et al., 2004) • A family history in the first and second degree relatives may be evident (Craig et al., 2004) • In occasional instances, toenails just occupy too much of the nail bed as they may be too large (Craig et al., 2004) • Hyperhidrosis (Onumah et al., 2006)

8 • Excess internal pressure which causes the nail plate to curve (Onumah et al., 2006) • Underlying systemic disease such as diabetes mellitus or arthritis (Onumah et al., 2006) • Onychomycosis (Onumah et al., 2006) • Indinavir, a medication used to treat AIDS patients, has been shown to cause onychocryptosis (Bourezane et al., 1999).

2.2.5 Pathophysiology of onychocryptosis

According to Craig et al. (2004), onychocryptosis is a foreign body reaction. It results from a modification of the fit of the nail plate into the nail groove, owing to the nail compacting the nail bed. This causes the sharp corners of the nail to be driven into the cuticle surrounding it. The keratin from the nail and natural flora from the skin is then introduced into the cuticle and the body sees this as foreign and starts a defence reaction in the form of an inflammatory response.

Onumah (2006) affirms this and adds that the direction of nail growth in a normal nail is straight forward, whereas in onychocryptosis, the direction of nail growth is lateral. The sharp corner of the nail therefore penetrates and punctures the lateral skin fold which then results in a very painful inflammatory response. The clinical symptoms of this are erythema, oedema, heat and acute pain. In the advanced stages, there are additional symptoms such as purulence, infection, ulceration and hyperhidrosis. The lateral soft tissue swells and hypertrophies and granulation tissue forms over the injured area as a protective mechanism.

2.2.6 Types and stages of onychocryptosis

Onychocryptosis is divided into 3 stages.

9 Stage one involves erythema (redness), oedema (swelling) and tenderness to pressure – this is the easiest stage of onychocryptosis to treat. Treatment is never surgical at this stage. Management includes wearing shoes with a wide toe-box or even open-toed shoes. The patient must be instructed to cut the toenails straight across the top of the toe and not skew. The nails should not be cut too short and should be left to grow past the actual tissue (Egland et al., 2006).

Stage two involves crusting and purulence that is noted between the nail plate and the medial or lateral nail fold – this stage is a little more difficult to treat and may involve surgery occasionally. Otherwise, non-surgical treatment involves lifting the ingrown part of the nail gently away from the tissue, placing a small pledget of cotton under the nail edge in order to break contact between the nail and the soft tissue. The foot should then be elevated as much as possible and warm antiseptic soaks are recommended (Egland et al., 2006).

Stage three involves chronic infections. These are noted when granulation tissue protrudes over the nail plate – this stage is treated surgically. The procedure involves removing the nail margin completely, called avulsion of the border of the nail plate and the excision of excess granulation tissue. Ablation may be indicated if avulsion is unsuccessful. Ablation is performed by means of electrocautery of the underlying matrix of the nail (the part of the nail that actually grows). The Cochrane Collaboration have enhanced this method with the addition of a chemical ablatant, phenol. Phenol is applied to the nail matrix with a cotton-tipped applicator and this actually destroys the matrix so that it cannot grow anymore (Egland et al., 2006).

2.2.7 Treatment for onychocryptosis

The treatment is divided into surgical and non-surgical practices.

10 2.2.7.1 Surgical treatment

2.2.7.1.1. Nail avulsion – this is most commonly used in stages 2 and 3 of onychocryptosis. It is also the most common surgical procedure used in nail surgery. It is a therapeutic treatment for acute and chronic onychocryptosis, onychomycosis and acute bacterial infections (Onumah et al., 2006). However, according to Dawber et al. (1994), simple nail avulsion alone, without the use of phenol, only has a cure rate of 30%. It is important for the surgeon to exercise caution when performing this procedure, due to the cosmetic and functional outcomes. The procedure involves covering the entire toe with iodine or chlorhexidine in order to ensure an antiseptic environment. Anaesthetisation is then performed by means of a digital block with 1% lidocaine. A Penrose drain is secured with a haemostat clamp and is used for hemostasis. One of three possible instruments may be used for the procedure, either the mosquito haemostat, the Freer septum elevator or the dental spatula. The chosen instrument is inserted just between the free edge of the nail and the underlying nail bed in order to separate the two. Separation is directed proximally towards the matrix with great resistance until the matrix is reached. Upon reaching the matrix, the elevator is inserted, stroking it forwards and backwards until the nail is separated from the nail bed. The haemostat is then used to remove the nail. The use of a urea ointment as a debriding agent at this stage is common practice (Onumah et al., 2006).

2.2.7.1.2. Matrisectomy – this is the process of destroying the nail matrix (the part of the nail that actually grows) by means of surgical, chemical or electrical means. This results in loss of the nail plate, therefore the nail ceases to grow as a new nail plate cannot be formed. Onychocryptosis is the most common indication for this surgery (Onumah et al., 2006). A complete or partial matrisectomy can be performed, the partial matrisectomy is preferred, because only the diseased part of the nail matrix is removed, while preserving the rest of the nail structurally and functionally (Ceilley and Collison, 1992).

11 Total matrisectomy has the advantage of being curative in most cases since it completely destroys the entire nail plate and is reserved for chronic or severe nail disease (Onumah et al., 2006).

The partial matrisectomy process once again involves complete sterilisation and anesthetization as with nail avulsion, mentioned above. The Penrose drain is again used as a tourniquet to maintain haemostasis. A nail splitter and a nail elevator are the instruments of choice. The splitter is used to cut longitudinally through the nail plate. Then the elevator is used to free the nail from the nail bed. The avulsed nail is grasped and removed to expose the matrix. A scalpel blade is then used to excise the matrix in the nail bed. This sample of tissue and matrix are removed with very small scissors. This open wound may be closed with sutures, otherwise it will just be dressed appropriately with iodoform or petroleum jelly gauze (Onumah et al., 2006).

2.2.7.1.3. Chemical matrisectomy is usually performed with one of two chemicals, phenol or sodium hydroxide. Both chemicals are successful, and therefore commonly used by podiatrists. Chemical matrisectomy involves applying either the phenol or the sodium hydroxide in order to destroy the nail matrix completely. The function of phenol is to denature proteins, it has antibacterial value and maintains anaesthetization. It is applied while the tourniquet is still on because blood inactivates phenol. It is applied only to the avulsed area (the surrounding skin is covered with petroleum jelly) in 30 second applications with a cotton-tipped applicator (Onumah et al., 2006). The success rate of the sodium hydroxide treatment is 95.1% and for the phenol treatment, it is 95.8%. According to Seher et al. (2007), the average time for complete recovery is 10.8 days for the sodium hydroxide treatment, and 18.02 days for the phenol treatment.

2.2.7.1.4. Silicone gel sheeting – this is an effective treatment in cases where the onychocryptosis has been so severe that it has left hypertrophic and keloid

12 scarring. The process involves incising the affected nail plate without affecting the granulation tissue. About 24 hours later, the silicone is placed on the granulation tissue and the part of the nail bed that is exposed. The silicone gel sheet is then bandaged without additional pressure. Patients are then given a gel to apply at home for up to four months. This may be a useful treatment in preventing recurring bouts of onychocryptosis by decreasing the thickness of the hypertrophied nail fold (Aksakal et al., 2003).

2.2.7.1.5. Modified sleeve method - this is not a commonly used method of treating onychocryptosis. It involves local anaesthesia and the insertion of a thin, narrow, flexible, little plastic tube underneath the nail along its lateral border. The inflamed tissue is removed either by excision or electrocautery. This process is a fairly successful method of treating onychocryptosis as it is fairly simple to perform and has a very low recurrence rate (Abby et al., 2002).

Contra-indications to surgery include various diseases such as peripheral vascular disease, diabetes mellitus, collagen vascular disease and hemostatic disorders. Patients who present with inflammation or acute infection of the nail itself cannot be considered for surgery until such time as the infection has cleared (Onumah et al., 2006).

Regarding local anaesthesia, Epinephrine should not be administered to the peripheral areas of patients who suffer from a medical history of thrombotic or vasospastic vascular disease, severe hypertension and heart disease (Denkler, 2001). The reason that it is contra-indicated in these risky patients, is that Epinephrine is classed as a vasoconstrictor and would act as an uncontrolled tourniquet, thereby causing poor wound healing and necrosis in these patients (Onumah et al., 2006).

2.2.7.2 Non-surgical treatment

Non-surgical treatment is used in stage 1 and occasionally in stage 2 if it is still an acute problem. There are several types of oral allopathic drugs on the market for

13 onychocryptosis sufferers. These treatments are all symptomatic and the problem tends to recur readily. They all also have side-effects and must be used on a regular basis in order to obtain some relief from the condition. The drugs are:

2.2.7.2.1. Antibiotics such as penicillin with known side effects such as candidiasis, diarrhea, drug interactions, nausea, vomiting (Reyzelman et al., 2000).

2.2.7.2.2. Analgesics such as paracetamol or acetaminophen and codeine, with known side effects such as constipation, kidney and liver failure, CNS depression, drug interactions, nausea, vomiting.

2.2.7.2.3. Non-steroidal anti-inflammatory drugs (NSAID), for example ibuprofen, diclofenac, naproxen, meloxicam with side effects such as stomach ulcers, bleeding stomach lining, kidney failure, drug interactions, vertigo, tinnitus, nausea, diarrhoea and skin rashes (Seager et al., 2001).

2.2.7.2.4. Anti-fungals such as terbinafine and fluconazole. These drugs aim to destroy the wall of the fungi cells because they cannot survive and replicate without it. They present with side effects such as drug interaction, nausea, vomiting, liver problems, skin rashes, vaginal and yeast infections (British National Formulary, 2006).

2.2.7.2.5. Nail paints - there are only a handful of nail paints on the market. A nail paint is a solution which can be applied topically to the nail as well as the surrounding skin in order to give immediate relief of pain and inflammation. Examples include Trosyd and Scholl’s Ingrown Toenail Solution. Plain iodine can also be used as an antiseptic. The function of a nail paint ranges from anti-fungal activity (often associated with onychocryptosis) (Connelly et al., 1999), to softening the nail and hardening the skin. The side effects associated with these paints are staining of clothing and linen and strong, unpleasant odours.

14 2.2.7.2.6. Warm water soaks - soaking the feet in warm salt water daily and applying an antiseptic or antibacterial cream and bandaging the affected toe (Craig et al., 2004).

2.2.7.2.7. Cotton-wool pledgets – this process involves lifting the ingrown part of the nail gently away from the tissue, and placing a small pledget of cotton-wool under the nail edge in order to break contact between the nail and the soft tissue. This has a 72% success rate when treating ingrowing toenails (Weaver et al., 2004).

2.2.7.2.8. Toe spacer - wearing a toe spacer between the affected toe and the next unaffected toe. The pressure of the unaffected toe onto the affected toe is one of the leading aggravations of onychocryptosis. This process helps to relieve that pressure (Gunal et al., 2003).

Various conventional medications for treating the symptoms of onychocryptosis have been mentioned above. Bearing the aim of the present study in mind, it is imperative that this condition is now considered from a homoeopathic perspective.

2.3 Homoeopathy

The various laws and principles governing the practice of homoeopathy receive attention first.

2.3.1 Laws and principles governing the practice of homoeopathy

The word homoeopathy originates from the two Greek words, namely homoios, meaning ‘similar’ and pathos, meaning ‘suffering’. There are a few laws which govern the use of homoeopathic medicines - which were contributed by Dr Samuel Hahnemann, who discovered homoeopathy – and which are pertinent to this study (Hahnemann, 1996).

15 2.3.1.1 The Law of Similars

The main principle that governs homoeopathy is the law of similars (Similia similibus curantur). Hahnemann (2003) defined this law in the Organon of Medicine as “A dynamic disease in the living economy of man is extinguished in a permanent manner by another that is more powerful when the latter (without being of the same species) bears a strong resemblance to it in its mode of manifesting itself”. This law means that a homoeopathic remedy is to be administered to a sick patient for a disease in which, if the substance was given in crude form, would produce similar symptoms to that of the disease (Gunavante, 1994; Kent, 1979). The symptoms that the sick person manifests, must match the symptoms that the remedy produces in order to establish resonance between the patient and that particular remedy for it to act successfully (Vithoulkas, 1980).

2.3.1.2 The Single Remedy

In Aphorism 273 of the Organon of Medicine, Hahnemann (2003) says that it is never necessary to give a patient more than one single remedy at any time: “In no case under treatment is it necessary and therefore not permissible to administer to a patient more than one single, simple medicinal substance at one time.” If given more than one remedy at any time, the various remedies may interact with one another and then the physician cannot single out beneficial or adverse effects accurately. All the remedies have been proven and tested singly, as individual remedies. They have not been proven in complexes, and therefore their action is unknown in a complex. This poses a problem when the patient has an aggravation, or if their symptoms deteriorate or improve. The physician has no way of knowing which of the remedies he has given is the correct one and which is the incorrect one (Vithoulkas 1980).

16 2.3.1.3 The Minimum Dose

Only the very minutest amount of a remedy is needed to act favourably on the patient. In Aphorism 275, Hahnemann (2003) says: “The suitableness of a medicine for any given case of disease does not depend on its accurate homoeopathic selection alone, but likewise on the proper size, or rather smallness, of the dose.” The reasoning for this is due to the succussion and trituration of the remedy in its preparation. This process creates an “intimate mixture” so that there is an equal distribution of the medicinal substance within the attenuating fluid, as well as adding kinetic energy. This energy makes the remedy more powerful in its action, and by giving it in too large a quantity, harm can be caused (Dudgeon 1995).

2.3.1.4 Potentization

Vithoulkas (1980) describes potentization as the process whereby the intensity of the electromagnetic field of the medicinal substance is increased in order to “liberate the energy contained within the substance in such a way as to make it more available to interaction with the dynamic plane of the organism”. This results in the homoeopathic remedy, which has an enhanced ability, to produce lasting cure. Potentization or dynamization is often confused with dilution. Although the remedies are greatly diluted so as to minimize their toxic side effects, dilution also minimizes their therapeutic effect. That is why the potentization process involves succussion or shaking. Shaking the diluted remedy adds kinetic energy to the mixture. The amount of shaking is directly proportional to the increase in therapeutic effect. Hence, homoeopathic remedies exhibit two extraordinary properties: they are greatly diluted so as to have minimal toxic side effects, and they are succussed many times so that they have maximal therapeutic ability.

2.3.1.5 Homoeopathic aggravation

A homoepathic aggravation occurs when existing symptoms become temporarily worse. According to De Schepper (2006) there are two types of aggravations, namely similar

17 and dissimilar aggravations. Similar aggravations occur when a patient’s original symptoms are intensified. This is a sign that the correct remedy has been administered but the potency was too high, it was repeated too often or re-administered too soon. In other words, such a medicinal aggravation is indicative that the correct remedy has been used but that it was incorrectly administered. A dissimilar or a pathogenic aggravation produces new symptoms as it is indicative that the incorrect remedy has been administered. In this case immediate attention is required to correct the imbalance of the vital force.

Most homoeopaths aim to avoid aggravations as they are uncomfortable to the patient. However, aggravations do occur and as mentioned above, similar aggravations indicate that the correct remedy has been used whereas dissimilar aggravations indicate an incorrect remedy (De Schepper, 2006). Similar aggravations can therefore be a positive sign that the patient is on the road to recovery and are often followed by a cure although not always comfortable when being experienced (Vithoulkas, 1980).

2.3.2 Magnetis Polus Australis in the treatment of onychocryptosis

Hahnemann (1997) stated in the Organon of Medicine, in Aphorism 287, that the Materia Medica Pura states that there is no uncertainty regarding the positive healing powers of a magnet.

In the Materia Medica Pura, Hahnemann (1996) maintains that a carefully constructed magnetic steel rod can cause disorder in health – even when not in actual contact with the body, but covered with thick material. A magnetic rod can also cure the most severe disease for which it is suited. This was most likely the first homoeopathic proving of Magnetis Polus Australis.

According to Vermeulen (2001), Magnetis Polus Australis in particular is useful in curing “severe (sore) pain on [the] inner side of [the] nail of the big toe”. It feels worse when walking or even on slightest touch. He associates the words “ingrowing toenail”

18 with this remedy in particular. Magnetis Polus Australis is also recommended by Allen (2001) and Mathur (2000) as having a specific affinity for ingrowing toenails. The single dose of 2M is recommended by Clarke (2003) in his dictionary of Materia Medica, where he claims to have treated numerous cases of onychocryptosis using this potency.

Rohl (2003) conducted a study on the efficacy of Magnetis Polus Australis 7cH and 30cH in the treatment of onychocryptosis of the hallux. This study shows that the 30cH potency causes the greatest improvement in the symptoms of onychocryptosis. There was a significant improvement regarding tenderness of the hallux to pressure. Pain in the hallux and oedema of the lateral nail fold also showed improvement.

In 2004, Khan looked at the effect of Magnetis Polus Australis 200cH and 1M on onychocryptosis of the hallux. Her study demonstrates that Magnetis Polus Australis shows an overall improvement in most of the symptoms of onychocryptosis, with the 1M potency showing the greatest improvement. Both the studies by Rohl in 2003 and by Khan in 2004 show promising results, however, the sample sizes in both studies contained only ten participants per group. Neither study reported any complications or adverse reactions.

At present, apart from the studies by Hahnemann (1996; 2003), Clarke (2003), Rohl (2003) and Khan (2004), there is no additional information available on the use of this remedy for the treatment of onychocryptosis, and certainly no published data. In order to understand the remedy, Magnetis Polus Australis, the understanding of the meaning of magnetism and magnet therapy is essential.

2.4 Magnet therapy

The history of magnet therapy is discussed first, then attention is paid to the medical function of magnets before a description is given of the preparation of Magnetis Polus Australis, the remedy used in the present study.

19 2.4.1 History of magnet therapy

Although magnet therapy is nowadays not accepted or practised in many Western mainstream medical practices, it has been in use for thousands of years. The Chinese, Indians, Egyptians and various homoeopaths, believed that the body has a Vital Force or Chi. This is the life force within every living being that is influenced by outside forces, including magnets. Paracelsus was said to have said that “the magnet is the king of all secrets”. Magnetic healing has been researched in depth for the last 30 to 40 years, mostly in Europe and Asia, which are not as dependant on pharmaceutical products as Western countries. Magnet therapy has proved to be useful for a wide variety of ailments, ranging from acute foot pain, severe back pain or chronic pelvic pain, to wound healing from bone fractures and plastic surgery (Khan, 2000).

According to Philpott et al. (2000), the oldest written findings on magnetic healing dates back to 2000 B.C. in China and was written in the Yellow Emperor’s Book of Internal Medicine. From then on, word of the healing power of magnets spread rapidly. In the 4th century B.C. Aristotle and Cleopatra discovered the healing power of magnets and a French doctor, Martel, treated hand and foot pain with magnets. In the 6th century, Alexandre de Tralles used magnets to treat joint pain and an Arab doctor, Hall Abbas, treated spasms. By the 16th century, Paracelsus started treating inflammatory conditions with magnets and in the 17th century, William Gilbert (Elizabeth I’s physician), wrote the first fully comprehensive, scientific book on magnets, called De Magnete. He called them iodestones and used them to successfully treat haemorrhage. In the 18th century, the French Royal Society of Medicine declared that magnets did indeed have antispasmodic properties. In 1925, a French doctor, Durville published his book on magnet therapy describing his success in treating many ailments with magnet therapy. In 1976, the first International Conference on Biomagnetism was held in Boston in the USA and in 1991, the Eighth International Conference on Biomagnetism was held in Munster in Germany. In 1983, the rarest biomagnets were found. They were neodymium biomagnets. These magnets retain their charge for an indefinite period of time and are 700% more powerful than the older ceramic magnets. Although initially expensive to purchase, they have

20 since become more affordable. Today, magnet therapy is an internationally recognised therapy in more than 45 countries (Philpott et al. 2000).

2.4.2 Function of magnets

According to Khan (2000), magnets appear to function medically in three ways:

• Analgesic – magnets serve a dual function here. Firstly, magnets are thought to achieve pain relief by acting on nerve cells. They change the electrical potential within the cell preventing it from transmitting nerve impulses to the brain which then does not detect the pain. Secondly, magnets may increase the body’s production of endorphins, which are the body’s own natural painkillers.

• Accelerated wound healing – this is due to the increase in blood flow to the area. As blood carries nutrients, oxygen and immune cells, wound healing should occur much quicker as inflammation and infection are decreased.

• Increasing energy – the human body vibrates at its own natural frequency. When exposed to external extremely low frequency (ELF) electromagnetic fields, the body’s natural frequency is altered. Magnet therapy could help restore the balance of the body’s natural magnetic field.

2.4.3 Preparation of Magnetis Polus Australis

There is very little literature available on the preparation of this remedy. The information below was compiled according to personal communication.

The 2M potency of Magnetis Polus Australis is only available from the United Kingdom. Lawrence (2007), the technical director of Helios Pharmacy in the United Kingdom, oversees the laboratory which prepared the 2M potency of Magnetis Polus Australis from a stock potency. The original remedy was prepared with one vial each of

21 water, alcohol and lactose. A strong audio speaker magnet and a compass were used to determine the south pole. The vials were then attached to the magnet and left undisturbed for 24 hours. Thereafter the lactose was triturated to a 3cH potency, and then potentized to a 4cH potency. The liquid vials (water and alcohol) were potentized to a 4cH potency after the 24 hour period. The three vials were then combined and potentized to the desired potencies in 90% alcohol.

In South Africa, Magnetis Polus Australis is available from a local homoepathic laboratory in potency up to 1M. Hohl (2007), the laboratory technician at Natura Laboratory in Pretoria, states that the 30cH potency of Magnetis Polus Australis was prepared in 73% alcohol, in a 3cH or 4cH imported from France or Germany. The laboratory workers then hand-succuss the remedy to a 30cH potency in 20% alcohol.

2.5 Summary

In view of the aim of this study, the relevant literature available on onychocryptosis and its treatment by both conventional and homoeopathic methods were reviewed. In particular, attention was paid to magnet therapy and the preparation of Magnetis Polus Australis as used in this study.

In the next chapter the methodology used to conduct the research reported on in this study, is dealt with.

22 CHAPTER THREE

MATERIALS AND METHODS

3.1 Research sample – recruitment of participants / sample selection

Forty pre-diagnosed onychocryptosis participants were recruited using non-probability convenient sampling by means of the distribution of pamphlets at the University of Johannesburg’s Doornfontein Campus, the “Especially For You” Skin and Body Clinic in Midrand, at Weleda Pharmacy in Fourways, two free advertising websites (www.indiansgauteng.co.za and www.junkmail.co.za) and Silverstream Retirement Village in Malanshof, Johannesburg. The participants were randomly chosen regardless of population group and occupation, and were requested to sign a consent form.

3.2 Delimitations - inclusion criteria

The criteria according to which participants were included in the study, are the following:

• Participants suffering from uncomplicated acute or chronic onychocryptosis • Participants over the age of 18 years • Participants with pre-diagnosed onychocryptosis

3.3 Delimitations - exclusion criteria

The criteria according to which participants were excluded from the study, are the following:

• Participants suffering from infected onychocryptosis

23 • Participants taking any oral or topical allopathic or alternative treatment for onychocryptosis for the duration of the study • Participants suffering from arthritis, immune system deficiencies, uncontrolled diabetes mellitus or vascular disorders • Participants younger than 18 years of age

3.4 Purchasing and preparation of medication

The medication was prepared in liquid form, in 20% alcohol. Magnetis Polus Australis 2M was obtained from the Helios Pharmacy in the United Kingdom. They shipped a 5ml bottle of the medicating potency, in 96% alcohol, to the researcher in Johannesburg, South Africa. In the dispensary of the University of Johannesburg, the dispenser prepared fifteen of the forty-five powders with one drop of Magnetis Polus Australis 2M in 96% alcohol. The other thirty powders were placebo powders which merely consisted of lactose granules which looked identical to the 2M Magnetis Polus Australis powders.

As mentioned in Chapter 2, Magnetis Polus Australis 30cH was obtained from Natura Laboratories in Pretoria, South Africa. They dispensed fifteen 50ml bottles of Magnetis Polus Australis 30cH in 20% dispensing alcohol. As also mentioned, in the dispensary of the University of Johannesburg, the other thirty bottles were prepared as placebo drops merely consisting of 50ml of 20% dispensing alcohol which looked identical to the 30cH Magnetis Polus Australis bottles. The University of Johannesburg’s dispenser then randomised the medication.

3.5 Administration and randomisation of medication

The initial remedy was in powder form and had to be taken as a once-off dose in the presence of the researcher. The participants were given the remedy in liquid form to take home. At home, each participant had to take five drops under the tongue twice per day for six weeks. The participants were requested to shake the bottle before taking each dose. As the drops are best absorbed away from food they were requested to take the

24 drops either half an hour before or one hour after eating. They were also requested not to take the drops together with any strong tastes such as peppermint, curry, coffee or even toothpaste (Appendix A).

The medication was pre-packed in white plastic bags consisting of one powder and 50ml liquid, by the dispenser of the University of Johannesburg. Each pack was randomly allocated a serial number ranging from 1 to 45. The treatment group it belonged to was recorded by the dispenser. During the first consultation, the participant chose a pack, thereby automatically assigning themselves to one of the three treatment groups. On completion of the study, the serial number of the participant was checked to ascertain which group they belonged to.

3.6 Research and trial procedure – control and experimental groups

This was a double-blind placebo research study in that neither the participants, nor the researcher were aware of the status of the medication given. The study involved forty participants with pre-diagnosed onychocryptosis and took place over a six week period.

At the first consultation, participants were informed of the study (see Appendix A) and asked to sign a consent form (see Appendix B). They were then screened by filling in a participant profile form (see Appendix C). The feet were examined to note initial presentation of symptoms and to evaluate the severity of onychocryptosis (see Appendix D). The examination of the feet included looking for redness and swelling, and palpating the hallux for pain and tenderness to pressure. The eligible participants were then given a numbered packet containing the medication, thereby randomly assigning themselves into one of three groups.

At the second consultation, the feet were once again examined in the same way as at the first consultation to note any changes (see Appendix D). This consultation occurred three weeks after the initial consultation.

25 At the third consultation, three weeks after the second, the feet were once again examined in the same way as at the first two consultations to note any changes (see Appendix E). The second part of Appendix E was then filled in by the patient. This part of the questionnaire is subjective in nature as it aims to note changes in symptoms of the patient’s condition from their point of view.

This study included only one affected hallux per participant, and also only one affected side (medial or lateral) of that affected toe, even if the participant presented with more than one affected toe. As seen in tables 4.25 to 4.28, the majority of participants had the lateral side of the hallux affected (this is the side that presses on the second toe).

3.7 Data collection and analysis

All the recorded data were analyzed and compared using SAS statistical analysis software. The precise test that was used was a Fisher Exact Test (FET) according to the symptoms of onychocryptosis, and the graphs were generated from these statistics, using Microsoft Excel software. The FET is used for a small sample group as it is highly accurate. Fisher tests are used for data in a two by two contingency table. This occurs when data is compared to a control group, and the outcome is binary (in this case whether the remedy works or not). Reporting on the results obtained with a Fisher Exact Test is fairly difficult, as “it has no formal test statistic and no critical value” (Simon, 2007); it only provides a p value. The p value is 0.05 (the same as for a chi-square). This p value determines whether the researcher accepts or rejects the null hypothesis. If the p value is small (less than 0.05), then the hypothesis is accepted (and the null hypothesis is rejected), thereby concluding that the treatment does indeed affect the outcome (Kirkman 1996). In other words, the results are statistically significant and show that the remedy has worked. If the p value is greater than 0.05, the hypothesis is rejected (and the null hypothesis is accepted). It means that the results are not statistically significant. Therefore there is no relationship between the sample group in which the participant was randomly placed and the severity of their symptoms. The differences are then explained by

26 coincidence and there is no statistically significant improvement in their symptoms. Therefore the treatment did not affect the outcome and the remedy has not worked.

3.8 Ethical considerations

Participation in the study was completely voluntary and required each participant to sign a consent form (Appendix B). Confidentiality and privacy was ensured by not linking the participant’s details to their data. Each participant remained totally anonymous by being linked to a control number used to identify the date of birth.

There were no anticipated risks associated with this study. During the first consultation participants were informed that not all of them would benefit from the study, particularly not the placebo group, as onychocryptosis is a painful condition in itself. In the event of infection or severe discomfort the participant was to be referred to a podiatrist for further treatment.

The participants had full right to freedom of expression and were allowed to ask questions at any time. They were also allowed to exercise their right to withdraw from the study whenever they chose to and for whatever reason. Participants were able to obtain their results at the end of the study by contacting the researcher at the telephone number given on the consent form (Appendix B).

The ethical clearance number was 52/06 and it was passed on the 13th October 2006 by the Higher Degrees and Ethical Committees of the University of Johannesburg.

3.9 Summary

In this chapter the methodology used to conduct this particular study, was laid out step by step. It was a double-blind placebo controlled study involving forty participants.

The results of the study and the interpretation of these results are presented in Chapter 4.

27 CHAPTER 4

RESEARCH RESULTS

4.1 Gender distribution

Tables 4.1 to 4.4 reflect the gender distribution of all the participants in the study. On average more females than males took part. The ratio was roughly 60% females to 40% males, even though the participants were randomly chosen. This ratio matches to an extent the statistics mentioned by Weaver et al. (2004), who state that onychocryptosis is much more prevalent in females than in males – with a ratio of as much as 2:1. The placebo group (see Table 4.4) especially, consisted of almost 70% females.

Table 4.1 Overall gender distribution in all three groups of the study Gender Frequency Total Percentage Male 15 40 37.5% Female 25 40 62.5%

Table 4.2 Gender distribution in the 2M potency group Gender Frequency Total Percentage Male 6 15 40% Female 9 15 60%

Table 4.3 Gender distribution in the 30cH potency group Gender Frequency Total Percentage Male 5 12 47.5% Female 7 12 58.3%

28 Table 4.4 Gender distribution in the placebo group Gender Frequency Total Percentage Male 4 13 30.8% Female 9 13 69.2%

4.2 Age distribution

Tables 4.5 to 4.8 reflect the age distribution of the three groups in the study. The average age of participants who took part was roughly 54 years. The youngest participant was 18 years old and the oldest was 96 years. Weaver et al. (2004) mention that females are more affected by onychocryptosis than males, after the age of 75 years. Table 4.5 Overall age distribution in all three groups Number of Mean Std. deviation Minimum age Maximum age participants 40 54.3 25.2 18 96

Table 4.6 Age distribution in the 2M potency group Number of Mean Std. deviation Minimum age Maximum age participants 15 55.4 26.4 26 96

Table 4.7 Age distribution in the 30cH potency group Number of Mean Std. deviation Minimum age Maximum age participants 12 54.1 30.5 18 93

Table 4.8 Age distribution in the placebo group Number of Mean Std. deviation Minimum age Maximum age participants 13 53.2 19.7 19 81

29 4.3 Duration of time that participants have been afflicted by onychocryptosis

Tables 4.9 to 4.12 reflect the duration of time that participants in the three groups in the study have been afflicted by onychocryptosis. On average, the majority of participants have been affected between one and five years before participating in this study. The relationship between the duration of time that participants have had the condition, and the effect of the remedy will receive more attention in Chapter 5. Table 4.9 Overall duration of time that participants have been afflicted by onychocryptosis in all three groups Years Frequency Total Percentage < 1 year 3 40 7.5 1 – 5 years 14 40 35 5 – 10 years 12 40 30 > 11 years 11 40 27.5

Table 4.10 Duration of time that participants have been afflicted by onychocryptosis in the 2M potency group Years Frequency Total Percentage < 1 year 0 15 0 1 – 5 years 5 15 33.3 5 – 10 years 4 15 26.7 > 11 years 6 15 40

Table 4.11 Duration of time that participants have been afflicted by onychocryptosis in the 30cH potency group Years Frequency Total Percentage < 1 year 3 12 25 1 – 5 years 3 12 25 5 – 10 years 4 12 33.3 > 11 years 2 12 16.7

30 Table 4.12 Duration of time that participants have been afflicted by onychocryptosis in the placebo group Years Frequency Total Percentage < 1 year 0 13 0 1 – 5 years 6 13 46.2 5 – 10 years 4 13 30.8 > 11 years 3 13 23.1

4.4 Number of participants who have previously had treatment for onychocryptosis

Tables 4.13 to 4.16 reflect the number of participants who have previously had any kind of treatment for onychocryptosis. On average, this was the first time for the majority of participants (60%) to have treatment for this condition.

Table 4.13 Overall number of participants who have previously had treatment for onychocryptosis in all three groups Previously treated Frequency Total Percentage No 24 40 60 Yes 16 40 40

Table 4.14 Number of participants who have previously had treatment for onychocryptosis in the 2M potency group Previously treated Frequency Total Percentage No 9 15 60 Yes 6 15 40

31 Table 4.15 Number of participants who have previously had treatment for onychocryptosis in the 30cH potency group Previously treated Frequency Total Percentage No 7 12 58.3 Yes 5 12 41.7

Table 4.16 Number of participants who have previously had treatment for onychocryptosis in the placebo group Previously treated Frequency Total Percentage No 8 13 61.5 Yes 5 13 38.5

4.5 Right foot versus Left foot versus Both feet affected by onychocryptosis

Tables 4.17 to 4.20 reflect which foot, if not both, was affected by onychocryptosis in the three groups in the study. More than half the participants had, on average, both feet affected.

Table 4.17 Overall results for feet affected by onychocryptosis in all three groups Foot Frequency Total Percentage Both 23 40 57.5 Left 9 40 22.5 Right 8 40 20

Table 4.18 Results for feet affected by onychocryptosis in the 2M potency group Foot Frequency Total Percentage Both 8 15 53.3 Left 4 15 26.7 Right 3 15 20

32 Table 4.19 Results for feet affected by onychocryptosis in the 30cH potency group Foot Frequency Total Percentage Both 6 12 50 Left 4 12 33.3 Right 2 12 16.6

Table 4.20 Results for feet affected by onychocryptosis in the placebo group Foot Frequency Total Percentage Both 9 13 69.2 Left 1 13 7.7 Right 3 13 23.1

4.6 Number of ingrown toenails per participant per foot

Tables 4.21 to 4.24 reflect the number of ingrown toenails per foot that each participant presented with. The majority of participants had the left hallux affected by onychocryptosis. The second highest percentage involves the right hallux. The other toes include a very small percentage of the results. Table 4.21 Overall number of ingrown toenails per foot in the three groups Foot Number of toes Number of participants Total Percentage Left 1 22 32 68.8 Left 2 6 32 18.8 Left 3 3 32 9.4 Left 4 0 32 0 Left 5 1 32 3.1 Right 1 17 31 54.8 Right 2 5 31 16.1 Right 3 7 31 22.6 Right 4 1 31 3.2 Right 5 1 31 3.2

33 Table 4.22 Number of ingrown toenails per foot in the 2M potency group Foot Number of toes Number of participants Total Percentage Left 1 8 12 66.8 Left 2 2 12 16.7 Left 3 1 12 8.3 Left 4 0 12 0 Left 5 1 12 8.3 Right 1 6 11 54.6 Right 2 2 11 18.2 Right 3 2 11 18.2 Right 4 0 11 0 Right 5 1 11 9.1

Table 4.23 Number of ingrown toenails per foot in the 30cH potency group Foot Number of toes Number of participants Total Percentage Left 1 8 10 80 Left 2 1 10 10 Left 3 1 10 10 Left 4 0 10 0 Left 5 0 10 0 Right 1 4 8 50 Right 2 2 8 25 Right 3 1 8 12.5 Right 4 1 8 12.5 Right 5 0 8 0

34 Table 4.24 Number of ingrown toenails per foot in the placebo group Foot Number of toes Number of participants Total Percentage Left 1 6 10 60 Left 2 3 10 30 Left 3 1 10 10 Left 4 0 10 0 Left 5 0 10 0 Right 1 7 12 58.3 Right 2 1 12 8.3 Right 3 4 12 33.3 Right 4 0 12 0 Right 5 0 12 0

4.7 Side of the hallux affected by onychocryptosis – medial versus lateral

Tables 4.25 to 4.28 reflect the results regarding which side of the hallux was affected by onychocryptosis. The majority of participants had the lateral side of the hallux affected. This is the side that presses on the second toe.

Table 4.25 Side of the hallux affected in all three groups Side Frequency Total Percentage Lateral 24 40 60 Medial 16 40 40

Table 4.26 Side of the hallux affected in the 2M potency group Side Frequency Total Percentage Lateral 9 15 60 Medial 6 15 40

35 Table 4.27 Side of the hallux affected in the 30cH potency group Side Frequency Total Percentage Lateral 8 12 66.7 Medial 4 12 33.3

Table 4.28 Side of the hallux affected in the placebo group Side Frequency Total Percentage Lateral 7 13 53.9 Medial 6 13 46.2

4.8 Comparison regarding the percentage improvement in pain

Tables 4.29 to 4.31 reflect the results regarding the percentage improvement in pain for the participants involved in the study. The three tables compare the improvement in pain amongst the three groups, as well as improvement in pain over the time-period while the study was being conducted. The interpretation and a discussion of these findings appear in Chapter 5.

Table 4.29 Percentage improvement in pain from week 0 - 3 Group Frequency Total Percentage 2M 2 15 13.3 30cH 2 12 16.7 Placebo 6 13 46.2

The p value = 0.1245, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

36 Table 4.30 Percentage improvement in pain from week 3 - 6 Group Frequency Total Percentage 2M 4 15 26.7 30cH 5 12 41.7 Placebo 6 13 46.2

The p value = 0.5579, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.31 Percentage improvement in pain from week 0 - 6 Group Frequency Total Percentage 2M 2 15 13.3 30cH 5 12 41.7 Placebo 9 13 69.2

In this case, the p value = 0.0095 for the comparison between the 2M potency and the placebo. As this is less than 0.05, it means that the null hypothesis is rejected and we accept the alternative hypothesis as these results are statistically significant. These results pertain to the pain experienced in the placebo group, not the 2M group and therefore the results as not statistically significant for the 2M group.

4.9 Comparison regarding the percentage improvement in tenderness to pressure

Tables 4.32 to 4.34 reflect the results regarding the percentage improvement in tenderness to pressure for the participants involved in the study. The three tables compare the improvement in tenderness to pressure amongst the three groups, as well as improvement in tenderness to pressure over the time-period while the study was being conducted. The interpretation and a discussion of these findings appear in Chapter 5.

37 Table 4.32 Percentage improvement in tenderness to pressure from week 0 - 3 Group Frequency Total Percentage 2M 7 15 46.7 30cH 5 12 41.7 Placebo 9 13 69.2

The p value = 0.3545, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.33 Percentage improvement in tenderness from week 3 - 6 Group Frequency Total Percentage 2M 4 15 26.7 30cH 8 12 66.7 Placebo 8 13 61.5

The p value = 0.0876, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.34 Percentage improvement in tenderness to pressure from week 0 - 6 Group Frequency Total Percentage 2M 8 15 53.3 30cH 8 12 66.7 Placebo 10 13 76.9

The p value = 0.4557, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

4.10 Comparison regarding the percentage improvement in swelling

Tables 4.35 to 4.37 reflect the results regarding the percentage improvement in swelling for the participants involved in the study. The three tables compare the improvement in

38 swelling amongst the three groups, as well as improvement in swelling over the time- period while the study was being conducted. The interpretation and a discussion of these findings appear in Chapter 5.

Table 4.35 Percentage improvement in swelling from week 0 - 3 Group Frequency Total Percentage 2M 3 15 20 30cH 4 12 33.3 Placebo 7 13 53.9

The p value = 0.1886, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.36 Percentage improvement in swelling from week 3 - 6 Group Frequency Total Percentage 2M 7 15 46.7 30cH 8 12 66.7 Placebo 10 13 76.9

The p value = 0.2748, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.37 Percentage improvement in swelling from week 0 - 6 Group Frequency Total Percentage 2M 6 15 40 30cH 8 12 66.7 Placebo 11 13 84.6

The p value = 0.0594, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

39 4.11 Comparison regarding the percentage improvement in redness

Tables 4.38 to 4.40 reflect the results regarding the percentage improvement in redness for the participants involved in the study. The three tables compare the improvement in redness amongst the three groups, as well as improvement in redness over the time-period while the study was being conducted. The interpretation and a discussion of these findings appear in Chapter 5.

Table 4.38 Percentage improvement in redness from week 0 - 3 Group Frequency Total Percentage 2M 4 15 26.7 30cH 6 12 50 Placebo 8 13 61.5

The p value = 0.1672, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

Table 4.39 Percentage improvement in redness from week 3 - 6 Group Frequency Total Percentage 2M 7 15 46.7 30cH 7 12 58.3 Placebo 10 13 76.9

The p value = 0.2610, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant. Table 4.40 Percentage improvement in redness from week 0 - 6 Group Frequency Total Percentage 2M 9 15 60 30cH 10 12 83.3 Placebo 11 13 84.6

40 The p value = 0.3148, which is > 0.05. This means that we accept the null hypothesis and the results are not statistically significant.

4.12 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails

Tables 4.41 to 4.44 reflect that the majority of participants (70%) presented with more than just the hallux being ingrown. Of this percentage of participants, more than half agreed that the study was beneficial to the other ingrown toenails as well.

Table 4.41 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in all three groups > 1 Ingrown Frequency Total Percentage No 12 40 30 Yes 28 40 70

Helped Frequency Total Percentage No 11 27 40.7 Yes 16 27 59.2

Table 4.42 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the 2M potency group > 1 Ingrown Frequency Total Percentage No 5 15 30 Yes 10 15 70

41 Helped Frequency Total Percentage No 7 10 70 Yes 3 10 30

Table 4.43 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the 30cH potency group > 1 Ingrown Frequency Total Percentage No 4 12 33.3 Yes 8 12 66.7

Helped Frequency Total Percentage No 1 7 14.3 Yes 6 7 85.7

Table 4.44 Percentage of participants who presented with more than one ingrown toenail, and felt that the study benefited the hallux as well as the other ingrown toenails, in the placebo group > 1 Ingrown Frequency Total Percentage No 3 13 23 Yes 10 13 76.9

Helped Frequency Total Percentage No 3 10 30 Yes 7 10 70

4.13 Percentage of participant compliance regarding taking the medication

Tables 4.45 to 4.48 reflect that overall, more than half the participants complied 100% with the rules on how to take the medication properly. The second group, the 30cH potency, is the most important group to consider here, as they are the only group who

42 received active medication on a bi-daily basis, and therefore, participant compliance is of the utmost importance.

Table 4.45 Percentage of participant compliance regarding taking the medication in all three groups Frequency Participant’s view Total Percentage of % complied complied 8 50% 40 20 10 75% 40 25 22 100% 40 55

Table 4.46 Percentage of participant compliance regarding taking the medication in the 2M potency group Frequency Participant’s view Total Percentage of % complied complied 3 50% 15 20 5 75% 15 33.3 7 100% 15 46.7

Table 4.47 Percentage of participant compliance regarding taking the medication in the 30cH group Frequency Participant’s view Total Percentage of % complied complied 1 50% 12 8.3 3 75% 12 25 8 100% 12 66.7 Table 4.48 Percentage of participant compliance regarding taking the medication in the placebo group Frequency Participant’s view Total Percentage of % complied complied 4 50% 13 30.8 2 75% 13 15.4 7 100% 13 53.9

43 4.14 Percentage of participant compliance regarding the rules and regulations of the study

Tables 4.49 to 4.52 reflect that, overall, more than half the participants complied 100% with the rules and regulations of the study.

Table 4.49 Percentage of participant compliance regarding the rules and regulations of the study in all three groups Frequency Participant’s view Total Percentage of % complied complied 10 75% 40 25 30 100% 40 75

Table 4.50 Percentage of participant compliance regarding the rules and regulations of the study in the 2M potency group Frequency Participant’s view Total Percentage of % complied complied 5 75% 15 33.3 10 100% 15 66.7

Table 4.51 Percentage of participant compliance regarding the rules and regulations of the study in the 30cH potency group Frequency Participant’s view Total Percentage of % complied complied 3 75% 12 25 9 100% 12 75

Table 4.52 Percentage of participant compliance regarding the rules and regulations of the study in the placebo group Frequency Participant’s view Total Percentage of % complied complied 2 75% 13 15.4 11 100% 13 84.6

44 4.15 Percentage of participant’s perception that the study was beneficial

This was the last question asked at the third and final consultation. It should be noted that this was a subjective question based on the participant’s point of view. The participants were asked if they felt that, regardless of their symptoms that had been noted on the questionnaires, if the study had been at all beneficial to them. Tables 4.53 to 4.56 reflect the results.

Table 4.53 Percentage of participant’s perception that the study was beneficial in the three groups Frequency Participant’s view Total Percentage of % beneficial complied 8 0% 40 20 3 25% 40 7.5 11 50% 40 27.5 3 75% 40 7.5 15 100% 40 37.5

Table 4.54 Percentage of participant’s perception that the study was beneficial in the 2M potency group Frequency Participant’s view Total Percentage of % beneficial complied 5 0% 15 33.3 1 25% 15 6.7 5 50% 15 33.3 0 75% 15 0 4 100% 15 26.7

45 Table 4.55 Percentage of participant’s perception that the study was beneficial in the 30cH potency group Frequency Participant’s view Total Percentage of % beneficial complied 2 0% 12 16.7 1 25% 12 8.3 2 50% 12 16.7 3 75% 12 25 4 100% 12 33.3

Table 4.56 Percentage of participant’s perception that the study was beneficial in the placebo group Frequency Participant’s view Total Percentage of % beneficial complied 1 0% 13 7.7 1 25% 13 7.7 1 50% 13 30.8 0 75% 13 0 7 100% 13 53.9

4.16 Summary

This chapter reflected the results obtained in this study. The interpretation and discussion of the findings are presented in the next chapter.

46 CHAPTER 5

INTERPRETATION AND DISCUSSION OF FINDINGS

5.1 Introduction

As mentioned in Chapter 1 (paragraph 1.3), this study was aimed at determining the efficacy of the remedy Magnetis Polus Australis 30cH in repeated doses versus 2M in a single dose, in the treatment of onychocryptosis with regard to symptoms such as pain in the great toe (hallux), tenderness to pressure, infection, erythema and oedema of the medial or lateral nail fold.

The present study further aimed to compare the effect of Magnetis Polus Australis 30cH versus Magnetis Polus Australis 2M in treating symptoms of onychocryptosis. It differs from those by Rohl (2003) and Khan (2004) in the following respects:

• Potency: Rohl (2003) used Magnetis Polus Australis in a 7cH and a 30cH potency. Kahn (2004) used Magnetis Polus Australis in a 200cH and a 1M potency. The present study used Magnetis Polus Australis in a 30cH and a 2M potency. • Identification and presentation of medication: Rohl (2003) used the remedy in liquid form. Kahn (2004) used the remedy in the form of impregnated lactose tablets. The present study used the 2M potency of the remedy as a once-off impregnated lactose powder and the 30cH in liquid form – similarly to Rohl (2003), in 20% alcohol. • Dosage, directions for use and duration: Rohl (2003) required administration of the remedy of five drops twice a day for a total of three weeks. Kahn (2004) required administration of the remedy of one tablet three times a day for three weeks. The present study required administration of the once-off powder immediately in the presence of the researcher and the five drops of the liquid twice a day for a total of six weeks.

47 • Sample size: Both Rohl (2003) and Kahn (2004) recruited 30 participants each. Forty participants were recruited for the present study.

The results of this study cannot support the position of the Materia Medica that Magnetis Polus Australis is a specific remedy for onychocryptosis. Furthermore, previous findings by Rohl (2003) and Khan (2004) in this regard are also not confirmed.

Results of the present study do not demonstrate an improvement in the symptoms of onychocryptosis. In contrast to the findings of the two studies by Rohl (2003) and Kahn (2004), the placebo group showed a surprisingly greater overall improvement in symptoms compared to the improvement in symptoms of the 30cH potency and the 2M potency. However, when comparing the 30cH to the 2M potency of Magnetis Polus Australis, the 30cH shows a greater overall improvement in general symptoms but the results were still not statistically significant. This particular finding does not confirm the results of Angelika Rohl’s study conducted in 2003, in which she also tested the 30cH potency and found it to be more effective than the 7cH potency for relieving the symptoms of onychocryptosis. The 30cH potency therefore fails to be proven to be the optimal potency to be used in the treatment of the symptoms of onychocryptosis. As shown below, there was one statistically significant result that showed improvement in pain symptoms but it was for the placebo group, not the 2M potency group, over the entire six week study.

The results of the study that were presented in Chapter 4 above, are now interpreted and discussed in detail, first in terms of gender, then age. Then the results for the specific symptoms for the overall time period of six weeks are illustrated by means of graphs.

5.2 Gender

As shown in table 4.4 in Chapter 4, the placebo group contained a higher percentage ratio (70:30) of female participants to males. This factor is in accordance with the findings by Weaver et al. (2004), mentioned in Chapter 2 (paragraph 2.2.1), namely that

48 onychocryptosis is twice more likely to affect females than males. Weaver et al. (2004) also mentions that after age 75, women are more likely to suffer from onychocryptosis than men.

5.3 Age

As mentioned in Chapter 4 (paragraph 4.2), the age distribution also seemed to pose a problem, even though it may be relatively negligible. A number of elderly participants from an old-age home participated in the study who had been afflicted by onychocryptosis for some time.

The effects of the 2M potency as compared to the 30cH are discussed in more detail and are also illustrated by means of graphs in the next section.

5.4 The 2M versus the 30cH potency overall average from zero to six weeks

The symptoms of onychocryptosis, after administration of the 2M and the 30cH potencies, were also compared from the first consultation up to the third consultation, which was six weeks later. The results showed that there was a statistically significant improvement in the symptom of pain in onychocryptosis.

The 2M potency showed 13.3% improvement in pain of the hallux versus 41.7% of the 30cH potency, whereas the placebo showed 69.2% (see Figure 5.1):

49 80

70

60

50

40 69.2 30 Percentage

20 41.7

10 13.3 0 2M 30cH Placebo Potencies

Figure 5.1 Percentage improvement in pain from week 0 - 6

In this case, the p value = 0.0095 for the comparison between the 2M potency and the placebo. As this is less than 0.05, it means that the null hypothesis is rejected and we accept the alternative hypothesis as these results are statistically significant. However, the placebo group out-performed the 2M potency and therefore this particular potency is not an effective treatment for pain for onychocryptosis over a period of six weeks.

The 2M potency showed 53.3% improvement in tenderness to pressure of the medial or lateral nail fold versus 66.7% of the 30cH potency, whereas the placebo showed 76.9% (Figure 5.2):

50 90

80 70

60

50

40 76.9

Percentage 66.7 30 53.3 20 10

0 2M 30cH Placebo Potencies

Figure 5.2 Percentage improvement in tenderness to pressure from week 0 – 6

The 2M potency showed 40% improvement in swelling of the hallux versus 66.7% of the 30cH potency, whereas the placebo showed 84.6% (see Figure 5.3):

90 80 70 60 50 40 84.6

Percentage 66.7 30

20 40 10 0 2M 30cH Placebo Potencies

Figure 5.3 Percentage improvement in swelling from week 0 – 6

The 2M potency showed 60% improvement in redness of the medial or lateral nail fold versus 83.3% of the 30cH potency, whereas the placebo showed 84.6% (see Figure 5.4):

51

90

80 70

60

50 40 83.3 84.6

Percentage 30 60 20 10

0 2M 30cH Placebo Potencies

Figure 5.4 Percentage improvement in redness from week 0 – 6

In the next paragraph, a comparison is made as regards time amongst the experimental groups, thereby highlighting the limitations of the study.

5.5 Limitations of the study

Most participants in the placebo group had an advantage as they had been suffering from symptoms of onychocryptosis for only 1 to 5 years. In contrast, the majority of sufferers in the 2M potency group had been afflicted by this condition for more than 11 years. The trend seems to be that the participants who have been afflicted by onychocryptosis for the longer period of time, did not respond well to the remedy, here the 2M potency, over the six week duration of the study. It seems that the higher the potency, the more time is needed for it to show an effect. The lower potencies seem to require less time. It would therefore seem that a longer trial period than six weeks is required in order to record the necessary symptomatic changes.

Both of the potency groups showed improvement in pain, but not a statistically significant improvement. Compared to the 2M potency, the placebo showed a statistically

52 significant improvement. There was also an overall improvement from the first consultation to the last, mainly by the placebo group, however, from week zero to week three and from week three to week six, the placebo group showed no improvement. Owing to this lack of response, it is possible that the remedy exhibited a similar or medicinal aggravation in the different potencies over time as follows:

Table 5.1 Aggravation caused by potencies over time POTENCY TIME NO PARTICIPANTS PERCENTAGE 2M 0 – 3 weeks 4 out of 15 26.6 3 – 6 weeks 1 out of 15 6.6 30cH 0 – 3 weeks 3 out of 12 25.0 3 – 6 weeks 2 out of 12 16.6

These results show that some participants in the 2M potency group showed a greater aggravation of symptoms over a shorter time period (26.6% over 3 weeks versus 6.6% over 6 weeks). This finding confirms that some participants may have experienced a similar or medicinal aggravation owing to the high potency being administered. The higher the potency, the more time may be needed for it to show an effect. Some participants in the 30cH potency group also showed a similar or medicinal aggravation of symptoms over a shorter time period (25.0% over 3 weeks versus 16.6% over 6 weeks) owing to the bidaily administration of the remedy. The lower potencies seem to require less time to show an effect. This increases the need for a longer administration period than six weeks in order to accurately assess any symptomatic changes of onychocryptosis.

Both of the potency groups showed improvement in tenderness to pressure, but the 30cH potency showed a greater improvement overall than the 2M potency, but it was not a statistically significant improvement. There was an overall improvement from the first consultation to the last, mainly by the placebo group. However, in the 2M potency group, the symptoms actually worsened from week three to week six, when compared to week zero to week three. This again points to the possibility of a homoeopathic aggravation and

53 highlights the necessity for a longer time period in order to accurately assess any symptomatic changes of onychocryptosis.

In respect of swelling, there was an overall improvement in symptoms from the first consultation to the last, mainly by the placebo group but it was not a statistically significant improvement. Both of the potency groups showed improvement in swelling, but the 30cH potency showed a greater improvement in swelling than the 2M potency.

In respect of redness, there was an overall improvement from the first consultation to the last, mainly by the placebo group but it was not a statistically significant improvement. Both of the potency groups also showed improvement in redness, but the 30cH potency showed a greater improvement in redness than the 2M potency.

In addition, it should be mentioned that the number of years that a participant has been afflicted by onychocryptosis seems to have had an impact on the success of the treatment. Results indicate that less improvement in symptoms was recorded in participants who had been suffering from onychocryptosis for a longer period of time. This means that the more chronic the condition, the less effect the remedy had in the short term.

In conclusion, when comparing the two experimental groups to whom the 2M and 30cH potencies had been administered, both of them showed an overall improvement in symptoms of onychocryptosis over a longer period of time although these results were not statistically significant. Very little improvement in symptoms is noticed from the first to the second consultation, and also from the second to the third consultation. The most notable improvement is recorded from the first to the third consultation, in other words, over a treatment period of six weeks. These two factors of time (duration of affliction and duration of study) pose a limitation on this study. In view of the fact that similar or medicinal aggravations may have been present in some participants, a six week period for conducting clinical trials such as this was too short. It is suggested that in order to overcome any aggravations, and for optimal changes in symptoms of onychocryptosis to be observed, a time period of between three and six months would be required.

54 5.6 Summary

As this chapter covered the interpretation of the findings recorded in Chapter 4, the final chapter makes suggestions and recommendations in respect of any future research that may be conducted on this particular topic.

55 CHAPTER 6

CONCLUDING REMARKS AND RECOMMENDATIONS

6.1 Conclusions

This study aimed to determine the efficacy of the remedy Magnetis Polus Australis 30cH in repeated doses versus 2M in a single dose, in the treatment of onychocryptosis with regard to symptoms such as pain in the hallux, tenderness to pressure, infection, erythema and oedema of the medial or lateral nail fold. These findings did not confirm the findings by both Rohl (2003) and Kahn (2004) and this means that Magnetis Polus Australis has not been proven to be an effective non-surgical approach to treat the symptoms of onychocryptosis.

The results of the Fischer Exact Test surprisingly indicated that there was a statistically significant increase in the improvement of symptoms in the placebo group, with regards to pain, whereas there was no statistically significant increase in the improvement of symptoms in the 2M and the 30cH experimental groups.

When comparing the two experimental groups, the 30cH potency showed a greater improvement than the 2M potency regarding the symptoms of onychocryptosis, namely, pain in the hallux, tenderness to pressure, swelling and redness of the medial and lateral nail fold, however, these results were not statistically significant. Some participants in the 2M potency group showed more aggravation than the participants in the 30cH group. Such aggravation could possibly be ascribed to the fact that participants in this group happened to have suffered from chronic onychocryptosis and experienced more acute pain than the other group.

In order to evaluate these findings in any future research on this topic, the following recommendations regarding onychocryptosis should be taken into consideration.

56 6.2 Recommendations

• Choosing a much larger sample size, for example, 100 participants, in order to validate chi-square testing. • Matching future studies in terms of gender, age and duration of condition in order to possibly minimize the placebo effect. • Extending the research period over a longer time, for example, from three to six months in order to observe physical changes in the nail itself, as well as observe more accurate changes in levels of improvement in symptoms. • Experimenting with different repetitions of the 2M potency dosage. • Applying a topical solution of Magnetis Polus Australis to the affected nail. • Testing and comparing other indicated remedies for onychocryptosis to Magnetis Polus Australis, for example Silicea and Hepar Sulph.

In conclusion, the purpose of this research study was mainly to compare the effects of the homoeopathic remedy Magnetis Polus Australis in two different potencies, 30cH and 2M. It is unfortunate that no distinctive beneficial results could be proven as regards either of these potencies of this homoeopathic treatment for relieving the uncomfortable symptoms of onychocryptosis.

57 REFERENCES

Abby, N.S., Roni, P., Amnon, B. and Yan, P. (2002) Modified sleeve method treatment of ingrown toenail, Dermatologic Surgery, 28(9):852-5 http://bhj.org/journal/20044505jan/html/ingrowing78.htm accessed 3/5/2007

Aksakal, A., Ozsoy, E. and Gurer, M. A. (2003) Silicone Gel Sheeting for the Management and Prevention of Onychocryptosis, Dermatologic Surgery, 29(3):261-264 http://www.blackwell-synergy.com accessed on 3/5/2007

Allen, H.C. (2001) Materia Medica of the Nosodes, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 252

Beers, M.H. and Berkow, R. (1999) The Merck Manual of Diagnosis and Therapy 17th ed, Merck Research Laboratories publishers, USA, pp. 459, 487, 495, 801

Boericke, W. (2004) Pocket Manual of Homoeopathic Materia Medica and Repertory and a chapter on Rare and Uncommon Remedies, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 42

Bourezane, Y., Thalamy, B., Viel J.F., Bardonnet K., Drobacheff, C., Gil, H., Vuitton, D.A., Hoen, B. (1999) Aidsline, Ingrown toenail and Indinavir: case-control study demonstrates strong relationship, 13(15):2181-2 http://bhj.org/journal/20044505jan/html/ingrowing78.htm accessed 8/6/2005

British National Formulary (2006) Anti-fungal medicines http://www.patient.co.uk/showdoc/27000437 accessed on 3/5/2007

Ceilley, R.I and Collison, D.W. (1992) Matricectomy, Journal of Dermatological Surgery, 18(8):728-734

58 Clarke, J.H. (2003) A Dictionary of Practical Materia Medica, ISIS 2005 edition, MICCANT publishers

Connelly, L.K., Dinehart, S.M. and McDonald, R. (1999) Onychocryptosis associated with the treatment of onychomycosis, Journal of the American Podiatric Medical Association, 89(8):424-426

Cox, H.A. and Jones, R.O. (1995) Direct extension osteomyelitis secondary to chronic onychocryptosis - three case reports, Journal of the American Podiatric Medical Association, 85(6):321-9 http://bhj.org/journal/20044505jan/html/ingrowing78.htm accessed 8/6/2005

Craig, T., Egland, A.G. and Rozdeba, C. (2004) Ingrown nails, eMedicine Journal, http://www.emedicine.com accessed on 27/07/2005

Crocco, J.A. (1977) Gray’s Anatomy, Crown Publishers, Inc., New York, USA, pp. 1139-1140

Denkler, K. (2001) A comprehensive review of epinephrine in the finger: to do or not to do, Plastic Reconstructive Surgery, 108(1):114-124

De Schepper, L. (2006) Hahnemannian Textbook of Classical Homeopathy for the Professional, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 240-246

Dawber, R.P. and Baran, R. (1994) The nails in disease, Butterworth-Heinemann publishers, Oxford, p. 209-221

Dougans, I. (2000) Reflexology – A Practical Introduction, Element Books Limited, Boston, USA, p. 108-109

59 Dudgeon, R. E. (1995) The Lesser Writings of Samuel Hahnemann, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 728

Egland, A.G. and Craig, T. (2006) Ingrown nails, eMedicine Journal, http://www.emedicine.com accessed on 18/04/2007

Gunal, I., Kosay, C., Veziroglu, A., Balkan, Y. and Ilhan, F. (2003) Relationship between onychocryptosis and foot type and treatment with toe spacer, Journal of the American Podiatric Medical Association, 93(1): 33-36

Gunavante, S.M. (1994) Introduction to Homoeopathic Prescribing, 4th edition, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 4-5

Hahnemann, S. (1996) Materia Medica Pura, Vol. 2, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 106

Hahnemann, S. (2003) Organon of Medicine, 6th edition, B. Jain Publishers (Pvt.) Ltd., New Delhi, pp. 296, 298, 299, 309

Hohl, U. (2007) Manufacturing process of 30cH potency Magnetis Polus Australis. Personal discussion, 19 November 2007 (Laboratory manager for Natura, Pretoria)

Kent, J. T. (1979) Lectures on Homoeopathic Philosophy, North Atlantic Books, Berkeley, California, pp. 102-104

Khan, S (2000) Healing Magnets: A Guide for Pain Relief, Speeding Recovery and Restoring Balance http://www.magneto-therapy.com/magneto-home.html accessed on 03/05/2007

60 Khan, T. (2004) The efficacy of Magnetic Polus Australis 200cH and 1M in the treatment of Onychocryptosis of the Hallux, Unpublished M Tech Homoeopathy dissertation, Technikon Witwatersrand

Kirkman, T.W. (1996) Statistics to Use, physics website http://www.physics.csbsju.edu/stats/exact.html accessed on 21/10/2007

Lawrence, B. (2007) Manufacturing process of 2M potency Magnetis Polus Australis. Personal discussion, 21 June 2007 (Technical director of Helios pharmacy, United Kingdom)

Mader, S.S. (1998) Biology, 6th ed, McGraw-Hill Companies, Inc., USA, p. 725

Marieb, E.N. (2000) Essentials of Human Anatomy and Physiology, 6th ed, Wesley Longman, Inc., San Francisco, pp. 101-102

Mathur, K.N. (2000) Principles of Prescribing, B. Jain Publishers (Pvt.) Ltd., New Delhi, p. 24

Merriam-Webster (2002) Medical Desk Dictionary, Merriam-Webster Incorporated Publishers, Massachusetts, USA, p. 572

Onumah, N. and Scher, R.K. (2006) Nail surgery, eMedicine Journal, http://www.emedicine.com accessed on 18/04/2007

Oster, J.A. (2007) Toe nail injuries, http://www.myfootshop.com /images/anatomy/ scans/scan_hallux_nail_mod.jpg accessed on 20/10/2007 (figure 2.1.) and http://www.myfootshop.com/ images/anatomy/ scan_hallux_AP_mod.jpg accessed on 20/10/2007 (figure 2.2.)

61 Philpott, W. H., Kalita, D. K. and Goldberg, B. (2000) Magnet Therapy, AlternativeMedicine.com Books, Tiburon, USA http://innerself.ca/Health/history_magnets.htm accessed on 3/5/2007

Piraccini, B.M., Parente, G.L., Varotti, E. and Tosti, A. (2000) Congenital hypertrophy of the lateral nail folds of the hallux: clinical features, Paediatric Dermatology 17(5):348-51 http://bhj.org/journal/20044505jan/html/ingrowing78.htm accessed 8/6/2005

Reyzelman, A.M., Trombello, K.A., Vayser, D.J., Armstrong, D.G. and Harkless, L.B. (2000) Are antibiotics necessary in the treatment of locally infected ingrown toenails?, Archives of Family Medicine 9(9):930-2 http://bhj.org/journal/20044505jan/html/ingrowing78.htm accessed 8/6/2005

Rohl, A. (2003) The efficacy of Magnetic Polus Australis 7cH and 30cH in the treatment of Onychocryptosis of the Hallux, Unpublished M Tech Homoeopathy dissertation, Technikon Witwatersrand

Schoeman, H.S. Prof. (2007) Statistical analysis of empirical data obtained for the present research study: A comparison of Magnetis Polus Australis 30cH to 2M on the symptoms of Onychocryptosis of the Hallux. (Qualifications: DSc PriSciNat.)

Seager, J. M. and Hawkey, C. J. (2001) ABC of the upper gastrointestinal tract: Indigestion and non-steroidal anti-inflammatory drugs, British Medical Journal 323:1236-1239 http://www.patient.co.uk/showdoc/27000439 accessed on 3/5/2007

Seher, B., Pelin, K. and Erbak, G. (2007) Comparison of phenol and sodium hydroxide chemical matrisectomies for the treatment of ingrowing toenails, Journal of Dermatological Surgery, 33(6):680-5

62 Simon, S. (2007) Fisher’s Exact Test website http://www.childrens-mercy.org/stats/ask/fishers.asp accessed on 21/10/2007

Weaver, T.D., Minh, V.T. and Thuan, V.P. (2004) Ingrowing toenails: Management practices and research outcomes, The International Journal of Lower Extremity Wounds, 3(1):22-34

Vermeulen, F. (2001) Concordant Materia Medica, B. Jain Publishers, New Delhi, India, p. 627

Vithoulkas, G. (1980) The Science of Homeopathy, Grove Press, Broadway, New York, pp. 98, 101, 102, 217, 218, 219, 227, 228

63 Appendix A

Participant information sheet

Dear Participant

My name is Katri Kruger. I am a fifth-year homeopathy student at the University of Johannesburg and I am currently doing my research dissertation on ingrown toenails (onychocryptosis). Ingrown toenails are very common, and although the condition is not life-threatening, it most certainly is very painful and uncomfortable.

This study aims to determine the efficacy of Magnetis Polus Australis 30cH versus 2M on the symptoms of onychocryptosis (ingrown toenails) with regard to pain in the big toe (hallux), tenderness to pressure, erythema and oedema of the lateral nail fold.

If you suffer from pre-diagnosed ingrown toenails, I would like to invite you to take part in this study!

The word homoeopathy originates from the two Greek words “homoios” meaning ‘similar’ and “pathos” meaning ‘pathology’ or ‘suffering’ and is a gentle form of treatment which makes use of highly diluted medicines. Homoeopathy is believed to work by stimulating the body to heal itself.

What to expect at your consultations: At the first consultation you will be requested to fill out a consent form, participant profile form, as well as a questionnaire together with me, the researcher, and I will examine your feet. You are requested to please remove all nail polish from all the toes before your examination and to please not apply any polish to the toenails for the duration of the fourty-two day study. The entire research study will be explained to you in detail. You will be requested to choose a set of medication containing a powder and a

64 bottle of liquid. You will be requested to take the powder immediately in my presence. The drops will be taken home. The second consultation is three weeks later (an appointment will be made) and once again we will complete a questionnaire and a foot examination. The last consultation is three weeks after the second one and once again we will complete a questionnaire and foot exam.

How to take your medicine and fill in the calendar: The drops are best absorbed away from food and should therefore be taken either half an hour before or one hour after eating. They must also not be taken with any strong tastes such as peppermint, curry, coffee or even toothpaste. Please shake the bottle before every dose of medicine. The dosage is five drops taken under the tongue twice a day for the entire duration of the six week study. The calendar corresponds to the study which is 42 days long and each day is split into a morning (am) and evening (pm) slot. Please tick each block of the calendar on each day that you took the medication. Please begin ticking the first block on the day of the first consultation. However, if you did not take the medication on that day, or even if you missed the morning or evening dose of medication, DO NOT TICK THE BLOCK. This is very important for statistical reasons, and to support patient compliance.

Your participation in the study: The advantage of participating in this research project is that you may experience relief from symptoms associated with your ingrown toenails. Some of the participants will receive placebo medications. Placebos are medicines without active medical substance. The use of a placebo group allows comparison between groups and results in more reliable statistical evaluation of the medicines and the potencies.

While the study is being conducted, neither you nor I will be aware as to which potency of remedy you are receiving, if any. At the end of the study you are welcome to contact me on the telephone number on the consent form, in order to obtain the results of the

65 study. I will tell you which potency of remedy you had, or if you had the placebo and what the results of the study were.

Please note that you will be requested to stop taking any other medication for ingrown toenails for the duration of the study. This includes nail paints of any kind.

Your participation in this study is completely voluntary and your details will be kept anonymous at all times. Confidentiality and privacy will be ensured by not linking your personal details to your data. You will have your own control number which will be used to identify your date of birth, but never your name. You are free to withdraw from the study at any time you choose for whatever reason. This will have no negative impact on you. Thank you for your contribution to science.

66 Appendix B

Consent form

I, ______, the voluntary participant, acknowledge that the aim of the study is to determine the efficacy of the homoeopathic remedy Magnetis Polus Australis 30cH versus 2M versus placebo in treating ingrown toenails and agree to give my full consent in order to participate. I understand that the study is completely voluntary and that I may withdraw at any time I choose. I understand that the study is completely confidential and at all times my personal details and results will be kept confidential. A copy of this consent form is available to you, the participant.

______Signature Date

I, Katri Kruger, the researcher, have fully informed the voluntary participant of the purpose of the study as well as the procedure that is to be followed and I will answer any further questions to the best of my ability.

______Signature Date

67 Appendix C

Participant profile

Control number:______Participant full name:______Participant gender: M F Date of birth:______Age:______Postal address:______Physical address:______Contact number: Cell:______Home:______Work:______E-mail address:______Do you suffer from any serious medical condition? If so, please specify: Arthritis: Y N Diabetes Mellitus: Y N Immune system deficiencies: Y N Other:______How long have you suffered from ingrown toenails?  Less than 1 year  1 to 5 years  5 to 10 years  More than 11 years Have you had any treatment previously for ingrown toenails? Y N If so, please specify:______Are you taking any medication in general? Y N If so, please specify:______Are you currently on medication for ingrown toenails? Y N If so, please specify:______Which foot is affected by an ingrown toenail? L R Both How many ingrown toenails do you have per foot?_Left______Right______Any further comments from the participant: ______

68 Appendix D

Initial visit and second follow up questionnaire

Participant name:______Control number:______Date of consultation:______Affected foot L R Toe number of the affected foot (from medial to lateral) 1 2 3 4 5 Side of the affected toe Medial Lateral

Please rate the following five symptoms on a scale of 0 to 5 in terms of their intensity:

None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe Tenderness to pressure Swelling Redness Infection

69 Appendix E

Final follow up questionnaire

Participant name:______Control number:______Date of consultation:______Affected foot L R Toe number of the affected foot (from medial to lateral) 1 2 3 4 5 Side of the affected toe Medial Lateral

Please rate the following five symptoms on a scale of 0 to 5 in terms of their intensity:

None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe Tenderness to pressure Swelling Redness Infection

Did you present with more than one ingrown toenail? Y N If you did, do you feel that the study has helped improve any of the other ingrown toenails? Y N To what extent have you complied with the specifications of taking the remedy?  0% 25% 50% 75% 100% To what extent have you complied with the rules and regulations of the study?  0% 25% 50% 75% 100% To what extent do you believe that the remedy has been beneficial to you?  0% 25% 50% 75% 100%

70 Appendix F

Calendar

Please tick each block on each day that you took the medication. The date is highlighted in bold and each date is split into a morning (am) and evening (pm) slot. Please begin ticking the block of the date on which you started with the first consultation. If you happen to get to the end of the calendar dates, go back to the beginning and continue from there. Because the study is 42 days long, there should ideally be 42 days filled with ticks. However, if you did not take the medication on that day, or even if you missed the morning or evening dose of medication, DO NOT TICK THE BLOCK. This is very important for statistical reasons, and to ensure patient compliance.

1 am 2 am 3 am 4 am 5 am 6 am 7 am pm pm pm pm pm pm pm 8 am 9 am 10 am 11 am 12 am 13 am 14 am pm pm pm pm pm pm pm 15 am 16 am 17 am 18 am 19 am 20 am 21 am pm pm pm pm pm pm pm 22 am 23 am 24 am 25 am 26 am 27 am 28 am pm pm pm pm pm pm pm 29 am 30 am 31 am 32 am 33 am 34 am 35 am pm pm pm Pm pm pm pm 36 am 37 am 38 am 39 am 40 am 41 am 42 am Pm pm pm Pm pm pm pm

71 Appendix G

Control numbers corresponding to potencies

Control number 30cH 2M Placebo 001 × 002 × 003 × 004 × 005 × 006 × 007 × 008 × 009 × 010 × 011 × 013 × 014 × 015 × 016 × 017 × 018 × 019 × 020 × 021 × 022 × 023 × 024 × 026 × 027 × 029 × 030 ×

72 031 × 032 × 033 × 034 × 035 × 037 × 038 × 039 × 041 × 042 × 043 × 044 × 045 ×

73 Appendix H Grading severity of symptoms of onychocryptosis per participant Potency 2M Control number 001 Date of birth 1917-11-26 Gender Female Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-02-22 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-03-15 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-05 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

74 Potency 2M Control number 002 Date of birth 1927-10-10 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 25%

Date 2007-07-26 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None 0 Hardly 1 Slight 2 Moderate 3 Severe 4 Excruciating 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

75 Potency 2M Control number 003 Date of birth 1981-12-24 Gender Male Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-08-03 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-24 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-14 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

76 Potency 2M Control number 004 Date of birth 1912-12-14 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 5 - 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

77 Potency 2M Control number 005 Date of birth 1911-02-21 Gender Female Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

78 Potency 30cH Control number 006 Date of birth 1928-03-05 Gender Female Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

79 Potency 30cH Control number 007 Date of birth 1914-08-27 Gender Female Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 - 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

80 Potency 30cH Control number 008 Date of birth 1926-02-02 Gender Female Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 5 - 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

81 Potency 30cH Control number 009 Date of birth 1970-10-26 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-07-22 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-12 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-02 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

82 Potency 30cH Control number 010 Date of birth 1928-10-31 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

83 Potency Placebo Control number 011 Date of birth 1962-04-12 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-22 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-12 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-02 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

84 Potency Placebo Control number 013 Date of birth 1928-04-02 Gender Male Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 25%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

85 Potency Placebo Control number 014 Date of birth 1933-04-02 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 5 - 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

86 Potency Placebo Control number 015 Date of birth 1932-07-12 Gender Female Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

87 Potency 2M Control number 016 Date of birth 1929-11-26 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

88 Potency 2M Control number 017 Date of birth 1954-03-09 Gender Male Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-03-20 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-10 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-01 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

89 Potency 2M Control number 018 Date of birth 1950-01-13 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-05-09 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-30 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-20 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

90 Potency 2M Control number 019 Date of birth 1968-12-27 Gender Female Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-04-05 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-17 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

91 Potency 2M Control number 020 Date of birth 1944-01-17 Gender Male Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-05-18 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-08 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-29 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

92 Potency 30cH Control number 021 Date of birth 1924-04-22 Gender Male Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

93 Potency 30cH Control number 022 Date of birth 1986-06-20 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails Less than 1 year To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 75%

Date 2007-07-22 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-12 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-02 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

94 Potency 30cH Control number 023 Date of birth 1986-10-19 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails Less than 1 year To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 75%

Date 2007-06-17 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-08 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-29 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

95 Potency 30cH Control number 024 Date of birth 1983-02-05 Gender Female Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-03-21 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-14 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-05 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

96 Potency Placebo Control number 026 Date of birth 1926-09-03 Gender Female Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

97 Potency Placebo Control number 027 Date of birth 1959-05-20 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-23 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-13 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-03 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

98 Potency Placebo Control number 029 Date of birth 1958-02-16 Gender Female Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-28 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-18 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-08 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

99 Potency Placebo Control number 030 Date of birth 1955-01-01 Gender Male Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-06-29 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-20 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-10 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

100 Potency 2M Control number 031 Date of birth 1969-05-09 Gender Male Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-06-05 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-17 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

101 Potency 2M Control number 032 Date of birth 1969-01-15 Gender Female Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-03-31 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-21 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-12 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

102 Potency 2M Control number 033 Date of birth 1980-02-27 Gender Male Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-25 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-15 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-05 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

103 Potency 2M Control number 034 Date of birth 1980-02-17 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 - 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-21 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-11 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-01 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

104 Potency 2M Control number 035 Date of birth 1980-10-02 Gender Female Which foot is affected Left Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-05-08 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-29 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-19 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

105 Potency 30cH Control number 037 Date of birth 1925-04-04 Gender Female Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 75%

Date 2007-07-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-16 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-09-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

106 Potency 30cH Control number 038 Date of birth 1983-02-08 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails Less than 1 year To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-04-10 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-01 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-05-22 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

107 Potency 30cH Control number 039 Date of birth 1977-10-29 Gender Male Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 – 10 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 25%

Date 2007-03-06 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-03-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-17 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

108 Potency Placebo Control number 041 Date of birth 1968-02-12 Gender Female Which foot is affected Left Which side of the big toe is affected Medial How long have you suffered from ingrown toenails More than 11 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 100%

Date 2007-07-20 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-10 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-31 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

109 Potency Placebo Control number 042 Date of birth 1957-03-03 Gender Male Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 5 - 10 years To what extent did you comply with the specifications of taking the remedy 50% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-07-10 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-31 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-08-21 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

110 Potency Placebo Control number 043 Date of birth 1952-11-05 Gender Female Which foot is affected Right Which side of the big toe is affected Medial How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 0%

Date 2007-03-15 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-05 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-04-26 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

111 Potency Placebo Control number 044 Date of birth 1982-01-07 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 75% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-06-09 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-30 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-07-21 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

112 Potency Placebo Control number 045 Date of birth 1987-10-03 Gender Female Which foot is affected Right Which side of the big toe is affected Lateral How long have you suffered from ingrown toenails 1 – 5 years To what extent did you comply with the specifications of taking the remedy 100% To what extent do you feel the remedy has been beneficial to you 50%

Date 2007-06-02 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection ×

Date 2007-06-23 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection × Date 2007-07-14 None Hardly Slight Moderate Severe Excruciating 0 1 2 3 4 5 Pain in the big toe × Tenderness to pressure × Swelling × Redness × Infection x

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