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