Submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homeopathy, Durban University of Technology, Durban, South Africa, 2016. / INTRODUCTION Dysmenorrhoea is defined as difficult menstrual flow or painful menstruation. Dysmenorrhoea is the most common gynaecological complaint in younger women who present themselves to clinicians. Primary dysmenorrhoea is defined as painful menstrual cramps without any evident pathology present. It refers to any degree of perceived cramping pain experienced during menstruation. Around 50% of menstruating females suffer from primary dysmenorrhoea. Prevalence decreases with age, with prevalence being highest in the 20 to 24 year old age group. This trial intended to evaluate the effectiveness of a phytotherapeutic complex in the treatment of primary dysmenorrhoea compared to homoeopathic similimum in a 30 cH plussed potency. This study aimed to provide the safe and effective alternative therapy for primary dysmenorrhoea, especially for the population that is contradicted to use the readily available forms of treatments. TRIAL DESIGN This double-blind randomised parallel clinical trial, aimed to determine the effectiveness of a phytotherapeutic complex consisting of Angelica sinensis1:10, Dioscorea villosa1:10, Matricaria chamomilla 1:10, Viburnum opulus 1:10, and Zingiber officinalis 1:10 in the treatment of primary dysmenorrhea, compared to homoeopathic similimum in a 30cH plussed potency. METHODOLOGY A sample group of 26 participants were voluntarily selected for the study on the basis of an inclusion and exclusion criteria. These participants were then randomly divided into two groups, 17 in the group receiving the phytotherapeutic complex, 8 in the control group receiving the similimum and 1 drop-out. Each participant had to attend a total of four consultations with the researcher over a three month period, at the Durban University of Technology (DUT) Homoeopathic Day Clinic. At each consultation the participant completed the Moos Menstrual Distress Questionnaire (MDQ) (Appendix B) as well as the Pain Rating Scale (PRS) (Appendix C). Intra-group analysis was performed using the non-parametric test for analysis of variance: Friedman’s test. Inter-group analysis was conducted using the Mann- Whitney U test for two independent samples. RESULTS Results from the intra-group analysis showed that in both groups most measured parameters relating to experience during the previous menstrual flow showed statistically significant reductions in intensity. This is to say that both the group receiving phytotherapy and the group receiving similimum experienced reductions in their symptoms as measured by both the MDQ and the PRS. Results from the inter-group analysis showed that there is no significant difference between the phytotherapy and similimum group in all symptoms except the water retention category, with regard to symptom perception during the last menstrual flow of the trial. CONCLUSION The conclusion reached in this study was that both the phytotherapeutic complex treatment and the homoeopathic similimum treatment were effective at reducing the clinical features of primary dysmenorrhea, but there was no significant difference between the phytotherapy and similimum group in all except the water retention category during the last menstrual period as measured by the MDQ Further, there was no statistically significant difference between groups treated with phytotherapy compared to similimum as measured by the PRS. / M

Submitted in partial compliance with the requirements of the Master’s Degree in Technology: Homeopathy, Durban University of Technology, Durban, South Africa, 2016. / INTRODUCTION Dysmenorrhoea is defined as difficult menstrual flow or painful menstruation. Dysmenorrhoea is the most common gynaecological complaint in younger women who present themselves to clinicians. Primary dysmenorrhoea is defined as painful menstrual cramps without any evident pathology present. It refers to any degree of perceived cramping pain experienced during menstruation. Around 50% of menstruating females suffer from primary dysmenorrhoea. Prevalence decreases with age, with prevalence being highest in the 20 to 24 year old age group. This trial intended to evaluate the effectiveness of a phytotherapeutic complex in the treatment of primary dysmenorrhoea compared to homoeopathic similimum in a 30 cH plussed potency. This study aimed to provide the safe and effective alternative therapy for primary dysmenorrhoea, especially for the population that is contradicted to use the readily available forms of treatments. TRIAL DESIGN This double-blind randomised parallel clinical trial, aimed to determine the effectiveness of a phytotherapeutic complex consisting of Angelica sinensis1:10, Dioscorea villosa1:10, Matricaria chamomilla 1:10, Viburnum opulus 1:10, and Zingiber officinalis 1:10 in the treatment of primary dysmenorrhea, compared to homoeopathic similimum in a 30cH plussed potency. METHODOLOGY A sample group of 26 participants were voluntarily selected for the study on the basis of an inclusion and exclusion criteria. These participants were then randomly divided into two groups, 17 in the group receiving the phytotherapeutic complex, 8 in the control group receiving the similimum and 1 drop-out. Each participant had to attend a total of four consultations with the researcher over a three month period, at the Durban University of Technology (DUT) Homoeopathic Day Clinic. At each consultation the participant completed the Moos Menstrual Distress Questionnaire (MDQ) (Appendix B) as well as the Pain Rating Scale (PRS) (Appendix C). Intra-group analysis was performed using the non-parametric test for analysis of variance: Friedman’s test. Inter-group analysis was conducted using the Mann- Whitney U test for two independent samples. RESULTS Results from the intra-group analysis showed that in both groups most measured parameters relating to experience during the previous menstrual flow showed statistically significant reductions in intensity. This is to say that both the group receiving phytotherapy and the group receiving similimum experienced reductions in their symptoms as measured by both the MDQ and the PRS. Results from the inter-group analysis showed that there is no significant difference between the phytotherapy and similimum group in all symptoms except the water retention category, with regard to symptom perception during the last menstrual flow of the trial. CONCLUSION The conclusion reached in this study was that both the phytotherapeutic complex treatment and the homoeopathic similimum treatment were effective at reducing the clinical features of primary dysmenorrhea, but there was no significant difference between the phytotherapy and similimum group in all except the water retention category during the last menstrual period as measured by the MDQ Further, there was no statistically significant difference between groups treated with phytotherapy compared to similimum as measured by the PRS. / M

Submitted in partial compliance with the requirements of the Master’s Degree in Technology in Homoeopathy, Durban University of Technology, Durban, South Africa, 2018. / Dysmenorrhoea is the term used to describe painful menstrual cramps, and is the most commonly encountered gynaecological disorder. It affects more than 50% of women of reproductive age, of which 10% to 12% experience severe dysmenorrhoea that interferes with their daily lives by incapacitating them for 1 to 3 days each month. Dysmenorrhoea is estimated to be the single greatest cause of working hours lost by women and school absence in teenage girls (Dawood 2008; Lindeque 2015: 6-9). Primary dysmenorrhoea is defined as painful, spasmodic cramping in the lower abdomen just before and/or during menstrual bleeding, in the absence of any identifiable macroscopic pathology. It is related to increased levels of inflammatory markers such as vasopressin, prostaglandins (PGF2α) and leukotrienes from the secretory endometrium. These induce ischaemia due to excessive prolonged uterine contractions, increased the sensitivity of pain fibres, and cause vasoconstriction (Iacovides, Avidon and Baker 2015: 1-17; Stewart and Deb 2014: 296-302). This double-blinded randomised study aimed to establish the efficacy of a homoeopathic complex (consisting of Angelica sinensis 6cH, Dioscorea villosa 6cH, Matricaria chamomilla 6cH, Viburnum opulus 6cH and Zingiber officinalis 6cH) compared to a homoeopathic similimum in 30cH plussed potency in the treatment of the symptoms of primary dysmenorrhoea, in terms of the participants’ perception of the treatment. Thirty female students, who signed the inform consent forms (Appendices B and D), from the Durban University of Technology were selected based on specified inclusion and exclusion criteria after they underwent an abdominal ultrasound examination (Appendix D) by a gynaecologist. They were randomly divided by means of convenience sampling according to a randomisation sheet into two groups. There were 20 in the experimental group which received the homoeopathic complex, and 10 in the control group which received the homoeopathic similimum. The study took place at the Homoeopathic Day Clinic, located at the Durban University of Technology. It was conducted over a period of three menstrual cycles per participant. The initial consultation took place prior to a menstrual period and the subsequent three follow-ups took place once a month, a week after each menstrual period. During each consultation, a detailed homoeopathic case history was conducted and a physical examination including an abdominal examination was performed. In addition, the participants were required to complete the Moos Menstrual Distress Questionnaire (Moos 1968) (Appendix G) and the Pain Rating Scale (British Pain Society 2006) (Appendix H). SPSS version 23.0 software was used to analyse the data collected from these questionnaires. The quantitative variables across the groups were compared using the Kruskal-Wallis test since the captured data was non-parametric. The one-way analysis of variance (ANOVA) was used to compare intra-group data. Quantitative variables were expressed as a mean ± standard deviation. A p-value less than 0.05 was considered significant. The intra-group analysis using the PRS and the MDQ scales (Appendices G and H) showed statistically significant changes in the subcategories of pain in the simillimum group, while these changes were noticed in the complex group only with the PRS scale, when different follow up mean pain score was compared to that at baseline. The different comparisons and p-values can be found in the Appendix G1. The homoeopathic complex group showed more statistically significant changes in the subcategories of behaviour change, negative affect, and control (Appendix G1); while the homoeopathic similimum also revealed other statistically significant changes in the autonomic response and appetite change subgroups (Appendix G1). The inter-group analysis did not reveal any statistically significant change between the groups, although a decrease in the majority of the various mean scores was observed throughout the study. The study’s results led to the conclusion that both the homoeopathic complex and homoeopathic similimum were effective (Appendix G1) in the treatment of symptoms of primary dysmenorrhoea during various follow-ups, as well as reducing the need for allopathic pain medications in the participants during the study. However that efficacy shown by the presence of statistically significant results could not been maintained throughout the study from the baseline to the third follow-ups, this could be due to the smaller sample size of the participants, the need for a better suited similimum remedy with a higher potency for the control group; or the need for another complex remedy, It was also noted that there was no evidence that one treatment was more beneficial than the other even though a decrease in the mean scores was observed in both groups. / M