M.Tech. (Homeopathy) / The purpose of this study was to compare the effectiveness of a mother tincture preparation of Vitex agnus-castus and a hornoeopathic 3x preparation of Vitex agnus-castus in the treatment of premenstrual syndrome. A sample of 15 subjects suffering from premenstrual syndrome was selected. The subjects were selected according to the diagnostic criteria of premenstrual syndrome and certain other criteria requtred for the study. The subjects were given questionnaires to complete regarding their medical history and menstrual details. All subjects signed a consent form before participating in the study. The subjects recorded their premenstrual symptoms on a PMS chart over two months. After the diagnosis of premenstrual syndrome was made. the subjects were then randomly divided into three equally sized groups by a neutral homoeopath. The first group received placebo medication. the second received a homoeopathic 3x preparation of Vitex agnus-castus and the third received a mother tincture preparation of Vitex agnus-eastus. Each subject was given Instructions on how and when to take her medication. At no stage did either the researcher or the subjects know which medication they were receiving. The subjects took their medication for three months. during which they continued to record their symptoms daily. After three months. the PMS charts were again collected and the scores compared to the pre-treatment scores. The Kruskal-Wallis test was used to statistically analyse the results. The homoeopathic 3x preparation of Vitex agnus-eastus was found to bring about a statistically significant improvement in symptoms. while the mother tincture preparation of Vitex agnus-castus was not. The common name of Vitex agnus-castus used in homoeopathy is Agnus castus. For the sake of consistency. the name Vitex agnus cestus. as used in the German Homoeopathic Pharmacopoeia. shall be used throughout.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / Since ancient times men have been using plants as food, and also for medicine preparation, for its necessity to cure diseases or alleviate pains. Innumerable scientific studies have been carried out aiming to validate popular information about the use of medicinal plants. The importance of this study is real for the following reasons: pain is one of the most complex problems that affect human beings, the costs of industrialized medicines are prohibitive, and the fact that Brazil as a developing country has 60% of the industrialized remedies being consumed by only 23% of the Brazilian population. This research may reduce costs of public health programs and consequently, be a way of extending the number of benefits and users of these programs. The present work of experimental research aimed at evaluating antinociceptive action and acute toxicity of the watery extract taken from leaves of Vitex agnuscastus L, known, in caatinga of the state of Sergipe-Br, as chasteberry, a very common plant in this area, used for pain relief through the use of its leaves. The anti-nociceptive effect of the watery extract of Vitex agnus-castus leaves was tested through the experimental models of nociception in mice. The hydrous extract (200 and 400mg/Kg) decreased the acid nociception, produced by the ascetic acid (0.6%), in 46.5% and 70.7% and increased latency period (s) of the mice in the hot plate test. In the formalin test (1%) the extract (400mg/Kg) reduced the nociception in 59.6%. The anti-nociceptive effect of the plant was reverted by naloxone (5mg/Kg). The hydrous extract of V. agnus-castus did not have reach DL50 until the dose of 5g/Kg, indicating low acute toxicity in mice. The anti-nociceptive effect of this plant is associated with the opioid system. / O homem usa as plantas desde os primórdios para alimentação, como também, para preparação de medicamentos, pela sua necessidade de curar ou aliviar seus males e suas dores. Inúmeros estudos científicos vêm sendo realizados no sentido de validar as informações populares referentes ao uso de plantas medicinais. Como a dor é um dos maiores males que atingem o ser humano, e os custos dos medicamentos industrializados não são acessíveis às populações mais carentes e como o Brasil é um país em desenvolvimento, em que 60% dos remédios industrializados são consumidos por apenas 23% da população brasileira, torna-se evidente a importância do estudo científico das plantas medicinais, como forma de baixar os custos dos programas de saúde pública e, conseqüentemente, ampliar o número de benefícios e usuários de seus programas. O presente trabalho de pesquisa experimental teve como objetivo avaliar a ação antinociceptiva e toxicidade aguda do extrato aquoso obtido das folhas da Vitex agnus-castus L, conhecida na caatinga do Estado de Sergipe-BR como pimenta-da-costa , planta muito utilizada pela comunidade para alívio da dor através do uso de suas folhas. O efeito antinociceptivo do extrato aquoso das folhas de Vitex agnus-castus foi testado através dos modelos experimentais de nocicepção em camundongos. O extrato aquoso (200 e 400mg/kg) reduziu em 46.5% e 70.7% a nocicepção produzida pelo ácido acético (0.6%) e aumentou o tempo (s) de latência dos camundongos no teste da placa quente. No teste da formalina (1%) o extrato (400mg/kg) reduziu a nocicepção em 59.6%. O efeito antinociceptivo da planta foi revertido pela naloxona (5mg/kg). O extrato aquoso de V. agnus-castus não apresentou DL50 até a dose de 5g/kg, indicando baixa toxicidade aguda em camundongos. O efeito antinociceptivo desta planta está associado ao sistema opióide.

Submitted in partial fulfillment of the requirements for the Degree of Master of Technology in Homoeopathy, Durban University of Technology, Durban, South Africa, 2018. / Research Problem Statement Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS) that involves a combination of emotional and physical symptoms that result in significant functional impairment. PMDD can be debilitating and there are multiple treatment options available, but these are not without side effects. Although complimentary or alternative medicine may be beneficial in treating PMDD, however, there is not enough data available to validate their effectiveness. This study aimed at comparing and determining the efficacy of a homoeopathic mother tincture complex (Vitex agnus castus, Melissa officinalis and Valeriana officinalis) compared to placebo in the management of PMDD. Methodology A sample size of 30 consenting female participants with PMDD who met the inclusion criteria as set out in the Diagnostic and Statistical Manual of Mental Disorders. The duration of the study was three months for each participant. Participants were randomly divided into experimental and placebo groups with three consultations over the study period where Kessler Psychological Distress Scale and Visual Analogue Scale were applied. Non-parametric and inferential analysis of data were performed to analyse and compare the effects of treatment and time on symptoms over the three consultation periods (α.05). Results Results for both scales showed no statistical significance in the interaction between time and treatment. The results showed no statistical differences between the control and experimental group in the management of PMDD. However, the mean value measured in the experimental group were consistently lower than the control. Conclusion The conclusion derived from this study is that the homoeopathic complex studied is not effective in the treatment of PMDD. None of the results showed significant differences between the treatment and the placebo group trials. Further studies are highly recommended in this field. / M

Background: Interest in alternatives to hormone therapy (HT) for menopausal symptoms increased following its association with serious health risks. In terms of phytotherapeutic interventions, while traditional use supports a range of herbs for treating menopausal symptoms, evidence from rigorous scientific trials is limited, and has largely focused on the phytoestrogenic plants. Because of some safety concerns over long-term use of isoflavones, the present study focused on two non-estrogenic herbs, Hypericum perforatum and Vitex agnus-castus, also employed in this context in the Anglo-American and European traditions. Both herbs have shown effectiveness for the alleviation of symptoms of premenstrual syndrome (PMS), which is reported to be more severe during the perimenopause, and may account for many of the so-called 'menopausal symptoms' at this time. Research on menopausal vasomotor symptoms is prone to substantial placebo responses. There has been much interest in increasing our understanding of the placebo response with a view to controlling it in clinical research and harnessing it in clinical practice. Methods & Results: A double-blind, randomised controlled trial (RCT), with a 16-week treatment phase, was conducted on 100 late-perimenopause and early postmenopause women. The herbal combination (Hypericum and Vitex) was not found to be superior to placebo for any of the endpoints - daily weighted flushing scores, overall menopausal symptoms (on the Greene Climacteric Scale) and depression (on the Hamilton Depression Inventory). However, significant improvements across the treatment phase were observed in both arms for all of these outcome measures. No significant change was found for either group on the Utian quality of life scale. The effects of the herbal combination were also examined on PMS-like symptoms in the small sub-population of late-perimenopausal women, and found to be superior to placebo for total PMS-like symptoms and the sub-clusters, PMS-D (depression) and PMS-C (cravings). The active treatment group also showed significant improvements on PMS-A (anxiety) and PMS-H (hydration), although these effects were not superior to placebo. Predictors of the placebo response were investigated and found to include study-entry anxiety for the outcome measures of flushing, depression and overall menopausal symptoms, and improvement during non-treatment run-in for depression and overall symptoms. Because no difference had been found between 'active' and placebo groups in the menopause RCT, it was hypothesised that the same predictors would predict the response to the study treatment. However, low anxiety was significantly associated with improvement in this group. None of the other variables that predicted the placebo response was relevant to the study treatment response. This finding is discussed with reference to the possibility that 'drug' effects and placebo effects are not necessarily additive, and that the same magnitude of effect in both arms might not necessarily imply activity via the same pathways. Conclusions: This research contributes to the growing body of scientific knowledge about evidence-based complementary therapies that informs the community, health-care providers and regulatory authorities. The findings may facilitate identification of potential placebo responders in future research. The need for more research in the area of mechanisms of placebo versus active responses is supported.