The efficacy of a complementary formulation of Folliculinum D6 and Five-Flower Formula, in the treatment of menopausal symptoms

Abstract

Menopausal symptoms are common causes for women to seek treatment. The severity of symptoms vary from patient to patient and reduces the quality of life for many women. Most women reach menopause between the ages of 45 and 55, some not until 60 and some at an early age in their thirties or forties (Stoppler, 2008). Aim This study aimed to offer an alternative form of treatment for women that are experiencing the unpleasant symptoms that are experienced with menopause, since hormone replacement therapy, may have adverse effects in some women (Wang-Cheng, 2007). This double-blind placebo controlled study investigated the efficacy of a complementary formulation of Folliculinum D6 and Five-Flower Formula™, (Folliculinum D6, Rock Rose, Impatiens, Clematis, Star of Bethlehem, Cherry Plum ) in the treatment of menopausal symptoms in terms of participants’ perception of the treatment. iii This formula is currently available commercially as an unregistered product trading under the name of Femme Rosa. This formula was developed by Dr Maharaj, and is prepared by Natura®. The formula consists of Folliculinum D6 and Five-Flower Formula™. Methodology A total of 60 female participants who were going through natural menopause and currently experiencing menopausal symptoms took part in the study. They were randomly assigned according to the randomization sheet drawn up by the supervisor, 29 participants to the treatment group and 31 to the placebo group. The study was conducted over a period of six weeks and participants were required to attend two consultations at the Homoeopathic Day Clinic at the Durban University of Technology. Participants were recruited according to the inclusion criteria set out. During the first consultation the participants completed the Greene Climacteric Scale questionnaire and a concise case history was taken, thereafter each patient was handed two hot flush diaries to be completed one week before treatment and during the sixth week of treatment. Each participant was required to take one tablet every morning and evening for 6 weeks. Six weeks after the first consultation participants attended the second consultation and the Greene Climacteric Scale was completed for the final time and the hot flush diaries collected. iv Results The results of the first questionnaire and hot flush diary were used as a baseline for statistical analyses. As each group consisted of 29 and 31 subjects, non-parametric tests were used for data analysis. All statistical analyses were carried out using SPSS version 15.0. Conclusion An improvement was demonstrated in both treatment and placebo groups after treatment yet this improvement was not statistically significant. The only symptoms that improved in the treatment group were the hot flushes and psychological symptoms however, there were no significant differences between the treatment and placebo group. It was concluded that the complementary formulation of Folliculinum D6 and Five-Flower Formula™ was not statistically effective in the treatment of menopausal symptoms in terms of the participants’ perception of the treatment.