Abstrakt

Homoeopathic medicine-Sepia for management of Menopausal Symptoms: A Multi-centric Randomized Double Blind Placebo Controlled Clinical Trial

Jaya Gupta

Background: Based on the results of Central Council for Research in Homoeopathy’s previous study, wherein Sepia was indicated and prescribed in maximum number of cases, this study was planned to further validate efficacy of Sepia in the management of menopausal symptoms. Sepia for management of Menopausal Symptoms: A Multi-centric Randomized Double Blind Placebo Controlled Clinical Trial Objectives: The study was conducted with the objectives of evaluating the efficacy of Homoeopathic medicine ,Sepia in the management of menopausal symptoms using ‘The Greene Climacteric Scale’ (GCS) and the quality of life using Utian Quality of Life Scale (UQOL). Material and methods: A randomized double-blind placebo controlled clinical study was conducted from April 2012 to September 2014 at four research centres of CCRH. Peri-menopausal cases (n=471) were screened and those fulfilling the eligibility criteria (n=88) were enrolled and randomized to either homoeopathic intervention i.e. Sepia (n=44) or the identical placebo (n=44) and followed up for six months for assessment of predefined clinical outcomes. Results: 88 patients were considered for primary outcome analysis. The primary outcome measure i.e. total score of Greene Climacteric Scale (GCS) when compared after 6 months was reduced from 30.23±8.1 to 7.86±4.6 in Sepia group (improvement of 73.9%) and 30.05±8.9 to 12.73±8.3 in placebo group (improvement of 57.63%) (p=0.001) . There was improvement in quality of life score also. With respect to secondary objective, the total UQoL score was 59.09±7.74 for Sepia group and 57.39±7.80 for placebo group at baseline indicating slight difference in quality of life after six months. Conclusion: Sepia is able to allay the menopausal symptoms when prescribed on symptomatic indications as per homoeopathic principles.