Homoeopathy in polycystic ovarian syndrome: A randomized placebo‑controlled pilot study

Abstract

Background: Polycystic ovarian syndrome (PCOS) is an emerging health problem in young females characterized by ovarian dysfunction and hyperandrogenism. Existing information indicates a positive role of homoeopathy but more rigorous studies are desirable. This protocol has been developed to undertake a pilot study to evaluate the efficacy of homoeopathic intervention using established diagnostic criteria. Methods/Design: It will be a multi‑centric, randomized, placebo controlled pilot study with a 6‑month intervention and follow up period. Minimum 60 cases fulfilling the eligibility criteria will be enrolled and randomized to receive either the homoeopathic intervention or the identical placebo. Both the arms follow lifestyle modification for weight reduction. Primary endpoint will be the establishment of regular menstrual cycle along with improvement in either ultrasonology or hirsutism/acne. Secondary endpoints will be to compare the changes in total and individual domain scores of PCOS questionnaire at monthly interval and the changes in ultrasound of polycystic ovaries. For the primary outcome and each of the secondary outcomes, both per protocol and modified intention to treat analysis will be done. Discussion: This pilot study has been planned considering the varied presentation of PCOS as per international diagnostic criteria and accordingly the composite endpoints have been kept for evaluation. The outcome of this pilot study will help in planning a definite study. Trial registration: CTRI/2013/09/003983 [Registered on: 16/09/2013].