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Efficacy of Topical Application of Plant Extract Based Natural Oils in Management of Polycystic Ovarian Syndrome: a Two-Arm Parallel Group Randomised Double-Blind Placebo-Controlled Clinical Study

Amul S Bahl

Background: Literature indicates current treatments of PCOS are designed to manage individual symptoms and not the syndrome itself. Pharmacological treatments may have side effects in long-term. Whereas, the studies to measure effectiveness of complementary and alternative medicine (CAM) are done on rat models. Thus, there are also no human clinical trials to establish CAM efficacy to manage PCOS. Objective: This study objective is to scientifically establish the clinical efficacy of topical application of 100% plant extract based natural oil-blend on PCOS management by addressing the subjective (viz., irregular menstruation, menstrual cycle duration, bleeding quantity, pain during menses) and objective (viz., hirsutism, ovarian volume, number of follicular cysts, number of mature follicles) PCOS symptoms. Method: In a two-arm parallel group, prospective, randomized, double-blind, placebo-controlled study with adult female participants diagnosed with PCOS and fulfilling inclusion criteria; 100 participants were allocated between two study arms (test and placebo) in the ratio of 1:1 using a randomisation list. Findings: After treatment, compared to placebo, test group showed significant decrease (p<0.01) in the average composite score for subjective symptoms. Test oil resulted in significant decrease in hirsutism, in ovarian volume in both right and left ovaries, and in number of follicular cysts on both the ovaries. Mature follicles in test group increased resulting in 17 incidences of conception out of 46 after 6 months post-study follow-up. No adverse events were reported. Conclusion: The test oil-blend effectively managed eight studied symptoms of PCOS rather than working on isolated symptoms of PCOS.