Expected and Unexpected Outcomes of Probiotics and Metformin Interventions in Polyendocrine Metabolic Ovary Syndrome (PMOS, former PCOS): Findings from a Randomised Placebo-Controlled Trial
Abstract
Abstract Background : Polyendocrine Metabolic Ovary Syndrome (PMOS, formerly known as Polycystic Ovary Syndrome, PCOS) is a complex endocrine disorder characterised by hyperandrogenism, oligo-or anovulation, metabolic disturbances and polycystic ovarian morphology. Depending on symptom profile and treatment goals, management commonly includes lifestyle interventions, oral contraceptives, and/or insulin-sensitizing medication. Because gut microbiome alterations are common features in PMOS, this study explores dietary probiotic supplements as a potential therapeutic approach. Methods : A mono-centric, double-blind, randomised phase IV trial assessed a 6-month probiotic intervention versus placebo and open-label metformin (positive control). Recruitment occurred from November 2020 to March 2023, mainly during the COVID pandemic. Primary outcome was a change in serum free testosterone. Secondary outcomes included hormonal, metabolic, nutritional and gut-microbiome parameters. Within-group effects (baseline to 6 months) and between-group effects (comparisons of treatment effects) were analysed using t-test, Mann-Whitney U-test, and ANCOVA as appropriate. Results : Of 112 participants screened, 102 were randomised (32 probiotic, 36 placebo, 34 metformin). The target sample size of n= 60 per group was not achieved. The primary endpoint was evaluable in 79 participants (25 probiotics, 27 placebo, 24 metformin). Changes in serum free testosterone were not different between the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 112 participants or records.
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