Randomized controlled trial of combined lifestyle and herbal medicine in women with polycystic ovary syndrome

Study question: Does combined lifestyle intervention and a novel herbal formulation improve oligomenorrhoea compared to lifestyle alone in overweight community based women with polycystic ovary syndrome (PCOS)? Summary answer: At three months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% CI,23.3–42.6, p < 0.01) compared to controls, estimated as a moderate-large effect. Main results and the role of chance: At three months the mean menstrual cycle length was 43 days (95% CI, 21 to 65, p < 0.001) lower for women in the combination group compared to those in the lifestyle only group. Secondary outcomes were significantly improved for women taking combined herbal medicine and lifestyle compared to controls for BMI (MD -1.0 95% CI -1.6 to -0.5, p < 0.01), increased oestradiol (MD 68.9 pmol/L, 95% CI 5.5 to 132.3, p = 0.03); lowered LH (MD -1.82IU/L, 95% CI -3.5 to -0.1, p = 0.04), fasting insulin (MD -5.9mU/l, 95% CI -10.9 to -1.0, p = 0.02; systolic (MD -3.6 mmHg, 95%CI-6.3 to -0.9, p = 0.01) and diastolic (-5.1 mmHg, 95%CI -7.8 to - 2.4, p < 0.01) blood pressure; PCOSQ score (MD -31.1, 95% CI -41.4 to -20.7, p < 0.01), depression (-4.3, (95% CI -5.9 to -2.7, p < 0.01), anxiety (-4.0, 95% CI -5.4 to -2.6, p < 0.01) and stress (-5.0, 95% CI -6.5 to -3.5, p < 0.01) scores and increased conception rates (RR 3.9, 95% CI 1.1 to 13.1, p = 0.01). The residual effect of loss of body weight on the primary outcome (number of days in the menstrual cycle) after controlling for baseline menstrual variation was not significant (p = 0.07). Two women in in the herbal medicine group were withdrawn due to non-serious adverse effects.