Cangfu Daotan decoction with Diane-35 in phlegm-dampness polycystic ovary syndrome: A meta-analysis and systematic review

Xiaomeng ZhouYun Wang^*

• Department of Obstetrics and Gynecology, Hangzhou Women's Hospital, Hangzhou, China

Background: To systematically evaluate the efficacy of Cangfu Daotan decoction combined with Diane-35 in treating phlegm-dampness polycystic ovary syndrome (PCOS) and its effects on endocrine- and metabolism-related outcomes. Methods: Major English and Chinese databases (PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, CQVIP, and SinoMed) were searched. Randomized controlled trials comparing Cangfu Daotan–based therapy plus Diane-35 versus Diane-35–based regimens were included. Two reviewers independently screened studies, extracted data, and assessed the risk of bias via the Cochrane tool. The meta-analysis was conducted with RevMan 5.4. The relative risk (RR) with 95% confidence intervals (CIs) was used for dichotomous outcomes, and the mean difference (MD) with 95% CIs was used for continuous outcomes. Fixed- or random-effects models were applied according to heterogeneity (I² threshold of 50%). Publication bias was assessed via funnel plots. Results: Sixteen trials were included. Compared with the controls, the combination therapy significantly improved the total effective rate (RR = 1.24, 95% CI 1.18–1.31, p < 0.00001). It also significantly reduced serum testosterone (MD = –0.26, 95% CI –0.37 to –0.15, p < 0.00001), luteinizing hormone (MD = –1.64, 95% CI –2.46 to –0.82, p < 0.0001), follicle-stimulating hormone (MD = –0.62, 95% CI –1.11 to –0.13, p = 0.01), and the LH/FSH ratio (MD = –0.27, 95% CI –0.43 to –0.12, p = 0.0006). BMI also decreased (MD = –1.55, 95% CI –3.06 to –0.04, p = 0.04). Funnel plots suggested no obvious publication bias. Overall risk-of-bias assessment indicated insufficient reporting or implementation of blinding and unclear allocation concealment. Conclusions: Cangfu Daotan decoction combined with Diane-35 may enhance clinical efficacy and improve key hormonal indicators and BMI in patients with phlegm-dampness -related PCOS. However, the evidence is limited by methodological weaknesses and heterogeneity across studies; well-designed, large-scale RCTs are needed to confirm these findings.