Abstract
Purpose To assess the efficacy and safety of berberine on reproductive endocrine and metabolic outcomes in women with polycystic ovary syndrome (PCOS). Methods PubMed (from 1950), the Cochrane Library, the CNKI (from 1979), the VIP (from 1989), and the Wanfang Data (from 1990) and the reference lists of the retrieved articles were searched for randomized controlled trials in human beings with the search terms including “polycystic ovary syndrome/PCOS” and “berberine/BBR/Huangliansu (in Chinese)/Xiao bojian (in Chinese)” till 30 May 2019. Relevant indicators were collected and the data were analyzed by using RevMan 5.3 software. Results Eventually, a total of 12 randomized controlled trials were included in this systematic review. Our study suggested that berberine had similar live birth rates compared with placebo or metformin and lower live birth rates (RR: 0.61, 95% CI: 0.44 to 0.82) compared with letrozole. There was a significant difference between berberine and placebo and between berberine and no treatment in terms of decreasing total testosterone and luteinizing hormone to follicle-stimulating hormone (LH/FSH) ratio (8 RCTs, 577 participants, MD: −0.34, 95% CI: −0.47 to −0.20; 3 RCTs, 179 participants, MD: −0.44, 95% CI: −0.68 to −0.21, respectively). Berberine was associated with decreasing total cholesterol (3 RCTs, 201 participants; MD: −0.44, 95% CI: −0.60 to −0.29), waist circumference (3 RCTs, 197 participants, MD: −2.74, 95% CI: −4.55 to −0.93), and waist-to-hip ratio (4 RCTs, 258 participants, MD: −0.04, 95% CI: −0.05 to −0.03) compared with metformin, but not with improved BMI (4 RCTs, 262 participants, MD: −0.03, 95% CI: −0.46 to 0.39). Berberine did not increase the incidence of gastrointestinal adverse events (3 RCTs, 567 participants, RR: 1.01, 95% CI: 0.76 to 1.35) or serious events during pregnancy (RR: 0.98, 95% CI: 0.70 to 1.37) compared with placebo. Conclusion This review found no solid evidence that berberine could improve live birth or other clinical outcomes in women with PCOS. However, berberine appeared to be more efficacious for improving insulin resistance and dyslipidemia and decreasing androgen levels and LH/FSH ratio in women with PCOS when compared with metformin.
Highlights
Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder, and the prevalence worldwide ranges from 4% to 21%, depending on different diagnostic criteria [1, 2]
Insulin resistance has an important role in the mechanism of PCOS in both obese and nonobese women, and hyperinsulinemia in response to insulin resistance increases ovarian androgen synthesis and decreases hepatic sex-hormone binding globulin (SHBG) synthesis resulting in androgen excess [3]
Some studies report that metformin might improve live birth rates compared with placebo, and coupling metformin with clomiphene citrate might improve clinical pregnancy and ovulation rates when compared with clomiphene citrate alone [5,6,7,8]
Summary
Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder, and the prevalence worldwide ranges from 4% to 21%, depending on different diagnostic criteria [1, 2]. Information extracted included descriptions of the studies (authors, country, year of publication, diagnostic criteria for PCOS, primary and secondary outcomes, sample size, and follow-up), participants (mean age and BMI), interventions (type, dose, and duration of berberine), and study results according to the outcomes outlined above (Table 1). Rotterdam: 2003 Rotterdam ESHRE/ASRM criteria; BBR: berberine; MET: metformin; CPA: cyproterone; LET: letrozole; BMI: body mass index; WC: waist circumference; WHR: waist circumference-to-hip circumference ratio; TT: total testosterone; SHBG: sex-hormone binding globulin; FAI: free androgen index; LH: luteinizing hormone; FSH: follicle-stimulating hormone; LF: luteinizing hormone to follicle-stimulating hormone ratio; FPG: fasting plasma glucose; PPG: postprandial plasma glucose; FINS: fasting insulin; PPINS: postprandial plasma insulin; HOMA: homeostasis model assessment of insulin resistance; TC: total cholesterol; TG: triglycerides; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol. Sensitivity analysis was carried out to explore heterogeneity due to extreme data. e funnel plot was used to detect small-study effects or publication biases
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