Chinese herbal medicines for subfertile women with polycystic ovarian syndrome

Review question

We reviewed the evidence about the effect of Chinese herbal medicines (CHM) on rates of live birth pregnancy and adverse events in subfertile women with polycystic ovarian syndrome (PCOS).

Background

PCOS is a common and complex reproductive endocrine disorder, affecting 5% to 10% of women of reproductive age. Women with PCOS may present with irregular menstrual cycles, subfertility (failure to conceive), hirsutism (excessive hair growth), acne and obesity. Many western medical therapies have been used to manage PCOS, such as oral contraceptives, insulin sensitizers and laparoscopic ovarian drilling (LOD). CHM have been suggested as an alternative approach for subfertile women with PCOS. We wanted to investigate the effectiveness and safety of CHM compared to other therapies for subfertile women with PCOS.

Study characteristics

We searched evidence from commonly used databases and it is current to 9 June 2016. We included five RCTs with 414 participants. These included studies comparing CHM to western medicine, CHM plus western medicine versus western medicine, and CHM plus surgery versus surgery. All the included studies were in Chinese. All studies had fewer than six menstrual cycles treatment duration and less than one year follow-up duration. None of the included studies reported live birth, all reported pregnancy, two reported ovulation and only one reported adverse events.

Key results

There was insufficient evidence to support the use of CHM for women with PCOS and subfertility. No data were available on live birth, and there was no consistent evidence to indicate that CHM improves fertility outcomes. When CHM was compared with clomiphene (with or without laparoscopic ovarian drilling (LOD) in both arms), the pregnancy rates were no different between the groups. When CHM with follicle aspiration and ovulation induction was compared with follicle aspiration and ovulation induction alone, pregnancy rates were no different between the groups. When CHM with LOD was compared with LOD alone, the pregnancy rates were no different between the groups. However there was limited low quality evidence to suggest that the addition of CHM to clomiphene may improve pregnancy rates. There was no evidence of a difference between any of the comparison groups for any other outcomes. There was insufficient evidence on adverse effects to indicate whether CHM is safe.

Quality of the evidence

The quality of the evidence was low or very low. The main limitations in the evidence were failure to report live birth or adverse events, failure to describe study methods in adequate detail, and imprecision, with very low event rates and wide confidence intervals.

Authors' conclusions: 

There is insufficient evidence to support the use of CHM for women with PCOS and subfertility. No data are available on live birth, and there is no consistent evidence to indicate that CHM influences fertility outcomes. However there is very limited low quality evidence to suggest that the addition of CHM to clomiphene may improve pregnancy rates. There is insufficient evidence on adverse effects to indicate whether CHM is safe.

Read the full abstract...
Background: 

Polycystic ovarian syndrome (PCOS) is one of the most common reproductive endocrinology abnormalities, and affects 5% to 10% of women of reproductive age. Western medicines, such as oral contraceptives, insulin sensitizers and laparoscopic ovarian drilling (LOD), have been used to treat PCOS. Recently, many studies have been published that consider Chinese herbal medicine (CHM) as an alternative treatment for women with PCOS.

Objectives: 

To assess the efficacy and safety of CHM for subfertile women with PCOS.

Search strategy: 

We searched sources, including the following databases, from inception to 9 June 2016: the Cochrane Gynaecology and Fertility Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED), PsycINFO, Chinese National Knowledge Infrastructure (CNKI), VIP, Wanfang and trial registries. In addition, we searched the reference lists of included trials and contacted experts in the field to locate trials.

Selection criteria: 

Randomized controlled trials (RCTs) that considered the use of CHM for the treatment of subfertile women with PCOS.

Data collection and analysis: 

Two review authors independently screened appropriate trials for inclusion, assessed the risk of bias in included studies and extracted data. We contacted primary study authors for additional information. We conducted meta-analyses. We used the odds ratios (ORs) to report dichotomous data, with 95% confidence intervals (CI). We assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.

Main results: 

We included five RCTs with 414 participants. The comparisons in the included trials were as follows: CHM versus clomiphene, CHM plus clomiphene versus clomiphene (with or without ethinyloestradiol cyproterone acetate (CEA)), CHM plus follicle aspiration plus ovulation induction versus follicle aspiration plus ovulation induction alone, and CHM plus laparoscopic ovarian drilling (LOD) versus LOD alone. The overall quality of the evidence for most comparisons was very low.

None of the included studies reported live birth rate, and only one study reported data on adverse events.

When CHM was compared with clomiphene (with or without LOD in both arms), there was no evidence of a difference between the groups in pregnancy rates (odds ratio (OR) 1.98, 95% confidence interval (CI) 0.78 to 5.06; two studies, 90 participants, I² statistic = 0%, very low quality evidence). No study reported data on adverse events. When CHM plus clomiphene was compared with clomiphene (with or without CEA), there was low quality evidence of a higher pregnancy rate in the CHM plus clomiphene group (OR 2.62, 95% CI 1.65 to 4.14; three RCTs, 300 women, I² statistic = 0%, low quality evidence). No data were reported on adverse events.

When CHM with follicle aspiration and ovulation induction was compared with follicle aspiration and ovulation induction alone, there was no evidence of a difference between the groups in pregnancy rates (OR 1.60, 95% CI 0.46 to 5.52; one study, 44 women, very low quality evidence), severe luteinized unruptured follicle syndrome (LUFS) (OR 0.60, 95% CI 0.06 to 6.14; one study, 44 women, very low quality evidence), ovarian hyperstimulation syndrome (OHSS) (OR 0.16, 95% CI 0.00 to 8.19; one study, 44 women, very low quality evidence) or multiple pregnancy (OR 0.60, 95% CI 0.06 to 6.14; one study, 44 women, very low quality evidence).

When CHM with LOD was compared with LOD alone, there was no evidence of a difference between the groups in rates of pregnancy (OR 3.50, 95% CI 0.72 to 17.09; one study, 30 women, very low quality evidence), No data were reported on adverse events.

There was no evidence of a difference between any of the comparison groups for any other outcomes. The quality of the evidence for all other comparisons and outcomes was very low. The main limitations in the evidence were failure to report live birth or adverse events, failure to describe study methods in adequate detail and imprecision due to very low event rates and wide CIs.

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