Chinese herbal medicine Er-xian decoction for primary ovarian insufficiency: A systematic review of randomized controlled trials and meta-analyses

Abstract

Introduction

The limitations of hormone therapy for managing primary ovarian insufficiency (POI) have prompted trialists to evaluate the Chinese herbal medicine, Er-xian decoction (containing Curculiginis Rhizome, Epimrdii Herba, Angelicae Sinensis Radix, Morindae Officinalis Radix, Phellodendri Chinrnsis Cortex and Anemarrhenae Rhizoma) for treating POI. This review was conducted to evaluate the effectiveness and safety of Er-xian decoction alone or in addition to hormone therapy in treating POI.

Methods

We conducted a systematic review of randomized controlled trials (RCTs) that reported on Er-xian decoction alone or in addition to hormone therapy in women with POI. Seven databases were searched from inception to 7 June 2023. The included studies were screened with Endnote X9, and methodological quality was assessed using the Cochrane “Risk of bias” tool v1.0. Effects were calculated as mean difference (MD), standard mean difference (SMD), or relative risk with 95% confidence interval (CI) using Review Manager 5.4.1, and data not suitable for statistical analyses were assessed by qualitative methods.

Results

Fifteen studies involving 1274 participants (13 drop-outs) were included. Er-xian decoction plus hormone therapy significantly lowered the follicle-stimulating hormone level (MD –12.48, 95 %CI –15.90 to –9.06; N = 8; P < 0.001) and luteinizing hormone level (MD –8.20, 95 %CI –11.22 to –5.17; N = 8; P < 0.001) and increased the estrogen level (SMD 2.35, 95 %CI 1.52 to 3.18; N = 8; P < 0.001) compared with hormone therapy. There was no significant difference between Er-xian decoction alone and hormone therapy alone in terms of follicle-stimulating hormone level (MD –0.69; 95 %CI, –7.94 to 6.56; N = 5; P = 0.85), luteinizing hormone level (MD 0.29, 95 %CI –3.96 to 4.54; N = 5; P = 0.89) or estrogen level (SMD 0.16, 95 %CI –0.36 to 0.67; N = 5; P = 0.55). In addition, both Er-xian decoction alone and Er-xian decoction plus hormone therapy effectively improved women's menopausal symptoms. Seven studies reported on the occurrence of adverse events, and no severe events were reported.

Conclusion

The findings suggest Er-xian decoction, with or without hormone therapy, may be an effective treatment for POI. However, limitations in the evidence included a high risk of bias and substantial heterogeneity. Further research should be conducted in well-designed and rigorously executed clinical trials with large samples.

Review registration

INPLASY 2,021,110,107.