Introduction

The limitations of hormone therapy for managing primary ovarian insufficiency (POI) have promoted 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) in treating primary ovarian insufficiency (POI). This study 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 2021110107.

Funding

National Natural Science Foundation of China (grant number: 81973892).

中文翻译：

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中草药二仙汤治疗原发性卵巢功能不全：随机对照试验和荟萃分析的系统评价

介绍

激素治疗治疗原发性卵巢功能不全（POI）的局限性促使试验者评估中草药二仙汤（含仙茅、淫羊藿、当归、巴戟天、黄柏和知母）治疗原发性卵巢功能不全（POI）。本研究旨在评价二仙汤单用或联合激素治疗治疗 POI 的有效性和安全性。

方法

我们对随机对照试验 (RCT) 进行了系统评价，这些试验报告了二仙汤单独或联合激素治疗 POI 女性的情况。从开始到 2023 年 6 月 7 日，检索了七个数据库。纳入的研究使用 Endnote X9 进行筛选，并使用 Cochrane“偏倚风险”工具 v1.0 评估方法学质量。使用 Review Manager 5.4.1 将效果计算为平均差 (MD)、标准平均差 (SMD) 或具有 95% 置信区间 (CI) 的相对风险，并且通过定性方法评估不适合统计分析的数据。

结果

纳入了 15 项研究，涉及 1274 名参与者（13 名退出者）。二仙汤联合激素治疗显着降低促卵泡激素水平（MD –12.48，95%CI –15.90至–9.06；N = 8；P < 0.001）和黄体生成激素水平（MD –8.20，95%CI – 11.22 至 –5.17；N = 8；P < 0.001），与激素治疗相比，雌激素水平升高（SMD 2.35，95% CI 1.52 至 3.18；N = 8；P < 0.001）。单用二仙汤与单用激素治疗在卵泡刺激素水平（MD –0.69; 95%CI, –7.94 to 6.56; N = 5; P  = 0.85）、黄体生成素水平（ MD 0.29，95%CI –3.96 至 4.54；N = 5；P  = 0.89）或雌激素水平（SMD 0.16，95%CI –0.36 至 0.67；N = 5；P  = 0.55）。此外，单用二仙汤和二仙汤加激素治疗均能有效改善女性更年期症状。七项研究报告了不良事件的发生，但没有报告严重事件。

结论

研究结果表明，二仙汤无论是否联合激素治疗，都可能是治疗 POI 的有效方法。然而，证据的局限性包括高偏倚风险和显着的异质性。进一步的研究应该在精心设计和严格执行的大样本临床试验中进行。

审核注册

INPLASY 2021110107。

资金

国家自然科学基金（批准号：81973892）。