Department of Traditional Chinese Medicine, Cancer Hospital of the University of Chinese Academy of Sciences; Zhejiang Cancer Hospital, Hangzhou, China.
Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.
Ann Palliat Med. 2021 Aug;10(8):8772-8786. doi: 10.21037/apm-21-1755.
To evaluate the efficacy and safety of the controversial Chinese herbal prescriptions containing Ejiao or Velvet antler (VA) in the treatment of uterine fibroids.
We searched 4 famous Chinese databases, the Chinese Clinical Trial Registry, PubMed, Cochrane Central, Google Scholar, Embase, and J-STAGE up to July 2019. We included all eligible randomized controlled trials (RCTs) which compared Chinese herbal prescriptions containing Ejiao or VA (E/VA) with placebo, pharmaceutical intervention, surgery, or other traditional Chinese medicines (TCMs) for uterine fibroids and assessed the risk of bias according to the Cochrane Collaboration's tool. The software Review Manager (RevMan) 5.1 was used for data analysis.
A total of 9 RCTs involving 844 patients were identified. Meta-analyses demonstrated that TCM (E/VA) plus mifepristone reduced the volume of uterine fibroids to a greater degree than mifepristone alone [standardized mean difference (SMD): 0.59, 95% CI: 0.33 to 0.85, P<0.00001, I2=50%]; TCM (E/VA) did not enlarge the volume of fibroids when menopausal hormone therapy (MHT) significantly increased the volume (SMD: 1.06, 95% CI: 0.73 to 1.38, P<0.00001, I2=0. The uterine volume change difference was larger via combination therapy of TCM (E/VA) and mifepristone than that of mifepristone (SMD: 0.29, 95% CI: 0.09 to 0.49, P=0.005, I2=0%). The TCM (E/VA) group of had an advantage over the control group in the improvement of fibroid-related symptoms [relative risk (RR): 1.24, 95% CI: 1.15 to 1.35, P<0.00001, I2=0%]. It was found that TCM (E/VA) plus mifepristone could lower estradiol (E2) levels to a greater degree than mifepristone alone (SMD: 1.63, 95% CI: 0.42 to 2.83, P=0.008, I2=97%), as well as progesterone (P) level (SMD: 0.79, 95% CI: 0.55 to 1.04, P<0.00001, I2=43%) in non-menopausal women. A total of 5 studies reported adverse events (AEs), the TCM (E/VA) group was potentially safer than the control group, with lower incidence of AEs (RR: 0.24, 95% CI: 0.15 to 0.40, P<0.00001, I2=25.8%).
TCM prescriptions containing E/VA seemed superior to the control group in shrinking the volume of uterine fibroids and uterus, improving related symptoms, and reducing non-menopausal women's E2 and P levels, with lower incidence of AEs.
评估含有阿胶或鹿茸（VA）的有争议的中草药处方治疗子宫肌瘤的疗效和安全性。
我们检索了 4 个著名的中文数据库、中国临床试验注册中心、PubMed、Cochrane 中心、Google Scholar、Embase 和 J-STAGE，检索截至 2019 年 7 月。我们纳入了所有符合条件的随机对照试验（RCT），这些试验将含有阿胶或 VA（E/VA）的中草药处方与安慰剂、药物干预、手术或其他中药（TCM）治疗子宫肌瘤进行比较，并根据 Cochrane 协作组的工具评估偏倚风险。使用 Review Manager（RevMan）5.1 软件进行数据分析。
共纳入 9 项 RCT，涉及 844 名患者。Meta 分析表明，与单独使用米非司酮相比，中药（E/VA）加米非司酮更能降低子宫肌瘤的体积[标准化均数差（SMD）：0.59，95%置信区间：0.33 至 0.85，P<0.00001，I2=50%]；当绝经激素治疗（MHT）显著增加肌瘤体积时，中药（E/VA）不会增加肌瘤体积[SMD：1.06，95%置信区间：0.73 至 1.38，P<0.00001，I2=0]。与米非司酮相比，中药（E/VA）联合米非司酮治疗的子宫体积变化差异更大[SMD：0.29，95%置信区间：0.09 至 0.49，P=0.005，I2=0%]。与对照组相比，中药（E/VA）组在改善肌瘤相关症状方面具有优势[相对风险（RR）：1.24，95%置信区间：1.15 至 1.35，P<0.00001，I2=0%]。发现中药（E/VA）加米非司酮可以比单独使用米非司酮更显著地降低雌二醇（E2）水平[SMD：1.63，95%置信区间：0.42 至 2.83，P=0.008，I2=97%]，以及孕激素（P）水平[SMD：0.79，95%置信区间：0.55 至 1.04，P<0.00001，I2=43%]在非绝经妇女中。共有 5 项研究报告了不良事件（AE），中药（E/VA）组的安全性可能优于对照组，AE 发生率较低（RR：0.24，95%置信区间：0.15 至 0.40，P<0.00001，I2=25.8%）。
含有 E/VA 的中药处方在缩小子宫肌瘤和子宫体积、改善相关症状、降低非绝经妇女 E2 和 P 水平方面似乎优于对照组，且 AE 发生率较低。
