Wu Haoran, Gao Zezheng, Dai Dan, Liu Xing, Fang Yini, Chen Xuemei, Wang Qi
National Institute of Traditional Chinese Medicine Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing, China.
Institute of Metabolic Diseases, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Andrology. 2023 Oct;11(7):1345-1367. doi: 10.1111/andr.13420. Epub 2023 Mar 14.
Several patients with erectile dysfunction do not accept or benefit from conventional therapy with phosphodiesterase type 5 inhibitors; thus, alternative and complementary therapies are in need. Traditional Chinese medicine has been treating erectile dysfunction in China, but its clinical value is inconclusive.
To systematically evaluate the efficacy and safety of traditional Chinese medicine in treating erectile dysfunction.
Randomized controlled trials were retrieved from a comprehensive search in the literature published in the past decade from the Web of Science, PubMed, Embase, Cochrane Library, SinoMed, China National Knowledge Internet, WanFang, and VIP. We performed a meta-analysis of the International Index of Erectile Function 5 questionnaire scores, clinical recovery rates, and testosterone levels using Review Manager 5.4 software. The trial sequential analysis was conducted to check the results.
A total of 45 trials with 5016 patients were included. Meta-analysis results showed that traditional Chinese medicine effectively improved the International Index of Erectile Function 5 questionnaire scores (weighted mean difference = 3.78, 95% confidence interval: 3.12, 4.44; p < 0.001), clinical recovery rates (risk ratio = 1.57, 95% confidence interval: 1.38, 1.79; p < 0.001), testosterone levels (weighted mean difference = 2.42, 95% confidence interval: 1.59, 3.25; p < 0.001) compared with the controls. The single and add-on applications of traditional Chinese medicine could improve the International Index of Erectile Function 5 questionnaire score (p < 0.001). The trial sequential analysis confirmed the robustness of the analysis of the International Index of Erectile Function 5 questionnaire scores. A significant difference in the incidence of adverse effects between the treatment and control groups was not observed (risk ratio = 0.82, 95% confidence interval: 0.65, 1.05; p = 0.12).
Traditional Chinese medicine can gain better responses in improving the International Index of Erectile Function 5 questionnaire scores, clinical recovery rates, and testosterone levels as an alternative and complementary treatment, with no increase in side effects. However, more standardized, long-term, traditional Chinese medicine and integrative therapy clinical trials are needed to support the clinical application of traditional Chinese medicine.
部分勃起功能障碍患者不接受或无法从传统的5型磷酸二酯酶抑制剂治疗中获益；因此，需要替代和补充疗法。在中国，传统中医一直在治疗勃起功能障碍，但其临床价值尚无定论。
系统评价中医治疗勃起功能障碍的疗效和安全性。
通过全面检索过去十年发表在Web of Science、PubMed、Embase、Cochrane Library、中国生物医学文献数据库、中国知网、万方和维普上的文献，检索随机对照试验。我们使用Review Manager 5.4软件对国际勃起功能指数-5问卷评分、临床治愈率和睾酮水平进行了荟萃分析。进行试验序贯分析以检验结果。
共纳入45项试验，涉及5016例患者。荟萃分析结果显示，与对照组相比，中医有效提高了国际勃起功能指数-5问卷评分（加权均数差=3.78，95%置信区间：3.12，4.44；p<0.001）、临床治愈率（风险比=1.57，95%置信区间：1.38，1.79；p<0.001）、睾酮水平（加权均数差=2.42，95%置信区间：1.59，3.25；p<0.001）。中医的单独应用和联合应用均可提高国际勃起功能指数-5问卷评分（p<0.001）。试验序贯分析证实了国际勃起功能指数-5问卷评分分析结果的稳健性。未观察到治疗组和对照组之间不良反应发生率的显著差异（风险比=0.82，95%置信区间：0.65，1.05；p=0.12）。
作为一种替代和补充治疗方法，中医在提高国际勃起功能指数-5问卷评分、临床治愈率和睾酮水平方面能获得更好的效果，且不会增加副作用。然而，需要更多标准化、长期的中医及中西医结合治疗临床试验来支持中医的临床应用。
