Yuan Fan, Wang Yang, Ma Ziyang, Jing Mingyi, You Yaodong, Yu Xujun, Chang Degui, Zhang Peihai
Traditional Chinese Medicine Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Department of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Transl Androl Urol. 2021 Sep;10(9):3684-3696. doi: 10.21037/tau-21-730.
Low-intensity extracorporeal shockwave therapy (LI-ESWT) may be a successful complementary treatment approach for erectile dysfunction (ED). In this study, we aimed to review and summarize the research evidence from systematic reviews (SRs)/meta-analyses (MAs) regarding the clinical effectiveness of LI-ESWT for ED.
Studies on LI-ESWT for ED were searched using eight electronic databases from establishment of each database to 31 June 2021 with the language restrictions of Chinese and English. All articles were screened, and qualifying data were recorded based on the inclusion criteria. Methods including: the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2); the Risk of Bias in Systematic Reviews (ROBIS); the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA); and Grading of Recommendations, Assessment Development, and the Evaluation (GRADE) were used by two independent raters to assess methodological quality, risk of bias, reporting quality, and SR evidence of quality, respectively.
Eight SRs/MAs met all inclusion criteria. Seven reviews were rated as critically low on overall confidence and one review was low on confidence based on the AMSTAR-2 appraisal tool. While most PRISMA criteria were met, the major reporting flaws were in relation the financial statements not being included, along with no protocol registrations. Three SRs/MAs were classed as low risk regarding bias as measured by the ROBIS tool. Based on the GRADE method, only one SRs/MAs of high-quality evidence and seven SRs/MAs of moderate-quality evidence were found. The present research results supported LI-ESWT as a complementary therapy for ED patients, but the evidence should be considered carefully due to the methodological flaws identified.
Our results showed that LI-ESWT as an adjunctive therapy has benefits for ED patients. There were no obvious side effects, and the number of shockwave treatments and energy flux density (EFD) would affect the IIEF-EF, EHS and PSV scores. However, due to the limited sample size and the quality of reporting evidence, our conclusions may not be fully representative.
低强度体外冲击波疗法（LI-ESWT）可能是治疗勃起功能障碍（ED）的一种成功的辅助治疗方法。在本研究中，我们旨在回顾和总结系统评价（SRs）/荟萃分析（MAs）中关于LI-ESWT治疗ED临床疗效的研究证据。
使用八个电子数据库检索从各数据库建立至2021年6月31日关于LI-ESWT治疗ED的研究，语言限制为中文和英文。对所有文章进行筛选，并根据纳入标准记录合格数据。两名独立评估者分别使用以下方法：系统评价方法学质量评估2（AMSTAR-2）；系统评价中的偏倚风险（ROBIS）；系统评价和荟萃分析的首选报告项目（PRISMA）；以及推荐分级、评估发展和评价（GRADE）来评估方法学质量、偏倚风险、报告质量和SR证据质量。
八项SRs/MAs符合所有纳入标准。根据AMSTAR-2评估工具，七项评价的总体置信度被评为极低，一项评价的置信度为低。虽然大多数PRISMA标准得到满足，但主要报告缺陷在于未包括财务报表以及未进行方案注册。根据ROBIS工具测量，三项SRs/MAs的偏倚风险被归类为低。基于GRADE方法，仅发现一项高质量证据的SRs/MAs和七项中等质量证据的SRs/MAs。目前的研究结果支持LI-ESWT作为ED患者的辅助治疗方法，但由于所发现的方法学缺陷，证据应谨慎考虑。
我们的结果表明，LI-ESWT作为辅助治疗对ED患者有益。没有明显的副作用，冲击波治疗次数和能量通量密度（EFD）会影响国际勃起功能指数-勃起功能（IIEF-EF）、勃起硬度评分（EHS）和阴茎海绵体动脉收缩期峰值流速（PSV）评分。然而，由于样本量有限和报告证据的质量，我们的结论可能不具有充分代表性。
