Yang Mingxiao, Du Ting, Sun Mingsheng, Long Hulin, Li Dehua, Shen Zhifu, Wu Qiaofeng, Lao Lixing, Liang Fanrong
School of Chinese Medicine, University of Hong Kong, Hong Kong.
Department of Rehabilitation, Xishan People's Hospital of Wuxi Municipality, Wuxi, China.
BMJ Open. 2018 Apr 4;8(4):e019798. doi: 10.1136/bmjopen-2017-019798.
Previous reviews indicate that the effect of acupuncture on stable angina pectoris (SAP) remains controversial. The results of trials published in the past 5 years may possibly change this situation, but an updated systematic review is not available. We therefore designed this study to systematically assess the efficacy and safety of acupuncture for treating SAP.
Nine online databases will be searched without language or publication status restrictions from their inception to September 2017. Randomised controlled trials that include patients with stable angina receiving acupuncture therapy versus a control group will be deemed eligible. The selection of studies, data extraction and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan V.5.3 software with either a fixed effects model or random effects model, depending on the heterogeneity test. Evidence quality will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. The efficacy-effectiveness spectrum for each included trial will be rated using the Rating of Included Trials on the Efficacy-effectiveness Spectrum tool. Outcomes of interest include the improvement of weekly angina attacks and reduction of nitroglycerin medication use after receiving acupuncture treatment, the incidence of cardiovascular events, heart rate variability, pain intensity measured on a visual analogue scale, total workload and exercise duration at peak exercise, safety and adverse events. A meta-analysis will be conducted if no considerable heterogeneity is detected. The results will be presented as risk ratios with 95% CIs for dichotomous data and weighted mean differences or standardised mean differences with 95% CIs for continuous data.
This systematic review will not involve private information from individuals or endanger their rights, and therefore does not necessarily require ethical approval. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.
CRD42015016201.
既往综述表明，针刺治疗稳定型心绞痛（SAP）的效果仍存在争议。过去5年发表的试验结果可能会改变这种情况，但尚无更新的系统评价。因此，我们设计了本研究，以系统评价针刺治疗SAP的疗效和安全性。
检索9个在线数据库，检索时间从建库至2017年9月，无语言或发表状态限制。纳入接受针刺治疗的稳定型心绞痛患者与对照组的随机对照试验。由两名独立的评价者进行研究选择、数据提取和偏倚风险评估。根据异质性检验结果，使用RevMan V.5.3软件采用固定效应模型或随机效应模型进行数据合成。采用推荐分级的评估、制定与评价（GRADE）系统评估证据质量。使用疗效-效果谱纳入试验评分工具对每个纳入试验的疗效-效果谱进行评分。感兴趣的结局包括针刺治疗后每周心绞痛发作次数的改善、硝酸甘油用药量的减少、心血管事件的发生率、心率变异性、视觉模拟量表测量的疼痛强度、峰值运动时的总工作量和运动持续时间、安全性和不良事件。如果未检测到显著异质性，则进行Meta分析。结果将以二分类数据的风险比及95%可信区间和连续性数据的加权均数差或标准化均数差及95%可信区间表示。
本系统评价不涉及个人隐私信息或危及个人权利，因此不一定需要伦理批准。研究结果可能发表在同行评审期刊上或在相关会议上传播。
CRD 42015016201。
