Randomized controlled trials of acupuncture for the treatment of essential hypertension: a meta-analysis

目的 系统评价针刺治疗原发性高血压的疗效和安全性。 方法 通过计算机检索中国知网(CNKI)、重庆维普数据库(CQVIP), 万方学术期刊全文数据库(Wanfang)、中国生物医学文献数据库(CBM)、PubMed、EMBASE和CochraneLibrary数据库自建库至2021年1月30日所收录的以针刺作为主要干预手段治疗原发性高血压的临床随机对照试验。根据Cochrane手册对纳入研究进行偏倚风险评估。使用Review Manager 5.4.1软件和Stata 15.0软件进行数据分析。 结果 共纳入46项随机对照试验, 共包括3 859例受试者。主要结局指标包括干预后舒张压变化{8项研究显示针刺联合西药治疗组优于单用降压药组[MD=1.45, 95%CI (0.48, 2.43), P=0.004, 固定效应模型; I ^2=39%]}和干预后收缩压变化{11项研究表明针刺联合西药治疗组优于单用降压药组[MD=8.60, 95%CI (7.12, 10.07), P <0.00001, 固定效应模型; I ^2=26%]}。次要结局指标为降压疗效, 12项单独针刺治疗组的研究[RR=1.20, 95%CI (1.12, 1.28), P <0.00001, 固定效应模型; I ^2=36%]与15项针刺联合降压药组的研究[RR=1.27, 95%CI (1.20, 1.34), P <0.00001, 固定效应模型; I ^2=6%]皆显示其降压效果优于单用降压药。在不良反应方面, 4项研究表明单独针刺组不良反应少于单用降压药组[RR=0.10, 95%CI (0.04, 0.25), P <0.00001, 固定效应模型; I ^2=0%]。 结论 Meta分析表明, 针刺联合降压药物的降压效果优于单用西药, 且针刺治疗原发性高血压有效、安全、副作用少。然而, 该领域尚缺乏高质量、多中心的随机双盲对照试验, 仍需要严谨设计的大样本临床研究对上述结论进行验证。 Objective To systematically assess the efficacy and safety of acupuncture therapy for essential hypertension. Methods A computerized literature search of the Chinese National Knowledge Infrastructure (CNKI), Chongqing VIP Database (CQVIP), Wanfang Academic Journal Full-text Database (Wanfang), China Biology Medicine Disc (CBM), PubMed, EMBASE, and Cochrane Library was conducted to retrieve randomized controlled clinical trials on acupuncture as the main intervention for the treatment of essential hypertension published from the inception of the database to 30 January 2021. The risk-of-bias assessment was carried out for each included study according to the Cochrane Handbook. Data analysis was performed using Review Manager 5.4.1 and Stata 15.0. Results After the screening, 46 randomized controlled trials involving a total of 3 859 subjects were included. Primary outcomes included changes in the diastolic blood pressure after intervention [eight studies showed that the acupuncture plus antihypertensive drug group was better than the antihypertensive drug monotherapy group [mean difference (MD)=1.45, 95% confidence interval (CI) (0.48, 2.43), P =0.004, fixed effects model; I ^2=39%] and changes in the systolic blood pressure after intervention {11 studies showed that the acupuncture plus antihypertensive drug group was better than the antihypertensive drug monotherapy group [MD=8.60, 95%CI (7.12, 10.07), P <0.00001, fixed effects model; I ^2=26%]}. The secondary outcome was antihypertensive efficacy, 12 studies of acupuncture monotherapy group [risk ratio (RR)=1.20, 95%CI (1.12, 1.28), P <0.00001, fixed effects model; I ^2=36%] and 15 studies of acupuncture combined with antihypertensive drug group [RR=1.27, 95%CI (1.20, 1.34), P <0.00001, fixed effects model; I ^2=6%] showed better results than the antihypertensive drug monotherapy group in antihypertensive efficacy. In terms of the adverse events, four studies showed that the acupuncture monotherapy group had fewer adverse events than the antihypertensive drug monotherapy group [RR=0.10, 95%CI (0.04, 0.25), P <0.00001, fixed effects model; I ^2=0%]. Conclusion Acupuncture combined with antihypertensive drugs is superior to antihypertensive drugs alone in reducing blood pressure, and acupuncture therapy is effective and safe for the treatment of essential hypertension with fewer side effects. However, there is still a lack of high-quality multicenter randomized double-blinded controlled trials in this field. Rigorous large-sample clinical trials are needed to validate these findings.