Yang Jie, Chen Jiao, Yang Mingxiao, Yu Siyi, Ying Li, Liu Guan J, Ren Yu-Lan, Wright James M, Liang Fan-Rong
Acupuncture and Tuina College, Chengdu University of Traditional Chinese Medicine, 37# shi-er-qiao Road, Chengdu, Sichuan, China, 610075.
Cochrane Database Syst Rev. 2018 Nov 14;11(11):CD008821. doi: 10.1002/14651858.CD008821.pub2.
Elevated blood pressure (hypertension) affects about one billion people worldwide. It is important as it is a major risk factor for stroke and myocardial infarction. However, it remains a challenge for the medical profession as many people with hypertension have blood pressure (BP) that is not well controlled. According to Traditional Chinese Medicine theory, acupuncture has the potential to lower BP.
To assess the effectiveness and safety of acupuncture for lowering blood pressure in adults with primary hypertension.
We searched the Hypertension Group Specialised Register (February 2017); the Cochrane Central Register of Controlled Trials (CENTRAL) 2017, Issue 2; MEDLINE (February 2017); Embase (February 2017), China National Knowledge Infrastructure (CNKI) (January 2015), VIP Database (January 2015), the World Health Organisation Clinical Trials Registry Platform (February 2017)and ClinicalTrials.gov (February 2017). There were no language restrictions.
We included all randomized controlled trials (RCTs) that compared the clinical effects of an acupuncture intervention (acupuncture used alone or add-on) with no treatment, a sham acupuncture or an antihypertensive drug in adults with primary hypertension.
Two review authors independently selected studies according to inclusion and exclusion criteria. They extracted data and assessed the risk of bias of each trial, and telephoned or emailed the authors of the studies to ask for missing information. A third review author resolved disagreements. Outcomes included change in systolic blood pressure (SBP), change in diastolic blood pressure (DBP), withdrawal due to adverse effects, and any adverse events. We calculated pooled mean differences (MD) with 95% confidence intervals (CI) for continuous outcomes using a fixed-effect or random-effects model where appropriate.
Twenty-two RCTs (1744 people) met our inclusion criteria. The RCTs were of variable methodological quality (most at high risk of bias because of lack of blinding). There was no evidence for a sustained BP lowering effect of acupuncture; only one trial investigated a sustained effect and found no BP lowering effect at three and six months after acupuncture. Four sham acupuncture controlled trials provided very low quality evidence that acupuncture had a short-term (one to 24 hours) effect on SBP (change) -3.4 mmHg (-6.0 to -0.9) and DBP -1.9 mmHg (95% CI -3.6 to -0.3). Pooled analysis of eight trials comparing acupuncture with angiotensin-converting enzyme inhibitors and seven trials comparing acupuncture to calcium antagonists suggested that acupuncture lowered short-term BP better than the antihypertensive drugs. However, because of the very high risk of bias in these trials, we think that this is most likely a reflection of bias and not a true effect. As a result, we did not report these results in the 'Summary of findings' table. Safety of acupuncture could not be assessed as only eight trials reported adverse events.
AUTHORS' CONCLUSIONS: At present, there is no evidence for the sustained BP lowering effect of acupuncture that is required for the management of chronically elevated BP. The short-term effects of acupuncture are uncertain due to the very low quality of evidence. The larger effect shown in non-sham acupuncture controlled trials most likely reflects bias and is not a true effect. Future RCTs must use sham acupuncture controls and assess whether there is a BP lowering effect of acupuncture that lasts at least seven days.
高血压影响着全球约10亿人。高血压很重要,因为它是中风和心肌梗死的主要危险因素。然而,它仍然是医学界面临的一项挑战,因为许多高血压患者的血压控制不佳。根据中医理论,针灸有降低血压的潜力。
评估针灸对原发性高血压成人患者降低血压的有效性和安全性。
我们检索了高血压组专业注册库(2017年2月);Cochrane对照试验中心注册库(CENTRAL)2017年第2期;MEDLINE(2017年2月);Embase(2017年2月)、中国知网(CNKI)(2015年1月)、维普数据库(2015年1月)、世界卫生组织临床试验注册平台(2017年2月)以及ClinicalTrials.gov(2017年2月)。没有语言限制。
我们纳入了所有比较针灸干预(单独使用针灸或联合使用)与无治疗、假针灸或抗高血压药物对原发性高血压成人患者临床效果的随机对照试验(RCT)。
两位综述作者根据纳入和排除标准独立选择研究。他们提取数据并评估每个试验的偏倚风险,通过电话或电子邮件联系研究作者索要缺失信息。第三位综述作者解决分歧。结局包括收缩压(SBP)变化、舒张压(DBP)变化、因不良反应退出以及任何不良事件。我们在适当情况下使用固定效应或随机效应模型计算连续结局的合并均数差(MD)及其95%置信区间(CI)。
22项RCT(1744人)符合我们的纳入标准。这些RCT的方法学质量各不相同(由于缺乏盲法,大多数偏倚风险较高)。没有证据表明针灸有持续降低血压的效果;只有一项试验研究了持续效果,发现在针灸后3个月和6个月时没有降低血压的效果。四项假针灸对照试验提供了质量极低的证据,表明针灸对SBP(变化)有短期(1至24小时)影响,差值为-3.4 mmHg(-6.0至-0.9),对DBP影响为-1.9 mmHg(95%CI -3.6至-0.3)。八项比较针灸与血管紧张素转换酶抑制剂的试验以及七项比较针灸与钙拮抗剂的试验的合并分析表明,针灸在短期内降低血压的效果优于抗高血压药物。然而,由于这些试验的偏倚风险非常高,我们认为这很可能是偏倚的反映而非真实效果。因此,我们未在“结果总结”表中报告这些结果。由于只有八项试验报告了不良事件,所以无法评估针灸的安全性。
目前,没有证据表明针灸具有管理慢性高血压所需的持续降低血压的效果。由于证据质量极低,针灸的短期效果尚不确定。在非假针灸对照试验中显示出的较大效果很可能反映的是偏倚,而非真实效果。未来的RCT必须使用假针灸对照,并评估针灸是否具有至少持续七天的降低血压效果。