Xu Mangmang, Li Dan, Zhang Shihong
Department of Neurology, West China Hospital, Sichuan University, Chengdu, China, 610041.
Cochrane Database Syst Rev. 2018 Mar 30;3(3):CD003317. doi: 10.1002/14651858.CD003317.pub3.
Sensory stimulation via acupuncture has been reported to alter activities of numerous neural systems by activating multiple efferent pathways. Acupuncture, one of the main physical therapies in Traditional Chinese Medicine, has been widely used to treat patients with stroke for over hundreds of years. This is the first update of the Cochrane Review originally published in 2005.
To assess whether acupuncture could reduce the proportion of people with death or dependency, while improving quality of life, after acute ischemic or hemorrhagic stroke.
We searched the Cochrane Stroke Group trials register (last searched on February 2, 2017), the Cochrane Central Register of Controlled Trials Ovid (CENTRAL Ovid; 2017, Issue 2) in the Cochrane Library, MEDLINE Ovid (1946 to February 2017), Embase Ovid (1974 to February 2017), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCO (1982 to February 2017), the Allied and Complementary Medicine Database (AMED; 1985 to February 2017), China Academic Journal Network Publishing Database (1998 to February 2017), and the VIP database (VIP Chinese Science Journal Evaluation Reports; 1989 to February 2017). We also identified relevant trials in the Chinese Clinical Trial Registry (last searched on Feburuary 20, 2017), the World Health Organization (WHO) International Clinical Trials Registry Platform (last searched on April 30, 2017), and Clinicaltrials.gov (last searched on April 30, 2017). In addition, we handsearched the reference lists of systematic reviews and relevant clinical trials.
We sought randomized clinical trials (RCTs) of acupuncture started within 30 days from stroke onset compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischemic or hemorrhagic stroke, or both. Needling into the skin was required for acupuncture. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.
Two review authors applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data independently. We contacted study authors to ask for missing data. We assessed the quality of the evidence by using the GRADE approach. We defined the primary outcome as death or dependency at the end of follow-up .
We included in this updated review 33 RCTs with 3946 participants. Twenty new trials with 2780 participants had been completed since the previous review. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only six trials (668 participants) that compared acupuncture with sham acupuncture control. We downgraded the evidence to low or very low quality because of risk of bias in included studies, inconsistency in the acupuncture intervention and outcome measures, and imprecision in effect estimates.When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.46 to 0.79; very low-quality evidence; and OR 0.67, 95% CI 0.53 to 0.85; eight trials with 1436 participants; very low-quality evidence, respectively) and were not confirmed by trials comparing acupuncture with sham acupuncture (OR 0.71, 95% CI 0.43 to 1.18; low-quality evidence; and OR 0.67, 95% CI 0.40 to 1.12; low-quality evidence, respectively).In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain (standardized mean difference [SMD] 0.84, 95% CI 0.36 to 1.32; 12 trials with 1086 participants; very low-quality evidence; and SMD 1.08, 95% CI 0.45 to 1.71; 11 trials with 895 participants; very low-quality evidence). These findings were not confirmed in trials comparing acupuncture with sham acupuncture (SMD 0.01, 95% CI -0.55 to 0.57; low-quality evidence; and SMD 0.10, 95% CI -0.38 to 0.17; low-quality evidence, respectively).Trials comparing acupuncture with any control have reported little or no difference in death or institutional care at the end of follow-up (OR 0.78, 95% CI 0.54 to 1.12; five trials with 1120 participants; low-quality evidence), death within the first two weeks (OR 0.91, 95% CI 0.33 to 2.55; 18 trials with 1612 participants; low-quality evidence), or death at the end of follow-up (OR 1.08, 95% CI 0.74 to 1.58; 22 trials with 2865 participants; low-quality evidence).The incidence of adverse events (eg, pain, dizziness, faint) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain (OR 0.58, 95% CI 0.29 to 1.16; five trials with 576 participants; low-quality evidence).
AUTHORS' CONCLUSIONS: This updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.
据报道，通过针刺进行的感觉刺激可通过激活多条传出通路来改变众多神经系统的活动。针刺作为中医主要的物理疗法之一，已被广泛用于治疗中风患者达数百年之久。这是对2005年首次发表的Cochrane系统评价的首次更新。
评估针刺是否能降低急性缺血性或出血性中风后死亡或依赖的比例，同时改善生活质量。
我们检索了Cochrane中风小组试验注册库（最后检索时间为2017年2月2日）、Cochrane图书馆中的Cochrane对照试验中央注册库Ovid（CENTRAL Ovid；2017年第2期）、MEDLINE Ovid（1946年至2017年2月）、Embase Ovid（1974年至2017年2月）、护理及相关健康文献累积索引（CINAHL）EBSCO（1982年至2017年2月）、补充与替代医学数据库（AMED；1985年至2017年2月）、中国学术期刊网络出版总库（1998年至2017年2月）和维普数据库（维普中文科技期刊评价报告；1989年至2017年2月）。我们还在中国临床试验注册中心（最后检索时间为2017年2月20日）、世界卫生组织（WHO）国际临床试验注册平台（最后检索时间为2017年4月30日）和Clinicaltrials.gov（最后检索时间为2017年4月30日）中识别相关试验。此外，我们手工检索了系统评价和相关临床试验的参考文献列表。
我们纳入了在中风发作后30天内开始的针刺随机临床试验（RCT），将其与急性缺血性或出血性中风患者或两者兼有的安慰剂、假针刺或开放对照（无安慰剂）进行比较。针刺需要刺入皮肤。比较对象为：（1）所有对照（开放对照或假针刺），以及（2）假针刺对照。
两位综述作者应用纳入标准，评估试验质量和偏倚风险，并独立提取数据。我们联系研究作者索要缺失数据。我们使用GRADE方法评估证据质量。我们将主要结局定义为随访结束时的死亡或依赖。
我们在本次更新的综述中纳入了33项RCT，共3946名参与者。自上次综述以来，已完成20项新试验，共2780名参与者。有22项试验（2865名参与者）可获得比较针刺与任何对照（开放对照或假针刺）的结局数据，但只有6项试验（668名参与者）可获得比较针刺与假针刺对照的结局数据。由于纳入研究存在偏倚风险、针刺干预和结局测量不一致以及效应估计不精确，我们将证据降级为低质量或极低质量。与任何对照相比（11项试验，1582名参与者），针刺组在随访结束时和长期（≥3个月）死亡或依赖几率较低的结果尚不确定（比值比[OR]0.61，95%置信区间[CI]0.46至0.79；极低质量证据；以及OR0.67，95%CI0.53至0.85；8项试验，1436名参与者；极低质量证据），且在比较针刺与假针刺的试验中未得到证实（OR0.71，95%CI0.43至1.18；低质量证据；以及OR0.67，95%CI0.40至1.12；低质量证据）。在比较针刺与任何对照的试验中，针刺与全球神经功能缺损评分和运动功能评分增加相关的结果尚不确定（标准化均数差[SMD]0.84，95%CI0.36至1.32；12项试验，1086名参与者；极低质量证据；以及SMD1.08，95%CI0.45至1.71；11项试验，895名参与者；极低质量证据）。这些结果在比较针刺与假针刺的试验中未得到证实（SMD0.01，95%CI -0.55至0.57；低质量证据；以及SMD0.10，95%CI -0.38至0.17；低质量证据）。比较针刺与任何对照的试验报告，在随访结束时死亡或机构护理方面几乎没有差异（OR0.78，95%CI0.54至1.12；5项试验，1120名参与者；低质量证据），前两周内死亡（OR0.91，95%CI0.33至2.55；18项试验，1612名参与者；低质量证据），或随访结束时死亡（OR1.08，95%CI0.74至1.58；22项试验，2865名参与者；低质量证据）。开放和假对照试验的针刺组不良事件（如疼痛、头晕、昏厥）发生率为6.2%（64/1037名参与者），其中1.4%（14/1037名参与者）停止针刺。当针刺与假针刺比较时，不良事件的结果尚不确定（OR0.58，95%CI0.29至1.16；5项试验，576名参与者；低质量证据）。
本次更新的综述表明，针刺在急性中风中明显改善的结局受到与开放对照使用相关的偏倚风险的混淆。据报道，与针刺相关的不良事件较轻，通常不会导致停止治疗。未来需要进行研究以证实或反驳针刺在急性中风中的任何作用。试验应明确报告随机化方法、分配隐藏情况，以及是否实现了参与者、研究人员和结局评估者的盲法，同时密切关注针刺对长期功能结局的影响。
