Kim Tae-Hun, Lee Myeong Soo, Kim Kun Hyung, Kang Jung Won, Choi Tae-Young, Ernst Edzard
Department of Diagnostics of Korean Medicine, College of Oriental Medicine, Gachon University, 1342 SeongnamDaero, Sugeong-gu, SeongNam, Korea, South, 461-701.
Cochrane Database Syst Rev. 2014 Jun 23;2014(6):CD009065. doi: 10.1002/14651858.CD009065.pub2.
An acute ankle sprain is a sudden-onset injury of one or more of the ankle ligaments. It is one of the most common musculoskeletal injuries in the general population as well as in athletes. In some countries, such as China and Korea, acupuncture is frequently used in the treatment of ankle sprains, either as a single treatment or a secondary intervention accompanied by standard medical treatment.
To assess the effects (benefits and harms) of acupuncture for the treatment of ankle sprains in adults.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (May 2013), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2013, Issue 4), MEDLINE (1948 to May week 2 2013), EMBASE (1980 to May week 2 2013), China National Knowledge Infrastructure databases (1994 to August week 4 2013), the Cumulative Index to Nursing and Allied Health Literature (1937 to May 2013), the Allied and Complementary Medicine Database (1985 to May 2013), Science Links Japan (1996 to August week 4 2013), several Korean medical databases (August week 4 2013), the World Health Organization International Clinical Trials Registry Platform (August week 4 2013), the bibliographic references of included trials and conference proceedings.
We included randomised and quasi-randomised controlled trials involving adults with acute ankle sprains. We included all types of acupuncture practices, such as needle acupuncture, electroacupuncture, laser acupuncture, pharmacoacupuncture, non-penetrating acupuncture point stimulation (e.g. acupressure and magnets) and moxibustion. Acupuncture could be compared with control (no treatment or placebo) or another standard non-surgical intervention.
Two review authors independently screened the search results, assessed trial eligibility, assessed risk of bias and extracted data from the included trials. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences for continuous outcomes. We conducted meta-analyses using the fixed-effect method or, where appropriate, the random-effects method, and used 95% confidence intervals (CI) throughout.
We included a total of 20 heterogeneous studies (2012 participants with acute ankle sprains); three of which included more than one comparison. Seventeen trials were conducted in China. All of the studies had a high risk of bias due to lack of blinding. The results may also have been affected by selection bias, particularly as five studies were quasi-randomised controlled trials and 12 studies gave no information on their method of randomisation. Of our three prespecified primary outcomes, only cure rate was reported by the majority of studies. No study reported on patient-reported assessment of function and only one reported on adverse events (in which three participants receiving a control intervention experienced skin problems from over-the-counter Chinese herbal patches). The other 19 studies did not record or report on adverse events. We assessed the quality of evidence for cure rates as very low for all comparisons, which means we are very uncertain about the reliability of any of the estimates.The single study comparing acupuncture treatment with no treatment found acupuncture to be more effective with regard to cure rate at five days (31/31 versus 1/30; RR 20.34, 95% CI 4.27 to 96.68). Acupuncture plus another standard treatment versus that standard treatment alone was tested in eight studies; with cure rate data available for seven. Most of these studies reported higher cure rates in the acupuncture plus another standard treatment group than in the standard treatment alone group. However, while the results of an exploratory meta-analysis of cure rate data from eight trials testing acupuncture versus no acupuncture tended to favour acupuncture, the results were very inconsistent across the studies and the estimated effect was very imprecise (383/396 versus 272/355; RR 1.32, 95% CI 0.95 to 1.84; P value = 0.1; I(2) = 98%).Fourteen studies compared acupuncture with a variety of other non-surgical treatments, such as Chinese drug patches, hot and cold water, ice packs, oral Chinese herbal medicine and elastic bandage. Some studies found in favour of acupuncture, some in favour of the other treatment and some found a lack of evidence for a difference between the two interventions under test. The results of an exploratory meta-analysis of cure rate data from 11 trials testing acupuncture versus another non-surgical intervention tended to slightly favour acupuncture, but these were not statistically significant and the data were very heterogeneous (404/509 versus 416/497; RR 1.07, 95% CI 0.94 to 1.22; P value = 0.30; I(2) = 92%).
AUTHORS' CONCLUSIONS: The currently available evidence from a very heterogeneous group of randomised and quasi-randomised controlled trials evaluating the effects of acupuncture for the treatment of acute ankle sprains does not provide reliable support for either the effectiveness or safety of acupuncture treatments, alone or in combination with other non-surgical interventions; or in comparison with other non-surgical interventions. Future rigorous randomised clinical trials with larger sample sizes will be necessary to establish robust clinical evidence concerning the effectiveness and safety of acupuncture treatment for acute ankle sprains.
急性踝关节扭伤是一种累及一条或多条踝关节韧带的急性发作性损伤。它是普通人群以及运动员中最常见的肌肉骨骼损伤之一。在一些国家,如中国和韩国,针灸经常被用于治疗踝关节扭伤,既可以作为单一治疗方法,也可以作为标准药物治疗的辅助干预措施。
评估针灸治疗成人急性踝关节扭伤的效果(益处和危害)。
我们检索了Cochrane骨、关节和肌肉创伤专业组专门注册库(2013年5月)、Cochrane对照试验中心注册库(《Cochrane图书馆》2013年第4期)、MEDLINE(1948年至2013年5月第2周)、EMBASE(1980年至2013年5月第2周)、中国知网数据库(1994年至2013年8月第4周)、护理及相关健康文献累积索引(1937年至2013年5月)、补充和替代医学数据库(1985年至2013年5月)、日本科学链接数据库(1996年至2013年8月第4周)、几个韩国医学数据库(2013年8月第4周)、世界卫生组织国际临床试验注册平台(2013年8月第4周)、纳入试验的参考文献及会议论文集。
我们纳入了涉及成人急性踝关节扭伤的随机和半随机对照试验。我们纳入了所有类型的针灸疗法,如毫针针刺、电针、激光针灸、药物针灸、非穿透性穴位刺激(如指压和磁疗)以及艾灸。针灸可与对照(不治疗或安慰剂)或另一种标准非手术干预措施进行比较。
两位综述作者独立筛选检索结果,评估试验的合格性,评估偏倚风险并从纳入试验中提取数据。我们计算了二分结局的风险比(RRs)和连续结局的平均差。我们使用固定效应方法或在适当情况下使用随机效应方法进行荟萃分析,并始终使用95%置信区间(CI)。
我们共纳入了20项异质性研究(2012例急性踝关节扭伤患者);其中3项研究包含不止一组对照。17项试验在中国进行。由于缺乏盲法,所有研究都存在较高的偏倚风险。结果可能还受到选择偏倚的影响,特别是因为有5项研究是半随机对照试验,12项研究未提供随机化方法的信息。在我们预先设定的三个主要结局中,大多数研究仅报告了治愈率。没有研究报告患者报告的功能评估情况,只有一项研究报告了不良事件(其中3名接受对照干预的参与者因使用非处方中药贴剂出现皮肤问题)。其他19项研究未记录或报告不良事件。我们评估所有比较的治愈率证据质量均非常低,这意味着我们对任何估计值的可靠性都非常不确定。一项比较针灸治疗与不治疗的单项研究发现,在第5天时针灸在治愈率方面更有效(31/31对1/30;RR 20.34,95%CI 4.27至96.68)。八项研究测试了针灸加另一种标准治疗与单独使用该标准治疗的效果;其中七项有治愈率数据。这些研究中的大多数报告针灸加另一种标准治疗组的治愈率高于单独标准治疗组。然而,如果对八项测试针灸与不针灸的试验的治愈率数据进行探索性荟萃分析,结果倾向于支持针灸,但各研究结果非常不一致,估计效应非常不精确(383/396对272/355;RR 1.32,95%CI
0.95至1.84;P值 = 0.1;I² = 98%)。十四项研究将针灸与多种其他非手术治疗方法进行了比较,如中药贴剂、热水和冷水、冰袋、口服中药和弹性绷带。一些研究发现支持针灸,一些研究支持其他治疗方法,还有一些研究发现没有证据表明两种受试干预措施之间存在差异。对11项测试针灸与另一种非手术干预措施的试验的治愈率数据进行探索性荟萃分析,结果倾向于略微支持针灸,但这些结果无统计学意义,且数据非常异质性(404/509对416/497;RR 1.07,95%CI 0.94至1.22;P值 = 0.30;I² = 92%)。
目前从一组非常异质性的随机和半随机对照试验中获得的证据,评估针灸治疗急性踝关节扭伤的效果,并未为针灸治疗单独或与其他非手术干预措施联合使用的有效性或安全性提供可靠支持;也未与其他非手术干预措施进行比较。未来需要进行更严格的大样本随机临床试验,以建立关于针灸治疗急性踝关节扭伤有效性和安全性的有力临床证据。