The Center of Neurology and Rehabilitation, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou 325027, China.
J Ethnopharmacol. 2013 Jun 21;148(1):1-13. doi: 10.1016/j.jep.2013.04.002. Epub 2013 Apr 11.
Xiaoxuming decoction (XXMD) is a well-known traditional Chinese herbal prescription in treatment of patients with stroke. The objective of this study is to assess the efficacy and safety of XXMD for acute ischemic stroke.
A systematic literature search was conducted in 6 databases until June 2012 to identify randomized controlled trials (RCTs) of XXMD for acute ischemic stroke compared with western conventional medicine (WCM). The primary outcome measures were National Institutes of Health Stroke Scale (NIHSS) scores and modified Rankin Scale (mRS) scores. The secondary outcome measures were the clinical effective rate and adverse events at the end of treatment course. The methodological quality of RCTs was assessed independently using 12-item criteria according to the Cochrane Back Review Group. All data were analyzed using Review Manager 5.0 software.
Eight RCTs with 601 individuals published from 1992 to 2012 were identified. The studies were deemed to have a high risk of bias. Compared with WCM, 1 RCT showed significant effects of XXMD for improving mRS after stroke (p<0.05); 3 RCTs for improving NIHSS scores [n=186, weighted mean difference (WMD): -1.86, 95% CI: -3.25 to -0.48, z=2.63, p<0.01]; 7 RCTs for improving the clinical effective rate [n=531, risk ratio (RR)=1.17, 95% CI, 1.09 to 1.26, z=4.38, p<0.01]. Five trials contained safety assessments and stated that no adverse event was found, whereas the other 3 trials did not provide the information about adverse events.
This systematic review showed positive but weak evidence of XXMD for acute ischemic stroke because of the poor methodological quality and the small quantity of the included trials. The difficulties of fitting Chinese herbal medicine (CHM) into the double blinded RCTs have raised as follows: (A) traditional Chinese medicine (TCM) as whole systems of healthcare offers unique methodological and theoretical challenges for RCTs; (B) suspicions against the placebo and unwillingness to stop taking other CHMs make recruitment more difficulty, time-consumption, and cost; (C) the shortcomings of the TCM diagnostic process includes the lack of standardization in terminology, disagreement of pattern differentiation (Bianzheng), and neglect of formula corresponding to syndrome (TCM Zheng); (D) It is difficult to design credible herbal placebos with similar appearance, smells and tastes to the experimental CHM and at the same time is absent of any pharmacological activity; (E) the achieving efficacy of CHM complex interventions is often nonspecific and the outcome measures is subjective using Chinese quantitative instrument.
消栓明胶囊（XXMD）是治疗中风患者的一种著名的中药方剂。本研究旨在评估 XXMD 治疗急性缺血性中风的疗效和安全性。
系统检索 6 个数据库，直到 2012 年 6 月，以识别与西药（WCM）相比治疗急性缺血性中风的 XXMD 的随机对照试验（RCT）。主要结局指标为国立卫生研究院中风量表（NIHSS）评分和改良 Rankin 量表（mRS）评分。次要结局指标为治疗结束时的临床有效率和不良事件。使用 Cochrane 回顾组的 12 项标准独立评估 RCT 的方法学质量。所有数据均使用 Review Manager 5.0 软件进行分析。
共纳入 1992 年至 2012 年发表的 8 项 RCT，共 601 例。研究被认为存在高偏倚风险。与 WCM 相比，1 项 RCT 显示 XXMD 改善中风后 mRS 有显著效果（p<0.05）；3 项 RCT 改善 NIHSS 评分[n=186，加权均数差（WMD）：-1.86，95%CI：-3.25 至-0.48，z=2.63，p<0.01]；7 项 RCT 改善临床有效率[n=531，风险比（RR）=1.17，95%CI，1.09 至 1.26，z=4.38，p<0.01]。5 项试验包含安全性评估，并指出未发现不良事件，而另外 3 项试验未提供不良事件信息。
由于方法学质量差和纳入试验数量少，本系统评价显示 XXMD 治疗急性缺血性中风的疗效呈阳性但较弱。将中药（CHM）纳入双盲 RCT 存在以下困难：（A）中医药作为整体医疗体系，对 RCT 提出了独特的方法学和理论挑战；（B）对安慰剂的怀疑和不愿意停止服用其他 CHM 使得招募更加困难、耗时和昂贵；（C）中医诊断过程的缺点包括术语缺乏标准化、辨证不一致（Bianzheng）以及忽视与证候对应的配方（中医 Zheng）；（D）设计具有相似外观、气味和味道且无任何药理活性的可信草药安慰剂具有挑战性；（E）CHM 复杂干预的疗效往往是非特异性的，使用中文定量工具的结局指标是主观的。
