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用于治疗糖尿病周围神经病变的中草药

Chinese herbal medicine for diabetic peripheral neuropathy.

作者信息

Chen Wei, Zhang Yin, Liu Jian Ping

机构信息

Centre For Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing, China, 100029.

出版信息

Cochrane Database Syst Rev. 2011 Jun 15(6):CD007796. doi: 10.1002/14651858.CD007796.pub2.

Abstract

BACKGROUND

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy.

OBJECTIVES

To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy.

SEARCH STRATEGY

We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 June 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010 in The Cochrane Library), MEDLINE (January 1966 to June 2010), EMBASE (January 1980 to June 2010), AMED (January 1985 to June 2010), Chinese Biomedical Database (CBM) (1979 to June 2010), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to June 2010), and VIP Chinese Science and Technique Journals Database (1989 to June 2010). We searched for unpublished literature in the Chinese Conference Papers Database and Chinese Dissertation Database (from inception to March 2010). No language or publication restrictions were used.

SELECTION CRITERIA

We included randomized controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included.

DATA COLLECTION AND ANALYSIS

Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. The data analyses were carried out using Review Manager 5.1 (Cochrane software).

MAIN RESULTS

Thirty-nine randomized trials involving 2890 participants were included. All trials were conducted and published in China. Thirty different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 18 self-concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction velocity. There was inadequate reporting on adverse events in the included trials. Most of the trials did not mention whether they monitored adverse effects at all. Only two trials reported adverse events: one occurred in the control group in one trial and in which group was unclear in the other trial . Conclusions cannot be drawn from this review about the safety of herbal medicines due to inadequate reporting. Most of the trials were of low methodological quality and therefore the interpretation of any positive findings for the efficacy of the included Chinese herbal medicines for treating diabetic peripheral neuropathy should be made with caution.

AUTHORS' CONCLUSIONS: Based on this systematic review, there is no evidence to support the objective effectiveness and safety of Chinese herbal medicines for diabetic peripheral neuropathy. No well designed, randomized placebo controlled trial with objective outcome measures has been conducted.

摘要

背景

在中国,中药常用于治疗糖尿病周围神经病变。已经开展了许多对照试验来研究其疗效。

目的

评估中药对糖尿病周围神经病变患者的有益效果和危害。

检索策略

我们检索了Cochrane神经肌肉疾病组专业注册库(2010年6月15日)、Cochrane对照试验中心注册库(CENTRAL)(2010年第2期,载于《Cochrane图书馆》)、医学期刊数据库(MEDLINE,1966年1月至2010年6月)、荷兰医学文摘数据库(EMBASE,1980年1月至2010年6月)、联合和补充医学数据库(AMED,1985年1月至2010年6月)、中国生物医学文献数据库(CBM,1979年至2010年6月)、中国知网数据库(CNKI,1979年至2010年6月)以及维普中文科技期刊数据库(1989年至2010年6月)。我们在中国会议论文数据库和中国学位论文数据库中检索了未发表的文献(从建库至2010年3月)。未设语言或发表限制。

选择标准

我们纳入了针对糖尿病周围神经病变患者的中药随机对照试验(治疗持续时间至少四周),并与安慰剂、无干预措施或传统干预措施进行比较。还纳入了中药加传统药物与单纯药物比较的试验。

数据收集与分析

两位作者独立提取数据并评估试验质量。我们联系研究作者以获取更多信息。使用Review Manager 5.1(Cochrane软件)进行数据分析。

主要结果

纳入了39项随机试验,涉及2890名参与者。所有试验均在中国开展并发表。这些试验中测试了30种不同的中药,包括4种单味药(单味草药提取物)、8种中成药和18种自拟中药复方制剂。试验报告了整体症状改善情况(包括麻木或疼痛的改善)以及神经传导速度的变化。纳入试验中关于不良事件的报告不足。大多数试验根本未提及是否监测了不良反应。只有两项试验报告了不良事件:一项试验中不良事件发生在对照组,另一项试验中不清楚发生在哪个组。由于报告不足,无法从本综述中得出关于中药安全性的结论。大多数试验的方法学质量较低,因此对于所纳入的中药治疗糖尿病周围神经病变疗效的任何阳性结果,在解释时都应谨慎。

作者结论

基于本系统综述,没有证据支持中药对糖尿病周围神经病变具有客观有效性和安全性。尚未开展设计良好、采用客观结局指标的随机安慰剂对照试验。

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