Chen Wei, Zhang Yin, Li Xinxue, Yang Guoyan, Liu Jian Ping
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang District, Beijing, China, 100029.
Cochrane Database Syst Rev. 2013 Oct 6;2013(10):CD007796. doi: 10.1002/14651858.CD007796.pub3.
Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy.This is an update of a Cochrane review that was first published in the year 2011.
To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy.
On 14 May 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register CENTRAL (2012, Issue 4 in The Cochrane Library), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), AMED (January 1985 to May 2012) and in October 2012, the Chinese Biomedical Database (CBM) (1979 to October 2012), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to October 2012), and VIP Chinese Science and Technique Journals Database (1989 to October 2012). We searched for unpublished literature in the Chinese Conference Papers Database, and Chinese Dissertation Database (from inception to October 2012). There were no language or publication restrictions.
We included randomised 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.
Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information.
Forty-nine randomised trials involving 3639 participants were included. All trials were conducted and published in China. Thirty-eight different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 26 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. The positive results described from the 49 studies of low quality are of questionable significance. There was inadequate reporting on adverse events in the included trials. Eighteen trials found no adverse events. Two trials reported adverse events: adverse events occurred in the control group in one trial, and in the other it was unclear in which group the adverse events occurred. 29 trials did not mention whether they monitored adverse events. Conclusions cannot be drawn from this review about the safety of herbal medicines, due to inadequate reporting. Most of the trials were of very 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, randomised, placebo controlled trial with objective outcome measures has been conducted.
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。这是对2011年首次发表的Cochrane系统评价的更新。
评估中药对糖尿病周围神经病变患者的有益效果和危害。
2012年5月14日,我们检索了Cochrane神经肌肉疾病组专业注册库CENTRAL(2012年第4期,载于《Cochrane图书馆》)、MEDLINE(1966年1月至2012年5月)、EMBASE(1980年1月至2012年5月)、AMED(1985年1月至2012年5月),并于2012年10月检索了中国生物医学文献数据库(CBM)(1979年至2012年10月)、中国知网数据库(CNKI)(1979年至2012年10月)和维普中文科技期刊数据库(1989年至2012年10月)。我们在中国会议论文数据库和中国学位论文数据库(自建库至2012年10月)中检索未发表的文献。没有语言或发表限制。
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对比的试验。
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。
纳入了49项随机试验,涉及3639名参与者。所有试验均在中国进行并发表。这些试验中测试了38种不同的中药,包括4种单味药(单一草药提取物)、8种中成药和26种自拟中药复方制剂。试验报告了总体症状改善情况(包括麻木或疼痛的改善)以及神经传导速度的变化。这49项低质量研究中描述的阳性结果意义存疑。纳入试验中关于不良事件的报告不足。18项试验未发现不良事件。两项试验报告了不良事件:一项试验中对照组出现不良事件,另一项试验中不清楚不良事件发生在哪个组。29项试验未提及是否监测了不良事件。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非常低,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的解读都应谨慎。
基于本系统评价,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。尚未进行设计良好、随机、安慰剂对照且有客观结局指标的试验。