中药复方治疗不安腿综合征临床疗效Meta分析

目的:系统评价中药复方治疗不安腿综合征的临床疗效和安全性。方法:检索CNKI、维普、万方、CBM、PubMed等数据库,收集应用中药复方治疗不安腿综合征的临床随机对照试验文献。应用Cochrane 评价员手册进行风险偏倚评估后,使用RevMan 5.3软件对其临床疗效指标进行Meta分析。结果:最终纳入31篇文献,共涉及2301例患者,其中治疗组1181例,对照组1120例。Meta分析结果显示:中药复方治疗不安腿综合征总有效率OR=4.53,95%CI(3.02～6.81),P<0.00001],优于西药对照组; 中药复方联合西药治疗不安腿综合征总有效率OR=4.96,95%CI(3.13～7.87),P<0.00001],优于西药对照组; 在改善IRLS和PSQI评分方面中药复方联合西药组与西药对照组相比均没有显著性差异WMD=-3.00,95%CI(-8.22～2.23),P=0.26; WMD=-3.84,95%CI(-7.68～-0.01),P=0.05],安全性方面亦没有明显差异(P>0.05)。结论:中药复方及中药复方联合西药治疗不安腿综合征对比西药治疗均能取得更好的临床疗效。由于纳入文献的质量不高,尚需更多规模较大的高质量临床随机对照试验作为循证医学证据。

Meta-analysis on Chinese herbal compound in treating restless legs syndrome

Objective:To evaluate the efficacy and safety of Chinese herbal compound in treating restless legs syndrome.Methods:Retrieved CNKI,VIP,Wanfang,CBM,PubMed databases to collecting the randomized controlled trials about Chinese herbal compound in treating restless legs syndrome.we evaluated the quality of RCTs by the Cochrane scale,and then performed meta-analysis of curative effect index with RevMan5.3 software.Results:A total of 31 RCT literature were included,involving 2301 patients,including 1181 in the treatment group and 1120 in the control group.Meta-analysis results showed that Chinese herbal compound was effective in treating restless leg syndromeOR=4.53,95%CI(3.02~6.81),P<0.00001],better than the western medicine group;and Chinese medicine treatment combine with western medicine in treating restless legs syndrome also has obvious curative effectOR=4.96,95%CI(3.13~7.87),P<0.00001],better than the western medicine group;In terms of improving IRLS and PSQI score,there was no significant difference between the TCM compound combined with western medicine group and the western medicine control groupWMD=-3.00,95%CI(-8.22~2.23),P=0.26;WMD=-3.84,95%CI(-7.68~-0.01),P=0.05],and there was no significant difference in adverse reactions(P>0.05).Conclusion:Compared with western medicine,the effectiveness of Chinese herbal compound alone and Chinese herbal compound combined with western medicine in treating restless legs syndrome are more significant.Because of the low quality of the included literature,the more large sample-size high quality RCT is needed to as evidence-based basis.