中药痛泻要方治疗肠易激综合征疗效的荟萃分析

Meta-analysis of the effectiveness of Tong Xie Yao Fang in treating irritable bowel syndrome

目的:评价以痛泻要方(TXYF)为基础方的中药方剂(TXYFa)治疗肠易激综合征(IBS)的疗效.方法:通过对网上电子数据库、临床试验注册数据库、参考文献以及手工对相关会议检索的TXYF和TXYFa治疗IBS随机或半随机对照试验,对照组用西药、安慰剂或不治疗者的对象和数据进行荟萃分析.结果:31个临床试验涉及32个TXYFa符合入选条件而纳入研究.对所有纳入试验的数据分析显示TXFYa具有显著疗效(RR:1.30,95%CI:1.22-1.38,P<0.01).其中23个TXYFa(72%)分别与西药或安慰剂比较有显著疗效(P<0.05);11个和20个试验数据分别显示TXYFa显著改善IBS总体症状(RR:1.31,95%CI:1.23-1.40,P<0.01)和腹泻型IBS的相关症状(RR:1.33,95%CI:1.21-1.45,P<0.01).纳入试验的方法质量学评估均为低质量试验,倒漏斗图形显示不对称,提示存在发表偏畸.结论:痛泻要方的潜在疗效和安全性有待严格设计的随机、双盲、安慰剂对照试验加以证实.

AIM： To conduct a review to explore the efficacy of Tong Xie Yao Fang （TXYF） in treating irritable bowel syndrome （IBS）. METHODS： Computer-based and manual literature searches from Internet databases and registers of clinical trial databases and references, as well as related meetings were performed. Search strategy： randomized or quasi-randomized controlled trials for treating IBS patients with TXYF or TXYF with the addition of,other traditional Chinese medicines （TXYFa）, and controls treated with conventional medicines or a placebo, or with no treatment were included. RESULTS： A total of 31 met the inclusion criteria studies with 32 arms Meta-analysis of these studies showed that TXYFa had beneficial effects for relieving IBS symptoms （RR： 1.30, 95%CI： 1.22-1.38, P 〈 0.01）. Compared with the controls, 23 （72%） showed that TXYFa had significant benefit for IBS treatment （P 〈 0.05）. Combining data from 11 studies showed a global improve- ment of symptoms in IBS （RR： 1.31, 95% CI： 1.23-1.40, P 〈 0.01）. Combining data from 20 studies showed that TXYFa was advantageous in diarrhea-predominant IBS （RR： 1.33, 95%CI： 1.21-1.45, P 〈 0.01）. However, all these studies were of low quality. Further, a funnel plot was asymmetric, indicating the presence of a publi- cation bias. CONCLUSION： Although TXFYa had therapeutic benefit in IBS in the studies evaluated, the evidence is not strong enough for it to be recom- mended as a treatment for IBS because of the low quality of the studies and the publication bias. It will be necessary to conduct rigorous well-designed clinical trials to evaluate the efficacy and safety of TXFYa as a treatment for IBS.