以痛泻要方为基本方治疗肠易激综合征随机对照试验的系统评价

Systematic Review of Randomized Controlled Trials of Tongxie Yaofang and Its Modified Prescriptions for the Treatment of Irritable Bowel Syndrome

【目的】评价以痛泻要方为基本方治疗肝郁脾虚型肠易激综合征(IBS)的疗效。【方法】以"痛泻要方"、"肠易激综合征"、"随机对照试验"为关键词,在国内外中英文主要学术论文数据库查找,并进行相关参考文献的检索,用经过验证的中医药治疗性文献信息采集表对纳入的研究进行数据的采集与质量评价。以主要症状(腹痛、大便形状、大便频率等)和/或总体疗效评价以及生存质量为结局指标,将纳入文献分为腹泻型和不分亚型、中医辨证组和未配合中医辨证组等亚组,用Review Manager 4.2进行数据管理与Meta分析。用漏斗图分析发表性偏倚。【结果】46个随机对照试验符合纳入标准,共包括4 155例患者。以痛泻要方为基本方治疗IBS的疗效优于西药或安慰剂,其差异有统计学意义[OR为5.30,95%CI(4.38,6.41)]。亚组分析中,治疗腹泻型IBS的OR值[OR为5.61,95%CI(4.33,7.25)]高于不分亚型组OR值[OR为4.95,95%CI(3.74,6.55)],但差异无统计学意义;痛泻要方为基本方配合中医辨证加减治疗腹泻型IBS的OR值[OR为6.50,95%CI(3.78,11.20)]高于未配合中医辨证组OR值[OR为5.37,95%CI(4.01,7.19)],但差异无统计学意义。存在发表性偏倚。【结论】以痛泻要方为基本方治疗中医辨证为肝郁脾虚型的腹泻型肠易激综合征的效果优于西药或安慰剂,但尚未能证实配合中医辨证加减的疗效优于基本方,腹泻型疗效优于便秘型等其他类型;研究的总体质量偏低,受偏倚影响的机会较大;个别高质量研究的阴性结果值得进一步探讨。

Objective To assess the effectiveness of the Chinese herbal formula Tongxie Yaofang （TY） or its modified prescriptions in the management of irritable bowl syndrome （IBS）. Methods A systematic review was carried out according to the Cochrane standards. A computerized literature search was carried out in main Chinese and English databases including CNKI, CBMdisc, Database of Chinese Doctorate Dissertation, Database of excellent Chinese Master Dissertation, MEDLINE and Cochrane Library. Studies were retrieved when they were randomized controlled trials （RCTs） whose interventions for IBS patients were TY or modified prescriptions of TY with placebos or conventional medicine as controls. Outcome measurement included the alleviation of main symptoms such as abdominal pain, diarrhea frequency, and （or） comprehensive effectiveness and quality of life （QOL）. Meta-analysis was performed after evaluating the quality of included studies. Subgroup analysis was done between subgroups of diarrhea-predominant IBS and subtype-regardless IBS, and was also done between diarrhea- predominant IBS treated with TCM syndrome differentiation and that without TCM syndrome differentiation. Funnel plot analysis was used to analyze the publication bias. Results Forty-six studies met the inclusion criteria, and 4155 participants were included in the meta-analysis. The results showed that the effectiveness of TY or modified prescriptions of TY was better than that of conventional medicine or placebos [ OR = 5.30, 95% CI （4. 38, 6. 41 ） ]. Subgroup analysis showed that the OR of TY or modified prescriptions of TY in the diarrhea-predominant groups [ OR =5.61, 95% CI （4.33, 7.25） 1 was higher than that of subtype-regardless groups [ OR = 4. 95, 95% CI （3.74, 6. 55）], and OR of TY or modified prescriptions of TY in the studies of diarrhea-predominant IBS treated based on TCM syndrome differentiation [ OR = 6.50, 95% CI （3.78, 11.20）1 was higher than that of the studies without TCM syndrome differentiation [ OR = 5.37, 95% CI （4.01, 7.19） ], but the difference was insignificant. Funnel plot showed certain publication bias. Conclusion The effectiveness of TY or modified prescriptions of TY for IBS patients is better than that of western medicine and placebo. But their effectiveness for diarrhea-predominant IBS or with TCM syndrome differentiation was not proved to be better than those for other subtypes or without TCM syndrome differentiation. Biases may exist for overall quality of the studies is low; negative results in some high quality studies need further discussion.