| BACKGROUND:Irritable bowel syndrome (IBS) is a kind of common gastrointestinal disease globally, which the prevalence is high and has a tendency to increase every year. IBS can break out repeatedly and affect patient’s quality of life severely so that has already occupied a great deal of health resources. The pathogenesis of irritable bowel syndrome is unclear and treatments are various. In spite of many studies about5-hydroxytryptamine receptor moderator have been reported in recent years, the exact efficacy and safety has no distinct conclusion.OBJECTIVE:The primary objective was to systematically review the evidence on the efficacy and safety of different mixed5-HT4agonists/5-HT3antagonists (cisapride、mosapride、renzapride) in the treatment of patients with IBS.METHODS:1. Materials and methods:establish inclusion and exclusion criterion, search computer datas and hand-search kinds of correlated journals, use the quality assessment criteria of Cochrane Reviewer Handbook5.1to assess eligible RCT, collect and extract data and use Cochrane RevMan5.1.2to analysis.2. Outcome measures:The unimprovement of the IBS global symptoms, single symptoms and incidence rate of adverse events.RESULTS:1. Search results:238papers were searched out, and8papers were included,4in cisapride,O in mosapride and4in renzapride.2. Characteristic of included studies:all studies were in English, which maximum sample included1798patients and minimum sample included48patients. Maximum mean age of patients was49.5years old and minimum mean age was36years old. Most patients were women in7studies while patients were only women in1study.7trials included C-IBSand1trial included A-IBS.3. Quality assessment:all studies were randomized controlled trials, only3of which described randomization and allocation concealment in detail. All studies were double blind trials, only2of which described blinding in detail. All studies reported exit of patients during test and had no selection report.4. Analysis results:1) CisaprideThe unimprovement of the IBS global symptoms, abdominal pain or constipation were not found different in the presence of cisapride versus control(RR=0.91,95%CI(0.58,1.43); RR=0.90,95%CI(0.72,1.11); RR=0.91,95%CI(0.74,1.12)). There was no significant difference in adverse events between the cisapride and placebo group(RR=1.52,95%CI(0.58,3.99)).2) MosaprideThere was no eligible randomized controlled trial to include. 3) RenzaprideIn the presence of renzapride, lower dose with lmg/d or2mg/d was not found to be superior to that of control in attenuating the global symptoms either,(RR=0.95,95%CI(0.67,1.35); RR=0.79,95%CI(0.67,1.17)). However, high dose of renzapride with4mg/d make significantly effect with a rate of67.8%vs.73.9%in control,(RR=0.91,95%CI(0.86,0.96)). Renzapride (1mg/d、2mg/d、4mg/d) was not found to be superior to that of control in attenuating the abdominal pain/discomfort(RR=1.01,95%CI(0.92,1.10)).There was no significant difference in adverse events between the renzapride and placebo group(RR=1.11,95%CI(0.98,1.24)).CONCLUSIONS:1. Cisapride might not improve global IBS symptoms, abdominal pain and constipation. There was no significant difference in adverse events between the cisapride and placebo.2. There was no available evidence of mosapride in the treatment of patients with IBS.3. Renzapride4mg/d might be effective in relieving global IBS symptoms for patients with C-IBS, but it might not improve symptoms of abdominal pain/discomfort. Renzapride lmg/d and2mg/d might not improve global IBS symptoms and abdominal pain/discomfort. There was no significant difference in adverse events between the renzapride and placebo.4. Because the methodological quality of most included studies was poor, further high-quality randomized controlled trials of IBS should be performed. |
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