Acute studies Comparison: loperamide versus placebo

OutcomeMeta- analysis detailsSummary Statisticsp (hetero) and I2Comments:Study qualityDirectnessImprecisionInconsistencyReporting BiasGRADE CommentsGRADE Evidence Rating
No of patients with no unformed stools at 1h1 trial; 115 patients; from RCT; (acute parallel design)RR= 1.25 (95%CI 0.99, 1.59)Not statistically significant, but favours loperamideGoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryAmery 1975. Industry funded; not IBS population; some childrenLow
No of patients with no unformed stools at 2h1 trial; 115 patients; from RCT; (parallel design)RR= 1.33 (95%CI 0.98, 1.82)Not statistically significant, but favours loperamideGoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryAmery 1975. Industry funded; not IBS population; some childrenLow
No of patients with no unformed stools at 4h1 trial; 115 patients; from RCT; (parallel design)RR= 1.66 (95%CI 1.1, 2.49)Statistically significant in favour of loperamide. NNT 5 (95%CI 3, 17), for control group rate of 36%GoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryAmery 1975. Industry funded; not IBS population; some childrenLow
No of patients with no unformed stools at 24h1 trial; 115 patients; from RCT; (parallel design)RR= 1.73 (95%CI 0.99, 3.01)Borderline significant, favours loperamideGoodIndirect patients - minor, closely related conditnFairly wide CIConsistentPoor - studies, industryAmery 1975. Industry funded; not IBS population; some childrenLow
No of patients with no unformed stools at 72h1 trial; 213 patients; from RCT; (parallel design)RR= 1.2 (95%CI 1.03, 1.4)Statistically significant, favours loperamideGoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryDettmar 1998. Industry funded. Not IBS populationLow
No of patients with first relief1 trial; 242 patients; from RCT; (parallel design)OR= 4.23 (95%CI 1.13, 15.82)Statistically significant, favours loperamideGoodIndirect patients - minor, closely related conditnWide CIConsistentPoor - studies, industryDreverman 0.5mg vs placebo. Unclear what precision, but assumed reasonable because large study. Industry sponsored. Not IBSLow
No of patients with first relief1 trial; 242 patients; from RCT; (parallel design)OR= 6.25 (95%CI 1.74, 22.42)Statistically significant, favours loperamideGoodIndirect patients - minor, closely related conditnWide CIConsistentPoor - studies, industryDreverman 1.0mg vs placebo. Unclear what precision, but assumed reasonable because large study. Industry sponsored. Not IBSLow
Time to first relief1 trial; 242 patients; from RCT; (parallel design)Median difference= 4.5 hoursDetails not given, but statistically significant in favour of loperamide (p=0.012)GoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryDreverman 0.5mg vs placebo. Unclear what precision, but assumed reasonable because large study. Industry sponsored. Not IBSLow
Time to first relief1 trial; 242 patients; from RCT; (parallel design)Median difference= 9.3 hoursDetails not given, but statistically significant in favour of loperamide (p=0.003)GoodIndirect patients - minor, closely related conditnPreciseConsistentPoor - studies, industryDreverman 1.0mg vs placebo. Unclear what precision, but assumed reasonable because large study. Industry sponsored. Not IBSLow

From: Appendix F, Grading the evidence

Cover of Irritable Bowel Syndrome in Adults
Irritable Bowel Syndrome in Adults: Diagnosis and Management of Irritable Bowel Syndrome in Primary Care [Internet].
NICE Clinical Guidelines, No. 61.
National Collaborating Centre for Nursing and Supportive Care (UK).
Copyright © 2008, Royal College of Nursing.

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