![]() 4 Symptoms of IBS-D include frequent loose or watery stools with associated urgency, which if associated with incontinence, 5 can severely limit socialising, travelling and eating out and markedly reduce quality of life and work productivity. Patients with IBS report abdominal pain and erratic bowel habit with around one-third meeting criteria for IBS with diarrhoea (IBS-D). Irritable bowel syndrome (IBS), which affects 3%–5% of the population, 1 accounts for 2.5% of the 340 million consultations per year in primary care in England and Wales, 2, 3 or approximately 8.5 million consultations per year. ConclusionsĪlthough small numbers meant the primary endpoint was not met in this trial, when pooled with other similar trials meta-analysis suggests ondansetron improves stool consistency and reduces days with loose stool and urgency. Meta-analysis of 327 patients from this, and two similar trials, demonstrated ondansetron was superior to placebo for the FDA composite endpoint (RR of symptoms not responding = 0.86 95% CI 0.75–0.98, NNT = 9) and stool response (RR = 0.65 95% CI 0.52–0.82, NNT = 5), but not abdominal pain response (RR = 0.95 95% CI 0.74–1.20). Ondansetron increased WGTT between baseline and week 12 (mean (SD) difference 3.8 (9.1) hours, versus placebo −2.2 (10.3) hours, p = 0.01). Ondansetron improved stool consistency compared with placebo (adjusted mean difference − 0.7 95% CI −1.0 to−0.3, p < 0.001). ![]() After literature review, results were pooled with other placebo-controlled trials in a meta-analysis to estimate relative risks (RR), 95% confidence intervals (CIs) and number needed to treat (NNT). ![]() Secondary and mechanistic endpoints included stool consistency (Bristol Stool Form Scale) and whole gut transit time (WGTT). Primary endpoint: % responders using the Food and Drug Administration (FDA) composite endpoint. (titrated up to 8 mg t.d.s.) in 400 IBS-D patients. To conduct a 12-week parallel group, randomised, double-blind, placebo-controlled trial of ondansetron 4 mg o.d. Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D).
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