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A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea
  1. Klara Garsed1,
  2. Julia Chernova1,
  3. Margaret Hastings2,
  4. Ching Lam1,
  5. Luca Marciani3,
  6. Gulzar Singh1,
  7. Amanda Henry4,
  8. Ian Hall4,
  9. Peter Whorwell2,
  10. Robin Spiller1
  1. 1Nottingham Digestive Diseases Biomedical Research Unit, Queens Medical Centre, Nottingham, UK
  2. 2Neurogastroenterology Unit, Wythenshawe Hospital, Manchester, UK
  3. 3Sir Peter Mansfield Magnetic Resonance Imaging Centre, University of Nottingham, Nottingham, UK
  4. 4Department of Molecular Medicine, School of Surgical and Medical Sciences, University of Nottingham, Nottingham, UK
  1. Correspondence to Professor Robin Spiller, Nottingham Digestive Diseases Centre, University Hospital, Nottingham NG7 2UH, UK; robin.spiller{at}


Background Irritable bowel syndrome with diarrhoea (IBS-D) is particularly debilitating due to urgency and episodic incontinence. Some 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (5-HT3RAs) have proven effective but have serious side effects. Ondansetron, also a 5-HT3RA, has been widely used as an antiemetic with an excellent safety record for over two decades. Our aim was to assess its effectiveness in IBS-D.

Methods 120 patients meeting Rome III criteria for IBS-D entered a randomised, double-blind, placebo-controlled crossover study of 5 weeks of ondansetron 4 mg versus placebo with dose titration allowed, up to two tablets three times daily in the first 3 weeks. Patients completed daily diaries documenting stool consistency using the Bristol Stool Form score. Gut transit was measured in the last week of each treatment. The primary endpoint was average stool consistency in the last 2 weeks of treatment.

Results Ondansetron significantly improved stool consistency (mean difference in stool form between ondansetron and placebo −0.9, 95% CI −1.1 to −0.6, p<0.001). Compared with placebo, patients on ondansetron experienced fewer days with urgency (p<0.001), lower urgency scores (p<0.001), reduced frequency of defaecation (p=0.002) and less bloating (p=0.002), although pain scores did not change significantly. IBS symptom severity score fell more with ondansetron than placebo (83±9.8 vs 37±9.7, p=0.001). 65% reported adequate relief with ondansetron but not placebo compared with 14% reporting relief with placebo but not ondansetron, relative risk 4.7, 95% CI 2.6 to 8.5, p<0.001.

Conclusions Ondansetron relieves some of the most intrusive symptoms of IBS-D, namely loose stools, frequency and urgency.

  • Irritable Bowel Syndrome
  • Serotonin
  • Clinical Trials

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