Randomised clinical trial: colestyramine vs. hydroxypropyl cellulose in patients with functional chronic watery diarrhoea. Issue 11 (10th April 2015)

• Record Type: Journal Article
• Authors: Fernández‐Bañares, F.; Rosinach, M.; Piqueras, M.; Ruiz‐Cerulla, A.; Modolell, I.; Zabana, Y.; Guardiola, J.; Esteve, M.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 41:Issue 11(2015)
• Page Start: 1132
• Page End: 1140
• Publication Date: 2015-04-10
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.13193
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt13193-abs-0001"> <title>Summary</title> <sec id="apt13193-sec-0001" sec-type="section"> <title>Background</title> <p>Idiopathic bile acid malabsorption (BAM) has been suggested as a cause of chronic watery diarrhoea, with a response to colestyramine in 70% of patients. However, the efficacy of this drug has never been investigated in placebo‐controlled trials.</p> </sec> <sec id="apt13193-sec-0002" sec-type="section"> <title>Aim</title> <p>To evaluate the efficacy of colestyramine as compared with hydroxypropyl cellulose in the treatment of functional chronic watery diarrhoea.</p> </sec> <sec id="apt13193-sec-0003" sec-type="section"> <title>Methods</title> <p>Patients with chronic watery diarrhoea were randomly assigned to groups given colestyramine sachets 4 g twice daily (<italic>n</italic> = 13) or identical hydroxypropyl cellulose sachets (<italic>n</italic> = 13) for 8 weeks. The primary end‐point was clinical remission defined as a mean of 3 or fewer stools per day during the week before the visit, with less than 1 watery stool per day. A secondary end‐point was the reduction in daily watery stool number. SeHCAT test was performed in all patients, but an abnormal test was not a prerequisite to be included.</p> </sec> <sec id="apt13193-sec-0004" sec-type="section"> <title>Results</title> <p>All included patients had a SeHCAT 7‐day retention ≤20%. There were no statistical differences in the percentage of patients in clinical remission at week 8 between colestyramine and hydroxypropyl cellulose with either intention‐to‐treat (53.8% vs. 38.4%; <italic>P</italic> = 0.43) or per‐protocol (63.6% vs. 38.4%; <italic>P</italic> = 0.22) analyses. However, the mean per cent decrease in watery stool number was significantly higher with colestyramine than with hydroxypropyl cellulose (−92.4 ± 3.5% vs. −75.8 ± 7.1%; <italic>P</italic> = 0.048). The rate of adverse events related to study drugs did not differ between groups.</p> </sec> <sec id="apt13193-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Colestyramine (4 g twice daily) is effective and safe for short‐term treatment of patients with chronic watery diarrhoea presumably secondary to BAM. Clinical Trials Register number EudraCT 2009‐011149‐14.</p> </sec> </abstract>