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Gastroenterology Research and Practice
Volume 2011 (2011), Article ID 783196, 8 pages
http://dx.doi.org/10.1155/2011/783196
Research Article

Efficacy of Diosmectite (Smecta)® in the Treatment of Acute Watery Diarrhoea in Adults: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

183 avenue Mohamed V, 1002 Tunis, Tunisia
2Regional Hospital, Route Mornag—Yasminet, 2013 Ben Arous, Tunisia
3Tahar Mamouri Regional Hospital, 8000 Nabeul, Tunisia
4Interior Security Forces Hospital, 2070 La Marsa, Tunisia
5Charles Nicolle Hospital, Boulevard du 9 avril, 1006 Tunis, Tunisia
6Ipsen, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
7Univ Lille Nord de France, F-59000 Lille, France
8CHU Lille, F 59000 Lille, France

Received 1 February 2011; Revised 29 March 2011; Accepted 27 April 2011

Academic Editor: A. Castells

Copyright © 2011 Faouzi Khediri et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Although diosmectite has demonstrated efficacy in the treatment of acute watery diarrhoea in children, its efficacy in adults still needs to be assessed. The objective of this study was therefore to assess the efficacy of diosmectite on the time to recovery in adults with acute diarrhoea. Methods. A total of 346 adults with at least three watery stools per day over a period of less than 48 hours were prospectively randomized to diosmectite (6 g tid) or placebo during four days. The primary endpoint was time to diarrhoea recovery. Results. In the intention-to-treat population, median time to recovery was 53.8 hours (range [3.7–167.3]) with diosmectite (n=166) versus 69.0 hours [2.2–165.2] with placebo, (n=163; P=.029), which corresponds to a difference of 15.2 hours. Diosmectite was well tolerated. Conclusion. Diosmectite at 6 g tid was well tolerated and reduced the time to recovery of acute watery diarrhoea episode in a clinically relevant manner.