The
efficacy of racecadotril (RC), an intestinal antisecretory drug acting via an enkephalinase
inhibition, was reviewed in paediatric acute diarrhoea but not yet in adults. Objective:
To estimate the effectiveness of RC in the symptomatic treatment of acute diarrhoea
in adults. Data Sources: A systematic review of MedLine, Cochrane Controlled Trials
Register, DARE, and Embase (up to November 2013). Additional studies were identified
by contacting clinical experts and the manufacturer. Study Selection and Appraisal:
Randomized Controlled Trials performed in adults suffering from acute diarrhoea
using RC in one treatment arm. Independent extraction of articles using predefined
data fields, and methodological quality measurement assessment. All randomised trials
performed in adults suffering from acute diarrhoea with RC as the studied group.
Statistics: The main efficacy endpoint was diarrhoea duration defined as time to
recovery compared between groups by survival techniques and converted into hazard
ratio (HR). We exclusively used a random-effect meta-analytic model. Constipation
proportion was the main safety endpoint, evaluated between treatments by the
Relative Risks (RR). Results: Twelve randomised trials (2619 patients) met
inclusion criteria. Duration of diarrhoea was much shorter in the RC group, the
proportion of patients having recovered at any time of the treatment period was
65% higher in the RC group, compared with placebo (HR = 1.65 [1.38-1.97], p < 0.00001, n= 1001). Duration of
diarrhoea was similar in the RC and loperamide groups (HR = 1.08 [0.95-1.22], p = 0.24, n = 1618). The proportions of
constipated patients were similar in the RC and placebo groups 0.95 [0.24-3.68], p = 0.97), however, about 3 times
more constipated patients were found in the loperamide group compared with the
RC group (RR = 0.34 [0.22-0.51], p < 0.0001). Conclusions: Compared to placebo,
RC is characterized by a clinically relevant earlier remission of diarrhoea. When
compared to loperamide, diarrhoea duration was similar, however, significantly fewer
secondary constipation adverse effects were observed.