Methods A two-centre, double-blind, parallel-group, randomized study was ca
rried out to compare the efficacy and tolerability of racecadotril (100 mg
three times daily) and placebo in 70 adult patients with acute diarrhoea. A
n objective criterion of antisecretory activity, stool weight, was used.
Results Racecadotril produced a significant (P = 0.025) decrease in stool w
eight during the first day of treatment compared with placebo, and was also
associated with significantly fewer diarrhoeic stools than placebo after 1
day of treatment (P = 0.027). Racecadotril and placebo were equally well t
olerated, and the frequency of symptoms and signs was similar in both group
s after 4 days of treatment. Fewer patients on racecadotril suffered from a
bdominal distension following treatment (5.6% vs. 18.2% on placebo).
Conclusions Racecadotril acts rapidly to resolve acute diarrhoea and has an
incidence of adverse events similar to that of placebo.