We evaluated two doses of loperamide oxide (1 mg and 2 mg) and placebo
in the treatment of acute diarrhea in 230 adult patients. Two tablets
were taken initially and then one tablet after each watery, loose, or
pasty stool to a maximum of eight tablets per day. The median time to
complete relief was 27 hours 55 minutes for the 1-mg loperamide oxide
group, 25 hours for the 2-mg loperamide oxide group, and 40 hours 35
minutes for the placebo group (P < 0.05). The investigator rated treat
ment as good or excellent for 78% of patients in each group treated wi
th loperamide oxide and 62% of patients who received placebo. Constipa
tion-like periods were no more common with loperamide oxide than with
placebo. Adverse events were reported by four patients given loperamid
e oxide and three patients given placebo. The results demonstrate supe
rior efficacy of loperamide oxide compared with placebo in the treatme
nt of acute diarrhea in adults; because both doses of loperamide oxide
are equally effective, the lower (1-mg) dose is preferred.