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Kaplan MA, Prior MJ, Ash RR, et al. Loperamide-simethicone vs lopera-mide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. Arch Fam Med. 1999 May/Jun; 8:243-8.
Question
In patients with diarrhea and gas-related abdominal discomfort, is loperamide plus simethicone as effective as each drug alone for decreasing the duration of diarrhea and relieving abdominal discomfort?
Design
Randomized (concealed), double-blind, placebo-controlled trial with follow-up at 48 to 72 hours after start of treatment.
Setting
A primary care, ambulatory clinic in Acapulco, Mexico.
Patients
493 patients (mean age 30 y, 51% women, 100% white) with acute diarrhea symptoms for < 48 hours. Inclusion criteria were age 18 years, 3 unformed stools within 24 hours before study entry, most recent bowel movement unformed, and moderate-to-severe gas-related abdominal discomfort. Exclusion crite ria were need for hospital admission, parenteral hydration, or antibiotics; fever > 38.6 °C; gross blood or pus in the stool; orthostatic hypotension; in- ability to take …