Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial

• Published in: Archives of family medicine Vol. 8; no. 3; pp. 243 - 248
• Main Authors: Kaplan, M A, Prior, M J, Ash, R R, McKonly, K I, Helzner, E C, Nelson, E B
• Format: Magazine Article
• Language: English
• Published: United States American Medical Association 01-05-1999
• Subjects: Abdominal Pain - complications; Abdominal Pain - etiology; Acute Disease; Adult; Antidiarrheals - therapeutic use; Antifoaming Agents - therapeutic use; Diarrhea - complications; Diarrhea - drug therapy; Double-Blind Method; Drug Therapy, Combination; Female; Flatulence - complications; Flatulence - drug therapy; Humans; Loperamide - therapeutic use; Male; Middle Aged; Simethicone - therapeutic use; Treatment Outcome
• ISSN: 1063-3987; 1941-1758
• DOI: 10.1001/archfami.8.3.243

Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact.
To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone, simethicone alone, and placebo in treating acute diarrhea with gas-related abdominal discomfort.
Randomized, placebo-controlled, double-blind trial of 48 hours' duration.
A primary care, ambulatory practice in Acapulco, Mexico.
A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort.
Each patient was randomly assigned to receive 2 chewable tablets containing loperamide hydrochloride, 2 mg, and simethicone, 125 mg (n = 124); loperamide hydrochloride, 2 mg (n = 123); simethicone, 125 mg (n = 123); or placebo (n = 123). This was followed by 1 tablet after each unformed stool, up to 4 tablets in any 24-hour period.
Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol-specified primary outcomes. Secondary outcomes included time to complete relief of diarrhea, number of unformed stools, and patient-assessed variables at the end of the study (overall illness relief, diarrhea relief, and abdominal discomfort relief).
Patients who received loperamide-simethicone had significantly (P < .001) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide, simethicone, or placebo alone. Loperamide-simethicone was significantly (P < or = .01) more effective than the other 3 treatments for all end-of-study patient-assessed outcomes and all clinically important secondary outcomes. No significant differences in adverse events were found among treatment groups.
The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort (gas pain, cramps, gas pressure, and bloating) than either of its components or placebo. The combination is well tolerated.