Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial.
BACKGROUND
Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact.


OBJECTIVE
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.


METHODS
Randomized, placebo-controlled, double-blind trial of 48 hours' duration.


METHODS
A primary care, ambulatory practice in Acapulco, Mexico.


METHODS
A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort.


METHODS
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.


METHODS
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).


RESULTS
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.


CONCLUSIONS
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.
Kaplan
M A
MA
Medical Department, McNeil Consumer Healthcare, Fort Washington, Pa., USA. mkaplan@mccus.jnj.com
Prior
M J
MJ
Ash
R R
RR
McKonly
K I
KI
Helzner
E C
EC
Nelson
E B
EB
D015746:Abdominal Pain / Q000150:complications* / Q000209:etiology; D000208:Acute Disease; D000328:Adult; D000930:Antidiarrheals / Q000627:therapeutic use*; D000934:Antifoaming Agents / Q000627:therapeutic use*; D003967:Diarrhea / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005414:Flatulence / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008139:Loperamide / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012841:Simethicone / Q000627:therapeutic use*; D016896:Treatment Outcome
D000930:Antidiarrheals; D000934:Antifoaming Agents; D008139:Loperamide; D012841:Simethicone