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Loperamide-simethicone vs loperamide 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(3):243-8.AF

Abstract

CONTEXT

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.

DESIGN

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

SETTING

A primary care, ambulatory practice in Acapulco, Mexico.

PATIENTS

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

INTERVENTIONS

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.

MAIN OUTCOME MEASURES

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.

Authors+Show Affiliations

Medical Department, McNeil Consumer Healthcare, Fort Washington, Pa., USA. mkaplan@mccus.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10333820

Citation

Kaplan, M A., et al. "Loperamide-simethicone Vs Loperamide Alone, Simethicone Alone, and Placebo in the Treatment of Acute Diarrhea With Gas-related Abdominal Discomfort. a Randomized Controlled Trial." Archives of Family Medicine, vol. 8, no. 3, 1999, pp. 243-8.
Kaplan MA, Prior MJ, Ash RR, et al. Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. Arch Fam Med. 1999;8(3):243-8.
Kaplan, M. A., Prior, M. J., Ash, R. R., McKonly, K. I., Helzner, E. C., & Nelson, E. B. (1999). Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. Archives of Family Medicine, 8(3), 243-8.
Kaplan MA, et al. Loperamide-simethicone Vs Loperamide 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(3):243-8. PubMed PMID: 10333820.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial. AU - Kaplan,M A, AU - Prior,M J, AU - Ash,R R, AU - McKonly,K I, AU - Helzner,E C, AU - Nelson,E B, PY - 1999/5/20/pubmed PY - 1999/5/20/medline PY - 1999/5/20/entrez SP - 243 EP - 8 JF - Archives of family medicine JO - Arch Fam Med VL - 8 IS - 3 N2 - CONTEXT: 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. DESIGN: Randomized, placebo-controlled, double-blind trial of 48 hours' duration. SETTING: A primary care, ambulatory practice in Acapulco, Mexico. PATIENTS: A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. SN - 1063-3987 UR - https://www.unboundmedicine.com/medline/citation/10333820/Loperamide_simethicone_vs_loperamide_alone_simethicone_alone_and_placebo_in_the_treatment_of_acute_diarrhea_with_gas_related_abdominal_discomfort__A_randomized_controlled_trial_ L2 - https://ClinicalTrials.gov/search/term=10333820 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -