Treatment of travelers' diarrhea

Ciprofloxacin plus loperamide compared with ciprofloxacin alone: A placebo-controlled, randomized trial

David N. Taylor, Jose L. Sanchez, William Candler, Scott Thornton, Charles McQueen, Peter Echeverria

Research output: Contribution to journalArticle

Abstract

Objective: To compare the safety and efficacy of loperamide used in combination with ciprofloxacin or ciprofloxacin alone for the treatment of travelers' diarrhea. Design: Double-blind, placebo-controlled, randomized clinical trial. Setting: United States Army hospital in Egypt. Participants: United States military personnel with travelers' diarrhea (n = 104) during a military exercise in November 1989. Persons who were noncompliant, had bloody diarrhea, or had received antidiarrheal medications before entry into the study were excluded. Interventions: All participants with travelers' diarrhea were treated with ciprofloxacin, 500 mg twice daily for 3 days. Fifty of these patients were randomly assigned to receive loperamide, a 4-mg first dose and 2 mg for every loose stool (as much as 16 mg/d), and 54 were randomly assigned to receive placebo. Measurements: Enterotoxigenic Escherichia coli was isolated from 57% of patients; Shigella and Salmonella, seen in 4% and 2% of patients, respectively, were not common. Main Results: After 24 hours, the symptoms of 82% of patients in the ciprofloxacin and loperamide group compared with 67% in the ciprofloxacin and placebo group had improved or fully recovered (odds ratio, 2.3; 95% CI, 0.8 to 6.3; P = 0.08). After 48 hours, the symptoms of 90% of both groups had improved or fully recovered. The mean number of stools for those receiving loperamide was not much lower than those who did not receive loperamide after 24 hours (1.9 ± 0.2 [SE] compared with 2.6 ± 0.2) or 48 hours (3.1 ± 0.3 compared with 4.0 ± 0.3) of treatment (P = 0.19). Conclusions: In a region where enterotoxigenic E. coli was the predominant cause of travelers' diarrhea, loperamide combined with ciprofloxacin was not better than treatment with ciprofloxacin alone. Loperamide appeared to have some benefit in the first 24 hours of treatment in patients infected with enterotoxigenic E. coli. Both regimens were safe.

Original languageEnglish (US)
Pages (from-to)731-734
Number of pages4
JournalAnnals of Internal Medicine
Volume114
Issue number9
StatePublished - May 1 1991
Externally publishedYes

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Loperamide
Ciprofloxacin
Diarrhea
Randomized Controlled Trials
Placebos
Enterotoxigenic Escherichia coli
Therapeutics
Antidiarrheals
Military Hospitals
State Hospitals
Shigella
Egypt
Military Personnel
Salmonella
Odds Ratio
Exercise
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Taylor, D. N., Sanchez, J. L., Candler, W., Thornton, S., McQueen, C., & Echeverria, P. (1991). Treatment of travelers' diarrhea: Ciprofloxacin plus loperamide compared with ciprofloxacin alone: A placebo-controlled, randomized trial. Annals of Internal Medicine, 114(9), 731-734.

Treatment of travelers' diarrhea : Ciprofloxacin plus loperamide compared with ciprofloxacin alone: A placebo-controlled, randomized trial. / Taylor, David N.; Sanchez, Jose L.; Candler, William; Thornton, Scott; McQueen, Charles; Echeverria, Peter.

In: Annals of Internal Medicine, Vol. 114, No. 9, 01.05.1991, p. 731-734.

Research output: Contribution to journalArticle

Taylor, DN, Sanchez, JL, Candler, W, Thornton, S, McQueen, C & Echeverria, P 1991, 'Treatment of travelers' diarrhea: Ciprofloxacin plus loperamide compared with ciprofloxacin alone: A placebo-controlled, randomized trial', Annals of Internal Medicine, vol. 114, no. 9, pp. 731-734.
Taylor, David N. ; Sanchez, Jose L. ; Candler, William ; Thornton, Scott ; McQueen, Charles ; Echeverria, Peter. / Treatment of travelers' diarrhea : Ciprofloxacin plus loperamide compared with ciprofloxacin alone: A placebo-controlled, randomized trial. In: Annals of Internal Medicine. 1991 ; Vol. 114, No. 9. pp. 731-734.
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abstract = "Objective: To compare the safety and efficacy of loperamide used in combination with ciprofloxacin or ciprofloxacin alone for the treatment of travelers' diarrhea. Design: Double-blind, placebo-controlled, randomized clinical trial. Setting: United States Army hospital in Egypt. Participants: United States military personnel with travelers' diarrhea (n = 104) during a military exercise in November 1989. Persons who were noncompliant, had bloody diarrhea, or had received antidiarrheal medications before entry into the study were excluded. Interventions: All participants with travelers' diarrhea were treated with ciprofloxacin, 500 mg twice daily for 3 days. Fifty of these patients were randomly assigned to receive loperamide, a 4-mg first dose and 2 mg for every loose stool (as much as 16 mg/d), and 54 were randomly assigned to receive placebo. Measurements: Enterotoxigenic Escherichia coli was isolated from 57{\%} of patients; Shigella and Salmonella, seen in 4{\%} and 2{\%} of patients, respectively, were not common. Main Results: After 24 hours, the symptoms of 82{\%} of patients in the ciprofloxacin and loperamide group compared with 67{\%} in the ciprofloxacin and placebo group had improved or fully recovered (odds ratio, 2.3; 95{\%} CI, 0.8 to 6.3; P = 0.08). After 48 hours, the symptoms of 90{\%} of both groups had improved or fully recovered. The mean number of stools for those receiving loperamide was not much lower than those who did not receive loperamide after 24 hours (1.9 ± 0.2 [SE] compared with 2.6 ± 0.2) or 48 hours (3.1 ± 0.3 compared with 4.0 ± 0.3) of treatment (P = 0.19). Conclusions: In a region where enterotoxigenic E. coli was the predominant cause of travelers' diarrhea, loperamide combined with ciprofloxacin was not better than treatment with ciprofloxacin alone. Loperamide appeared to have some benefit in the first 24 hours of treatment in patients infected with enterotoxigenic E. coli. Both regimens were safe.",
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N2 - Objective: To compare the safety and efficacy of loperamide used in combination with ciprofloxacin or ciprofloxacin alone for the treatment of travelers' diarrhea. Design: Double-blind, placebo-controlled, randomized clinical trial. Setting: United States Army hospital in Egypt. Participants: United States military personnel with travelers' diarrhea (n = 104) during a military exercise in November 1989. Persons who were noncompliant, had bloody diarrhea, or had received antidiarrheal medications before entry into the study were excluded. Interventions: All participants with travelers' diarrhea were treated with ciprofloxacin, 500 mg twice daily for 3 days. Fifty of these patients were randomly assigned to receive loperamide, a 4-mg first dose and 2 mg for every loose stool (as much as 16 mg/d), and 54 were randomly assigned to receive placebo. Measurements: Enterotoxigenic Escherichia coli was isolated from 57% of patients; Shigella and Salmonella, seen in 4% and 2% of patients, respectively, were not common. Main Results: After 24 hours, the symptoms of 82% of patients in the ciprofloxacin and loperamide group compared with 67% in the ciprofloxacin and placebo group had improved or fully recovered (odds ratio, 2.3; 95% CI, 0.8 to 6.3; P = 0.08). After 48 hours, the symptoms of 90% of both groups had improved or fully recovered. The mean number of stools for those receiving loperamide was not much lower than those who did not receive loperamide after 24 hours (1.9 ± 0.2 [SE] compared with 2.6 ± 0.2) or 48 hours (3.1 ± 0.3 compared with 4.0 ± 0.3) of treatment (P = 0.19). Conclusions: In a region where enterotoxigenic E. coli was the predominant cause of travelers' diarrhea, loperamide combined with ciprofloxacin was not better than treatment with ciprofloxacin alone. Loperamide appeared to have some benefit in the first 24 hours of treatment in patients infected with enterotoxigenic E. coli. Both regimens were safe.

AB - Objective: To compare the safety and efficacy of loperamide used in combination with ciprofloxacin or ciprofloxacin alone for the treatment of travelers' diarrhea. Design: Double-blind, placebo-controlled, randomized clinical trial. Setting: United States Army hospital in Egypt. Participants: United States military personnel with travelers' diarrhea (n = 104) during a military exercise in November 1989. Persons who were noncompliant, had bloody diarrhea, or had received antidiarrheal medications before entry into the study were excluded. Interventions: All participants with travelers' diarrhea were treated with ciprofloxacin, 500 mg twice daily for 3 days. Fifty of these patients were randomly assigned to receive loperamide, a 4-mg first dose and 2 mg for every loose stool (as much as 16 mg/d), and 54 were randomly assigned to receive placebo. Measurements: Enterotoxigenic Escherichia coli was isolated from 57% of patients; Shigella and Salmonella, seen in 4% and 2% of patients, respectively, were not common. Main Results: After 24 hours, the symptoms of 82% of patients in the ciprofloxacin and loperamide group compared with 67% in the ciprofloxacin and placebo group had improved or fully recovered (odds ratio, 2.3; 95% CI, 0.8 to 6.3; P = 0.08). After 48 hours, the symptoms of 90% of both groups had improved or fully recovered. The mean number of stools for those receiving loperamide was not much lower than those who did not receive loperamide after 24 hours (1.9 ± 0.2 [SE] compared with 2.6 ± 0.2) or 48 hours (3.1 ± 0.3 compared with 4.0 ± 0.3) of treatment (P = 0.19). Conclusions: In a region where enterotoxigenic E. coli was the predominant cause of travelers' diarrhea, loperamide combined with ciprofloxacin was not better than treatment with ciprofloxacin alone. Loperamide appeared to have some benefit in the first 24 hours of treatment in patients infected with enterotoxigenic E. coli. Both regimens were safe.

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