Original articleTreatment of Travelers’ Diarrhea: Randomized Trial Comparing Rifaximin, Rifaximin Plus Loperamide, and Loperamide Alone
Section snippets
Study Population
Eligible patients included otherwise healthy US students age 18 years or older attending school in Mexico (Guadalajara and Cuernavaca) for 2–5 weeks during June through August of 2004 or June through August of 2005 and suffering from TD (defined as the passage of ≥3 unformed stools in 24 hours with ≥1 symptom of enteric infection, including abdominal cramps and pain, nausea, vomiting, fever, tenesmus, and moderate to severe intestinal gas-related symptoms, lasting ≤72 hours). All individuals
Results
A total of 311 patients were included in the intention-to-treat population and safety analysis during the summers of 2004 and 2005. One patient in the rifaximin-loperamide treatment group discontinued the study after 1 day for nonmedical reasons. Therefore, 310 patients with acute diarrhea completed treatment with rifaximin (n = 102), loperamide (n = 104), or rifaximin-loperamide combination therapy (n = 104). The groups were comparable in terms of age, duration of diarrhea, race, sex, and
Discussion
Current guidelines for the treatment of TD suggest administration of symptomatic drugs for mild illness and antibacterial agents for moderate to severe illness.6 Loperamide is considered the most effective therapy for rapid symptomatic relief of TD,9, 10 but antibiotic treatment often is necessary to cure the intestinal illness.6, 26 To this end, clinical studies have evaluated the effects of combining loperamide with systemic antibiotics for the treatment of TD and have reported conflicting
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Cited by (0)
Supported by Salix Pharmaceuticals, Inc. Also supported in part by grants from the Public Health Service (DK 56338), which funds the Texas Gulf Coast Digestive Diseases Center, and the National Institutes of Health National Center for Research Resources to the University of Texas General Clinical Research Center (M01-RR 02558 and NIH NIAID R01 AI54948). In addition, H.L.D., P.C.O., and C.D.E. have received honoraria for speaking for Salix Pharmaceuticals, Inc., and H.L.D. and Z.-D.J. have received grants administered through the University of Texas for research from Salix Pharmaceuticals, Inc.