Efficacy and Safety of Diphenoxylate Hydrochloride and Atropine Sulfate for the Treatment of Traveler's Diarrhea

Background:Traveler's diarrhea (TD) is a major health concern in people traveling to developing countries. The current study aimed to determine the effectiveness and safety of Lomotil, a combination of diphenoxylate hydrochloride and atropine sulfate, and its applicability in TD. Methods: This was a cross-sectional, non-randomized, multicentric observational study. Patients of either sex, aged > 18 years, with 4-6 stools per day and symptoms of fever, nausea, vomiting, and abdominal cramps were included. Patients were given diphenoxylate hydrochloride & atropine sulfate. Outcomes were i) assessment of stool frequency, stool consistency, and abdominal cramps/gas from baseline to subsequent follow-ups (Days 1, 2, 3, 4, and one week) and ii) assessment of the occurrence of infection and adverse drug reactions. Results: A total of 327 patients were involved in the study, of which the majority were men (74.62%). The mean age of patients was 34.08 years and the most common (74%) symptom was vomiting. Post-treatment, patients showed a significant reduction in, i) stool frequency (5.09 vs. 0.20, p<0.0001), ii) stool consistency (5.00 vs. 0.20, p<0.0001), and iii) daily abdominal gas/discomfort (4.93 vs. 0.27, p<0.0001) from baseline to week 1, respectively. Amajority (59.63%) of patients had not reported adverse drug reactions with only 39.60% stating feeling dizzy or drowsy. The majority (47.48%) of the patients stated that they liked the treatment very much and 60% of physicians reported overall improvement in the patients. Conclusion: Diphenoxylate hydrochloride and atropine sulfate were demonstrated as effective in reducing symptoms of diarrhea, with minor adverse drug reactions signifying its use in the immediate relief of TD.