A CONTROLLED TRIAL OF BISMUTH SUBSALICYLATE IN INFANTS WITH ACUTE WATERY DIARRHEAL DISEASE

Background. Bismuth subsalicylate is a common constituent of over-the- counter medications for diarrhea. However, it is uncertain whether bis muth offers any more benefit than standard oral rehydration therapy wi th early feeding. Methods. We conducted a placebo-controlled, randomiz ed trial to evaluate the effect of bismuth subsalicylate (100 or 150 m g per kilogram of body weight per day for up to 5 days) on the duratio n and volume of acute watery diarrhea in 275 male infants and young bo ys (mean age, 13.5 months). Serum salicylate and bismuth levels were m onitored throughout the study and were also measured two weeks after d ischarge. All the patients received fluid replacement by the oral rout e and early feeding of easily digestible foods with high caloric densi ty. Results. Diarrhea stopped within 120 hours of admission in 74 perc ent of the patients given placebo, 89 percent of those given 100 mg of bismuth per kilogram (P = 0.009 vs. the placebo group), and 88 percen t of those given 150 mg of bismuth per kilogram (P = 0.019 vs. the pla cebo group). As compared with the patients given placebo, those given bismuth had significant reductions in their total stool output (P = 0. 015), total intake of oral rehydration solution (P = 0.013), and durat ion of hospitalization (P = 0.005); there was no significant differenc e between the two groups given bismuth in these clinical outcomes. All measurements of bismuth and salicylate concentrations in blood were w ell below concentrations considered toxic. No adverse reactions were s een. Conclusions. Treatment with bismuth subsalicylate decreases the d uration of diarrhea and is a safe and effective adjunct to oral rehydr ation therapy for infants and young children with acute watery diarrhe a.