bismuth-subsalicylate and Body-Weight

Bismuth subsalicylate is a common constituent of over-the-counter medications for diarrhea. However, it is uncertain whether bismuth offers any more benefit than standard oral rehydration therapy with early feeding.. We conducted a placebo-controlled, randomized trial to evaluate the effect of bismuth subsalicylate (100 or 150 mg per kilogram of body weight per day for up to 5 days) on the duration and volume of acute watery diarrhea in 275 male infants and young boys (mean age, 13.5 months). Serum salicylate and bismuth levels were monitored throughout the study and were also measured two weeks after discharge. All the patients received fluid replacement by the oral route and early feeding of easily digestible foods with high caloric density.. Diarrhea stopped within 120 hours of admission in 74 percent 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 percent of those given 150 mg of bismuth per kilogram (P = 0.019 vs. the placebo 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 duration of hospitalization (P = 0.005); there was no significant difference between the two groups given bismuth in these clinical outcomes. All measurements of bismuth and salicylate concentrations in blood were well below concentrations considered toxic. No adverse reactions were seen.. Treatment with bismuth subsalicylate decreases the duration of diarrhea and is a safe and effective adjunct to oral rehydration therapy for infants and young children with acute watery diarrhea.

Topics: Acute Disease; Bismuth; Body Weight; Chemotherapy, Adjuvant; Child, Preschool; Diarrhea, Infantile; Double-Blind Method; Fluid Therapy; Humans; Infant; Male; Multivariate Analysis; Organometallic Compounds; Salicylates

Twenty-nine infants and children, age 2-70 months with chronic diarrhea, were admitted to a double-blind, parallel clinical trial. The subjects were randomly assigned to receive either a bismuth subsalicylate liquid or a placebo liquid formulation. Treatment was given for 7 days with dosage varied according to age. Analysis of the results showed that the subjects in the bismuth subsalicylate-treated group gained significantly more weight (p less than 0.05), had significantly fewer (p less than 0.01) and firmer (p less than 0.01) stools with less water content (p less than 0.01) during the course of the study than did the placebo-treated group. Response to treatment, as graded by nursing staff, family, and physicians was moderate to excellent in 86% of the treated group while none of the placebo group received such a rating (p less than 0.01). No differences were noted between stool weights or bile acid excretion.

Topics: Bismuth; Body Weight; Child, Preschool; Chronic Disease; Clinical Trials as Topic; Defecation; Diarrhea, Infantile; Double-Blind Method; Drug Administration Schedule; Female; Humans; Infant; Male; Organometallic Compounds; Prospective Studies; Random Allocation; Salicylates