Document Detail

A controlled trial of bismuth subsalicylate in infants with acute watery diarrheal disease.
MedLine Citation:
PMID:  8487823     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
D Figueroa-Quintanilla; E Salazar-Lindo; R B Sack; R Le?n-Bar?a; S Sarabia-Arce; M Campos-S?nchez; E Eyzaguirre-Maccan
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  328     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1993 Jun 
Date Detail:
Created Date:  1993-06-10     Completed Date:  1993-06-10     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1653-8     Citation Subset:  AIM; IM; J    
Instituto Nacional de Salud del Ni?o, Lima, Peru.
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MeSH Terms
Acute Disease
Bismuth / administration & dosage,  therapeutic use*
Body Weight
Chemotherapy, Adjuvant
Child, Preschool
Diarrhea, Infantile / drug therapy*,  therapy
Double-Blind Method
Fluid Therapy
Multivariate Analysis
Organometallic Compounds / administration & dosage,  therapeutic use*
Salicylates / administration & dosage,  therapeutic use*
Reg. No./Substance:
0/Organometallic Compounds; 0/Salicylates; 14882-18-9/bismuth subsalicylate; 7440-69-9/Bismuth
Comment In:
N Engl J Med. 1993 Jun 10;328(23):1705-6   [PMID:  8487829 ]
N Engl J Med. 1993 Dec 2;329(23):1742; author reply 1743   [PMID:  8232479 ]
N Engl J Med. 1993 Dec 2;329(23):1742; author reply 1743   [PMID:  8232480 ]

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