Question

• Is Bismuth Subsalicylate a safe and effective treatment for shortening the duration of diarrhea in children with gastroenteritis?

Clinical Bottom Lines

1. Studies have shown a modest decrease in the duration of diarrhea in children given Bismuth Subsalicylate^1,2
2. However, routine use is not recommended because of the limited data available on the potential risk of Reye syndrome with subsalicylate exposure, likely poor compliance with the q4h dosing, and the cost of implementing the treatment.^3,4,5

Summary of Key Evidence

1. A placebo-controlled, randomized trial evaluated the effect of bismuth subsalicylate (100 mg/kg bismuth and 150 mg/kg bismuth q4h for up to 5 days) on the duration and volume of acute watery diarrhea in 275 males (mean age of 13.5 months). All patients received oral fluid replacement and early feeding of easily digestible foods with high caloric content. Placebo and control groups had similar characteristics at the onset of the study.¹
2. Serum salicylate and bismuth levels were measured throughout the study and two weeks after completion of the treatment. All measurements were below toxic levels in both of the treatment groups. No adverse reactions were seen.
3. Diarrhea stopped within 120 hrs of admission in 74% of the patients given placebo, 89% of those given 100 mg/kg bismuth (P=0.009 vs. placebo group, NNT=7), and 88% of those given 150 mg/kg bismuth (P=0.019 vs. placebo group, NNT=8).
4. Patients receiving bismuth had reduction in their stool output by about 30% (P=0.015) and a reduction of total intake of oral rehydration solution by about 25% (P=0.013) when compared to the placebo group.  

Additional Comments

• Study limitations:
  • 8 of the pts. in the placebo group had levels of bismuth present at the onset of the study
  • subjects were all males
  • anti-microbial pathogens may differ in United States (study performed in Peru)
• Insufficient data exists as to the risk of Reye syndrome associated with subsalicylate exposure.³
• Compliance would most likely be poor with a q4h home regimen.⁴
• Given the limited amount of money available in most developing nations, funds could be better spent on other areas of health care that may be more beneficial to children than shortening the duration of their diarrhea (e.g. money could be spent on oral rehydration solution, IVF, etc.).  If all 1.5 billion episodes of diarrhea in young children in the developing world were treated, it would cost about $5 billion annually, much more than some developing nations’ entire heathcare budget.⁵ 

Citation

1. Figueroa-Quintanilla D, Salazar-Lindo E, Sack RB, et al. A controlled trial of bismuth subsalicylate in infants with acute watery diarrheal disease. New England Journal of Medicine, 1993; 328:1653-1658.
2. Soriano-Brucher H, Avendano P, O’Ryan M, et al. Bismuth subsalicylate in the treatment of acute diarrhea in children: a clinical study.  Pediatrics, 1991; 87:18-27.
3. American Academyy of Pediatrics, Subcommittee on Acute Gastroenteritis.  Practice parameter:  the management of acute gastroenteritis in young children. Pediatrics, 1996; 97:424-435.
4. Cockburn J, Gibberd RW, Reid AL, Sanson-Fisher RW. Determinants of non-compliance with short term antibiotic regimens. BMJ, 1987; 295:814-81 .
5. Snyder JD. Can bismuth improve the simple solution for diarrhea?  New England Journal of Medicine, 1993; 328:1705-1706.

CAT Author: Priscilla Woodhams, MD

CAT Appraisers: John G. Frohna, MD

Date appraised: April 24, 2000