Rapid Communication
Copyright ©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Dec 28, 2008; 14(48): 7361-7370
Published online Dec 28, 2008. doi: 10.3748/wjg.14.7361
Adverse events with bismuth salts for Helicobacter pylori eradication: Systematic review and meta-analysis
Alexander C Ford, Peter Malfertheiner, Monique Giguère, José Santana, Mostafizur Khan, Paul Moayyedi
Alexander C Ford, José Santana, Mostafizur Khan, Paul Moayyedi, Gastroenterology Division, McMaster University, Health Sciences Centre, Hamilton, Ontario L8N 3Z5, Canada
Peter Malfertheiner, Klinic fur Gastroenterologie, Hepatologie, and Infektiologie, Otto-v.-Guerike Universitat, Magdeburg, Germany
Monique Giguère, AxCan Pharma Inc., Mont St-Hilaire, Quebec, Canada
Author contributions: Ford AC, Santana J, Khan M, and Moayyedi P extracted and analysed the data; Ford AC drafted the manuscript; All authors revised the manuscript for important intellectual content.
Supported by A Grant from AxCan Pharma Inc
Correspondence to: Dr. Alexander C Ford, Gastroenterology Division, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada. alexf12399@yahoo.com
Telephone: +1-90-55212100-76409 Fax: +1-90-55214958
Received: August 30, 2008
Revised: September 4, 2008
Accepted: September 11, 2008
Published online: December 28, 2008

AIM: To assess the safety of bismuth used in Helicobacter pylori (H pylori) eradication therapy regimens.

METHODS: We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched (up to October 2007) to identify randomised controlled trials comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppression. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals (CI).

RESULTS: We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth [relative risk (RR) = 1.01; 95% CI: 0.87-1.16], specific individual adverse events, with the exception of dark stools (RR = 5.06; 95% CI: 1.59-16.12), or adverse events leading to withdrawal of therapy (RR = 0.86; 95% CI: 0.54-1.37).

CONCLUSION: Bismuth for the treatment of H pylori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.

Keywords: Bismuth, Eradication therapy, Helicobacter pylori, Adverse events, Systematic review, Meta-analysis