Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis.
OBJECTIVE
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).


CONCLUSIONS
Bismuth for the treatment of H pylori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.
Ford
Alexander C
AC
Gastroenterology Division, McMaster University Medical Centre, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada. alexf12399@yahoo.com
Malfertheiner
Peter
P
Giguere
Monique
M
Santana
Jose
J
Khan
Mostafizur
M
Moayyedi
Paul
P
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D001729:Bismuth / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D016032:Randomized Controlled Trials as Topic
D000900:Anti-Bacterial Agents; D001729:Bismuth