A research team from Florence, Italy, investigated the effectiveness of ranitidine and sucralfate in the prevention of stress ulcer in critically ill patients. In addition, they assessed the risk of nosocomial pneumonia due to these treatments.
Five meta-analyses were conducted. Two evaluated effectiveness of the drugs in terms of bleeding rates (A: ranitidine vs. placebo, n = 398; B: sucralfate vs. placebo). The other three assessed infectious complications in terms of incidence of nosocomial pneumonia (C: ranitidine vs. placebo, n = 311; D: sucralfate vs. placebo, n = 226; E: ranitidine vs. sucralfate, n = 1825). Trial quality was determined with an empirical ad hoc procedure.
"There are insufficient data on effectiveness to be able to conclude anything one way or the other".
Dr A Messori.
A Medline literature search was carried out to identify randomized trials. Meta-analysis B was not carried out as the literature search selected only one clinical trial.
In meta-analysis A, ranitidine was found to have the same effectiveness as placebo (odds ratio of bleeding 0.72, 95% CI 0.30 to 1.70, P = 0.46).
In placebo-controlled studies (meta-analyses C and D) ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine significantly increased the incidence of nosocomial pneumonia (meta-analysis E: 1.35, 1.07 to 1.70, P = 0.012).
The mean quality score in the four analyses (on a 0 to 10 scale) ranged from 5.6 in meta-analysis E to 6.6 in meta-analysis A.
The team concluded that ranitidine is ineffective in the prevention of gastrointestinal bleeding in intensive care patients, and might increase the risk of pneumonia. Studies on sucralfate do not provide conclusive results. The authors remark that their findings are based on small numbers of patients, and firm conclusions cannot presently be proposed.