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Abstract
Background: To determine the effectiveness of ranitidine and sucralfate for preventing stress ulcer in critical patients and to assess if these treatments affect the risk of nosocomial pneumonia. Data sources: Published studies retrieved through MEDLINE and other tools for literature search. Review methods: Five separate meta-analyses evaluated the data of effectiveness in terms of bleeding rates (Meta-analyses: 1. Ranitidine vs. placebo; 2. Sucralfate vs. placebo) and the data of infectious complications in terms of nosocomial pneumonia incidence (Meta-analyses: 3. Ranitidine vs. placebo; 4. Sucralfate vs. placebo; 5. Ranitidine vs. sucralfate). The methodological quality of all pertinent trials was determined on the basis of an empiric ad hoc procedure. Main outcome measures included rates of clinically important gastrointestinal bleeding and nosocomial pneumonia (compared between the two study arms and expressed using study-specific odds-ratios and meta-analytic summary odds-ratios).
Results: The number of patients included in these 5 meta-analyses were 398 (5 studies), 54 (1 study), 311 (3 studies), 226 (2 studies), and 1825 (8 studies), respectively. Both ranitidine and sucralfate were found to have the same effectiveness as placebo (odds-ratio of bleeding = 0.72, IC95% = 0.30 to 1.70, p=0.46, for ranitidine in Meta-analysis 1 and 1.26, IC95% = 0.12 to 12.9, p= 0.70, for sucralfate in Meta-analysis 2). In placebo-controlled studies (Meta-analyses 3 and 4), both ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine increased the incidence of nosocomial pneumonia at levels of statistical significance (Meta-analysis 5: odds ratio = 1.35, IC95% = 1.07 to 1.70, p= 0.012). The the quality score of the studies included in the meta-analyses ranged from 7.0 in Meta-analysis 4 to 8.0 in Meta-analysis 3 (mean values on a 0 to 12 scale).
Conclusions: Ranitidine and sucralfate do not prevent gastrointestinal bleeding in critical patients at risk for stress ulcer. While the studies conducted many years ago with cimetidine showed a small, but significant reduction in the bleeding rate, relating the hypothetical effectiveness of ranitidine to these previous studies remains a matter of controversy. Our results indicate that ranitidine increases the risk of nosocomial pneumonia in comparison with sucralfate.
Results: The number of patients included in these 5 meta-analyses were 398 (5 studies), 54 (1 study), 311 (3 studies), 226 (2 studies), and 1825 (8 studies), respectively. Both ranitidine and sucralfate were found to have the same effectiveness as placebo (odds-ratio of bleeding = 0.72, IC95% = 0.30 to 1.70, p=0.46, for ranitidine in Meta-analysis 1 and 1.26, IC95% = 0.12 to 12.9, p= 0.70, for sucralfate in Meta-analysis 2). In placebo-controlled studies (Meta-analyses 3 and 4), both ranitidine and sucralfate had no influence on the incidence of nosocomial pneumonia. In comparison with sucralfate, ranitidine increased the incidence of nosocomial pneumonia at levels of statistical significance (Meta-analysis 5: odds ratio = 1.35, IC95% = 1.07 to 1.70, p= 0.012). The the quality score of the studies included in the meta-analyses ranged from 7.0 in Meta-analysis 4 to 8.0 in Meta-analysis 3 (mean values on a 0 to 12 scale).
Conclusions: Ranitidine and sucralfate do not prevent gastrointestinal bleeding in critical patients at risk for stress ulcer. While the studies conducted many years ago with cimetidine showed a small, but significant reduction in the bleeding rate, relating the hypothetical effectiveness of ranitidine to these previous studies remains a matter of controversy. Our results indicate that ranitidine increases the risk of nosocomial pneumonia in comparison with sucralfate.