Objective To assess the clinical efficacy and safety of proton pump inhibitor (PPI) and H2RA for stress ulcer bleeding in stroke patients. Methods Randomized controlled trials (RCT) were identified from MEDLINE ( 1966- Oct. 2005 ) ,EMBASE ( 1984- Oct. 2005 ), The Cochrane Library ( Issue 4,2005 ), CBMdisc ( 1980- Oct. 2005 ) and VIP( 1980- Oct. 2005 ). We handsearched the related published and unpublished data and their references. The quality of included trials was evaluated. Data were extracted by two reviewers independently with a designed extraction form. RevMan 4. 2.7 software was used for data analysis. Results Twenty RCT were included with 2 624 patients. The results of meta-analysis were listed as follows: (1) stress ulcer bleeding (SUB) : PPI ( OR 0.14,95% CI 0.08 to 0.24, NNT = 3 ) and H2RA (OR 0.24,95% CI 0.15 to 0.39, NNT =5) significantly reduced the incidence of SUB in comparison with control group. PPI significantly reduced the incidence of SUB compared with H2R.A(P 〈0. 00001 ). (2) Mortality: PPI (OR 0.22,95% CI 0. 11 to 0.47, NNT =8) and H2RA (OR 0.53,95% CI 0. 34 to 0.81, NNT =16) significantly decreased the mortality compared with non-prophylaxis group. PPI significantly decreased the mortality compared with H2RA (OR 0.28,95% CI 0.09 to 0. 89). (3) Adverse effect: There were not evident adverse effects in both PPI and H2RA groups. Conclusions PPI and H2RA may reduce the incidence and mortality of SUB in stroke patients, and PPls are better in reducing incidence of SUB than H2RA.
Objective To assess the efficacy and safety of histamine H2 receptor antagonist (H2RA) for the prevention of stress ulcer bleeding (SUB) in critically ill patients. Methods Trials were identified by searching Cochrane Controlled Trials (Issue 4, 2006), MEDLINE (1980 to October 2006),EMbase (1984 to October 2006) and the Chinese Biological Medicine Database (1978 to October), Chinese VIP Database (1989 to October 2006) and Chinese EBM Database. We also handsearched the proceedings of relevant conferences, 5 kinds of important Chinese journals and the references of all included trials. Two reviewers assessed the quality of studies and extracteddata independently. Disagreement was resolved by discussion . The primary outcomes included were incidence of SUB, incidence of nosocomial pneumonia (NP), mortality and adverse events. Secondary outcomes were gastric pH, length of hospital stayand length of ICU stay. RevMan4.2.7 software was used for meta-analyses. Results Sixteen trials involving 2 014 patients were included. Most of the trials were of poor quality. Meta-analyses showed that H2RA significantly less SUB comparedwith patients in the placebo or non-prophylaxis group (RR 0.39, 95%CI 0.28 to 0.56; Plt;0.000 01, NNT=6), but but there was no significant difference in the incidence of clinically important bleeding (RR 0.51 , 95%CI 0.17 to 1.53; P=0.11). No significant difference was observed in the incidence of NP(RR 1.02, 95%CI 0.55 to 1.89,P=0.95). H2RA significantly decreased mortality in comparison with placebo or non-prophylaxis (RR 0.68, 95%CI 0.52 to 0.90; P=0.007, NNT=18). H2RA had a good safety profile. We did not perform meta-analysis for gastric pH due to the methodological limitations. Conclusion H2RA may significantly reduce the incidence of SUB and mortality, but cannot reduce the incidence of clinically important bleeding. Due to the poor quality of included studies, the conclusion should be interpreted cautiously. More randomized controlled trials with sufficient sample size, uniform standards, higher quality and scientifically sound methodology should be performed.