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Systematic review

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Is the era of intravenous proton pump inhibitors coming to an end in patients with bleeding peptic ulcers? Meta-analysis of the published literature

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Authors Jian Z , Li H , Race NS , Ma T , Jin H , Yin Z
Journal British journal of clinical pharmacology
Year 2016
Links Pubmed DOI PubMed Central

This article includes 6 Primary studies 6 Primary studies (6 references)

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Aims: Oral and intravenous proton pump inhibitors (PPIs) are equipotent in raising gastric pH. However, it is not known whether oral PPIs can replace intravenous PPIs in patients with bleeding peptic ulcers. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials to compare oral and intravenous PPIs among patients with peptic ulcer bleeding. A search of all major databases and relevant journals from inception to April 2015, without a restriction on languages, was performed. Results: A total of 859 patients from seven randomized controlled trials were included in the meta-analysis. Similar pooled outcome measures were demonstrated between the two groups in terms of oral PPIs vs. intravenous PPIs in the rate of recurrent bleeding within the 30-day follow-up period [risk ratio = 0.90; 95% confidence interval (CI): 0.58, 1.39; P = 0.62; I2 = 0%). In terms of the rate of mortality, both oral and intravenous PPIs showed similar outcomes, and the pooled risk ratio was 0.88 (95% CI: 0.29, 2.71; P = 0.82; I2 = 0%). Likewise, no significant difference was detected in the need for blood transfusion and length of hospital stay; the pooled mean differences were -0.14 (95% CI: -0.39, 0.12; P = 0.29; I2 = 32%) and -0.60 (95% CI: -1.42, 0.23; P = 0.16; I2 = 79%), respectively. Conclusions: Our results suggest that oral PPIs are a feasible, safe alternative to intravenous PPIs in patients with bleeding peptic ulcers, and may be able to replace intravenous PPIs as the treatment of choice in these patients.

Systematic review

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Proton pump inhibitors therapy vs H2 receptor antagonists therapy for upper gastrointestinal bleeding after endoscopy: A meta-analysis.

Journal World Journal of Gastroenterology
Year 2015
Links Pubmed DOI PubMed Central

This article includes 10 Primary studies 10 Primary studies (10 references)

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AIM: To compare the therapeutic effects of proton pump inhibitors vs H2 receptor antagonists for upper gastrointestinal bleeding in patients after successful endoscopy. METHODS: We searched the Cochrane library, MEDLINE, EMBASE and PubMed for randomized controlled trials until July 2014 for this study. The risk of bias was evaluated by the Cochrane Collaboration's tool and all of the studies had acceptable quality. The main outcomes included mortality, re-bleeding, received surgery rate, blood transfusion units and hospital stay time. These outcomes were estimated using odds ratios (OR) and mean difference with 95% confidence interval (CI). RevMan 5.3.3 software and Stata 12.0 software were used for data analyses. RESULTS: Ten randomized controlled trials involving 1283 patients were included in this review; 678 subjects were in the proton pump inhibitors (PPI) group and the remaining 605 subjects were in the H2 receptor antagonists (H2RA) group. The meta-analysis results revealed that after successful endoscopic therapy, compared with H2RA, PPI therapy had statistically significantly decreased the recurrent bleeding rate (OR = 0.36; 95%CI: 0.25-0.51) and receiving surgery rate (OR = 0.29; 95%CI: 0.09-0.96). There were no statistically significant differences in mortality (OR = 0.46; 95%CI: 0.17-1.23). However, significant heterogeneity was present in both the numbers of patients requiring blood transfusion after treatment [weighted mean difference (WMD), -0.70 unit; 95%CI: -1.64 - 0.25] and the time that patients remained hospitalized [WMD, -0.77 d; 95%CI: -1.87 - 0.34]. The Begg's test (P = 0.283) and Egger's test (P = 0.339) demonstrated that there was no publication bias in our meta-analysis. CONCLUSION: In patients with upper gastrointestinal bleeding after successful endoscopic therapy, compared with H2RA, PPI may be a more effective therapy.

Systematic review

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Intermittent vs continuous proton pump inhibitor therapy for high-risk bleeding ulcers: a systematic review and meta-analysis.

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Authors Sachar H , Vaidya K , Laine L
Journal JAMA internal medicine
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 1 Structured summary of systematic reviews 13 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 13 Broad syntheses (1 reference)

This article includes 13 Primary studies 13 Primary studies (13 references)

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IMPORTANCE: Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor (PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk bleeding ulcers. Substitution of intermittent PPI therapy, if similarly effective as bolus plus continuous-infusion PPI therapy, would decrease the PPI dose, costs, and resource use. OBJECTIVE: To compare intermittent PPI therapy with the currently recommended bolus plus continuous-infusion PPI regimen for reduction of ulcer rebleeding. DATA SOURCES: Searches included MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases through December 2013; US and European gastroenterology meeting abstracts from 2009 to 2013; and bibliographies of systematic reviews. STUDY SELECTION: Randomized trials of patients with endoscopically treated high-risk bleeding ulcers (active bleeding, nonbleeding visible vessels, and adherent clots) comparing intermittent doses of PPIs and the currently recommended regimen (80-mg intravenous bolus dose of a PPI followed by an infusion of 8 mg/h for 72 hours). DATA EXTRACTION AND SYNTHESIS: Duplicate independent data extraction and risk-of-bias assessment were performed. Data were pooled using a fixed-effects model or a random effects model if statistical heterogeneity was present. MAIN OUTCOMES AND MEASURES: The primary outcome was rebleeding within 7 days; additional predefined outcomes included rebleeding within 3 and 30 days, need for urgent intervention, mortality, red blood cell transfusion, and length of hospital stay. The primary hypothesis, defined before initiation of the literature review, was that intermittent use of PPIs was noninferior to bolus plus continuous infusion of PPIs, with the noninferiority margin predefined as an absolute risk difference of 3%. RESULTS: The risk ratio of rebleeding within 7 days for intermittent vs bolus plus continuous infusion of PPIs was 0.72 (upper boundary of 1-sided 95% CI, 0.97) and the absolute risk difference was -2.64% (upper boundary of 1-sided 95% CI, -0.28%, which is well below the predefined noninferiority margin of 3%). Risk ratios for rebleeding within 30 days and 3 days, mortality, and urgent interventions were less than 1 and mean differences for blood transfusion and hospital length of stay were less than 0, indicating that no summary estimate showed an increased risk with intermittent therapy. The upper boundaries of 95% CIs for absolute risk differences were less than 1.50% for all predefined rebleeding outcomes. CONCLUSIONS AND RELEVANCE: Intermittent PPI therapy is comparable to the current guideline-recommended regimen of intravenous bolus plus a continuous infusion of PPIs in patients with endoscopically treated high-risk bleeding ulcers. Guidelines should be revised to recommend intermittent PPI therapy.

Systematic review

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Timing of rebleeding in high-risk peptic ulcer bleeding after successful hemostasis: a systematic review.

Journal Canadian journal of gastroenterology & hepatology
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 1 Broad synthesis 6 Broad syntheses (1 reference)

This article includes 6 Primary studies 6 Primary studies (6 references)

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BACKGROUND: Peptic ulcer rebleeding (PUR) usually occurs within three days following endoscopic hemostasis. However, recent data have increasingly suggested delayed rebleeding. 
 OBJECTIVE: To better characterize the timing of PUR (Forrest Ia to IIb) following initially successful endoscopic hemostasis. 
 METHODS: An exhaustive literature search (1989 to 2013), with cross-referencing, was performed to identify pertinent randomized controlled trial (RCT) arms. Patients receiving high-dose proton pump inhibitor (PPI) infusion following successful modern-day endoscopic hemostasis were included. A sensitivity analysis included any patients receiving PPI doses >40 mg daily. The main outcome measure was 30-day rebleeding, while weighted mean averages at t = three, seven, 14 and 28 to 30 days are also reported. RESULTS: Of 756 citations, six RCTs were included (561 patients; 58.5% to 89.5% male; 55.3 to 67.5 years of age). Among patients receiving high-dose PPI (five RCTs [393 patients]), 11.5% (95% CI 8.4% to 14.7%) experienced rebleeding, 55.6% (95% CI 41.1% to 70.1%) rebled within three days, 20% (95% CI 8.3% to 31.7%) between four and seven days, 17.8% (95% CI 6.6% to 28.9%) at eight to 14 days, and 6.7% (95% CI 0% to 14%) at 15 to 28 to 30 days. Using the relaxed lower PPI dosing threshold, similar respective rates were 14.4% (95% CI 11.5% to 17.3%) overall, with interval rates of 39.5% (95% CI 28.9% to 50.15%), 34.6% (95% CI 24.2% to 44.9%), 19.7% (95% CI 11% to 28.4%) and 6.2% (95% CI 0.95% to 11.5%). Qualitative review of patient characteristics, limited by small sample size, possible bias and study heterogeneity, suggested increased patient comorbidity and postendoscopic use of lower PPI dosing may predict delayed rebleeding. 
 CONCLUSION: In patients with high-risk PUR undergoing successful endoscopic hemostasis, most rebled within three days, with many experiencing later rebleeding. Additional research is needed to better predict such an outcome.

Systematic review

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Meta-analysis: comparison of oral vs. intravenous proton pump inhibitors in patients with peptic ulcer bleeding.

Authors Tsoi KK , Hirai HW , Sung JJ
Journal Alimentary pharmacology & therapeutics
Year 2013
Links Pubmed DOI

This article is included in 1 Broad synthesis 6 Broad syntheses (1 reference)

This article includes 6 Primary studies 6 Primary studies (6 references)

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BACKGROUND: The efficacy of adjuvant use of intravenous proton pump inhibitors (PPIs) after endoscopic therapy has been proved in peptic ulcer bleeding patients, but the efficacy of oral PPIs is uncertain. AIM: To compare the clinical outcomes of oral PPIs vs. intravenous PPIs in patients with peptic ulcer bleeding. METHODS: Prospective randomised controlled trials were systematically searched from OVID databases until June 2012. Trials comparing oral and intravenous PPIs among patients with peptic ulcer bleeding were included. Recurrent bleeding, length of hospitalisation, blood transfusion, requirement of surgery and mortality were measured. The risk of bias, study quality and heterogeneity were also evaluated. RESULTS: Six randomised trials from 2006 to 2011 were included. A total of 615 patients were randomly assigned to receive oral PPIs (n = 302) or intravenous PPIs (n = 313). The mean age was 60 years and 71.1% was male. No significant difference between oral and intravenous PPIs was observed regarding recurrent bleeding (RR: 0.92, 95% CI: 0.56-1.50), mean volume of blood transfused (-0.02 unit, 95% CI: -0.29-0.24 unit), requirement of surgery (RR: 0.82, 95% CI: 0.19-3.61) and all-cause mortality (RR: 0.88, 95% CI: 0.29-2.71). The duration of hospital stay in days was significantly shortened in those using oral PPIs (-0.74 day, 95% CI: -1.10 day to -0.39 day). CONCLUSION: Oral PPIs demonstrate a similar effectiveness to intravenous PPIs among patients with peptic ulcer bleeding, but the results were combined from open-labelled trials with limited sample size. A large double-blind non-inferiority trial is required to better assess the role of oral PPIs.

Systematic review

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High-dose vs non-high-dose proton pump inhibitors after endoscopic treatment in patients with bleeding peptic ulcer: A systematic review and meta-analysis of randomized controlled trials

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Authors Wang CH , Ma MH , Chou HC , Yen ZS , Yang CW , Fang CC , Chen SC
Journal Archives of internal medicine
Year 2010
Links Pubmed DOI

This article is included in 2 Structured summaries of systematic reviews 7 Structured summaries of systematic reviews (2 references) 1 Broad synthesis 7 Broad syntheses (1 reference)

This article includes 7 Primary studies 7 Primary studies (7 references)

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Background: High-dose proton pump inhibitors (PPIs) (80-mg bolus, followed by 8-mg/h continuous infusion for 72 hours) have been widely studied and used. However, to date no concrete evidence has shown that high-dose PPIs are more effective than non-high-dose PPIs. Methods: We performed a literature search for randomized controlled trials that compared the use of high-dose PPIs vs non-high-dose PPIs in patients with bleeding peptic ulcer and determined their effects on rebleeding, surgical intervention, and mortality. Outcomes data were combined in a meta-analysis and were reported as odds ratios (ORs) with 95% confidence intervals (CIs). Results: A total of 1157 patients from 7 high-quality randomized studies were included in this meta-analysis. High-dose PPIs and non-high-dose PPIs did not differ in their effects on the rates of rebleeding (7 studies and 1157 patients; OR, 1.30; 95% CI, 0.88-1.91), surgical intervention (6 studies and 1052 patients; 1.49; 0.66-3.37), or mortality (6 studies and 1052 patients; 0.89; 0.37-2.13). Post hoc subgroup analyses revealed that summary outcomes measures were unaffected by severity of signs of recent hemorrhage at initial endoscopy, route of PPI administration, or PPI dose. Conclusion: Compared with non-high-dose PPIs, high-dose PPIs do not further reduce the rates of rebleeding, surgical intervention, or mortality after endoscopic treatment in patients with bleeding peptic ulcer. © American Medical Association. All rights reserved.

Systematic review

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High-dose vs low-dose proton pump inhibitors for upper gastrointestinal bleeding: a meta-analysis.

Authors Wu LC , Cao YF , Huang JH , Liao C , Gao F
Journal World journal of gastroenterology : WJG
Year 2010
Links Pubmed DOI PubMed Central

This article is included in 1 Structured summary of systematic reviews 9 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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AIM: To evaluate the efficacy of high-dose proton pump inhibitors (PPIs) vs low-dose PPIs for patients with upper gastrointestinal bleeding. METHODS: PubMed, Embase, the Cochrane Library, and Web of Science were searched to identify relevant randomized controlled trials (RCTs). Eligible trials were RCTs that compared high-dose PPI with low-dose PPI following endoscopic hemostasis. The primary endpoint was rebleeding; secondary endpoints were patient numbers that needed surgery, and mortality. The meta-analysis was performed with a fixed effects model or random effects model. RESULTS: Nine eligible RCTs including 1342 patients were retrieved. The results showed that high-dose intravenous PPI was not superior to low-dose intravenous PPI in reducing rebleeding [odds ratio (OR) = 1.091, 95% confidential interval (CI): 0.777-1.532], need for surgery (OR = 1.522, 95% CI: 0.643-3.605) and mortality (OR = 1.022, 95% CI: 0.476-2.196). Subgroup analysis according to different region revealed no difference in rebleeding rate between Asian patients (OR = 0.831, 95% CI, 0.467-1.480) and European patients (OR = 1.263, 95% CI: 0.827-1.929). CONCLUSION: Low-dose intravenous PPI can achieve the same efficacy as high-dose PPI following endoscopic hemostasis.

Systematic review

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Intravenous pantoprazole as an adjuvant therapy following successful endoscopic treatment for peptic ulcer bleeding

Authors Wang J , Yang K , Ma B , Tian J , Liu Y , Bai Z , Jiang L , Sun S , Li J , Liu R , Hao X , He X
Journal Canadian journal of gastroenterology = Journal canadien de gastroenterologie
Year 2009
Links Pubmed DOI PubMed Central

This article is included in 1 Structured summary of systematic reviews 5 Structured summaries of systematic reviews (1 reference)

This article includes 5 Primary studies 5 Primary studies (5 references)

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Background: Several studies have suggested that proton pump inhibitions are efficacious in preventing rebleeding when administered immediately after endoscopic treatments. However, there are limited clinical outcome data on the use of intravenous pantoprazole. Objective: To evaluate the efficacy of intravenous pantoprazole after succesful endoscopic treatment for peptic ulcer bleeding using evidence from ramdomized controlled trials (RCTs). Methods: The Cochrane Library, MEDLINE, EMBASE and several Chinese databases up to July 2008 were searched. RCTs that compared the relative effectiveness of intravenous pantoprazole with placebo, H2,receptor antagonist or other agents for patients with peptic ulcer bleeding who were pretreated with successful endoscopic therapies were retrieved. Results: Five RCTs comprising a total of 821 participants were included in the final meta-analysis. Overall, there were significant differences in ulcer rebleeding, (RR 0.31; 95% Cl 0.18 to 0.53; pooled rates were 4.7% for pantoprazole and 15.0% for control), surgical intervention (RR 0.28, 95% Cl 0.09 to 0.83; pooled rates were 1.4% in pantoprazole group versus 6.5% in control) and total length of hospital stay (weighted mean difference -1.53; 95% Cl -1.91 to -1.16), but not on mortality (RR 0.72, 95% Cl 0.29 to 1.81; pooled mortality rates were 1.9% for pantoprazole versus 2.8% for control) and btcod transfusion requirements (weighted mean difference -0,53; 95% Cl for random effects -1.04 to -0.02) when compared with control treatments. A series of subgroup analyses supported the results from the main analysis. Conclusions: Intravenous administration of pantoprazole After endoscopic therapy for peptic ulcer bleeding reduces rates of ulcer rebleeding, surgical intervention and overall duration of hospital stay, but not mortality and blood transfusion requirements compared with placebo, H2 receptor antagonist or somatostatin. © 2009 Pulsus Group Inc. All rights reserved.

Systematic review

Unclassified

Treatment with proton pump inhibitors in acute non-variceal upper gastrointestinal bleeding: A meta-analysis

Journal Journal of gastroenterology and hepatology
Year 2005
Links Pubmed DOI

This article includes 26 Primary studies 26 Primary studies (26 references)

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Medical therapy is an attractive adjuvant to endoscopic treatment in upper gastrointestinal (UGI) bleeding. This review aims to assess the treatment effects of proton pump inhibitor (PPI) therapy in acute non-variceal UGI bleeding. Outcome measures evaluated were further bleeding, surgery, all-cause deaths, ulcer deaths and non-ulcer deaths. We searched MEDLINE (1966-2002) and EMBASE (1974-2002) using the terms 'gastrointestinal hemorrhage', 'peptic ulcer hemorrhage', 'proton pump inhibitor', 'omeprazole', 'pantoprazole', 'lansoprazole', 'rabeprazole' and 'esomeprazole'. The search was extended to the Cochrane controlled trials registry database, published abstracts from five international gastroenterology conferences, manufacturers of PPI, known contacts and bibliographies from each full-length published report. We included trials published in English and non-English languages. Eligible studies were randomized controlled trials that compared the treatment effects of PPI therapy with placebo or H2 receptor antagonists in patients with acute non-variceal UGI bleeding. Of the 175 articles screened, 26 controlled trials including 4670 subjects (2317 in treatment arm and 2353 in control arm) were analyzed. The methodology, population, intervention, and outcomes of each selected trial were evaluated using duplicate independent review. Disagreements were resolved by consensus. PPI therapy significantly reduced rates of further bleeding (odds ratio [OR], 0.48; 95% confidence interval [CI], 0.40-0.57) and surgery (OR, 0.61; 95% CI, 0.48-0.76). All-cause deaths were unaffected (OR, 1.02; 95% CI, 0.76-1.37). Ulcer deaths showed a significant reduction (OR, 0.58; 95% CI, 0.35-0.96), while non-ulcer deaths showed a significant increase (OR, 1.60; 95% CI, 1.06-2.41) in the PPI therapy group. Sensitivity analysis of 22 trials published in peer-reviewed journals, 10 trials with double-blind design and 19 trials with high quality score and 22 trials using omeprazole in the treatment group showed results similar to those seen in the analysis of all 26 trials, confirming the stability of the conclusions. Subgroup analysis revealed that summary outcome measures were not influenced by control group therapy (placebo vs H2 receptor antagonists) or the use of prior endoscopic treatment to achieve hemostasis (given vs not given). However, the summary treatment effects for further bleeding and need for surgery were significant in only those trials enrolling patients with peptic ulcers having high risk for rebleeding and not in those trials enrolling patients with all causes of UGI bleeding. The summary treatment effects for further bleeding and need for surgery were significant in trials using intravenous as well as oral PPI. However, summary OR for all-cause deaths and non-ulcer deaths in trials using intravenous PPI were higher in the treatment group and not in trials using oral PPI. This raised the possibility of intravenous PPI-therapy-associated non-ulcer deaths in high-risk patients. PPI therapy in acute non-variceal UGI bleeding reduced rates of further bleeding, surgery and deaths caused by ulcer complications. However, non-ulcer deaths were increased. The overall mortality was unaffected. PPI therapy is useful only in a selected group of patients with acute non-variceal UGI bleeding, namely those with peptic ulcers having endoscopic high-risk stigmata for rebleeding. © 2004 Blackwell Publishing Asia Pty Ltd.

Systematic review

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Proton-pump inhibitors and outcome of endoscopic hemostasis in bleeding peptic ulcers: A series of meta-analyses

Journal The American journal of gastroenterology
Year 2005
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 34 Structured summaries of systematic reviews (1 reference)

This article includes 34 Primary studies 34 Primary studies (34 references)

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OBJECTIVE: To perform metaanalyses of studies on outcome of bleeding ulcers of different proton-pump inhibitors (PPIs) regimens, after stratification of patients by endoscopic stigmata, and analysis of studies with and without endotherapy. METHODS: A total of 35 randomized trials comparing PPIs to placebo and/or H2-receptor antagonists (H2RAs) in 4,843 patients with high-risk endoscopic stigmata were retrieved. Outcomes were rebleeding, surgery, and mortality. RESULTS: Monotherapy with oral or bolus PPIs was superior to placebo and H2RAs in reducing rebleeding in both bleeders and nonbleeders at index endoscopy; the need for surgery was reduced only when compared to H2RAs. In nonbleeders, PPI monotherapy was as effective as a combination of endotherapy with H2RAs. A combination of endotherapy with PPIs was superior to monotherapy in reducing bleeding and surgery, and superior to endotherapy alone in minimizing rebleeding, but not surgery; the benefit was lost when confronted to endotherapy plus H2RAs, whether PPIs were given as infusion or bolus. By pooling data from studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. CONCLUSIONS: Combination of endotherapy with either PPIs or H2RAs is indicated for nonbleeding ulcers at endoscopy with the intent to reduce rebleeding and surgery. Its value may extend to bleeding lesions, but current data are scanty. The benefit appears to be independent from route and doses of PPIs, as oral, bolus, or infusional methods are all effective. © 2005 by Am. Coll. of Gastroenterology.