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BMJ Clinical Evidence Oct 2009The principal effect of Helicobacter pylori infection is lifelong chronic gastritis, affecting up to 20% of younger adults but 50% to 80% of adults born in resource-rich... (Review)
Review
INTRODUCTION
The principal effect of Helicobacter pylori infection is lifelong chronic gastritis, affecting up to 20% of younger adults but 50% to 80% of adults born in resource-rich countries before 1950.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of H pylori eradication treatment in people with a confirmed duodenal ulcer, a confirmed gastric ulcer, confirmed gastro-oesophageal reflux disease (GORD), confirmed non-ulcer dyspepsia, uninvestigated dyspepsia, localised B cell lymphoma of the stomach, and non-steroidal anti-inflammatory drug (NSAID)-related peptic ulcers? What are the effects of H pylori eradication treatment for preventing NSAID-related peptic ulcers in people with or without previous ulcers or dyspepsia? What are the effects of H pylori eradication treatment on the risk of developing gastric cancer? Do H pylori eradication treatments differ in their effects? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 58 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: effects of H pylori eradication in different populations; relative effects of triple regimens, quadruple regimens, and sequential regimens.
Topics: Duodenal Ulcer; Dyspepsia; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans
PubMed: 21718575
DOI: No ID Found -
The American Journal of Gastroenterology Oct 2008An increased knowledge regarding the predictors of rebleeding after endoscopic therapy for bleeding ulcers should improve clinical management and outcomes. The aim of... (Review)
Review
BACKGROUND
An increased knowledge regarding the predictors of rebleeding after endoscopic therapy for bleeding ulcers should improve clinical management and outcomes. The aim of this systematic review was to identify the strongest and most consistent predictors of rebleeding to assist in the development of tools to stratify and appropriately manage patients after endoscopic therapy.
METHODS
Bibliographic database searches for prospective studies assessing rebleeding after endoscopic therapy for bleeding ulcers were performed. Relevant studies were identified, and data were abstracted in a duplicate and independent fashion. The primary outcomes sought were significant independent predictors of rebleeding by multivariable analyses in > or =2 studies.
RESULTS
Ten articles met the prespecified inclusion criteria. The pooled rate of rebleeding after endoscopic therapy was 16.4%. The independent pre-endoscopic predictors of rebleeding were hemodynamic instability (significant in 5 of 5 studies; summary odds ratio [OR] 2.75, 95% confidence interval [CI] 1.99-3.51) and comorbid illness (significant in 2 of 7 studies; insufficient data to calculate summary OR or report OR range). The independent endoscopic predictors of rebleeding were active bleeding at endoscopy (significant in 5 of 8 studies; summary OR 1.93, 95% CI 1.30-2.55), large ulcer size (significant in 4 of 5 studies; summary OR 2.01, 95% CI 1.21-2.80), posterior duodenal ulcer (significant in 2 of 3 studies; insufficient data to calculate summary OR or report OR range), and lesser gastric curvature ulcer (significant in 2 of 2 studies; insufficient data to calculate summary OR or report OR range).
CONCLUSIONS
The independent predictors of recurrent hemorrhage after endoscopic therapy, particularly those that are the strongest and most consistent in the literature, may be used to select patients who are most likely to benefit from aggressive post-hemostasis care, including intensive care unit (ICU) observation and second-look endoscopy. Prospective studies designed to formally assess the relative utilities of these factors in predicting rebleeding and dictating management are needed.
Topics: Hemostasis, Endoscopic; Humans; Incidence; Peptic Ulcer Hemorrhage; Prognosis; Recurrence; United States
PubMed: 18684171
DOI: 10.1111/j.1572-0241.2008.02070.x -
Alimentary Pharmacology & Therapeutics Mar 2008In clinical trials of peptic ulcer prevention, the most appropriate definition of an ulcer remains challenging. (Review)
Review
BACKGROUND
In clinical trials of peptic ulcer prevention, the most appropriate definition of an ulcer remains challenging.
AIMS
To evaluate the ulcer definitions used in clinical trials of ulcer prevention among non-steroidal anti-inflammatory drug users and to determine whether any specific definition is preferred.
METHODS
A systematic literature search of the PubMed, Medline and EMBASE databases was conducted. Results were limited to full papers published in English from June 1987 to June 2007 that met the following criteria: randomized, controlled non-steroidal anti-inflammatory drug trials of > or =8 weeks' duration, with a primary end point of ulcer upon endoscopy.
RESULTS
Forty five publications met the inclusion criteria and were reviewed. Overall, an ulcer diameter of > or =3 mm was used in 25 publications and most included a description of ulcer depth. Of the remainder, ulcer was defined as any lesion with unequivocal/observable depth (with no lower limit for ulcer diameter; five publications) or an excavated mucosal break >3 mm (one publication), whereas nine defined a minimum ulcer size of > or =5 or >5 mm. Ulcer definition was unclear in the remaining five publications.
CONCLUSION
In clinical trials of ulcer prevention among non-steroidal anti-inflammatory drug users, a gastric or duodenal lesion > or =3 mm in diameter with significant depth is the preferred definition.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Humans; Peptic Ulcer; Terminology as Topic
PubMed: 18194499
DOI: 10.1111/j.1365-2036.2008.03610.x -
Alimentary Pharmacology & Therapeutics Oct 2004The effect of Helicobacter pylori in provoking or protecting against gastro-oesophageal reflux disease is unclear and studies have given conflicting results. Recent... (Review)
Review
BACKGROUND
The effect of Helicobacter pylori in provoking or protecting against gastro-oesophageal reflux disease is unclear and studies have given conflicting results. Recent guidelines recommend H. pylori eradication in patients on long-term proton pump inhibitors.
AIM
To ascertain the effect of H. pylori eradication on gastro-oesophageal reflux disease outcomes (reflux oesophagitis and heartburn) in patients with duodenal ulcer disease, and to ascertain the effect of H. pylori infection on reflux oesophagitis concerning heartburn, pH, severity, healing and relapse rates.
METHODS
A systematic review of electronic databases was undertaken to September 2003. Experts in the field, pharmaceutical companies and journals were contacted about unpublished trials. Studies were reviewed according to predefined eligibility and quality criteria. Twenty-seven studies/trials were included in the systematic review.
RESULTS
Study variation rather than therapy-influenced results in relation to the presence or absence of oesophagitis in patients with duodenal ulcer who underwent H. pylori eradication at 6-48 months follow-up. In patients with reflux oesophagitis no obvious differences were discovered in heartburn scores, 24-h pH values, healing and relapse rates between H. pylori-positive and -negative cases.
CONCLUSION
There is no evidence to indicate that H. pylori eradication in duodenal ulcer disease provokes reflux oesophagitis or worsens heartburn; (ii) there are insufficient data to draw firm conclusions about the impact of H. pylori in patients with reflux oesophagitis.
Topics: Duodenal Ulcer; Esophagitis; Gastroesophageal Reflux; Helicobacter Infections; Helicobacter pylori; Humans
PubMed: 15379833
DOI: 10.1111/j.1365-2036.2004.02172.x -
The Cochrane Database of Systematic... 2000Non-steroidal anti-inflammatory drugs (NSAIDs) are important agents in the management of arthritic and inflammatory conditions, and are among the most frequently... (Review)
Review
BACKGROUND
Non-steroidal anti-inflammatory drugs (NSAIDs) are important agents in the management of arthritic and inflammatory conditions, and are among the most frequently prescribed medications in North America and Europe. However, there is overwhelming evidence linking these agents to a variety of gastrointestinal (GI) toxicities.
OBJECTIVES
To review the effectiveness of common interventions for the prevention of NSAID induced upper GI toxicity.
SEARCH STRATEGY
A literature search was conducted, according to the Cochrane methodology for identification of randomized controlled trials in electronic databases, including MEDLINE from 1966 to January 2000, Current Contents for 6 months prior to January 2000, Embase to Febuary 1999, and a search of the Cochrane Controlled Trials Register from 1973 to 1999. Recent conference proceedings were reviewed and content experts and companies were contacted.
SELECTION CRITERIA
Randomized controlled clinical trials (RCTs) of prostaglandin analogues (PA), H2-receptor antagonists (H2RA) or proton pump inhibitors (PPI) for the prevention of chronic NSAID induced upper GI toxicity were included.
DATA COLLECTION AND ANALYSIS
Two independent reviewers extracted data regarding population characteristics, study design, methodological quality and number of patients with endoscopic ulcers, ulcer complications, symptoms, overall drop-outs, drop outs due to symptoms. Dichotomous data was pooled using Revman V3.1. Heterogeneity was evaluated using a chi square test.
MAIN RESULTS
Thirty-three RCTs met the inclusion criteria. All doses of misoprostol significantly reduced the risk of endoscopic ulcers. Misoprostol 800 ug/day was superior to 400 ug/day for the prevention of endoscopic gastric ulcers (RR=0.18, and RR=0. 38 respectively, p=0.0055). A dose response relationship was not seen with duodenal ulcers. Misoprostol caused diarrhea at all doses, although significantly more at 800ug/day than 400ug/day (p=0.0012). Misoprostol was the only prophylactic agent documented to reduce ulcer complications. Standard doses of H2RAs were effective at reducing the risk of endoscopic duodenal (RR=0.24; 95% CI: 0.10-0. 57) but not gastric ulcers(RR=0.73; 95% CI:0.50-1.09). Both double dose H2RAs and PPIs were effective at reducing the risk of endoscopic duodenal and gastric ulcers (RR=0.44; 95% CI:0.26-0.74 and RR=0.37;95% CI;0.27-0.51 respectively for gastric ulcer), and were better tolerated than misoprostol.
REVIEWER'S CONCLUSIONS
Misoprostol, PPIs, and double dose H2RAs are effective at preventing chronic NSAID related endoscopic gastric and duodenal ulcers. Lower doses of misoprostol are less effective and are still associated with diarrhea. Only Misoprostol 800ug/day has been directly shown to reduce the risk of ulcer complications.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Chronic Disease; Duodenal Ulcer; Histamine H2 Antagonists; Humans; Misoprostol; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Stomach Ulcer
PubMed: 10908548
DOI: 10.1002/14651858.CD002296 -
British Journal of Clinical Pharmacology Dec 1999To assess whether frequency of placebo administration is associated with duodenal ulcer healing. (Meta-Analysis)
Meta-Analysis
AIMS
To assess whether frequency of placebo administration is associated with duodenal ulcer healing.
METHODS
A systematic literature review of randomized clinical trials was undertaken. 79 of 80 trials that met the inclusion criteria. The pooled 4 week placebo healing rate of all duodenal ulcer trials that employed a four times a day regimen was compared with the rate obtained from trials with a twice a day regimen.
RESULTS
The pooled 4 week healing rate of the 51 trials with a four times a day regimen was 44. 2% (805 of 1821 patients) compared with 36.2% (545 of 1504 patients) in the 28 trials with a twice a day regimen (difference, 8.0% [equal effects model]; 95% confidence interval, 4.6% to 11.3%). Depending on the statistical analysis, the rate difference ranged from 6.0% (multivariable random effects model) to 8.0% (equal effects model). A number of sensitivity analyses showed comparable differences between the two regimens. Most of these sensitivity analyses were not significant, probably because a number of trials were excluded resulting in a loss of power.
CONCLUSIONS
We found a relation between frequency of placebo administration and healing of duodenal ulcer. We realize that the comparison was based on nonrandomized data. However, we speculate that the difference between regimens was induced by the difference in frequency of placebo administration. A better knowledge of various placebo effects is required in order to make clinically relevant assessments of treatment effects derived from placebo-controlled trials.
Topics: Duodenal Ulcer; Gastrointestinal Agents; Humans; Models, Statistical; Placebo Effect; Placebos; Randomized Controlled Trials as Topic
PubMed: 10594490
DOI: 10.1046/j.1365-2125.1999.00094.x