Dr Hooper and colleagues from Manchester, England undertook a study to assess the effectiveness of five gastroprotective strategies for people taking non-steroidal anti-inflammatory drugs (NSAIDs).
The investigators looked at H2 receptor antagonists plus non-selective (or cyclo-oxygenase-1) NSAIDs; proton pump inhibitors plus non-selective NSAIDs; misoprostol plus non-selective NSAIDs; COX-2 selective NSAIDs; or COX-2 specific NSAIDs.
The researchers evaluated the ability of these strategies to reduce serious gastrointestinal complications, symptomatic ulcers, serious cardiovascular or renal disease, and deaths, and improve quality of life.
The research group collected data from a variety of sources, including: The Cochrane Library, Medline, Embase, Current Controlled Trials, and System for Information on Grey Literature in Europe (SIGLE) were searched to May 2002.
Bibliographies and author contacts were used to identify further studies; non-English articles were included.
The researchers only rejected articles if the study was not a randomized controlled trial; did not assess a gastroprotective strategy versus placebo; included exclusively children or healthy volunteers; lasted less than 21 days; or no review outcomes were measured.
The investigators used random effects meta-analysis, meta-regression and subgrouping to pool effects and analyze associations with length of follow up, mean age, and baseline gastrointestinal status.
|All strategies except COX-2 selectives reduced the risk of endoscopic ulcers|
|British Medical Journal|
The researchers examined heterogeneity and performed sensitivity analyses.
The research team included 112 randomized controlled trials with a total of 74,666 participants.
Out of these, the researchers judged 5 to be at low risk of bias.
In total, 138 deaths and 248 serious gastrointestinal events were reported overall.
When the researchers compared gastroprotective strategies versus placebo they found no evidence of the effectiveness of H2 receptor antagonists for any primary outcomes (few events reported).
In addition, proton pump inhibitors were found to possibly reduce the risk of symptomatic ulcers.
The researchers found that misoprostol reduced the risk of serious gastrointestinal complications and symptomatic ulcers, COX-2 selectives reduced the risk of symptomatic ulcers and COX-2 specifics reduced the risk of symptomatic ulcers and possibly serious gastrointestinal complications.
All strategies except COX-2 selectives reduced the risk of endoscopic ulcers (at least 3 mm in diameter).
Dr Lee Hooper concluded, "Misoprostol, COX-2 specific and selective NSAIDs, and probably proton pump inhibitors significantly reduce the risk of symptomatic ulcers, and misoprostol and probably COX-2 specifics significantly reduce the risk of serious gastrointestinal complications, but data quality is low."
He added, "More data on H2 receptor antagonists and proton pump inhibitors are needed, as is better reporting of rare but important outcomes."