Over-the-counter (OTC) doses of ibuprofen are generally well-tolerated.
Cyclooxygenase 2 (COX-2)-selective inhibitors cause less ulceration than prescription-dose nonselective nonsteroidal anti-inflammatory drugs (NSAIDs).
In this study, physicians from the United States compared endoscopic injury related to nonprescription ibuprofen doses with celecoxib. The team also compared prescription doses of naproxen with placebo as a positive control.
The team performed a randomized, placebo-controlled, double blind, double-dummy endoscopic evaluation with concealed allocation. A 2-way crossover with a 4–5-week washout period was used.
|18% of the ibuprofen treated subjects developed ulcers.|
|Clinical Gastroenterology and Hepatology|
All participants were healthy adults with normal baseline endoscopic findings.
A total of 79 subjects completed both study phases.
The team found that 20% of participants had Helicobacter pylori infection. In addition, 79% and 67% had a current or past medical problem, respectively.
Participants were stratified by the presence or absence of H. pylori infection and were randomly assigned to 1 of 4 treatments: ibuprofen/celecoxib, celecoxib/ibuprofen, naproxen/placebo, or placebo/naproxen.
The physicians measured the frequency of endoscopic ulcers and erosions.
They found that 3% of the celecoxib-treated subjects developed ulcers, compared with 18% of the ibuprofen treated subjects.
In addition, the team determined that naproxen treatment was associated with a significantly greater ulceration compared with placebo.
Dr James Scheiman and colleagues concluded, "Short-term use of…ibuprofen and naproxen is associated with a greater risk for endoscopic mucosal injury compared with the COX-2-selective inhibitor celecoxib or placebo".
"A prospective analysis appropriately powered to address the incidence of clinically significant gastroduodenal ulceration associated with the short-term use of these agents is required".