Upper gastrointestinal symptoms in patients treated with nonsteroidal anti-inflammatory drugs: prevalence and impact--the COMPLAINS study.

Objectives: To investigate the prevalence and type of upper gastrointestinal symptoms during nonsteroidal anti-inflammatory drug (NSAID) therapy, the impact of these symptoms on daily life and adherence to treatment and the concordance between physicians' and patients' assessments.

Methods: A sample of 1000 French rheumatologists was invited to participate in the study, of which 630 accepted. Participating physicians enrolled all patients above 18 years of age seen during a 1-week period who had been receiving daily NSAID treatment for at least 3 days (n = 8269). Data on gastrointestinal symptoms were collected using a standardized questionnaire. In the first two symptomatic patients seen by each physician, patient and physician questionnaires were used to investigate concordance between symptom evaluations.

Results: Two thousand seven hundred and ninety-nine patients (33.8%) reported upper gastrointestinal symptoms; of these, 1056 (12.8% of the total population) had acid reflux symptoms (heartburn and/or acid regurgitation). The most common symptoms were epigastric burning (17.3%) and epigastric discomfort or pain (14.4%). Symptoms were less common with coxibs than with nonselective NSAIDs (26.4 vs. 35.4%, P<10). There was moderate or good agreement between physicians' and patients' symptom assessments. Upper gastrointestinal symptoms resulted in NSAID dose reduction in 5.8% of patients, temporary withdrawal of treatment in 17.2% and permanent withdrawal in 10.8%. Half of the patients reported at least moderate impairment of daily activities because of their symptoms.

Conclusion: Approximately, one-third of NSAID-treated patients complained of upper gastrointestinal symptoms, with coxibs being better tolerated than nonselective NSAIDs. These symptoms have a marked impact on the quality of life and adherence to therapy.