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

OBJECTIVE

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.

CONCLUSIONS

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.