Naproxen: long-term study in rheumatoid arthritis and "placebo pulse".

Naproxen is by now a relatively well-known antirheumatic drug, and many short-term studies have shown its efficacy and relatively good tolerance. We have observed 64 patients with definite or classical rheumatoid disease, 27 of whom have been followed for well over two years on daily doses of naproxen to ascertain the persistence of drug efficacy and safety. In this part of our study, patients were subjected to complete clinical and biochemical evaluations at two-monthly intervals. Naproxen was well tolerated, and the few side effects reported were transient and mild in nature. Sequential laboratory studies revealed no significant anomaly. Clinical evaluation showed no pattern suggestive of decreasing antirheumatic activity. A question frequently encountered in the treatment of certain diseases such as rheumatoid arthritis is whether long-term improvement is due to efficacious suppressive therapy or spontaneous abatement of disease activity. We devised a double-blind placebo pulse phase in which 19 of our 28 long-term patients participated in a study within a study lasting four weeks. They were divided into two groups. The first group took their usual dose of naproxen during the first two weeks and a corresponding number of placebo tablets in the next two weeks. The procedure was reversed in the other group. We conclude that naproxen remains efficacious.

RCT Entities:   Population Interventions Outcomes