A double-blind crossover study comparing tolmetin sodium and naproxen in the treatment of ankylosing spondylitis

Summary

A double-blind crossover study was carried out to compare the efficacy and tolerance of tolmetin sodium and naproxen in patients with ankylosing spondylitis. Patients were only included in the study after demonstration that their disease was in an active phase, this being accomplished by monitoring pain and stiffness before and after 1 week's placebo therapy. Only those patients whose condition deteriorated were admitted to active treatment. Also, patients were carefully selected for those with unequivocal diagnosis. A total of 88 patients was screened and 34 enrolled in the study. Of these, 27 patients completed 4-weeks' treatment with each drug as planned. Pain and stiffness improved on active treatments when compared to placebo, nocturnal pain and immobility stiffness significantly so. Spinal mobility also improved; the decrease in occiput-wall distance was statistically significant for tolmetin sodium when compared to both naproxen and placebo. Comparative global assessments and drug preference were similar for both drugs. Side-effect incidence was acceptable; I patient withdrew from naproxen with limiting gastro-intestinal problems and 1 from tolmetin sodium treatment because of lack of effect.

Key Words::

• Tolmetin
• naproxen
• spondylitis
• ankylosing