Diclofenac sodium (Voltaren) and indomethacin in the ambulatory treatment of rheumatoid arthritis: a double-blind multicentre study.

In a double-blind crossover trial conducted on a multicentre basis, 109 patients with "classic" or "definite" rheumatoid arthritis were treated for two weeks with diclofenac sodium (Voltaren, 25 mg t.i.d.) and indomethacin (25 mg t.i.d). Both drugs led to a clear-cut decrease in morning stiffness, as well as to a significant improvement in pain at rest and on movement. In these respects no significant difference between the two-drugs was observed. As regards their effect on status of rheumatoid condition, however, a trend towards a significant improvement was discernible, in the investigator's opinion, only in response to diclofenac sodium. "Unwanted effects" were mentioned by 25 patients before the trial, by 31 during treatment with diclofenac sodium, and by 33 during treatment with indomethacin. While the patients were receiving indomethacin, five of them discontinued treatment on account of side effects (headache in three cases, headache and tiredness in one case, and an allergic skin reaction in one case) and one of them, who complained of headache, lowered the dosage; treatment with diclofenac sodium was discontinued because of side effects by only one patient, who had developed an allergic skin reaction.

RCT Entities:   Population Interventions Outcomes