[Clinical trial in couples of effectiveness and side-effects of gold and D-penicillamine in long term treatment of rheumatoid arthritis (author's transl)].

A prospective clinical trial in couples was done to compare effectiveness and toxicity of gold and D-penicillamine (D-Pen.) in treatment of rheumatoid arthritis (r.A.). Respecting defined criteria 70 patients were put to couples according to a random list and were treated with gold or D-Pen. alternatively. Physical and laboratory indices of inflammatory activity were checked every 3 months, X-rays every 12 months. Dropouts (side effects, missing compliance, uneffectiveness) were replaced by the nextcoming fitting patient. Thirty-two of 147 totally recruited patients stopped treatment because of side effects, three because of unsatisfying efficiency. Forty-two patients shuned the necessary controls. The clinical course was better in 16 couples with gold, only in sex couples with D-Pen. Thirteen pairs showed no difference in this respect (p = 0.05). Looking to the laboratory parameters separately D-Pen. tends to be superior (p < 0.05), radiografic deterioration seems to be more seldom with gold (< 0.05). Side effects occur with both drugs in comparable frequency (15/44 with D-Pen., 17/52 with gold), but the complications with D-Pen. are more serious. Altogether this trial shows gold superior to D-Pen. in the long-term treatment of r.A.

RCT Entities:   Population Interventions Outcomes