EFFICACY OF ADDITIVE DMARD THERAPY IN PATIENTS WITH RHEUMATOID-ARTHRITIS - DOUBLE-BLIND CONTROLLED TRIAL USING BUCILLAMINE AND PLACEBO WITHMAINTENANCE DOSES OF GOLD SODIUM THIOMALATE

Objective. To examine the efficacy of the addition of small doses of a dditional disease modifying antirheumatic drugs (DMARD) to ongoing DMA RD treatment [additive DMARD therapy (ADT)]. Methods. A 3-month prospe ctive, double blind, randomized, placebo controlled study was performe d using either 100 mg/day of bucillamine (Buc) or an inactive placebo (P1). Two groups of 12 patients each who had experienced an insufficie nt benefit from gold sodium thiomalate (GSTM) alone were enrolled in t he study. Results The addition of Buc proved more beneficial than P1 r egarding improvement in disease activity (p = 0.0032) and drug usefuln ess (p = 0.0025). A significant within group improvement was observed in joint swelling count, the Lansbury activity index, erythrocyte sedi mentation rate and C-reactive protein. However, the difference in the clinical variables between the 2 groups was minimal. Conclusion. The u sefulness of ADT was suggested by this trial; however, further confirm ation by additional studies is still needed.