Levamisole, an anthelminthic agent with immunostimulatory properties, was used in a double-blind, controlled therapeutic trial in rheumatoid arthritis. Patients received either levamisole 100 mg 4 days a week, or placebo, for a period of 4 months. Significant improvement in the treated group, as compared with the control group, was found in the number of tender and swollen joints, grip strength, range of joint motion, sedimentation rate, and C-reactive protein. On double-blind global evaluation by the examining physicians, 9 of 14 patients on levamisole and none of 13 on placebo were considered to have improved. Adverse effects did not differ in frequency between the two groups except for mild alteration in taste, which was more common with levamisole. (2,3). contrasting with the suppressive effects of corticosteroids (4) and cytotoxic agents (5). We have performed a double-blind, placebo-controlled trial, which demonstrates that levamisole produces significant shortterm improvement in patients with rheumatoid arthritis.
PATIENTS AND METHODSThirty patients with definite or classic rheumatoid arthritis, as defined by the criteria o f the American Rheumatism Association, entered the study with informed consent and were assigned at random to receive identical tablets containing either levamisole 100 mg, or placebo, on 4 consecutive days per week. None of the patients received gold or corticosteroids within 5 months before the trial. All were considered to have active disease and were receiving salicylates and other nonsteroidal antiinflammatory agents, which were continued in the same doses during the study.Assessments were performed on two occasions, 2 days apart, at the beginning and end of the 16-week study period, and at 4-week intervals during the trial, always by the same physician. The measurements included a determination of the number of tender and swollen joints, the number and size of rheumatoid nodules, grip strength, 50-foot walking time, duration of morning stiffness, Westergren sedimentation rate (ESR), and C-reactive protein (CRP). Routine hematologic studies and chemical profile were performed monthly. The range of joint motion, rheumatoid factor by the latex fixation method and skin testing with streptokinase-streptodornase, PPD, candida, and mumps antigens were recorded at the