Safety of Mud-Bath Applications in Moderately Active Rheumatoid Arthritis

Objective: To evaluate safety of mud-bath therapy in mild-moderately rheumatoid arthritis [RA]. Methods: We planned a randomized, double-blinded, placebo-controlled trial in patients with moderate active RA, treated with active or placebo mud applied for 15 to 20 minutes at 39 to 40 degrees C and followed by a shower and thermal bath at 37 to 38 degrees C for 10 to 12 minutes. The first 50 patients were evaluated for an interim analysis and considered "treated patients" without blinding breakdown. Patients were evaluated before treatment [visit 1], at the end of the treatment [visit 2], after four weeks [visit 3], and after six months [visit 4, end of the study] for flare, Disease Activity Score [DAS], C-reactive protein, swollen joints, Health Assessment Questionnaire, and adverse reactions. As a control group, 50 matched RA patients were enrolled at the same outpatient clinic and evaluated four weeks apart. Results: The baseline characteristics of the two groups were similar. No significant differences were noted as for disease flares. Thirty-three [66 percent] treated and 12 [24 percent] control patients had an improvement of more than 0.6 on the DAS [p <.001]. Concerning the treated patients, DAS, C-reactive protein, swollen joints, and the Health Assessment Questionnaire showed a significant reduction at visit 2 when compared to the baseline, lasting until visit 4. No significant side effects were noted. Conclusions: A negative effect of hot application in mild to moderately active RA seems to be excluded. The observed improvement in disease activity should be the subject of further studies.