OBJECTIVE: To follow those patients who participated in a randomized, double blind placebo controlled trial investigating the effect of pulse methylprednisolone treatment in 60 patients with rheumatoid arthritis (RA) starting chrysotherapy. METHODS: Following completion of the original 24-week trial, 47 of the original 60 patients were reexamined between 32 and 67 weeks after completion of the original study. Patients were assessed by a composite clinical score, the Health Assessment Questionnaire (HAQ), erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor levels. RESULTS: At the end of the 24-week trial, the number of patients who responded well to therapy was significantly greater (p < 0.05) in the patients who had received methylprednisolone (17/30) compared with the placebo group (8/30). At the longterm followup assessment, the mean disability score (HAQ) was significantly less (p < 0.05) in patients receiving the initial steroid pulses. No significant difference in drug toxicity or the length of time that patients remained on gold, was observed between the 2 treatment groups. CONCLUSION: Our study supports a beneficial adjunctive role of pulse corticosteroids in patients with RA starting gold therapy.
RCT Entities:
OBJECTIVE: To follow those patients who participated in a randomized, double blind placebo controlled trial investigating the effect of pulse methylprednisolone treatment in 60 patients with rheumatoid arthritis (RA) starting chrysotherapy. METHODS: Following completion of the original 24-week trial, 47 of the original 60 patients were reexamined between 32 and 67 weeks after completion of the original study. Patients were assessed by a composite clinical score, the Health Assessment Questionnaire (HAQ), erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor levels. RESULTS: At the end of the 24-week trial, the number of patients who responded well to therapy was significantly greater (p < 0.05) in the patients who had received methylprednisolone (17/30) compared with the placebo group (8/30). At the longterm followup assessment, the mean disability score (HAQ) was significantly less (p < 0.05) in patients receiving the initial steroid pulses. No significant difference in drug toxicity or the length of time that patients remained on gold, was observed between the 2 treatment groups. CONCLUSION: Our study supports a beneficial adjunctive role of pulse corticosteroids in patients with RA starting gold therapy.