OBJECTIVE: To obtain preliminary evidence on the safety and efficacy of low dose hydroxyurea as a treatment for rheumatoid arthritis (RA). METHODS:Five patients with active RA unresponsive to conventional therapy were entered into a 12 week, open label trial of hydroxyurea followed by a one month postdrug evaluation. RESULTS: Three of the 4 patients completing the study had a decrease in morning stiffness and number of swollen and tender joints. All 4 patients had a decrease in pain and an increase in function as measured by a modified health assessment questionnaire. No patient had improvement in sedimentation rate, C-reactive protein, or subjective measures of global well being. However, 3 of the 4 patients had disease flare after the drug was withdrawn, demonstrated by increased number of swollen and tender joints. CONCLUSION: Low dose hydroxyurea may be effective in the treatment of RA, but confirmation will require further testing by a randomized double blind placebo controlled trial of patients with a broader spectrum of disease severity over a longer period of therapeutic intervention.
RCT Entities:
OBJECTIVE: To obtain preliminary evidence on the safety and efficacy of low dose hydroxyurea as a treatment for rheumatoid arthritis (RA). METHODS: Five patients with active RA unresponsive to conventional therapy were entered into a 12 week, open label trial of hydroxyurea followed by a one month postdrug evaluation. RESULTS: Three of the 4 patients completing the study had a decrease in morning stiffness and number of swollen and tender joints. All 4 patients had a decrease in pain and an increase in function as measured by a modified health assessment questionnaire. No patient had improvement in sedimentation rate, C-reactive protein, or subjective measures of global well being. However, 3 of the 4 patients had disease flare after the drug was withdrawn, demonstrated by increased number of swollen and tender joints. CONCLUSION: Low dose hydroxyurea may be effective in the treatment of RA, but confirmation will require further testing by a randomized double blind placebo controlled trial of patients with a broader spectrum of disease severity over a longer period of therapeutic intervention.