Placebo controlled trial of methotrexate in systemic sclerosis

Eighteen adult patients of systemic sclerosis were included in this prospective study from Rheumatology Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka during the period of July 1997 to December 1999 to observe the effectiveness of treatment with methotrexate (MTX) versus placebo. Among the eighteen patients 9 patients were randomly assigned to MTX and 9 to placebo therapy. Nine patients were dropped out (6 in placebo and 3 in the MTX group), because of toxicity and non-compliance. Clinical improvement following treatment was observed in 33.33% of the patient in MTX group but none in placebo group, but this difference was not statistically significant. Anorexia, nausea and occasional vomiting were common side effects in MTX group and subsided in most cases with the passage of time despite the continuation of therapy.