Controlled multicenter double blind trial of an oral analog of prostacyclin in the treatment of primary Raynaud's phenomenon. French Microcirculation Society Multicentre Group for the Study of Vascular Acrosyndromes

Abstract

Objective: To compare the efficacy and tolerance of beraprost sodium, an oral prostanoid prostaglandin I2 analog, with a placebo in patients with primary Raynaud's phenomenon (RP).

Methods: 125 patients with disabling primary RP participated in a multicenter, randomized, double blind trial in 2 parallel groups, lasting 8 weeks, and conducted during the winter months only; a meteorological survey was also conducted for each patient. Main outcome measures were frequency and severity of attacks of RP, overall disability, and digital cold challenge tests.

Results: The number of attacks decreased significantly in both groups (confidence intervals of improvement: 35-53% in beraprost group and 25-49% in placebo group), but did not differ significantly in the 2 groups. Similar results were found for the severity of RP attacks and overall disability. No severe side effects occurred, but headache was more frequent in the beraprost group (p = 0.001). Cold tests remained equally abnormal in both groups throughout the study.

Conclusion: Although we observed 37% improvement in the number of attacks of RP in the beraprost group, prostanoid treatment proved no more beneficial than placebo.