CONTROLLED MULTICENTER DOUBLE-BLIND TRIAL OF AN ORAL ANALOG OF PROSTACYCLIN IN THE TREATMENT OF PRIMARY RAYNAUDS-PHENOMENON

Objective. To compare the efficacy and tolerance of beraprost sodium, an oral prostanoid prostaglandin I-2 analog, with a placebo in patient s with primary Raynaud's phenomenon (RP). Methods. 125 patients with d isabling primary RP participated in a multicenter, randomized, double blind trial in 2 parallel groups, lasting 8 weeks, and conducted durin g the winter months only; a meteorological survey was also conducted f or each patient. Main outcome measures were frequency and severity of attacks of RP, overall disability, and digital cold challenge tests. R esults. 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 group s. Similar results were found for the severity of RP attacks and overa ll disability. No severe side effects occurred, but headache was more frequent in the beraprost group (p = 0.001). Cold tests remained equal ly abnormal in both groups throughout the study. Conclusion. Although we observed 37% improvement in the number of attacks of RP in the bera prost group, prostanoid treatment proved no more beneficial than place bo.