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A Multicenter Double-blind Placebo-Controlled Clinical Trial

Condylomata International Collaborative Study Group

JAMA. 1991;265(20):2684-2687.

Abstract
Systemic interferon has been advocated as an effective therapy for recurrent genital warts. A double-blind, placebo-controlled, multicenter international trial involving 172 patients with recurrent condylomata was conducted using systemic interferon alfa-2a in doses of 3 or 9 MIU three times per week for 4 weeks. The treatment period was followed by a treatment-free follow-up period of 2 months. Complete responders at month 3 were followed up to 9 months or until they had a recurrence, whichever occurred first. The combined rates of complete response (total disappearance of all lesions without appearance of new ones) and major incomplete response (at least a 75% reduction in total lesion area) at 3 months after the commencement of therapy were 34%, 25%, and 30%, respectively, in 166 patients receiving 3 and 9 MIU of interferon alfa-2a and placebo. The recurrence rates at the end of 9 months were 9% in the placebo and 3-MIU groups and 36% in the 9-MIU group. We conclude that systemic interferon alfa-2a administered three times weekly for 4 weeks at doses of 3 and 9 MIU is not effective as monotherapy for genital warts that have recurred after standard ablative therapy.

(JAMA. 1991;265:2684-2687)

Footnotes
The data in this report come from studies of the Condylomata International Collaborative Study Group. The report was written by a committee comprising representatives from each participating institution.

The costs of this research were paid in part by grants from Roche Pharmaceuticals to the individual investigators.

Reprint requests to University of Queensland, Department of Medicine, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102, Australia (Dr Hogan).

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