Efficacy trial of topically administered interferon gamma-1 beta gel in comparison to laser treatment in cervical intraepithelial neoplasia.

Author(s): Schneider A, Grubert T, Kirchmayr R, Wagner D, Papendick U, Schlunck G

Affiliation(s): Department of Obstetrics and Gynecology, University of Ulm, Germany.

Publication date & source: 1995, Arch Gynecol Obstet., 256(2):75-83.

Publication type: Clinical Trial; Clinical Trial, Phase II; Randomized Controlled Trial

OBJECTIVE: Dose dependent response of cervical intraepithelial neoplasia (CIN) to topically administered interferon (IFN) gamma was assessed and compared with conventional laser therapy. PATIENT AND METHODS: 33 women were included in a randomized phase II trial which was double blinded for IFN dosages. Twenty-four patients received IFN gamma-1 beta gel and a control group of nine patients was treated with laser surgery. 18 patients had smears suggesting CIN II and 15 patients had smears suggesting CIN III. The response was assessed 6 months after starting of IFN gamma-1 beta treatment or having laser surgery. RESULTS: Topical IFN gamma-1 beta treatment gave a cure rate of 42% independent of IFN dosage as compared to an 89% cure rate with laser therapy (P = 0.02). Patients with CIN II responded better compared with patients with CIN III. Current smokers showed a significantly lower cure rate whereas use of oral contraceptives (OC) did not influence response. High viral load with high risk types of human papillomaviruses (HPV) was associated with a better response.