Randomized placebo-controlled evaluation of intramuscular interferon beta treatment of recurrent human papillomavirus

Objective: To evaluate the effectiveness and safety of interferon beta in w omen with recurrent cervical human papillomavirus (HPV) lesions. Methods: Women with recurrent HPV of the cervix were assigned randomly to r eceived either 3 million IU of interferon beta daily for 5 days, followed b y 2 days of rest for 3 weeks, or placebo on the same schedule (N = 61 in ea ch group). They were evaluated at 6 and 12 months after cytology, colposcop y, and directed punch biopsy. Comparison between groups was carried out by chi (2) Fisher exact test, and Student t test, depending on the variable. M ultivariable logistic regression was used to evaluate influence of variable s to treatment and categorical and continuous variables were compared by Ma ntel-Haenszel and Wilcoxon tests. Results: When treatment success rates for all patients at 6 and 12 months w ere compared, a highly significant statistical difference was found in the treated group compared with the placebo group [48 of 61 (79%) versus 33 of 61 (54%), P = .001, and 43 of 61 (70%) versus 26 of 61 (43%), P = .002, res pectively]. Multivariable analysis showed treatment success rates with inte rferon beta were higher between the group with initial histopathology of ce rvical intraepithelial neoplasia (CIN) (odds ratio 4.86; 95% confidence int erval 1.75, 13.49), and the group receiving placebo (P = .002). Side effect s treatments were minimal in 70% of women; the most severe events were head aches and flulike symptoms that did not interfere with the treatment. No cl inically significant changes were found in laboratory measurements of gluco se or transaminases during treatment or follow-up. Conclusions: Intramuscular injections of interferon beta were effective for treating recurrent HPV lesions, particularly when associated with GIN. The only side effects were mild and controllable. (C) 2001 by The American Col lege of Obstetricians and Gynecologists.