A randomized trial of efficacy of beta-sitosterol and its glucoside as adjuvant to cryotherapy in the treatment of anogenital warts.

All available treatments for anogenital warts have substantial failure rates. An immunomodulating treatment that enhances the patient's own immunity could be valuable as an adjuvant to conventional methods. About 123 patients were enrolled in this study and were randomized either to undergo only cryotherapy every 3 weeks (n = 60 patients) or to undergo cryotherapy and to receive a mixture containing 20 mg sterol and 0.2 mg sterolin (BSS-BSSG mixture), known for its immunomodulating properties (n = 63). A complete response after 3 months was demonstrated by 18.3% of the patients in the first group and 30.2% of the second group, while 61.7% of the first group and 79.4% of the second group were lesion free at the end of the 6-month follow-up period. Cox regression analysis of the time until response showed a significant advantage to the mixture treatment group (hazard ratio 2.76, 95% confidence interval 1.61-5.67). The study was not placebo controlled. The BSS-BSSG mixture gave promising results as an adjuvant to cryotherapy and may be used in patients with refractory warts.