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

Abstract Introduction: 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. 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). Results: 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). Limitations: The study was not placebo controlled. Conclusion: The BSS–BSSG mixture gave promising results as an adjuvant to cryotherapy and may be used in patients with refractory warts.