Abstract
The purpose of this double-blind, placebo-controlled, comparative study was to evaluate the specific clinical efficacy and tolerance of human leukocyte interferon-α (2×l06 IU/g) and podophyllotoxin 0.5% incorporated in a hydrophilic cream to cure genital warts. Preselected Asian women (n=60) aged 18–40 years (mean 22.9), with a clinical and biopsy-confirmed diagnosis of genital warts, harboring 322 lesions (mean 5.36) were randomly assigned to three parallel groups to receive one of the two test drugs or placebo. Each patient received a preceded tube (40 g) containing either human leukocyte interferon-α, podophyllotoxin, or identically appearing placebo cream for 3 days' usage. In addition to written instructions, each subject was shown how to apply a minimal amount of trial medication on their lesions thrice daily for 3 consecutive days per week (maximum nine topical applications per week). Patients were examined on a weekly basis, and a cure was considered to be a biopsy-confirmed, total elimination of a lesion. Moreover, patients cured during the study period were spared further therapy, and were requested to return in 16 weeks to monitor for the occurrence of a relapse. The remaining patients' empty tubes were collected, and similarly precoded replacement tubes were given to continue the treatment; a total of 214 tubes were used. The study was scheduled for 16 weeks with 4 weeks of active treatment. Individuals were excluded from the study due to pregnancy, breast feeding, or the receiving of any type of antiviral therapy during the 4 weeks preceding enrollment. Better results were obtained with leukocyte interferon-α cream than with podophyllotoxin both in terms of the number of cured patients (18/20 vs. 12/20, or 90% vs. 60%; P<0.0285) and the number of eliminated lesions (105/110) vs. 87/108, or 95.5% vs. 80.5%; P<0.001. In the placebo group 4/20 (20%) patients were cured, indicating lower results. Out of the 60 patients 51 (85%) complained of no drug-related symptomatic side effects. However, the most frequent nonobjective adverse symptoms experienced by the patients were mild tenderness 4/60 (6.6%), burning sensation 3/60 (5%), and transitory increase in body temperature (>38°C) accompanied by headache and itching 2/60 (3.3%). None of the patients suffering from these side effects elected to discontinue the study. The patients were evaluated for 1 year after the initial visit, and among the 34/60 (56.6%) cured patients two had a relapse after 9 months. In conclusion, the clinical results of this study demonstrate that leukocyte interferon-α (2×l06 IU/g) is more efficacious than 0.5% podophyllotoxin and placebo in hydrophilic cream, and substantiates that along with mild, nonobjective, transient, localized, adverse symptoms, human leukocyte α-interferon therapy is more effective and better than podophyllotoxin in cream for curing genital warts in women
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Syed, T.A., Khayyami, M., Kriz, D. et al. Management of genital warts in women with human leukocyte interferon-α vs. podophyllotoxin in cream: a placebo-controlled, double-blind, comparative study. J Mol Med 73, 255–258 (1995). https://doi.org/10.1007/BF00189926
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DOI: https://doi.org/10.1007/BF00189926