Human Leukocyte Interferon-Alpha versus Podophyllotoxin in Cream for the Treatment of Genital Warts in Males

Abstract

Background: The incidence of overt genital warts, a common sexually transmitted disease of high prevalence, has been on the rise for the last few years. The infection is caused by several types of human papillomaviruses (HPVs), some of which have been accepted as a factor in the pathogenesis of genital squamous-cell carcinomas. Objective: The aim of this double-blind, placebo-controlled study was to compare and evidence differences in clinical efficacy and tolerance between human leukocyte interferon-α (2 × 10⁶ IU/g) and podophyllotoxin (0.5%), incorporated in a hydrophilic cream base to cure genital warts in Asian males. Methods: Sixty patients, circumcised, who ranged in age from 18 to 40 years (mean 25.0), diagnosed with the evidence of penoscopy and HPV DNA (Southern dot blot) as harboring396 lesions (mean 6.6), were randomized to three parallel groups. Each subject was allocated a precoded tube (40 g) containing one of two trial preparations or matching placebo for 3 days’ (consecutive) usage, thrice daily. The study lasted 16 weeks with 4 weeks of active treatment. The patients were examined on a weekly basis, and a clinically and HPV-DNA-confirmed total regression of lesions was recorded as cured. Patients cured during the treatment were spared further therapy and were requested to visit us as scheduled for poststudy follow-up. Results: Findings indicated that patients treated with leukocyte interferon-α cream had shown comparatively better results than the podophyllotoxin-treated group (90 vs. 55%, p < 0.0285) or the placebo group (15%). Mild and transient localized erythema (8.3%), burning sensation (6.6%) and transitory increase in body temperature ( > 38 °C; 6.6%) were the most frequent adverse symptoms with no dropout. The study was followed up for 1 year, and out of 32/60 (53.3%) cured patients 3 had a relapse after 10 months. Conclusion: Leukocyte interferon-α (2 × 10⁶ IU/g) has shown comparatively better results than 0.5% podophyllotoxin and placebo in a hydrophilic cream base, thus leukocyte interferon-α in cream may provide an alternative and effective regimen to treat genital warts in males.

Meta-Analysis of 5% Imiquimod and 0.5% Podophyllotoxin in the Treatment of Condylomata Acuminata

“…After screening the titles, 129 articles seemed related to our question. After eliminating the duplicate articles and obviously irrelevant studies by reading the abstracts, 16 full texts [8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23] met the predefined criteria for inclusion. We excluded one open label study [20] and 3 studies [21,22,23] which were different versions of the study by Edwards et al [9].…”

“…Five of them were multicentre [9, 11, 15, 18, 21], 3 compared 5% imiquimod [8,9,10] with placebo and 9 compared 0.5% podophyllotoxin with placebo [11,12,13,14,15,16,17,18,19]. Of the 9 trials in which 0.5% podophyllotoxin was used, 3 used cream or gel preparations, 5 used solution preparations, and 1 used both cream and solution preparations.…”

CO₂ Laser Surgery for Extensive, Cauliflower-Like Anogenital Condylomata acuminata: Retrospective Long-Term Study on 19 HIV-Positive and 45 HIV-Negative Men

“…Several randomized controlled trials have investigated the impact of adjuvant interferon after surgical ablation of CA [20]. The majority of these trials have found a benefit, which did not always reach the level of statistical significance [16, 17, 21, 22, 23]. The modest impact on the recurrence rates, the route of administration and the relatively high cost prevented interferon to become a routine modality in the treatment of CA.…”

A comprehensive review on the phytochemical and pharmacological aspects of Podophyllum hexandrum: a high value medicinal plant

“…The aqueous extract of Podophyllum peltatum has showed strong antiviral activity [28] and podophyllotoxin was found to be the most active component in inhibiting the replication of measles and herpes simplex type I virus [29,30]. Podophyllotoxin has also been used as an antiviral agent against human Papilloma virus (HPV) that causes condyloma acuminatum [31] Radioprotection Podophyllum hexandrum extract can arrest the cell division and therefore has the potential to act as radioprotectant.…”