title: Efficacy of inosine pranobex oral therapy in subclinical human papillomavirus infection of the vulva: a randomized double-blinded placebo controlled study.
abstract: A randomized double-blind placebo controlled study was carried out to assess the efficacy of inosine pranobex (1 g orally 3 times a day for 6 weeks) in the treatment of symptomatic subclinical human papillomavirus infection of the vulva. In a series of 55 women, 22 patients in the inosine pranobex group and 24 patients in the placebo group were suitable for analysis. A total of 14 (63.5%) of the inosine pranobex treated patients and 4 (16.7%) of the placebo treated patients showed significant vulval epithelial morphological improvement (P = 0.005) at 2 months after initiation of treatment. Whereas 13 (59.1%) and 9 (37.5%) patients in the respective groups showed significant improvement in the severity of pruritus vulvae (P = 0.435). Twelve (66.7%) of 18 patients with morphological improvement compared to 10 (35.7%) of 28 patients with no morphological improvement experienced significant symptomatic alleviation of pruritus vulvae (P = 0.041). Similar results were seen at the second assessment 4 months after the initiation of treatment. Adverse drug reactions were reported by 2 patients in the treatment group and by 2 patients (skin rash) in the placebo group. These adverse reactions were mild and self limiting. It is concluded that inosine pranobex demonstrated a significant pharmacological activity in subclinical HPV infection of the vulva and should be considered an alternative treatment for the condition.
authors.affiliation: Singapore General Hospital, Singapore.
authors.forename: S K
authors.initials: SK
authors.lastname: Tay
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007542:Inosine Pranobex / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000188:drug therapy*; D011539:Pruritus Vulvae / Q000188:drug therapy; D014412:Tumor Virus Infections / Q000188:drug therapy*; D014844:Vulva / Q000821:virology
chemical_list: D000998:Antiviral Agents; D007542:Inosine Pranobex