Efficacy of inosine pranobex oral therapy in subclinical human papillomavirus infection of the vulva: a randomized double-blinded placebo controlled study

Int J STD AIDS. 1996 Jul;7(4):276-80. doi: 10.1258/0956462961917960.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Inosine Pranobex / administration & dosage
  • Inosine Pranobex / adverse effects
  • Inosine Pranobex / therapeutic use*
  • Middle Aged
  • Papillomaviridae*
  • Papillomavirus Infections / drug therapy*
  • Pruritus Vulvae / drug therapy
  • Tumor Virus Infections / drug therapy*
  • Vulva / virology


  • Antiviral Agents
  • Inosine Pranobex