Short communication: Oral inosiplex in the treatment of cervical condylomata acuminata: a randomised placebo-controlled trial
Article first published online: 25 AUG 2006
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 113, Issue 9, pages 1088–1091, September 2006
How to Cite
Georgala, S., Katoulis, A., Befon, A., Georgala, C. and Rigopoulos, D. (2006), Short communication: Oral inosiplex in the treatment of cervical condylomata acuminata: a randomised placebo-controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 113: 1088–1091. doi: 10.1111/j.1471-0528.2006.01041.x
- Issue published online: 25 AUG 2006
- Article first published online: 25 AUG 2006
- Accepted 20 June 2006.
- Genital warts;
- human papillomavirus;
- inosine pranobex;
- systemic therapy;
Conventional therapies for human papillomavirus infection aim to remove clinically apparent lesions, while latent infection may remain, representing a threat for transmission and carcinogenesis. The use of a systemic agent may more effectively control the virus. We conducted a randomised placebo-controlled study to investigate the efficacy and safety of oral inociplex in the treatment of cervical condylomata acuminata (CA) that had been resistant to conventional therapies. Thirty-eight white European women, aged 20–43 years, with genital warts of the cervix, refractory to at least one conventional therapy, were randomly assigned to receive either inosiplex, 50 mg/kg daily peros for 12 weeks (group 1), or placebo (group 2). Of the 17 evaluable group 1 women, 4 responded to the treatment completely, 7 responded partially and 6 did not respond. Of the 19 group 2 women, none responded to the treatment completely, 3 responded partially and 16 did not respond. The therapeutic difference between women receiving active and placebo therapy was statistically significant (χ2= 6.69, P < 0.01) and remained significant when an intention-to-treat analysis was performed (χ2= 7.69, P < 0.01). None of the complete responders experienced recurrence during the 12-month follow up. Adverse effects were mild and resolved upon completion of therapy. Compared with placebo, inosiplex showed considerable efficacy with insignificant and reversible adverse effects and without recurrences. Inosiplex may represent an efficacious and safe alternative systemic form of therapy for cervical genital warts.