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Randomised controlled trial and economic evaluation of podophyllotoxin solution, podophyllotoxin cream, and podophyllin in the treatment of genital warts
  1. C J N Lacey1,
  2. R L Goodall2,
  3. G Ragnarson Tennvall3,
  4. R Maw4,
  5. G R Kinghorn5,
  6. P G Fisk6,
  7. S Barton7,
  8. I Byren8,
  9. For The Perstorp Pharma Genital Warts Clinical Trial Group*
  1. 1Imperial College of Science, Technology, and Medicine, London, UK
  2. 2Medical Research Council Clinical Trials Unit, London, UK
  3. 3IHE, The Swedish Institute for Health Economics, Lund, Sweden
  4. 4Department of GU Medicine, Royal Victoria Hospital, Belfast, Northern Ireland, UK
  5. 5Department of GU Medicine, Royal Hallamshire Hospital, Sheffield, UK
  6. 6Department of GU Medicine, Leicester Royal Infirmary, Leicester, UK
  7. 7Department of GU Medicine, Chelsea and Westminster Hospital, London, UK
  8. 8GU Medicine Clinic, Radcliffe Infirmary, Oxford, UK
  1. Correspondence to:
    Dr C J N Lacey, Faculty of Medicine, Imperial College of Science, Technology and Medicine, Norfolk Place, London W2 1PG, UK;


Objectives: To evaluate the efficacy and cost effectiveness of self applied podophyllotoxin 0.5% solution and podophyllotoxin 0.15% cream, compared to clinic applied 25% podophyllin in the treatment of genital warts over 4 weeks.

Methods: We conducted a randomised controlled trial in 358 immunocompetent men and women with genital warts of 3 months’ duration or less.

Results: In the principal analysis both podophyllotoxin solution (OR 2.93, 95% CI 1.56 to 5.50) and podophyllotoxin cream (OR 1.97, 95% CI 1.04 to 3.70) were associated with significantly increased odds of remission of all warts compared to podophyllin. We performed two further analyses. When subjects defaulting from follow up were assumed to have been cured odds of remission of all warts were also significantly increased both for podophyllotoxin solution (OR 3.04, 95% CI 1.68 to 5.49) and for podophyllotoxin cream (OR 2.46, 95% CI 1.38 to 4.40). When subjects defaulting from follow up were assumed not to have been cured odds of remission of all warts were significantly increased for podophyllotoxin solution (OR 1.92, 95% CI 1.13 to 3.27), but not for podophyllotoxin cream (OR 1.17, 95% CI 0.69 to 2.00). Local side effects were seen in 24% of subjects, and recurrence of warts within 12 weeks of study entry in 43% of all initially cleared subjects, without statistically significant differences between the treatment groups. Direct, indirect, and total costs were similar across the three treatment groups. Podophyllotoxin solution was the most cost effective treatment, followed by podophyllotoxin cream, with podophyllin treatment being the least cost effective.

Conclusions: Self treatment of anogenital warts with podophyllotoxin showed greater efficacy and cost effectiveness than clinic based treatment with podophyllin.

  • genital warts
  • podophyllotoxin
  • podophyllin

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