Results of carbon dioxide laser therapy and topical 5-fluorouracil treatment for subclinical condyloma found by magnified penile surface scanning. Management of intravaginal warts in women with 5-fluorouracil (1%) in vaginal hydrophilic gel: a placebo-controlled double-blind study. Treatment of men with flat (FC) or acuminata (CA) condylomata with interferon alpha-2a. [Treatment of condyloma acuminatum with 0.5% 5-fluorouracil-solution, A double-blind clinical trial]. 5-Fluorouracil in the treatment of penile and urethral condylomata acuminata.
Previously we demonstrated a 68 per cent recurrence rate for subclinical penile human papillomavirus infections found by magnified penile surface scanning and treated with the carbon dioxide laser. In this report it is shown that the addition of a regimen of adjuvant topical 5-fluorouracil does not lower the recurrence rate. This knowledge combined with the evidence for a subclinical urethral reservoir of human papillomavirus implies that any strictly topical therapy will fail at 4 months of followup and that improved systemic therapy may be needed. The purpose of this placebo-controlled, double-blind study was to determine the safety, tolerability and clinical efficacy of 5-fluorouracil (1%) in a vaginal hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal papillomas in women. Pre-selected, 60 women ranging between 18 and 50 years of age (mean 24.6), having 312 vaginal condylomas (mean 5.2) joined the study. The diagnosis of human papillomavirus (HPV) was established with clinical, histopathological and polymerase chain reaction (PCR) techniques. Subjects were randomized into 2 parallel groups. Each patient was allocated a pre-coded tube 15 g (active or placebo) with graduated vaginal applicators (disposable), and instructions how to insert 4 g of the trial medication deep into the vagina once at bedtime on every other day (1, 3 and 5) per week, to visit the clinic on day 7 for clinical evaluations and to receive the same pre-coded replacement to continue the regimen for another week. A maximum 12 applications were to be used in 4 weeks. Cure was defined as absence of clinical signs of infection, re-confirmed by PCR and Southern blot hybridization negative HPV DNA. By the end of the treatment 48.4% patients and 51.9% lesions were cured. Breaking the code revealed that 5-fluorouracil (1%) gel had cured 83.3% patients and 87% intravaginal warts. Placebo resolved 13.3% patients and 14% condylomas; (active gel versus placebo; P < 0.001). Twelve patients (20%) mostly in the active gel experienced mild erythema, erosion and oedema, with no drop-outs. Among cured patients 3 had a relapse after 16 months. In conclusion, the clinical results of the study demonstrate that 5-fluorouracil (1%) in a vaginal hydrophilic gel is safe, tolerable and significantly more effective than placebo to cure intravaginal warts in women. This study was undertaken to assess the effect of CO2 laser vaporization, 5-fluorouracil 5% (5-FU) topical application and Interferon alpha-2a (IFA alpha-2a) in the treatment of C.A. or F.C. of the male genital tract. From March 1986 to September 1991, 1372 men, sexual partners of women with F.C. or C.A. or cervical intraepithelial neoplasia, were submitted to peoscopy. One thousand and nineteen (74.27%) men presented with various penile lesions caused by HPV (histologically confirmed); of these 505 were treated for C.A. or F.C. or a combination of F.C. and C.A. The best treatment modalities, irrespective of the kind of lesion, were found to be the combination of 5-FU plus IFN alpha-2a (high dose) (98.27%), the combination of CO2 laser vaporization plus 5-FU plus IFN alpha-2a (high dose) (93.93%) and the combination of CO2 laser vaporization plus 5-FU (87.23%). In conclusion we believe that IFN alpha-2a can be used with excellent results as first line treatment in combination with CO2 laser vaporization or/plus 5-FU in patients with C.A. or F.C. or combined condylomata. 30 males and 29 females with condyloma acuminatum took part in a double-blind randomized trial with 0,5% 5-fluorouracil (5-FU) salicylic acid containing varnish for warts versus the varnish without 5-FU. The females were treated twice weekly at the clinic, the males were treated once daily at home by themselves. The 5-FU solution was found significantly superior to placebo (P less than 0,01). 60% of the 5-FU treated patients were healed with a median healing time of two weeks in the males and three weeks in the females. In the placebo group 27,6% healed with a median healing time of 2,5 weeks (males) an 3,5 weeks (females). Blood tests obtained before and after the trial were normal. Patch tests with 0,5% 5-FU revealed no sensitization after the therapy. 5-Fluorouracil (5-FU) cream was compared with podophyllin 25 percent in alcohol for treating genital and urethral condylomata acuminata. The cure rate after four weeks was found to be 6 of 18 patients treated with 5-FU and 10 of 19 treated with podophyllin. By changing the treatment for those not cured, warts regressed after four weeks in four more patients in each group. Patients were followed up for four to nine months; 10 of 27 treated with 5-FU and 14 of 31 treated with podophyllin remained in remission. It is not possible to support earlier reports on the successful treatment of meatal warts using 5-FU cream. More than half of the patients given 5-FU reported side effects after 10 to 14 days' treatment, which in some cases led them to stop using the cream. Twenty-one men considered to be treatment failures or relapses were examined by urethroscopy. No intraurethral condylomata were found but three cases of warts in the fossa navicularis were doscovered; this prompted us to introduce an instrument to examine the urethral meatus and the fossa navicularis.
The reviewed trials were highly variable in methods and quality, and the evidence provided by these studies was weak. Cure rates with several treatments were variable, and although 5-FU presents therapeutic results that are inferior to those seen with 5-FU + Inf α-2a (high dose) and 5-FU + CO2 Laser + Inf α-2a (high dose), the treatment should not be abandoned. Topical treatment with 5-FU has a therapeutic effect; however, the benefits and risks have not been determined clearly and further studies are needed.