A prospective study of biopsy-confirmed cervical intraepithelial neoplasia grade 1: colposcopic, cytological, and virological risk factors for progression.

OBJECTIVES: The objective of this prospective study of histologically confirmed cervical intraepithelial neoplasia (CIN) (including equivocal CIN1) was to determine risk factors for progression to histologically confirmed CIN3, particularly human papillomavirus (HPV) types and cofactors. We postulated that HPV DNA positivity would be a strong, prospective risk factor for progression. MATERIALS AND METHODS: Possible participants were referred with an abnormal cytological diagnosis of CIN1 or lower-grade disease or external genital warts. Women with histologically confirmed CIN1 (including koilocytotic atypia) or equivocal CIN1 were eligible for follow-up. Of these, 163 women were assessed every 3 months (if a lesion were present) or every 6 months (if a lesion regressed colposcopically during the course of the study), for up to 52 months. Progression was defined histologically, whereas persistence and regression were defined by combined cytological, colposcopic, and histological assessments. Subjects who progressed to a biopsy-confirmed CIN3 or who developed a lesion that was clinically unsafe to follow up (i.e., because of movement into the endocervical canal), were removed from the study and were treated. RESULTS: A total of 237 patients were evaluated as possible participants. The 74 exclusions at enrollment included 33 patients who had an entry diagnosis of CIN2 to CIN3 or who had lesions that were otherwise already unsafe to follow up, 39 who did not have a lesion on colposcopically directed biopsy, and 2 who were immediately noncompliant. Among the remaining 163 participants, the overall progression rate to histologically confirmed CIN3 was 8%, the persistence rate was 49%, and the regression rate was 43%. All progressions occurred among women who were HPV DNA-positive and had colposcopically immature abnormal transformation zones.

Flashlamp-excited dye laser therapy of idiopathic vulvodynia is safe and efficacious.

OBJECTIVE: The management of chronic vulvovaginal pain, not explicable on specific histologic grounds, presents a major problem in referral centers for lower genital tract diseases. STUDY DESIGN: This article reports on a two-step protocol in a sample of 175 medical nonresponders, drawn from a 2-year cohort of 725 women with vulvovaginal pain. The first maneuver was the use of a flashlamp-excited dye laser to selectively photocoagulate symptomatic subepithelial blood vessels in 168 women; the second was the microsurgical removal of chronically painful Bartholin's glands in 52 women not responsive or not suited to flashlamp-excited dye laser photothermolysis. RESULTS: Dye laser response rates were independent of whether patients manifested macroscopic foci of painful erythema ("vestibular adenitis") or just colposcopically apparent hyperemia-ectasia of the individual blood vessels ("pruritic papillomatosis") (56% vs 45% after a single surgical procedure; 76% vs 65% after serial retreatment; p not significant). Conversely, response rates were much lower among women in whom pressure on the Bartholin's glands produced sharp, lancinating pain (15% vs 66% after a single surgical procedure; 22% vs 93% after serial retreatment; p < 0.001). Forty-two (85%) of 50 patients with flashlamp-excited dye laser failure had deep pain; however, the impasse to progress was broken by gland removal. Final response rates were 92.5% (complete response 62%; partial response 30%) in the "surface-only" group and 80.3% in the "surface-plus-deep" group (chi 2 = 14.9; p < 0.001). The major complication was acute bacterial cellulitis, occurring in the first postoperative week. Modification of the treatment protocol to include topical antibiotics with an occlusive dressing reduced the cellulitis rate from 17.2% to 2.5%. In four women (1.8%) Koebner-like exophytic condylomas also developed within 1 month of flashlamp-excited dye laser surgery. CONCLUSION: The availability of a safe, efficacious, and relatively noninvasive treatment should reduce the need for resective surgery in most patients with idiopathic vulvodynia.

A double-blind, randomized trial of 0.5% podofilox and placebo for the treatment of genital warts in women.

Patient-applied formulations of 0.5% podofilox (podophyllotoxin) were evaluated for the treatment of external genital warts in a double-blind, placebo-controlled study. Seventy-two women were enrolled and, using a randomized, computer-generated list, assigned to receive either active drug or placebo in a 2:1 ratio. Patients were instructed to apply the medication to their external warts twice each day for 3 consecutive days, followed by 4 days without treatment. This cycle was repeated at weekly intervals for a maximum of 4 weeks (and a minimum of 2 weeks). Patients were evaluated weekly for the first month and then at weeks 6 and 10. The number of warts present was recorded and the overall improvement was assessed. The treated area was examined, the patients were questioned about any adverse effects, and standard hematologic/biochemical studies were conducted. The final results showed that podofilox cleared 74% of the total wart count, compared with an 18% regression in the placebo group (P less than .001). The investigators' assessments of improvement correctly distinguished active drug from placebo at every observation point. Local untoward effects were minor and transient. There was no evidence of systemic effects. It is concluded that patient-applied podofilox is a safe and effective therapy for genital condylomata in women. When available, this drug will simplify the treatment of genital warts by providing a patient-applied alternative therapy.