A randomized trial of laser vaporization in the management of cervical intraepithelial neoplasia associated with human papilloma virus infection.

A randomized controlled trial was carried out at colposcopy clinics in the Birmingham and Midland Hospital for Women, to determine the efficacy of laser vaporization in the management of cervical Human Papilloma Virus (HPV) infection occurring alone or in association with cervical intraepithelial neoplasia (CIN), and to study the natural history of these lesions. The subjects were 365 women referred for investigation of cytological abnormality who were found to have histological evidence of HPV infection alone or in association with CIN1 or CIN2 and were considered suitable for local destructive treatment. The intervention consisted of immediate treatment using a carbon dioxide laser or no treatment. Women in both groups were followed by cytological and colposcopic examinations at intervals of four months. Twelve months after randomization, 25 per cent of women in the non-treatment group had progressed to a more severe degree of histological abnormality compared with 4 per cent in the treatment group (95 per cent confidence interval (CI) for difference in proportion 14-28 per cent). Spontaneous regression of cytological abnormality occurred in 26 per cent (95 per cent CI 19-33 per cent) of untreated women. It is concluded that the short-term efficacy of laser vaporization in the treatment of these lesions has been established. The substantial rate of spontaneous regression suggests, however, that intervention is frequently unnecessary.

RCT Entities:   Population Interventions Outcomes