A randomised controlled trial evaluating a novel cytotoxic drug delivery system for the treatment of cervical intraepithelial neoplasia

Objective To investigate the efficacy of a novel method for the treatment of cervical intraepithelial neoplasia. A cytotoxic drug delivery system using a bilaminar bioadhesive polymeric film was applied directly to the cervix. This cytotoxic drug delivery system allowed the dose, the site and the duration of application of the cytotoxic drug (5-fluorouracil) to be controlled. Design A prospective, double-blind randomised controlled trial. Setting The Departments of Obstetrics and Gynaecology and Pathology of Belfast City Hospital and The Queen's University of Belfast, and the Department of Pharmacy of The Queen's University of Belfast. Participants One hundred and four patients who had been referred to the colposcopy outpatient clinic because of abnormal cervical cytology were recruited into the trial. They were assessed colposcopically and biopsies for histopathology were obtained. Only patients with cervical intraepithelial neoplasia lesions Grades 1 and 2 were recruited. Interventions All patients were re-assessed one, three, and six months after application of the cytotoxic drug delivery system by colposcopy. Clinical endpoints were noted. Main outcome measures Pre-treatment histopathological biopsy results were compared with those obtained after treatment. Results The cytotoxic drug delivery system fulfilled the requirements for treatment of cervical intraepithelial neoplasia without causing any architechtural damage, but the chemotherapeutic agent, 5-fluorouracil, did not provide effective treatment of disease. Conclusions This study showed that the delivery system was effective, and further studies using this mechanism are now possible.