title: A randomised, double-blind, placebo-controlled trial of photodynamic therapy using 5-aminolaevulinic acid for the treatment of cervical intraepithelial neoplasia.
abstract: Photodynamic therapy (PDT) using topical 5-aminolaevulinic acid (ALA) has been used to treat histologically confirmed cervical intraepithelial neoplasia (CIN-I and -I/II) in a randomised, double-blind, placebo-controlled protocol. Fluorescence microscopy revealed that topical application of 3% ALA in Intrasite Gel to the cervix for 3 hr resulted in the accumulation of protoporphyrin IX in the cervical epithelium. Treatment of CIN with ALA-PDT was well tolerated, with only 3/12 patients in the PDT arm (0/13 in the placebo arm) reporting any discomfort during illumination. Histologic examination of the treated tissue following loop excision 3 months post-PDT indicated that 33% of patients had no evidence of CIN, 42% had no change in the grade of their disease, whilst 25% exhibited an apparent progression of disease. In the control group, the respective figures were 31%, 38% and 31%. There was no significant difference in response between the groups receiving ALA-PDT and those receiving placebo treatment.
authors.affiliation: School of Biomedical Sciences, University of Leeds, Leeds, United Kingdom.
authors.forename: Adrian A
authors.initials: AA
authors.lastname: Barnett
authors.forename: J Christoph
authors.initials: JC
authors.lastname: Haller
authors.forename: Fiona
authors.initials: F
authors.lastname: Cairnduff
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Lane
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Brown
authors.forename: David J H
authors.initials: DJ
authors.lastname: Roberts
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000622:Aminolevulinic Acid / Q000627:therapeutic use*; D002584:Cervix Uteri / Q000187:drug effects; D003127:Colposcopy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008856:Microscopy, Fluorescence; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011524:Protoporphyrins / Q000378:metabolism; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D002578:Uterine Cervical Dysplasia / Q000188:drug therapy*
chemical_list: D017319:Photosensitizing Agents; D011524:Protoporphyrins; D000622:Aminolevulinic Acid; C028025:protoporphyrin IX