A randomised, double-blind, placebo-controlled trial of photodynamic therapy using 5-aminolaevulinic acid for the treatment of cervical intraepithelial neoplasia.
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.
Barnett
Adrian A
AA
School of Biomedical Sciences, University of Leeds, Leeds, United Kingdom.
Haller
J Christoph
JC
Cairnduff
Fiona
F
Lane
Geoffrey
G
Brown
Stanley B
SB
Roberts
David J H
DJ
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*
D017319:Photosensitizing Agents; D011524:Protoporphyrins; D000622:Aminolevulinic Acid; C028025:protoporphyrin IX