title: Chemoprevention of cervical cancer with folic acid: a phase III Southwest Oncology Group Intergroup study.
abstract: Several epidemiological reports and experimental investigations have suggested a preventive role for folic acid in the etiology of cervical cancer. The effect of p.o. folic acid supplementation on the natural history of cervical intraepithelial neoplasia (CIN) was evaluated in a multiinstitutional prospective, randomized, double-blind, placebo-controlled trial. Three hundred thirty-one women with biopsy-proven koilocytic atypia, mild CIN, or moderate CIN were randomized to receive oral folic acid (5 mg) or a similar-appearing placebo daily for 6 months following a 1-month run-in placebo period. Colposcopy, Papanicolaou smear, and serum vitamin levels (folate, retinol, alpha-tocopherol, beta-carotene, and retinyl palmitate) were monitored every 3 months. Demographic, medical, dietary, and sexual history data were obtained from personal interviews. The primary end point of the study was improvement in both Papanicolaou smear and colposcopic picture after 3 and 6 months of treatment as compared to the start of treatment. After 6 months of treatment there was no significant difference between the two study groups in the percentage of patients improved. Median serum folate levels in the treatment arm at 3 and 6 months (29.0 and 20.0 micrograms/dl) were significantly higher than those in the placebo arm (7.8 and 7.1 micrograms/dl, respectively). Mean serum levels of retinol, retinyl palmitate, alpha-tocopherol, and beta-carotene did not differ significantly between the two treatment arms. Our data support the conclusion that supplementation with folic acid (5 mg/day) does not enhance the regression of early epithelial abnormalities of the cervix.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: University of Arizona Cancer Center, Tucson, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Childers
authors.forename: J
authors.initials: J
authors.lastname: Chu
authors.forename: L F
authors.initials: LF
authors.lastname: Voigt
authors.forename: P
authors.initials: P
authors.lastname: Feigl
authors.forename: H K
authors.initials: HK
authors.lastname: Tamimi
authors.forename: E W
authors.initials: EW
authors.lastname: Franklin
authors.forename: D S
authors.initials: DS
authors.lastname: Alberts
authors.forename: F L
authors.initials: FL
authors.lastname: Meyskens
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003127:Colposcopy; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D010919:Placebos; D011230:Precancerous Conditions / Q000473:pathology / Q000517:prevention & control; D011446:Prospective Studies; D012074:Remission Induction; D015206:Southwestern United States; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000517:prevention & control*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000517:prevention & control*
chemical_list: D010919:Placebos; D005492:Folic Acid