Effects of β-carotene and other factors on outcome of cervical dysplasia and human papillomavirus infection

Seymour L. Romney, Gloria Y.F. Ho, Prabhudas R. Palan, Jayasri Basu, Anna S. Kadish, Sara Klein, Magdy Mikhail, Robert J. Hagan, Chee Jen Chang, Robert D. Burk

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82 Scopus citations


Women with histopathologically confirmed cervical intraepithelial neoplasia (CIN) were followed at 3-month intervals in a randomized double- blinded trial to evaluate the efficacy of β-carotene to cause regression of CIN. Questionnaire data, plasma levels of micronutrients, and a cervicovaginal lavage for human papillomavirus (HPV) detection were obtained at each visit, and an endpoint biopsy was performed at 9 months. Sixty-nine subjects had a biopsy endpoint evaluation; 9 of 39 (23%) subjects in the β- carotene group versus 14 of 30 (47%) in the placebo group had regression of CIN (P = 0.039). Independent risk factors for persistent CIN at 9 months included type-specific persistent HPV infection (OR = 11.38, P = 0.006) and continual HPV infection with a high viral load (OR = 14.25, P = 0.007) at baseline and 9 months, an initial diagnosis of ≤CIN II (OR = 6.74, P = 0.016), and older age (OR for ≤25 years = 4.10, P = 0.072). After controlling for these factors, the β-carotene and placebo groups did not differ in risk for having CIN at 9 months (OR = 1.53, P = 0.550). Resolution of baseline HPV infection was significantly correlated with non-high-risk HPV types (RR = 2.94, P = 0.015), age <25 years (RR = 2.62, P = 0.014), and douching after sexual intercourse (RR = 3.02, P = 0.012), but not with randomization group. Our data indicate that a large proportion of mild CIN lesions regress; age and HPV infection play an important role in the natural course of CIN; and repeated HPV testing may have a value in distinguishing women who need aggressive treatment for CIN versus those who do not. Supplementation of β-carotene does not appear to have a detectable benefit in treatment of CIN.

Original languageEnglish
Pages (from-to)483-492
Number of pages10
JournalGynecologic Oncology
Issue number3
StatePublished - Jun 1997
Externally publishedYes


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