TY - JOUR
T1 - Effects of β-carotene and other factors on outcome of cervical dysplasia and human papillomavirus infection
AU - Romney, Seymour L.
AU - Ho, Gloria Y.F.
AU - Palan, Prabhudas R.
AU - Basu, Jayasri
AU - Kadish, Anna S.
AU - Klein, Sara
AU - Mikhail, Magdy
AU - Hagan, Robert J.
AU - Chang, Chee Jen
AU - Burk, Robert D.
N1 - Funding Information:
This study was supported by Public Health Service Grant R01CA53818 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and EDT-9 from the American Cancer Society. G. Y. F. Ho and R. D. Burk are recipients of Junior Faculty Research Award and Faculty Research Award, respectively, from the American Cancer Society. The authors thank Dr. Hemmige Bhagavan at Hoffmann–LaRoche Inc. for providing the β-carotene and placebo capsules, and Mr. Andrew Fusina and Ms. Leslie Snyder for their technical help in HPLC analyses.
PY - 1997/6
Y1 - 1997/6
N2 - 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.
AB - 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.
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U2 - 10.1006/gyno.1997.4697
DO - 10.1006/gyno.1997.4697
M3 - Article
C2 - 9190980
AN - SCOPUS:0031172861
SN - 0090-8258
VL - 65
SP - 483
EP - 492
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -