A randomized clinical trial of beta carotene vs placebo for the treatment of cervical HPV infection

The objective of the study was to determine if oral beta carotene would improve abnormalities observed in Papanicolaou smears or reduce the amount of HPV DNA in genital samples. A randomized double blind placebo controlled trial was designed for 117 women with abnormal cervical morphology, not undergoing laser ablative therapy, at The Royal Women's Hospital, Victoria. Thirty milligrams of oral beta carotene were administered daily for 12 months. Post-intervention cervical cytology and the amount of HPV DNA present on tampon specimens as determined by polymerase chain reaction and Hybrid Capture were the main outcome measures. After 12 months therapy there was no difference between the beta carotene and placebo groups in Papanicolaou smear results (58% and 62% normal) and HPV positivity (42% and 46% positive) (P>0.86). Women taking beta carotene were not more likely to have improved cervical cytology or a decrease in the amount of HPV DNA (P>0.2). The median post-intervention beta carotene level was 0.63 μm ml^-1 (range 0.04-1.6) for the beta carotene group and 0.15 μm ml^-1 (range 0.02-1.51) for the lecithin group (P<0.0001). This clinical trial did not identify a beneficial effect of 30 mg of oral beta carotene on cervical cytology, or on the amount of HPV DNA present from tampon specimens.