1. In this randomized controlled trial, women in the 5-FU group were more likely to have regression of disease and negative HPV status at 6 months.
2. Women in the 5-FU group reported minimal side effects and high levels of satisfaction with their treatment.
Evidence Rating Level: 2 (Good)
Study Rundown: This study found that intravaginal 5% 5-fluorouracil (5-FU) is effective in promoting regression of cervical intraepithelial neoplasia-2 (CIN-2) and clearance of HPV. Prior studies have identified topical 5-FU as an effective therapy for preventing recurrence after excisional therapies in HPV-positive women. Current recommendations endorse expectant management of CIN-2, despite the fact that most cases persist or progress to CIN-3. The findings of this study support the use of topical 5-FU as an adjunct, and more proactive option, than watchful waiting of CIN-2.
Results are limited by a small sample size of 56 patients and may be confounded by mandatory dual contraception in the 5-FU group, as condom usage can reduce the risk of infection with different HPV strains. Additionally, actual contraception use was not assessed. Future studies might explore adherence to and efficacy of topical 5-FU treatment in a larger sample to determine whether the results presented here are reproducible.
Study Author, Dr. Lisa Rahangdale, MD, MPH, talks to 2 Minute Medicine: University of North Carolina, Director, NC Women’s Hospital Dysplasia Clinic, Associate Professor, Department of Obstetrics and Gynecology.
“Cervical dysplasia management recommendations have changed significantly over the last decade. Physicians are managing a paradigm shift where the expectation is to observe more women, lengthen surveillance windows and treat less. This study submits evidence that a patient-controlled medical option for therapy of cervical disease is desired, effective and safe.”
In-Depth [randomized controlled trial]: This study assessed the efficacy of intravaginal 5% 5-FU (n=31) as compared to observation (n=29), the current standard of care, in treating CIN-2 in women ages 18-29. Outcomes evaluated were regression of disease and HPV status at 6 months, pathology at 12 months, and safety and acceptability of 5-FU treatment.
At 6 months, women treated with 5-FU were more likely to have regression of disease (RR 1.62, CI 1.10-2.56) and clearance of HPV (RR 2.14, CI 1.07-5.37). Among the women evaluated at 12 months, those in the 5-FU group were more likely to have normal colposcopy results (45.0% vs. 25.0%). Overall, 48% of women in the 5-FU group reported side effects such as discharge and irritation but 83% reported satisfaction with treatment.
By Denise Pong, MPH and Leah Hawkins, MD, MPH
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