Abstract
OBJECTIVE: To compare intravaginal 5-fluorouracil (5-FU) and placebo for the treatment of cervical and/or vaginal human papillomavirus (HPV). METHODS: A randomized, placebo-controlled trial was performed. Women with HPV detected visually or by Papanicolaou (Pap) test and confirmed by colposcopic biopsy were randomized to receive either intravaginal 5-FU cream or an intravaginal placebo cream. Women with cervical or vaginal intraepithelial neoplasia were excluded. The primary outcome measure was cytologic regression of HPV as determined by Pap test screening 4 to 6 months after treatment. The secondary outcome was cytologic evidence of disease progression at both the 4-6-month and 12-month follow-up evaluations. Data were analyzed using the Chi square test with significance established at P < 0.05. RESULTS: A total of forty patients were randomized, and thirty patients had a follow-up Pap test 4 to 6 months after treatment. Of those patients treated with 5-FU, 28% demonstrated regression of HPV on cytologic evaluation, compared with 69% of those treated with placebo (P < 0.05). Twelve-month follow-up cytology was available from 18 of the study participants. There were no significant differences in the frequency of cytologic progression or regression between groups at 12 months. CONCLUSION: Four to six months post treatment, the use of intravaginal 5-FU for the treatment of cervical or vaginal HPV is associated with a lower rate of regression than the use of placebo.
Full Text
The Full Text of this article is available as a PDF (307.2 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Bellina J. H. The use of the carbon dioxide laser in the management of condyloma acuminatum with eight-year follow-up. Am J Obstet Gynecol. 1983 Oct 15;147(4):375–378. doi: 10.1016/s0002-9378(16)32228-1. [DOI] [PubMed] [Google Scholar]
- Brodman M., Dottino P., Friedman F., Jr, Heller D., Bleiweiss I., Sperling R. Human papillomavirus-associated lesions of the vagina and cervix. Treatment with a laser and topical 5-fluorouracil. J Reprod Med. 1992 May;37(5):453–456. [PubMed] [Google Scholar]
- Brown M. S., Phillips G. L., Jr Management of the mildly abnormal Pap smear: a conservative approach. Gynecol Oncol. 1985 Oct;22(2):149–153. doi: 10.1016/0090-8258(85)90020-4. [DOI] [PubMed] [Google Scholar]
- Carmichael J. A., Maskens P. D. Cervical dysplasia and human papillomavirus. Am J Obstet Gynecol. 1989 Apr;160(4):916–918. doi: 10.1016/0002-9378(89)90310-4. [DOI] [PubMed] [Google Scholar]
- Dungar C. F., Wilkinson E. J. Vaginal columnar cell metaplasia. An acquired adenosis associated with topical 5-fluorouracil therapy. J Reprod Med. 1995 May;40(5):361–366. [PubMed] [Google Scholar]
- Ferenczy A. Comparison of 5-fluorouracil and CO2 laser for treatment of vaginal condylomata. Obstet Gynecol. 1984 Dec;64(6):773–778. [PubMed] [Google Scholar]
- Husseinzadeh N., Guoth J. G., Jayawardena D. S. Subclinical cervicovaginal human papillomavirus infections associated with cervical condylomata and dysplasia. Treatment outcomes. J Reprod Med. 1994 Oct;39(10):777–780. [PubMed] [Google Scholar]
- Krebs H. B., Helmkamp B. F. Chronic ulcerations following topical therapy with 5-fluorouracil for vaginal human papillomavirus-associated lesions. Obstet Gynecol. 1991 Aug;78(2):205–208. [PubMed] [Google Scholar]
- Krebs H. B. Prophylactic topical 5-fluorouracil following treatment of human papillomavirus-associated lesions of the vulva and vagina. Obstet Gynecol. 1986 Dec;68(6):837–841. [PubMed] [Google Scholar]
- Krebs H. B. Treatment of vaginal condylomata acuminata by weekly topical application of 5-fluorouracil. Obstet Gynecol. 1987 Jul;70(1):68–71. [PubMed] [Google Scholar]
- Malviya V. K., Deppe G., Pluszczynski R., Boike G. Trichloroacetic acid in the treatment of human papillomavirus infection of the cervix without associated dysplasia. Obstet Gynecol. 1987 Jul;70(1):72–74. [PubMed] [Google Scholar]
- Richart R. M. Causes and management of cervical intraepithelial neoplasia. Cancer. 1987 Oct 15;60(8 Suppl):1951–1959. doi: 10.1002/1097-0142(19901015)60:8+<1951::aid-cncr2820601505>3.0.co;2-u. [DOI] [PubMed] [Google Scholar]
- Syrjänen K., Väyrynen M., Saarikoski S., Mäntyjärvi R., Parkkinen S., Hippeläinen M., Castren O. Natural history of cervical human papillomavirus (HPV) infections based on prospective follow-up. Br J Obstet Gynaecol. 1985 Nov;92(11):1086–1092. [PubMed] [Google Scholar]