Cryotherapy for HPV clearance in women with biopsy-confirmed cervical low-grade squamous intraepithelial lesions☆
Received 17 July 2009; received in revised form 18 August 2009; accepted 29 September 2009. published online 05 November 2009.
Abstract
Objective
To compare the clearance rate of HPV infection among women aged older than 30years with biopsy-confirmed cervical low-grade squamous intraepithelial lesions (LSIL) 1year after cryotherapy with the spontaneous clearance rate (observation).
Method
HPV DNA typing by polymerase chain reaction and reverse line blot hybridization were used to identify 14 high-risk types and 23 low-risk types. HPV DNA sequencing was also used for other types.
Result
Between December 2007 and March 2009, 100 women were recruited to the study and 60 cases had positive results on HPV testing. Twenty-nine patients were randomly allocated to the cryotherapy group and 31 to the observation group. At 1year, 89.7% (26/29; 95% CI, 78.6–100%) of the cryotherapy group and 90.3% (28/31; 95% CI, 79.9–100%) of the observation group had negative results on HPV testing (0.6% difference; 95% CI, –15.8 to 14.6%, P=0.94).
Conclusion
Cryotherapy failed to increase the clearance of prevalent HPV infections among women with LSIL, although in both arms the clearance rates were above 80%. However, in coupling with visual inspection with acetic acid as a single visit approach, its effect on prevention of HSIL and cervical cancer is still promising. Therefore, cryotherapy should not be withdrawn from such programs. (ClinicalTrials.gov Identifier: NCT00566579).