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. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD001318. doi: 10.1002/14651858.CD001318.pub2
Methods RCT
Participants 204 women with entire squamo-columnar junction visible
CIN 1 on 2 biopsies 3-6 months apart, CIN 2 or 3 not extending 3 mm into crypts No extension onto vagina or lesion or 12.5 mm into canal
Interventions Cryotherapy
Laser ablation
Outcomes Operators impression of significant peri-operative bleeding >25cc
Women’s subjective opinion of peri-operative pain (mild, moderate severe, Severe being that the woman would not consider the treatment again)
Women’s subjective opinion of post-operative discomfort, heavy discharge, bleeding (none, mild, moderate, severe)
Post operative cervical stenosis
Satisfactory follow-up colposcopy at 3 months
Berget 1991 reports longer follow up for residual disease outcome: residual disease (histological) at 3, 9, 15, 21, 33, 45, 80 months
Notes 103 randomised to laser, 101 randomised to cryotherapy
Laser performed ablated 2 mm lateral to transformation zone to a depth of 5-7mm
Cryo coagulation (double freeze thaw freeze technique) or more if the ice ball did not exceed the probe (25mm) by 4 mm.
Local analgesia was not routinely administered
6 laser and 2 cryotherapy women refused to be followed up
Women were offered repeat treatment with the same method of treatment as part of protocol. 3 laser and 6 cryotherapy women refused repeat treatment
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Not reported, “patients fulfilling the criteria were randomized to either laser or cryo treatment”
Allocation concealment? Unclear Not reported
Blinding?
All outcomes
Unclear Not reported
Incomplete outcome data addressed?
All outcomes
Yes For residual disease:
% analysed: 187/204 (92%)
Laser; 94/103 (91%)
Cryotherapy; 93/101 (92%)
All other outcomes had less loss to follow up
Free of selective reporting? Unclear Insufficient information to permit judgement
Free of other bias? Unclear Insufficient information to assess whether an important risk of bias exists