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. 2016 Jan 5;2016(1):CD011837. doi: 10.1002/14651858.CD011837.pub2

Naik 2006.

Methods RCT, single centre
13 women randomised
Participants Age: mean 44.6 years, range: 26 to 63
VIN grade: all 13 high‐grade
Smoking: smokers (n = 9), non‐smokers (n = 3)
HPV status: not documented
Recurrent disease: not reported
Focality: unifocal (n = 9), multifocal (n = 3)
Interventions Oral indole‐3‐carbinol: 200 mg/day versus 400 mg/day for 6 months
Outcomes Response to treatment: 6 weeks, 12 weeks and 6 months
Urine: 2‐hydroxyestrone:16‐alpha‐hydroxyestrone ratio
Symptom improvement
Side effects
Notes Vitamin C was commenced at the discretion of the investigator
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk % analysed: 10/13 (77%)
"One patient was withdrawn from the study at the 6‐week visit as there was difficulty in obtaining the I3C and two women did not attend the 6‐month review."
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists
Overall risk High risk Insufficient information