Naik 2006.
Methods | RCT, single centre 13 women randomised |
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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) |
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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 |
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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Incomplete outcome data (attrition bias) All outcomes | High risk | % analysed: 10/13 (77%) "One patient was withdrawn from the study at the 6‐week visit as there was difficulty in obtaining the I3C and two women did not attend the 6‐month review."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 |