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. 2017 Jan 8;2017(1):CD003430. doi: 10.1002/14651858.CD003430.pub2

MacLennan 1995.

Methods Allocation: randomised trial with a 2 x 2 x 2 factorial design
 Blindness: unclear
 Duration: 48 months
Setting: multicenter, Australia
Participants Inclusion criteria: age 30‐74 yrs, ≥ one adenoma, polyp‐free colon post colonoscopy
 Exclusion criteria: IBD, bowel resection, FAP, cancer, medically supervised diet
N = 424*
Sex: % male (monitoring at 24 months/48 months) 66.7/68.0
Age: mean (monitoring at 24 months/48 months) 56.3/55.9 years
 Baseline dietary fibre intake g/d: not reported
 Baseline characteristics similar for each group: yes
Interventions

  1. WBF 25 g /d. N = 193*

  2. No WBF supplement. N = 197*
Outcomes Adenoma recurrence
Adenoma size
Notes Other Interventions arms not used:

  1. Fat reduction to 25% of total energy, baseline counselling by dietician then periodic further counselling

  2. BC 20 mg/d


Control:

  1. Unmodified diet

  2. Placebo capsule daily


*The study randomised 424 participants, however, they did not report the number of participants in each group. Only data from 390 participants were reported with 193 in the WBF group and 197 in the WBF supplement group, respectively. So we conducted the sensitivity analysis based on 390 participants
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomized trial with a 2 x 2 x 2 factorial design, following pre‐randomisation stratification. Randomisation was computerised
Allocation concealment (selection bias) Unclear risk No details
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Described as partially double‐blind but did not state who was blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Described as partially double‐blind but did not state who was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Full reasons for loss to follow‐up not given. High attrition rate (27.8%), 118 participants lost to follow‐up at 48 months
Selective reporting (reporting bias) Low risk All measured outcomes were reported.
Other bias Unclear risk No details