Lack of effect of a high-fiber cereal supplement on the recurrence of colorectal adenomas. Phoenix Colon Cancer Prevention Physicians' Network.

The New England journal of medicine
Q1
Apr 2000
Citations:754
Influential Citations:15
Interventional (Human) Studies
83
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Methods
Design: randomized, double-blind, multicenter trial at 22 centers in the Phoenix, AZ area. Participants: men and women aged 40–80 years with one or more histologically confirmed colorectal adenomas removed within 3 months before recruitment; adequate nutritional status; normal renal and liver function; Southwest Oncology Group performance status 0–2. Exclusions: invasive cancer within the previous five years; history of colon resection; two first-degree relatives with adenomas. Run-in period of six weeks; 1429 randomized; 1303 completed.
Intervention
Daily wheat-bran fiber supplement delivered as cereal: high-fiber dose 13.5 g/day; low-fiber dose 2 g/day; duration about 3 years (median time to last colonoscopy 34 months for high-fiber, 36 months for low-fiber). Mid-study, fiber bars were introduced delivering high-fiber bars (~10 g) and low-fiber bars (~4 g); up to 25% of daily fiber could come from bars after year 2.
Results
Among 1303 completers, 338/719 (47.0%) in the high-fiber group and 299/584 (51.2%) in the low-fiber group had at least one recurrent adenoma. Multivariate-adjusted odds ratio for recurrence with high-fiber vs low-fiber: 0.88 (95% CI 0.70–1.11; P=0.28). No significant differences in recurrence after one year, nor in number, size, location, or histology of recurrent adenomas. Adverse events were similar. Conclusion: Wheat-bran fiber supplementation did not protect against recurrence of colorectal adenomas; results do not support using wheat-bran fiber for this purpose; possible explanations include insufficient total fiber intake or insufficient follow-up duration.
Limitations
Compliance with high-fiber supplementation declined over time (74% >75% intake by year 3 vs 84% in low-fiber); mid-study change from 1:1 to 4:1 randomization; baseline lifestyle imbalances (tobacco, alcohol, fat intake); total dietary fiber intake may have been insufficient; median follow-up of ~3 years may be too short to observe an effect.

Abstract

BACKGROUND The risks of colorectal cancer and adenoma, the precursor lesion, are believed to be influenced by dietary factors. Epidemiologic evidence that cereal fiber protects against colorectal cancer is equivocal. We conducted a randomized trial t...