Folic acid for the prevention of colorectal adenomas: a randomized clinical trial.

Study answer

What this study found

Folic acid did not reduce colorectal adenoma recurrence and overall showed no clear benefit, with some outcomes suggesting possible harm. In the first 3-year follow-up interval, any adenoma occurred in 44.1% of the folic acid group versus 42.4% of placebo (RR 1.04, 95% CI 0.90-1.20; P=.58), and advanced lesions occurred in 11.4% versus 8.6% (RR 1.32, 0.90-1.92; P=.15). In the later interval, advanced lesions were more frequent with folic acid (11.6% vs 6.9%; RR 1.67, 1.00-2.80; P=.05), and multiple adenomas were also higher (9.9% vs 4.3%; RR 2.32, 1.23-4.35; P=.02). Overall adenoma rate was…

Study & population

Randomized, double-blind, placebo-controlled multicenter trial in adults with a prior history of colorectal adenomas after a qualifying colonoscopy and safety screening.

Intervention

Oral folic acid 1 mg/day versus matching placebo, taken daily for a planned 3-year treatment period.

Key limitation

Interpretation is limited by relatively few advanced lesion events and subgroup analyses, which reduce precision for detecting benefit or harm.

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Original abstract