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document
Calcium and fibre supplementation in prevention of colorectal adenoma recurrence : a randomised intervention trial . European Cancer Prevention Organisation Study Group . BACKGROUND Some epidemiological studies have suggested that high dietary intake of calcium and fibre reduces colorectal carcinogenesis . Available data are not sufficient to serve as a basis for firm dietary advice . We undertook a multicentre randomised trial to test the effect of diet supplementation with calcium and fibre on adenoma recurrence . METHODS We randomly assigned 665 patients with a history of colorectal adenomas to three treatment groups , in a parallel design : calcium gluconolactate and carbonate ( 2 g elemental calcium daily ) , fibre ( 3.5 g ispaghula husk ) , or placebo . Participants had colonoscopy after 3 years of follow-up . The primary endpoint was adenoma recurrence . Analyses were by intention to treat . FINDINGS 23 patients died , 15 were lost to follow-up , 45 refused repeat colonoscopy , and five developed severe contraindications to colonoscopy . Among the 552 participants who completed the follow-up examination , 94 stopped treatment early . At least one adenoma developed in 28 ( 15.9 % ) of 176 patients in the calcium group , 58 ( 29.3 % ) of 198 in the fibre group , and 36 ( 20.2 % ) of 178 in the placebo group . The adjusted odds ratio for recurrence was 0.66 ( 95 % CI 0.38-1.17 ; p=0.16 ) for calcium treatment and 1.67 ( 1.01-2.76 , p=0.042 ) for the fibre treatment . The odds ratio associated with the fibre treatment was significantly higher in participants with baseline dietary calcium intake above the median than in those with intake below the median ( interaction test , p=0.028 ) INTERPRETATION Supplementation with fibre as ispaghula husk may have adverse effects on colorectal adenoma recurrence , especially in patients with high dietary calcium intake . Calcium supplementation was associated with a modest but not significant reduction in the risk of adenoma recurrence .
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Intervention_Pharmacological
Calcium and fibre supplementation
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Intervention_Pharmacological
calcium
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Intervention_Pharmacological
fibre
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Intervention_Pharmacological
diet supplementation with calcium and fibre
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Intervention_Other
calcium gluconolactate and carbonate ( 2 g elemental calcium daily )
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Intervention_Other
fibre ( 3.5 g ispaghula husk )
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Intervention_Control
placebo
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Outcome_Physical
colorectal adenoma recurrence
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Outcome_Physical
severe contraindications to colonoscopy
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Outcome_Adverse-effects
adenoma
4951
Outcome_Physical
recurrence
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Outcome_Physical
odds ratio associated with the fibre treatment
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Outcome_Adverse-effects
adverse effects on colorectal adenoma recurrence
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Outcome_Physical
adenoma recurrence
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Participant_Sample-size
665
4956
Participant_Condition
colorectal adenomas
4957
Participant_Sample-size
23
4958
Participant_Sample-size
15
4959
Participant_Sample-size
45
4960
Participant_Sample-size
five
4961
Participant_Sample-size
552
4962
Participant_Sample-size
94
4963
Participant_Sample-size
28
4964
Participant_Sample-size
176
4965
Participant_Sample-size
58
4966
Participant_Sample-size
198
4967
Participant_Sample-size
36
4968
Participant_Sample-size
178
4969
Participant_Condition
high dietary calcium intake