1.
Randomized trial of dietary fiber and Lactobacillus casei administration for prevention of colorectal tumors.
Ishikawa, H, Akedo, I, Otani, T, Suzuki, T, Nakamura, T, Takeyama, I, Ishiguro, S, Miyaoka, E, Sobue, T, Kakizoe, T
International journal of cancer. 2005;(5):762-7
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Abstract
The epidemiologic evidence that dietary fiber protects against colorectal cancer is equivocal. No large-scale clinical study of the administration of Lactobacillus casei has been reported. We examined whether dietary fiber and L. casei prevented the occurrence of colorectal tumors. Subjects were 398 men and women presently free from tumor who had had at least 2 colorectal tumors removed. Subjects were randomly assigned to 4 groups administered wheat bran, L. casei, both or neither. The primary end point was the presence or absence of new colorectal tumor(s) diagnosed by colonoscopy after 2 and 4 years. Among 380 subjects who completed the study, 95, 96, 96 and 93 were assigned to the wheat bran, L. casei, both and no treatment groups, respectively. Multivariate adjusted ORs for occurrence of tumors were 1.31 (95% CI 0.87-1.98) in the wheat bran group and 0.76 (0.50-1.15) in the L. casei group compared to the control group. There was a significantly higher number of large tumors after 4 years in the wheat bran group. The occurrence rate of tumors with a grade of moderate atypia or higher was significantly lower in the group administered L. casei. No significant difference in the development of new colorectal tumors was observed with administration of either wheat bran or L. casei. However, our results suggest that L. casei prevented atypia of colorectal tumors.
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[Interventional trial for colorectal cancer prevention in Osaka].
Ishikawa, H
Gan to kagaku ryoho. Cancer & chemotherapy. 2000;(8):1185-90
Abstract
We established a protocol for an interventional randomized controlled trial for the prevention of colorectal tumors, in which special importance was attached to practicality. The subjects are patients with multiple colorectal tumors, who form a high risk group for colorectal cancer. Two regimens were formulated for the prevention of colorectal cancer. One was dietary guidance alone (Regimen I), and the other was dietary guidance plus the ingestion of wheat bran biscuits (Regimen II). One of the two regimens is assigned at random each week in advance, and the patients are recruited to receive the regimen of the week in which they are first examined, after giving informed consent. The dietary guidance aims to restrict the energy intake of oil and fat to 18-22% of the total energy intake. Biscuits with a wheat bran content of 30% by weight, which we developed, were prescribed at 25 g/day (7.5 g/day as wheat bran). The main end points of the trial were examinations for recurrence of colorectal tumors after 4 years. The target number of patients is 200 in total, i.e., 100 for each group. The recruiting of subjects was started in June, 1993, and finished in September, 1997; 100 (90%) of 115 patients recruited for Regimen I and 100 (88%) of 116 patients recruited for Regimen II consented to participate in the trial. No severe adverse effects have been reported, and the trial is progressing well. The trial will be completed in September, 2001, when the 4-year follow-up of the last patient will end.