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. ' 2005 Wiley-Liss, Inc.
The inhibitory effect of n-3 polyunsaturated fatty acids on human colorectal cancer has been speculated on from epidemiological data and animal studies. We conducted a long-term trial of docosahexanoic acid (DHA)-concentrated fish oil capsules for patients in a high-risk group for colorectal cancer. During this trial, we experienced three patients with familial adenomatous polyposis (FAP) diagnosed as having malignant lesions. Three patients with FAP and two patients with multiple (more than 30) colorectal polyps were administered DHA-concentrated fish oil capsules_Hlk427554600[2.2 g of DHA and 0.6 g of eicosapentanoic acid (EPA) per day] for one or two years. Compliance with DHA-concentrated fish oil capsules was more than 90% in four patients and 61% in one patient. A marked increase or decrease in the number of polyps was not observed. Three patients with FAP developed endometrial cancer after 12 months, colon cancer after 24 months and lung cancer after 12 months, respectively. All cancers were diagnosed at an early stage and were resected curatively. We thought that the possibility of developing cancer from the long-term administration of fish oil capsules to patients with FAP needs to be investigated further, and that we should report these cases.
We established a protocol for an interventional randomized controlled trial for prevention of colorectal cancer by attaching special importance to feasibility. The subjects were patients with multiple colorectal tumors. Two regimens were formulated for prevention of colorectal cancer. One was dietary guidance alone (Regimen I), and the other was dietary guidance plus eating wheat bran biscuits (Regimen II). The main end points of the trial were examinations for recurrence of colorectal tumors after 2 and 4 years. The target number of patients was 200 in total, i.e. 100 for each group. During the 18 months from the beginning of recruiting of subjects (up to November 1994), 28 (97%) of the 29 patients recruited for Regimen I and 32 (97%) of the 33 patients recruited for Regimen II agreed to participate in the trial. The trial is progressing well.
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