Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.
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Beresford Shirley A A, Johnson Karen C, Ritenbaugh Cheryl, Lasser Norman L, Snetselaar Linda G, Black Henry R, Anderson Garnet L, Assaf Annlouise R, Bassford Tamsen, Bowen Deborah, Brunner Robert L, Brzyski Robert G, Caan Bette, Chlebowski Rowan T, Gass Margery, Harrigan Rosanne C, Hays Jennifer, Heber David, Heiss Gerardo, Hendrix Susan L, Howard Barbara V, Hsia Judith, Hubbell F Allan, Jackson Rebecca D, Kotchen Jane Morley, Kuller Lewis H, LaCroix Andrea Z, Lane Dorothy S, Langer Robert D, Lewis Cora E, Manson JoAnn E, Margolis Karen L, Mossavar-Rahmani Yasmin, Ockene Judith K, Parker Linda M, Perri Michael G, Phillips Lawrence, Prentice Ross L, Robbins John, Rossouw Jacques E, Sarto Gloria E, Stefanick Marcia L, Van Horn Linda, Vitolins Mara Z, Wactawski-Wende Jean, Wallace Robert B, Whitlock Evelyn
Аннотация
OBJECTIVE: To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.
DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States.
INTERVENTIONS: Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern.
MAIN OUTCOME MEASURE: Invasive colorectal cancer incidence.
RESULTS: A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.
CONCLUSION: In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.