From trial to real life: ten-year impact of a nutraceutical strategy on duodenal polyp burden in familial adenomatous polyposis

Background: Familial adenomatous polyposis (FAP) is characterized by the early development of colorectal and duodenal adenomas. Although colectomy reduces the risk of colorectal cancer, duodenal neoplasia remains a leading cause of mortality. Aims: To assess the long-term efficacy of a nutraceutical blend containing phytoestrogens and insoluble fibers (Adipol) in reducing duodenal polyp burden in FAP patients. Methods: This prospective cohort study followed 56 FAP patients for 10 years after completion of a randomised trial on Adipol. Importantly, post-trial treatment allocation was not randomised but based on patient choice. Patients freely choose one of four regimes: no therapy (Group 0), 3 months on/off (Group 1), 6 months on/off (Group 2), or continuous treatment (Group 3). Annual upper endoscopies evaluated duodenal polyp number and size. Results: At 120 months, the mean polyp count was significantly reduced in Group 3 vs Group 0 (8.2 ± 3.4 vs 25.1 ± 5.8; p