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STUDY PROTOCOL Open Access Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

By Takuma Higurashi, Hirokazu Takahashi, Hiroki Endo, Kunihiro Hosono, Eiji Yamada, Hidenori Ohkubo, Eiji Sakai, Takashi Uchiyama, Yasuo Hata, Nobutaka Fujisawa, Shiori Uchiyama, Akiko Ezuka, Hajime Nagase, Takaomi Kessoku, Nobuyuki Matsuhashi, Shoji Yamanaka, Yoshiaki Inayama, Satoshi Morita and Atsushi Nakajima


Background: Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF). ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design: This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those i

Year: 2016
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