PT  - JOURNAL ARTICLE
AU  - Hideki Ishikawa
AU  - Michihiro Mutoh
AU  - Sadao Suzuki
AU  - Shinkan Tokudome
AU  - Yoshihisa Saida
AU  - Takashi Abe
AU  - Shozo Okamura
AU  - Masahiro Tajika
AU  - Takashi Joh
AU  - Shinji Tanaka
AU  - Shin-ei Kudo
AU  - Takahisa Matsuda
AU  - Masaki Iimuro
AU  - Tomomi Yukawa
AU  - Tetsuji Takayama
AU  - Yasushi Sato
AU  - Kyowon Lee
AU  - Shinji Kitamura
AU  - Motowo Mizuno
AU  - Yasushi Sano
AU  - Nobuhisa Gondo
AU  - Kenji Sugimoto
AU  - Masato Kusunoki
AU  - Chiho Goto
AU  - Nariaki Matsuura
AU  - Toshiyuki Sakai
AU  - Keiji Wakabayashi
TI  - The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial
AID  - 10.1136/gutjnl-2013-305827
DP  - 2014 Nov 01
TA  - Gut
PG  - 1755--1759
VI  - 63
IP  - 11
4099  - http://gut.bmj.com/content/63/11/1755.short
4100  - http://gut.bmj.com/content/63/11/1755.full
SO  - Gut2014 Nov 01; 63
AB  - Objective To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. Design A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. Participants 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. Results The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. Conclusions Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. The clinical trial registry website and the clinical trial number http://www.umin.ac.jp (number UMIN000000697).