Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study.

Autor:	Chen YX; Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China., Gao QY; Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China., Zou TH; Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China., Wang BM; Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China., Liu SD; Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China., Sheng JQ; Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China., Ren JL; Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China., Zou XP; Division of Gastroenterology and Hepatology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China., Liu ZJ; Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University, Shanghai, China., Song YY; Department of Biostatistics, Clinical Research Institute, Shanghai Jiao-Tong University School of Medicine, Shanghai, China., Xiao B; Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China., Sun XM; Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University, Shanghai, China., Dou XT; Division of Gastroenterology and Hepatology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China., Cao HL; Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China., Yang XN; Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China., Li N; Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China., Kang Q; Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital, Beijing, China., Zhu W; Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China., Xu HZ; Department of Gastroenterology, Zhongshan Hospital, Xiamen University, Xiamen, China., Chen HM; Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China., Cao XC; Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China., Fang JY; Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, State Key Laboratory for Oncogenes and Related Genes, Key Laboratory of Gastroenterology & Hepatology, Ministry of Health, Renji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai, China. Electronic address: jingyuanfang@sjtu.edu.cn.
Jazyk:	angličtina
Zdroj:	The lancet. Gastroenterology & hepatology [Lancet Gastroenterol Hepatol] 2020 Mar; Vol. 5 (3), pp. 267-275. Date of Electronic Publication: 2020 Jan 08.
DOI:	10.1016/S2468-1253(19)30409-1
Abstrakt:	Background: Chemoprevention of colorectal adenoma and colorectal cancer remains an important public health goal. The present study aimed to investigate the clinical potential and safety of berberine for prevention of colorectal adenoma recurrence. Methods: This double-blind, randomised, placebo-controlled trial was done in seven hospital centres across six provinces in China. Individuals aged 18-75 years who had at least one but no more than six histologically confirmed colorectal adenomas that had undergone complete polypectomy within the 6 months before recruitment were recruited and randomly assigned (1:1) to receive berberine (0·3 g twice daily) or placebo tablets via block randomisation (block size of six). Participants were to undergo a first follow-up colonoscopy 1 year after enrolment, and if no colorectal adenomas were detected, a second follow-up colonoscopy at 2 years was planned. The study continued until the last enrolled participant reached the 2-year follow-up point. All participants, investigators, endoscopists, and pathologists were blinded to treatment assignment. The primary efficacy endpoint was the recurrence of adenomas at any follow-up colonoscopy. Analysis was based on modified intention-to-treat, with the full analysis set including all randomised participants who received at least one dose of study medication and who had available efficacy data. The study is registered with ClinicalTrials.gov, number NCT02226185; the trial has ended and this report represents the final analysis. Findings: Between Nov 14, 2014, and Dec 30, 2016, 553 participants were randomly assigned to the berberine group and 555 to the placebo group. The full analysis set consisted of 429 participants in the berberine group and 462 in the placebo group. 155 (36%) participants in the berberine group and 216 (47%) in the placebo group were found to have recurrent adenoma during follow-up (unadjusted relative risk ratio for recurrence 0·77, 95% CI 0·66-0·91; p=0·001). No colorectal cancers were detected during follow-up. The most common adverse event was constipation (six [1%] of 446 patients in the berberine group vs one [<0·5%] of 478 in the placebo group). No serious adverse events were reported. Interpretation: Berberine 0·3 g twice daily was safe and effective in reducing the risk of recurrence of colorectal adenoma and could be an option for chemoprevention after polypectomy. Funding: National Natural Science Foundation of China. (Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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