Tier 2 — strong

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

Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY
The lancet. Gastroenterology & hepatology 2020 5(3):267-275

Bibliography

PubMed
PMID 31926918
DOI
10.1016/s2468-1253(19)30409-1
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Indexed support: National Natural Science Foundation of China; Shanghai Municipal Education Commission; Shanghai Shenkang Hospital Development Center. See the publication for grant details.
Competing interests
A complete competing-interest declaration was not available in the accessible source; no absence of conflicts is inferred.

Study snapshot

DesignMulticenter double-blind placebo-controlled randomized trial
ModelHuman participants; see population
Sample1108 randomized; 891 in modified intention-to-treat efficacy analysis
InterventionBerberine 300 mg twice/day versus placebo after polypectomy
DurationUp to 2 years
EndpointsColorectal adenoma recurrence; Colorectal cancer occurrence; Adverse events

What the study showed, in plain terms

Berberine reduced adenoma recurrence after removal of prior adenomas. This was a recurrence-prevention trial, not treatment or proven prevention of colorectal cancer.

Key findings

  • Recurrence was 36% versus 47% in the analyzed groups; reported relative risk 0.77.

What this study can and cannot tell us

Substantial difference between randomized and efficacy-analysis denominators; no colorectal cancers occurred during follow-up.

Source detail: indexed abstract and bibliographic record; unavailable methods or disclosures are identified rather than assumed.

Related papers in the corpus

Tier 4
Berberine for preventing colorectal adenoma recurrence and neoplasm occurrence: 6-Year follow-up of a randomized clinical trial
Tan YJ et al. · Cell reports. Medicine · 2025
Tier 2
A Phase I Trial of Berberine in Chinese with Ulcerative Colitis
Xu L et al. · Cancer prevention research (Philadelphia, Pa.) · 2020
Tier 2
A Randomized Clinical Trial of Berberine Hydrochloride in Patients with Diarrhea-Predominant Irritable Bowel Syndrome
Chen C et al. · Phytotherapy research : PTR · 2015
Tier 2
Berberine inhibits acute radiation intestinal syndrome in human with abdomen radiotherapy
Li GH et al. · Medical oncology (Northwood, London, England) · 2010

Citation network

Articles citing this research paper

5 articles

Biohack Blueprint analyses that reference this study in their evidence base.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology