Tier 4 — mechanistic

Berberine for preventing colorectal adenoma recurrence and neoplasm occurrence: 6-Year follow-up of a randomized clinical trial

Tan YJ, Zou TH, Yu K, Sheng JQ, Jin P, Zhang MJ, Zou XP, Dou XT, Liu SD, Huang SH, Ren JL, Yang XN, Liu ZJ, Sun XM, Wang BM, Cao HL, Zhang YX, Gao QY, Chen HM, Cui Y, Chen YX, Fang JY
Cell reports. Medicine 2025 6(9):102293

Bibliography

PubMed
PMID 40795846
PubMed Central
PMC12490254
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 Shenkang Hospital Development Center; Shanghai Jiao Tong University; Innovative Research Team of High-level Local Universities in Shanghai; National Key Research and Development Program of China. 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

DesignExtended post-trial observational follow-up
ModelHuman participants; see population
Sample781 re-enrolled; 648 had a follow-up colonoscopy
InterventionPost-treatment observational follow-up of NCT02226185
DurationUp to 6 years after original treatment
EndpointsPost-trial adenoma recurrence; Neoplasm occurrence; Follow-up colonoscopy ascertainment

What the study showed, in plain terms

Longer follow-up found lower adenoma recurrence among participants originally assigned berberine. Treatment had stopped, and follow-up was observational.

Key findings

  • Observed recurrence was 34.7% versus 52.1% among follow-up groups.

What this study can and cannot tell us

Shared cohort with PMID 31926918; selection, missing colonoscopies and post-trial exposures limit causal interpretation.

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