Tier 2 — strong

A Phase I Trial of Berberine in Chinese with Ulcerative Colitis

Xu L, Zhang Y, Xue X, Liu J, Li ZS, Yang GY, Song Y, Pan Y, Ma Y, Hu S, Wen A, Jia Y, Rodriguez LM, Tull MB, Benante K, Khan SA, Cao Y, Jovanovic B, Richmond E, Umar A, Bergan R, Wu K
Cancer prevention research (Philadelphia, Pa.) 2020 13(1):117-126

Bibliography

PubMed
PMID 31619442
DOI
10.1158/1940-6207.capr-19-0258
Funding
Indexed support: National Natural Science Foundation of China; NIH NCI. 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

DesignDouble-blind randomized phase I safety trial
ModelHuman participants; see population
Sample16 adults; 12 berberine and 4 placebo
InterventionBerberine 900 mg/day or placebo with mesalamine in quiescent ulcerative colitis
Duration3 months
EndpointsAdverse events and liver enzymes; UCDAI and Geboes histologic grade; Tissue and plasma biomarkers

What the study showed, in plain terms

This phase I trial principally evaluated safety. One berberine participant had a grade-three transaminase elevation; selected histologic measures improved, while most biomarkers did not.

Key findings

  • This phase I trial principally evaluated safety. One berberine participant had a grade-three transaminase elevation; selected histologic measures improved, while most biomarkers did not.

What this study can and cannot tell us

Very small safety sample. This record does not support an unqualified claim of no liver adverse events.

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

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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