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A Phase I Dose Escalation Study Demonstrates Quercetin Safety and Explores Potential for Bioflavonoid Antivirals in Patients with Chronic Hepatitis C

Nu T Lu, Catherine M Crespi, Natalie M Liu, James Q Vu, Yasaman Ahmadieh, Sheng Wu, Sherry Lin, Amy McClune, Francisco Durazo, Sammy Saab, Steven Han, David C Neiman, Simon Beaven, Samuel W French
Phytotherapy research : PTR 2016 30(1):160

Bibliography

PubMed
PMID 26621580
PubMed Central
PMC5590840
Funding
Indexed grant support: R01 DK090794 — NIDDK NIH HHS — United States; T32 DK007180 — NIDDK NIH HHS — United States; CA16042 — NCI NIH HHS — United States; P30 CA016042 — NCI NIH HHS — United States; P30 DK041301 — NIDDK NIH HHS — United States; R01DK090794 — NIDDK NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
Reported disclosure: All authors have nothing to disclose.

Study snapshot

DesignOpen-label phase 1 dose-escalation trial
ModelHuman intervention research
Sample30 adults with untreated chronic hepatitis C
InterventionEscalating oral quercetin doses up to 5 g/day
DurationDose-escalation follow-up; exact cohort schedules require full methods
EndpointsLiver measurements; Protein activity, binding or signaling

What the study showed, in plain terms

Published in 2016, this source examined safety, interactions and special populations. Design: Open-label phase 1 dose-escalation trial. Sample/model: 30 adults with untreated chronic hepatitis C. The exposure or intervention was Escalating oral quercetin doses up to 5 g/day. Follow-up or treatment period: Dose-escalation follow-up; exact cohort schedules require full methods.

The investigators reported short-term tolerability and viral-load reductions in a subset, without significant liver-enzyme changes.

Uncontrolled, dose-finding study. It does not establish antiviral efficacy, routine high-dose safety or an alternative to hepatitis C treatment.

Continue with Quercetin Data Center

For topic-level interpretation, read Quercetin Side Effects and Safety: A Practical Guide. This is a related guide; the citation panel separately identifies articles that directly cite this paper.

Key findings

  • The investigators reported short-term tolerability and viral-load reductions in a subset, without significant liver-enzyme changes.
  • The recorded outcome domains were Liver measurements; Protein activity, binding or signaling.
  • The result applies to the tested exposure: Escalating oral quercetin doses up to 5 g/day; Dose-escalation follow-up; exact cohort schedules require full methods.

What this study can and cannot tell us

  • Uncontrolled, dose-finding study. It does not establish antiviral efficacy, routine high-dose safety or an alternative to hepatitis C treatment.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Source check: accessible full text and indexed metadata. Missing method details, funding information or participant denominators are not inferred.

Editorial review

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