Evidence map›Paper›PMID 27188915›Full record

SynthesisEuropean journal of clinical nutrition2016

Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials.

T Isomura, S Suzuki, H Origasa, A Hosono, M Suzuki, T Sawada, S Terao, Y Muto, T Koga

Erratum issued Registry-linked trialAbstract readSystematic Review
In one paragraph

Synthesis in European journal of clinical nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05195918 (Dose Ranging Study of Oral Epigallocatechin-3-gallate), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05195918 phase1completednot on this mapstarted 2023, after this paper: background citation

Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect

TypeinterventionalSponsorHal ChapmanRan2023 to 2026Enrolled50ConditionsIdiopathic Pulmonary FibrosisArmsEGCG 300 mg + Nintedanib, EGCG 300 mg + Pirfenidone, Placebo 2 capsules + Nintedanib or Pirfenidone, EGCG 600 mg + Nintedanib, EGCG 600 mg + Pirfenidone
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Trial
  2. Flavonoids.Advances in nutrition (Bethesda, Md.) · 2026
    Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Integrative Hematology: State of the Art.International journal of molecular sciences · 2023
    Review
  8. Hepatotoxicity due to herbal dietary supplements: Past, present and the future.Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association · 2022
    Review
  9. Impact of Green Tea (The Japanese dental science review · 2021
    Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Non-Alcoholic Fatty Liver Disease, an Overview.Integrative medicine (Encinitas, Calif.) · 2019
    Review
  16. Article
  17. Review
  18. Article
  19. Is obesity rather than the dietary supplement used for weight reduction the cause of liver injury?JGH open : an open access journal of gastroenterology and hepatology · 2018
    Review
  20. Scientific opinion on the safety of green tea catechins.EFSA journal. European Food Safety Authority · 2018
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

T IsomuraClinical Study Support Inc., Nagoya, Japan.
S SuzukiDepartment of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
H OrigasaDivision of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Toyama, Japan.
A HosonoDepartment of Public Health, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
M SuzukiClinical Study Support Inc., Nagoya, Japan.
T SawadaClinical Study Support Inc., Nagoya, Japan.
S TeraoClinical Study Support Inc., Nagoya, Japan.
Y MutoClinical Study Support Inc., Nagoya, Japan.
T KogaClinical Study Support Inc., Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5-9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

Indexed as

TeaAntioxidantsFood SafetyHumansLiverPlant ExtractsRandomized Controlled Trials as TopicAntioxidantsPlant ExtractsTea

Identifiers

PMID27188915
PMCPMC5193539

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.