Evidence map›Paper›PMID 27815860›Full record

Trial reportInternational journal of hematology2017

Phase 2 trial of daily, oral epigallocatechin gallate in patients with light-chain amyloidosis.

Sohsuke Meshitsuka, Sumito Shingaki, Masatoshi Hotta, Miku Goto, Makoto Kobayashi, Yuuichi Ukawa, Yuko M Sagesaka, Yasuyo Wada, Masanori Nojima, Kenshi Suzuki

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
  2. Review
  3. Protein clearance strategies for disease intervention.Journal of neural transmission (Vienna, Austria : 1996) · 2022
    Review
  4. Cardiac Amyloidosis Treatment.Methodist DeBakey cardiovascular journal · 2022
    Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Approach to a patient with cardiac amyloidosis.Journal of geriatric cardiology : JGC · 2019
    Article
  11. Article
  12. Novel Approaches for the Management of AL Amyloidosis.Current hematologic malignancy reports · 2018
    Review
  13. Novel Therapies in Light Chain Amyloidosis.Kidney international reports · 2018
    Review
  14. Scientific opinion on the safety of green tea catechins.EFSA journal. European Food Safety Authority · 2018
    Article
  15. Light Chain Amyloidosis.Mediterranean journal of hematology and infectious diseases · 2018
    Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Sohsuke MeshitsukaDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan. sohmeshi@ims.u-tokyo.ac.jp.
Sumito ShingakiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Masatoshi HottaDepartment of Radiology, National Center for Global Health and Medicine, Tokyo, Japan.
Miku GotoLaboratory for Clinical Nutrition, Department of Food and Nutrition, Faculty of Human Life, Jumonji University, Niiza, Japan.
Makoto KobayashiCentral Research Institute, ITO EN, Ltd, Makinohara, Japan.
Yuuichi UkawaCentral Research Institute, ITO EN, Ltd, Makinohara, Japan.
Yuko M SagesakaCentral Research Institute, ITO EN, Ltd, Makinohara, Japan.
Yasuyo WadaLaboratory for Clinical Nutrition, Department of Food and Nutrition, Faculty of Human Life, Jumonji University, Niiza, Japan.
Masanori NojimaCenter for Translational Research, The Institute of Medical Science Hospital, The University of Tokyo, 4-6-1, Shiroganedai, Minato, Tokyo, Japan.
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Japanese Red Cross Medical Center · JPJumonji University · JPNational Center for Global Health and Medicine · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Previous studies have suggested that an increase in mitochondrial reactive oxygen species may cause organ damage in patients with light-chain (AL) amyloidosis; however, this damage can be decreased by antioxidant-agent treatment. Epigallocatechin gallate (EGCG), the major natural catechin in green tea, has potent antioxidant activity. Because EGCG has recently been reported to have a favorable toxicity profile for treating amyloidosis, we sought to examine the clinical efficacy and toxicity of EGCG in patients with AL amyloidosis. Fifty-seven patients were randomly assigned to the EGCG and observation groups and observed for six months. There were no increases in grade 3-5 adverse events and EGCG therapy was well tolerated. Although a decrease in the urinary albumin level was found in the EGCG group in patients with obvious albuminuria after treatment initiation, its antioxidant activity may not be sufficient to clarify the potential effect of EGCG in patients with AL amyloidosis. Because some of the biological markers responsible for organ damage were well correlated to the level of antioxidant potential in patients' plasma, the status of oxidative stress in the blood may indicate the extent of organ damage in clinical situations.

Indexed as

AdultAgedAged, 80 and overAmyloidosisAntioxidantsCatechinFemaleHumansImmunoglobulin Light-chain AmyloidosisMaleMiddle AgedOxidative StressReactive Oxygen SpeciesTeaTreatment OutcomeAntioxidantsCatechinepigallocatechin gallateReactive Oxygen SpeciesTeaAmyloidosisBAPdROMEGCGLight chain disease

Identifiers

PMID27815860
OpenAlexW2546854096

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.