Evidence map›Paper›PMID 26270952›Full record

Trial reportBMJ open2015

Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).

Sim Yee Ong, Lara Dolling, Jeannette L Dixon, Amanda J Nicoll, Lyle C Gurrin, Michelle Wolthuizen, Erica M Wood, Greg J Anderson, Grant A Ramm, Katrina J Allen and 8 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01631708 (Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT01631708 nacompletednot on this map

Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2012 to 2016Enrolled100ConditionsHereditary HaemochromatosisArmsErythrocytapheresis, Plasmapheresis
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
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

18 authors at 9 institutions in 1 country.

Sim Yee OngBruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia Department of Medicine, The University of Melbourne, Parkville, Victoria, Australia.
Lara DollingBruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Jeannette L DixonIron Metabolism Group, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
Amanda J NicollDepartment of Gastroenterology, Eastern Health, Box Hill, Victoria, Australia Department of Gastroenterology, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Lyle C GurrinCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia.
Michelle WolthuizenBruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Erica M WoodTransfusion Research Unit, Department of Epidemiology and Preventive Medicine, Monash University, Prahran, Victoria, Australia.
Greg J AndersonIron Metabolism Group, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
Grant A RammHepatic Fibrosis Group, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
Katrina J AllenGastro and Food Allergy, Murdoch Childrens Research Institute, Parkville, Victoria, Australia Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia.
John K OlynykDepartment of Gastroenterology, Fiona Stanley and Fremantle Hospitals, Murdoch, Western Australia, Australia.
Darrell CrawfordSchool of Medicine, University of Queensland, Herston, Queensland, Australia.
Jennifer KavaDepartment of Gastroenterology, Fiona Stanley and Fremantle Hospitals, Murdoch, Western Australia, Australia.
Louise E RammHepatic Fibrosis Group, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia.
Paul GowDepartment of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia.
Simon DurrantBone Marrow Transplant and Haematology, Royal Brisbane Hospital, Herston, Queensland, Australia.
Lawrie W PowellRBWH Centre for the Advancement of Clinical Research, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia.
Martin B DelatyckiBruce Lefroy Centre, Murdoch Childrens Research Institute, Parkville, Victoria, Australia Clinical Genetics, Austin Health, Heidelberg, Victoria, Australia.
Murdoch Children's Research Institute · AUQIMR Berghofer Medical Research Institute · AUFiona Stanley Hospital · AURoyal Brisbane and Women's Hospital · AUUniversity of Melbourne · AUAustin Health · AUEastern Health · AUMonash University · AUUniversity of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHFE p.C282Y homozygosity is the most common cause of hereditary haemochromatosis. There is currently insufficient evidence to assess whether non-specific symptoms or hepatic injury in homozygotes with moderately elevated iron defined as a serum ferritin (SF) of 300-1000 µg/L are related to iron overload. As such the evidence for intervention in this group is lacking. We present here methods for a study that aims to evaluate whether non-specific symptoms and hepatic fibrosis markers improve with short-term normalisation of SF in p.C282Y homozygotes with moderate elevation of SF. METHODS AND ANALYSIS: Mi-iron is a prospective, multicentre, randomised patient-blinded trial conducted in three centres in Victoria and Queensland, Australia. Participants who are HFE p.C282Y homozygotes with SF levels between 300 and 1000 μg/L are recruited and randomised to either the treatment group or to the sham treatment group. Those in the treatment group have normalisation of SF by 3-weekly erythrocytapheresis while those in the sham treatment group have 3-weekly plasmapheresis and thus do not have normalisation of SF. Patients are blinded to all procedures. All outcome measures are administered prior to and following the course of treatment/sham treatment. Patient reported outcome measures are the Modified Fatigue Impact Scale (MFIS-primary outcome), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item short form V.2 (SF36v2) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF). Liver injury and hepatic fibrosis are assessed with transient elastography (TE), Fibrometer and Hepascore, while oxidative stress is assessed by measurement of urine and serum F2-isoprostanes. ETHICS AND DISSEMINATION: This study has been approved by the Human Research Ethics Committees of Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital. Study findings will be disseminated through peer-reviewed publications and conference presentations.

trial registrationTrial identifier: NCT01631708; Registry: ClinicalTrials.gov.

Indexed as

Blood Component RemovalErythrocyte TransfusionHomozygoteAdolescentAdultAgedFerritinsHemochromatosis ProteinHistocompatibility Antigens Class IHumansIron OverloadMembrane ProteinsMiddle AgedProspective StudiesTreatment OutcomeYoung AdultFerritinsHemochromatosis ProteinHFE protein, humanHistocompatibility Antigens Class IMembrane Proteinserythrocytapheresisferritinhaemochromatosisphlebotomyvenesection

Identifiers

PMID26270952
PMCPMC4538285
OpenAlexW2102096791

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.