Evidence map›Paper›PMID 37583966›Full record

ArticleERJ open research2023

Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Kathryn Date, Bronwen Williams, Judith Cohen, Nazia Chaudhuri, Sabrina Bajwah, Mark Pearson, Irene Higginson, John Norrie, Catriona Keerie, Sharon Tuck and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ERJ open research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. 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

14 authors at 6 institutions in 2 countries.

Kathryn DateHull Health Trials Unit, Hull York Medical School, University of Hull, Hull, UK.
Bronwen WilliamsHull Health Trials Unit, Hull York Medical School, University of Hull, Hull, UK.
Judith CohenHull Health Trials Unit, Hull York Medical School, University of Hull, Hull, UK.
Nazia ChaudhuriSchool of Medicine, University of Ulster, Coleraine, UK.
Sabrina BajwahCicely Saunders Institute, King's College London, London, UK.ORCID https://orcid.org/0000-0001-5338-8107
Mark PearsonWolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.ORCID https://orcid.org/0000-0001-7628-7421
Irene HigginsonCicely Saunders Institute, King's College London, London, UK.ORCID https://orcid.org/0000-0002-3687-1313
John NorrieEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.
Catriona KeerieEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.
Sharon TuckEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.ORCID https://orcid.org/0000-0002-6186-6794
Peter HallEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.ORCID https://orcid.org/0000-0001-6015-7841
David CurrowFaculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia.
Marie FallonEdinburgh Cancer Research Centre (IGMM), University of Edinburgh, Edinburgh, UK.
Miriam JohnsonWolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.
University of Hull · GBUniversity of Edinburgh · GBKing's College London · GBEdinburgh Cancer Research · GBUniversity of Ulster · GBUniversity of Wollongong · AU

Funding

Marie Curie MCCC-RP-15-A18859MRF_ MRF-145-0019-DG-HIGG-C0951
6 · The paper itself

Abstract

Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.

Identifiers

PMID37583966
PMCPMC10423982
OpenAlexW4380785198

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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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.