Evidence map›Paper›PMID 36730360›Full record

Trial reportPloS one2023

Endothelial dysfunction in ME/CFS patients.

Miriam Kristine Sandvik, Kari Sørland, Elisabeth Leirgul, Ingrid Gurvin Rekeland, Christina Særsten Stavland, Olav Mella, Øystein Fluge

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
9.3field-weighted citation impact, top 1% 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

28 citing papers in PubMed, 42 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

Miriam Kristine SandvikDepartment of Psychiatry and Addiction, Telemark Hospital Trust, Skien, Norway.ORCID 0000-0003-2172-4107
Kari SørlandDepartment of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.ORCID 0000-0003-4060-2586
Elisabeth LeirgulDepartment of Heart Disease, Haukeland University Hospital, Bergen, Norway.ORCID 0000-0002-4988-1203
Ingrid Gurvin RekelandDepartment of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.
Christina Særsten StavlandDepartment of Clinical Sciences, University of Bergen, Bergen, Norway.
Olav MellaDepartment of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.
Øystein FlugeDepartment of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.
Haukeland University Hospital · NOTelemark Hospital · NOUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveA few earlier studies have found impaired endothelial function in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The present study investigated large-vessel and small-vessel endothelial function in patients with ME/CFS. STUDY

designThe study was a substudy of the RituxME trial, a national, multicenter, randomized, double-blind, placebo-controlled phase III study on the effect of rituximab vs. placebo in ME/CFS patients in Norway. Flow-mediated dilation (FMD) and post-occlusive reactive hyperemia (PORH) was measured at baseline and after 18 months of treatment in 39 patients and compared with healthy controls. Other outcome measures were symptom severity and various physical function measures.

resultsME/CFS patients had markedly reduced FMD compared to healthy controls at baseline (5.1% vs. 8.2%, p< 0.0001, adjusted for arterial diameter and sex), and significantly lower microvascular regulation measured by PORH than healthy controls (1354 PU vs. 2208 PU, p = 0.002). There were no differences between the treatment and placebo groups in symptom changes or vascular measures. As a group, the ME/CSF patients experienced a slight, but significant improvement in clinical symptoms after 18 months. PORH, but not FMD, was similarly improved (1360 to 1834 PU, p = 0.028). There was no significant correlation between FMD and PORH. There were non-significant tendencies towards associations between symptom severity/physical function measures and lower FMD and PORH, and a significant correlation between PORH and steps per 24 hours at baseline.

conclusionsME/CFS patients had reduced macro- and microvascular endothelial function, indicating that vascular homeostasis may play a role in the clinical presentation of this disease.

Indexed as

Fatigue Syndrome, ChronicVascular DiseasesHumansNorwayRituximabRituximab

Identifiers

PMID36730360
PMCPMC9894436
OpenAlexW4318914496

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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.