Evidence map›Paper›PMID 36263035›Full record

Trial reportFrontiers in immunology2022

A randomized clinical trial to stimulate the cholinergic anti-inflammatory pathway in patients with moderate COVID-19-pneumonia using a slow-paced breathing technique.

Elisabeth Maria Balint, Beate Grüner, Sophia Haase, Mandakini Kaw-Geppert, Julian F Thayer, Harald Gündel, Marc N Jarczok

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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.

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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. 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

7 authors.

Elisabeth Maria BalintClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Ulm, Germany.
Beate GrünerClinic for Internal Medicine III, Division of Infectious Diseases, University Hospital Ulm, Ulm, Germany.
Sophia HaaseClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Ulm, Germany.
Mandakini Kaw-GeppertClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Ulm, Germany.
Julian F ThayerDepartment of Psychological Science, University of California, Irvine, Irvine, CA, United States.
Harald GündelClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Ulm, Germany.
Marc N JarczokClinic for Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Ulm, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: A characteristic problem occurring in COVID-19 is excessive elevations of pro-inflammatory cytokines (e.g. IL-6 and CRP) which are associated with worse clinical outcomes. Stimulation of the vagally-mediated cholinergic anti-inflammatory reflex by slow paced breathing with prolonged exhalation may present a clinically relevant way to reduce circulating IL-6. Method: Single-center randomized controlled clinical trial with enrolment of 46 patients hospitalized with confirmed severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (primary diagnosis). Differences between intervention (4sec inhalation, 6sec exhalation for 20 minutes 3x daily) and control group in IL-6 calculated using multilevel mixed-effect linear regression models with random slope including the covariates relevant comorbidities, COVID-19 medication, and age. Both groups received standard care. Results: Mean age was 57 years ± 13 years, N= 28 (60%) male, N=30 (65%) with relevant comorbidities. The model including group-by-time interaction revealed a significantly lower trajectory of IL-6 in the intervention group (effect size Cohens f Conclusion: Patients practicing slow-paced breathing had significantly lower IL-6 values than controls with a small to medium effect size and without relevant side effects. Further trials should evaluate clinical outcomes and an earlier start of the intervention. Slow-paced breathing could be an easy to implement, low-cost, safe and feasible adjuvant therapeutic approach to reduce circulating IL-6 in moderate COVID-19 pneumonia. Clinical Trial Registration: https://www.drks.de, identifier DRKS00023971, Universal Trial Number (UTN) U1111-1263-8658.

Indexed as

COVID-19CytokinesFemaleHumansInterleukin-6MaleMiddle AgedNeuroimmunomodulationSARS-CoV-2CytokinesInterleukin-6Cholinergic anti-inflammatory reflexCRPdose-response relationshipIL-6, acute viral infectionmoderate COVID-19 pneumoniaslow-paced breathingTNF-alpha

Identifiers

PMID36263035
PMCPMC9574246

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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.