Evidence map›Paper›PMID 31060559›Full record

Trial reportBMC complementary and alternative medicine2019

Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial.

Howard A Smithline, Michael Donnino, Fidela S J Blank, Richard Barus, Ryan A Coute, Alexander B Knee, Paul Visintainer

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00680706 (Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 15% 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.

NCT00680706 phase2completednot on this map

Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.

TypeinterventionalSponsorBaystate Medical CenterRan2008 to 2012Enrolled131ConditionsHeart Failure, DiabetesArmsThiamine, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Metabolic Therapy of Heart Failure: Is There a Future for B Vitamins?International journal of molecular sciences · 2021
    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 at 3 institutions in 1 country.

Howard A SmithlineDepartment of Emergency Medicine, Baystate Medical Center, University of Massachusetts Medical School - Baystate, 759 Chestnut Street, Springfield, MA, 01199, USA. howard.smithline@baystatehealth.org.ORCID http://orcid.org/0000-0001-6972-5833
Michael DonninoDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, One Deaconess Road, Rosenberg 2, Boston, MA, 02215, USA.
Fidela S J BlankDepartment of Emergency Medicine, Baystate Medical Center, 759 Chestnut Street, Springfield, MA, 01199, USA.
Richard BarusDepartment of Nursing, Baystate Medical Center, 759 Chestnut Street, Springfield, MA, 01199, USA.
Ryan A CouteUniversity of Alabama Hospital, 1802 6th Ave S, Birmingham, AL, 35233, USA.
Alexander B KneeBaystate Medical Center, Office of Research, Epidemiology/Biostatistics Research Core, University of Massachusetts Medical School, Baystate, 759 Chestnut Street, Springfield, MA, 01199, USA.
Paul VisintainerBaystate Medical Center, Office of Research, Epidemiology/Biostatistics Research Core, University of Massachusetts Medical School, Baystate, 759 Chestnut Street, Springfield, MA, 01199, USA.
Baystate Medical Center · USBeth Israel Deaconess Medical Center · USUniversity of Alabama at Birmingham Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this pilot study was to determine if a definitive clinical trial of thiamine supplementation was warranted in patients with acute heart failure. We hypothesized that thiamine, when added to standard of care, would improve dyspnea (primary outcome) in hospitalized patients with acute heart failure. Peak expiratory flow rate, type B natriuretic peptide, free fatty acids, glucose, hospital length of stay, as well as 30-day rehospitalization and mortality were pre-planned secondary outcome measures.

methodsThis was a blinded experimental study at two urban academic hospitals. Consecutive patients admitted from the Emergency Department with a primary diagnosis of acute heart failure were recruited over 2 years. Patients on a daily dietary supplement were excluded. Randomization was stratified by type B natriuretic peptide and diabetes medication categories. Subjects received study drug (100 mg thiamine or placebo) in the evening of their first and second day. Outcome measures were obtained 8 h after study drug infusion. Dyspnea was measured on a 100-mm visual analog scale sitting up on oxygen, sitting up off oxygen, and lying supine off oxygen with 0 indicating no dyspnea. Data were analyzed using mixed-models as well as linear, negative binomial and logistic regression models to assess the impact of group on outcome measures.

resultsOf 130 subjects randomized, 118 had evaluable data (55 in the control and 63 in the treatment groups), 89% in both groups were adjudicated to have primarily AHF. Thiamine values increased significantly in the treatment group and were unchanged in the control group. One patient had thiamine deficiency. Only dyspnea measured sitting upright on oxygen differed significantly by group over time. No change was found for the other measures of dyspnea and all of the secondary measures.

conclusionsIn mild-moderate acute heart failure patients without thiamine deficiency, a standard dosing regimen of thiamine did not improve dyspnea, biomarkers, or other clinical parameters.

trial registrationClinicalTrials.gov: NCT00680706 , May 20, 2008 (retrospectively registered).

Indexed as

Acute DiseaseAgedAged, 80 and overCardiovascular AgentsDyspneaFemaleHeart FailureHospitalizationHumansMaleMiddle AgedThiamineTreatment OutcomeVisual Analog ScaleCardiovascular AgentsThiamineAcute heart failureDyspneaThiamine

Identifiers

PMID31060559
PMCPMC6501378
OpenAlexW2947512246

What OpenQuestion holds

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LicenceCC BY
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.