Evidence map›Paper›PMID 26357864›Full record

Trial reportBMC pediatrics2015

Effects of low-dose clonidine on cardiovascular and autonomic variables in adolescents with chronic fatigue: a randomized controlled trial.

Even Fagermoen, Dag Sulheim, Anette Winger, Anders M Andersen, Johannes Gjerstad, Kristin Godang, Peter C Rowe, J Philip Saul, Eva Skovlund, Vegard Bruun Wyller

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

Trial report in BMC pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01040429 (The Norwegian Study of Chronic Fatigue Syndrome in Adolescents), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 21% 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.

NCT01040429 phase2completednot on this map

The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

TypeinterventionalSponsorOslo University HospitalRan2010 to 2012Enrolled120ConditionsChronic Fatigue Syndrome, Myalgic EncephalomyelitisArmsClonidine, Lactose capsula
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
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  5. Review
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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

10 authors at 7 institutions in 2 countries.

Even FagermoenInstitute of Clinical Medicine, Medical Faculty, University of Oslo, P.O.Box 1171, Blindern, 0318, Oslo, Norway. feef@online.no.
Dag SulheimDepartment of Paediatrics, Oslo University Hospital, P.O.Box 4950, Nydalen, 0424, Oslo, Norway. dag.sulheim@medisin.uio.no.
Anette WingerInstitute of Nursing Sciences, Oslo and Akershus University College of Applied Sciences, P.O. Box 4 St., Olavs plass, 0130, Oslo, Norway. Anette.Winger@hioa.no.
Anders M AndersenDepartment of Pharmacology, Oslo University Hospital, P.O.Box 4950, Nydalen, 0424, Oslo, Norway. Anders.Andersen2@oslo-universitetssykehus.no.
Johannes GjerstadNational Institute of Occupational Health, P.O Box 8149, Dep, 0033, Oslo, Norway. johannes.gjerstad@stami.no.
Kristin GodangSection of Specialized Endocrinology, Department of Endocrinology, Oslo University Hospital Rikshospitalet, P.O.Box 4950, Nydalen, 0424, Oslo, Norway. kgodang@ous-hf.no.
Peter C RoweDepartment of Paediatrics, Johns Hopkins University School of Medicine, 200 N. Wolfe Street, Baltimore, MD, 21287, USA. prowe@jhmi.edu.
J Philip SaulDepartment of Paediatrics, Medical University of South Carolina, 169 Ashley Avenue, Charleston, SC, 29425, USA. Phil.Saul@nationwidechildrens.org.
Eva SkovlundDepartment of Pharmaceutical Science, University of Oslo, P.O.Box 1068, Blindern, 0316, Oslo, Norway. eva.skovlund@farmasi.uio.no.
Vegard Bruun WyllerInstitute of Clinical Medicine, Medical Faculty, University of Oslo, P.O.Box 1171, Blindern, 0318, Oslo, Norway. brwylle@online.no.
Oslo University Hospital · NOAkershus University Hospital · NOJohns Hopkins University · USMedical University of South Carolina · USNational Institute of Occupational Health · NONorwegian Institute of Public Health · NOOsloMet – Oslo Metropolitan University · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic Fatigue Syndrome (CFS) is a common and disabling condition in adolescence with few treatment options. A central feature of CFS is orthostatic intolerance and abnormal autonomic cardiovascular control characterized by sympathetic predominance. We hypothesized that symptoms as well as the underlying pathophysiology might improve by treatment with the alpha2A-adrenoceptor agonist clonidine.

methodsA total of 176 adolescent CFS patients (12-18 years) were assessed for eligibility at a single referral center recruiting nation-wide. Patients were randomized 1:1 by a computer system and started treatment with clonidine capsules (25 μg or 50 μg twice daily, respectively, for body weight below/above 35 kg) or placebo capsules for 9 weeks. Double-blinding was provided. Data were collected from March 2010 until October 2012 as part of The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL). Effect of clonidine intervention was assessed by general linear models in intention-to-treat analyses, including baseline values as covariates in the model.

resultsA total of 120 patients (clonidine group n = 60, placebo group n = 60) were enrolled and started treatment. There were 14 drop-outs (5 in the clonidine group, 9 in the placebo group) during the intervention period. At 8 weeks, the clonidine group had lower plasma norepinephrine (difference = 205 pmol/L, p = 0.05) and urine norepinephrine/creatinine ratio (difference = 3.9 nmol/mmol, p = 0.002). During supine rest, the clonidine group had higher heart rate variability in the low-frequency range (LF-HRV, absolute units) (ratio = 1.4, p = 0.007) as well as higher standard deviation of all RR-intervals (SDNN) (difference = 12.0 ms, p = 0.05); during 20° head-up tilt there were no statistical differences in any cardiovascular variable. Symptoms of orthostatic intolerance did not change during the intervention period.

conclusionsLow-dose clonidine reduces catecholamine levels in adolescent CFS, but the effects on autonomic cardiovascular control are sparse. Clonidine does not improve symptoms of orthostatic intolerance.

trial registrationClinical Trials ID: NCT01040429, date of registration 12/28/2009.

Indexed as

AdolescentAdrenergic alpha-2 Receptor AgonistsClonidineCreatinineDouble-Blind MethodEpinephrineFatigue Syndrome, ChronicHeart RateHumansNorepinephrineOrthostatic IntoleranceTilt-Table TestAdrenergic alpha-2 Receptor AgonistsClonidineCreatinineEpinephrineNorepinephrine

Identifiers

PMID26357864
PMCPMC4566847
OpenAlexW1937697022

What OpenQuestion holds

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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.