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

BMC Pediatrics

Volumn 15, Issue 1, 2015, Pages

  Fagermoen, Even ^a,b   Sulheim, Dag ^b,c   Winger, Anette ^d   Andersen, Anders M ^b   Gjerstad, Johannes ^e,f   Godang, Kristin ^g   Rowe, Peter C ^h   Saul, J Philip ⁱ   Skovlund, Eva ^f,j   Wyller, Vegard Bruun ^a,k  

^a UNIVERSITY OF OSLO   (Norway)

^b OSLO UNIVERSITY HOSPITAL   (Norway)

^c Department of Paediatrics Oslo University Hospital ^*  (Norway)

^d OSLO METROPOLITAN UNIVERSITY   (Norway)

^e NATIONAL INSTITUTE OF OCCUPATIONAL HEALTH   (Norway)

^f UNIVERSITY OF OSLO   (Norway)

^g OSLO UNIVERSITY HOSPITAL   (Norway)

^h JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^j NORWEGIAN INSTITUTE OF PUBLIC HEALTH   (Norway)

^k AKERSHUS UNIVERSITY HOSPITAL   (Norway)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADRENALIN; CLONIDINE; CREATININE; NORADRENALIN; PLACEBO; ALPHA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; EPINEPHRINE;

ADOLESCENT; ADRENALIN BLOOD LEVEL; ARTICLE; AUTONOMIC CARDIOVASCULAR CONTROL; CARDIOVASCULAR PARAMETERS; CHRONIC FATIGUE SYNDROME; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG MECHANISM; FEMALE; GENE FREQUENCY; GENOTYPE; HEART RATE VARIABILITY; HUMAN; INTENTION TO TREAT ANALYSIS; LOW DRUG DOSE; LOW FREQUENCY BAND HEART RATE VARIABILITY; MAJOR CLINICAL STUDY; MALE; NERVOUS SYSTEM PARAMETERS; NORADRENALIN BLOOD LEVEL; ORTHOSTATIC INTOLERANCE; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SINGLE NUCLEOTIDE POLYMORPHISM; SYMPATHETIC TONE; TREATMENT DURATION; BLOOD; DRUG EFFECTS; FATIGUE SYNDROME, CHRONIC; HEART RATE; PATHOPHYSIOLOGY; TILT TABLE TEST; URINE;

ADOLESCENT; ADRENERGIC ALPHA-2 RECEPTOR AGONISTS; CLONIDINE; CREATININE; DOUBLE-BLIND METHOD; EPINEPHRINE; FATIGUE SYNDROME, CHRONIC; HEART RATE; HUMANS; NOREPINEPHRINE; ORTHOSTATIC INTOLERANCE; TILT-TABLE TEST;

EID: 84941215060     PISSN: None     EISSN: 14712431     Source Type: Journal    
DOI: 10.1186/s12887-015-0428-2     Document Type: Article

References (53)

1. Nijhof SL, Maijer K, Bleijenberg G, Uiterwaal CS, Kimpen JL, van der Putte EM. Adolscent chronic fatigue syndrome: prevalence, incidence, and morbidity. Pediatrics. 2011;127:e1169-75.
2. Crawley E. The epidemiology of chronic fatigue syndrome/myalgic encephalitis in children. Arch Dis Child. 2014;99:171-4.
3. Rowe KS. Double-blind randomized controlled trial to assess the efficacy of intravenous gammaglobulin for the management of chronic fatigue syndrome in adolescents. J Psychiatr Res. 1997;31:133-47.
4. Hoad A, Spickett G, Elliott J, Newton J. Postural orthostatic tachycardia syndrome is an under-recognized condition in chronic fatigue syndrome. QJM. 2008;101:961-5.
5. Stewart JM, Gewitz MH, Weldon A, Arlievsky N, Li K, Munoz J. Orthostatic intolerance in adolescent chronic fatigue syndrome. Pediatrics. 1999;103:116-21.
6. Stewart JM, Gewitz MH, Weldon A, Munoz J. Patterns of orthostatic intolerance: The orthostatic tachycardia syndrome and adolescent chronic fatigue. J Pediatrics. 1999;135:218-25.
7. Okamoto LE, Raj SR, Peltier A, Gamboa A, Shibao C, Diedrich A, et al. Neurohumoral and haemodynamic profile in postural tachycardia and chronic fatigue syndromes. Clin Sci. 2012;122:183-92.
8. Bou-Holaigah I, Rowe PC, Kan J, Calkins H. The relationship between neurally mediated hypotension and the chronic fatigue syndrome. JAMA. 1995;274:961-7.
9. Wyller VB, Due R, Saul JP, Amlie JP, Thaulow E. Usefulness of an abnormal cardiovascular response during low-grade head-up tilt-test for discriminating adolescents with chronic fatigue from healthy controls. Am J Cardiol. 2007;99:997-1001.
10. Wyller VB, Barbieri R, Thaulow E, Saul JP. Enhanced vagal withdrawal during mild orthostatic stress in adolescents with chronic fatigue. Ann Noninvasive Electrocardiol. 2008;13:67-73.
11. Wyller VB, Barbieri R, Saul P. Blood pressure variability and closed-loop baroreflex assessment in adolescent chronic fatigue syndrome during supine rest and orthostatic stress. Eur J Appl Physiol. 2011;111:497-502.
12. Boneva RS, Decker MJ, Maloney EM, Lin JM, Jones JF, Helgason HG, et al. Higher heart rate and reduced heart rate variability persist during sleep in chronic fatigue syndrome: a population-based study. Auton Neurosci. 2007;137:94-101.
13. Lewis I, Pairman J, Spickett G, Newton JL. Clinical characteristics of a novel subgroup of chronic fatigue syndrome patients with postural orthostatic tachycardia syndrome. J Intern Med. 2013;273:501-10.
14. Szabo B. Imidazoline antihypertensive drugs: a critical review on their mechanism of action. Pharmacol Ther. 2002;93:1-35.
15. Anavekar SN, Jarrott B, Toscano M, Louis WJ. Pharmacokinetic and pharmacodynamic studies of oral clonidine in normotensive subjects. Eur J Clin Pharmacol. 1982;23:1-5.
16. Cividjian A, Toader E, Wesseling KH, Karemaker JM, McAllen R, Quintin L. Effect of clonidine on cardiac baroreflex delay in humans and rats. Am J Physiol Regul Integr Comp Physiol. 2011;300:949-57.
17. Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, et al. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012;5:418.
18. Small KM, Liggett SB. Identification and functional characterixation of alpha2-adrenoceptor polymorphisms. Trend Pharm Sci. 2001;22:471-7.
19. National Institute for Health and Clinical Excellence. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy). Diagnosis and management of CFS/ME in adults and children. NICE clinical guideline 2007, no. 53. London, England: Royal College of Pediatrics and Child Health.
20. Royal College of Paediatrics and Child Health. Evidence Based Guideline for the Management of CFS/ME in Children and Young People. London England: National Institute for Health and Clinical Excellence; 2004.
21. Sulheim D, Hurum H, Helland IB, Thaulow E, Wyller VB. Concurrent improvement of circulatory abnormalities and clinical symptoms in adolescent chronic fatigue syndrome. Biopsychosoc Med. 2012;6:10.
22. Tsunoda M. Recent advances in methods for the analysis of catecholamines and their metabolites. Anal Bioanal Chem. 2006;386:506-14.
23. Kågedal B, Goldstein DS. Catecholamines and their metabolites. J Chromatogr. 1988;29:177-233.
24. Hjemdahl P. Catecholamine measurements by high-performance liquid chromatography. Am J Physiol. 1984;247:E13-20.
25. Müller C, Ramic M, Harlfinger S, Hünseler C, Theisohn M, Roth B. Sensitive and convenient method for the quantification of clonidine in serum of pediatric patients using liquid chromatography/tandem mass spectrometry. J Chromatogr A. 2007;1139:221-7.
26. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry. Bioanalytic method validation. MD, USA, 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf(2015.02.18).
27. Olsen MB, Jacobsen LM, Schistad EI, Pedersen LM, Rygh LJ, Røe C, et al. Pain intensity the first year after lumbar disc herniation is associated with the A118G polymorphism in the opioid receptor mu 1 gene: evidence of a sex and genotype interaction. J Neurosci. 2012;32:9831-4.
28. Sulheim D, Fagermoen E, Winger A, Andersen AM, Godang K, Müller F, et al. Disease mechanisms and clonidine treatment in adolescent chronic fatigue syndrome: a combined cross-sectional and randomized clinical trial. JAMA Pediatr. 2014;168:351-60.
29. de Jong-de Vos van Steenwijk CC, Wieling W, Johannes JM, Harms MP, Kuis W, Wesseling KH. Incidence and hemodynamic characteristics of near-fainting in healthy6- to 16-year old subjects. J Am Coll Cardiol. 1995;25:1615-21.
30. Fortin J, Habenbacher W, Heller A, Hacker A, Grüllenberger R, Innerhover J, et al. Non-invasive beat-to-beat cardiac output monitoring by an improved method of transthoracic bioimpedance measurement. Comput Biol Med. 2006;36:1185-203.
31. Bianchi AM, Mainardi LT, Meloni C, Chierchia S, Cerutti S. Continuous monitoring of the sympatho-vagal balance through spectral analysis. Eng Med Biol Mag. 1997;16:64-73.
32. Task force of the European society of cardiology and the North American society of pacing electrophysiology. Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Circulation. 1996;93:1043-65.
33. Malpas S. Neural influences on cardiovascular variability: possibilities and pitfalls. Am J Physiol Heart Circ Physiol. 2002;282:H6-20.
34. Suarez GA, Opfer-Gehrking TL, Offord KP, Atkinson EK, O'Brien PC, Low PA. The autonomic symptom profile: a new instrument to assess autonomic symptoms. Neurology. 1999;52:523-8.
35. Wagner D, Nisenbaum R, Heim C, Jones JF, Unger ER, Reeves WC. Psychometric properties of the CDC symptom inventory for assessment for Chronic Fatigue Syndrome. Popul Health Metr. 2005;3:8.
36. Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Int Med. 1994;121:953-9.
37. Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001;323:1123-4.
38. Pagani M, Lucini D, Mela GS, Langewitz W, Malliani A. Sympathetic overactivity in subjects complaining of unexplained fatigue. Clin Sci. 1994;87:655-61.
39. Stewart J, Weldon A, Arlievsky N, Li K, Munoz J. Neurally mediated hypotension and autonomic dysfunction measured by heart rate variability during head-up tilt testing in children with chronic fatigue syndrome. Clin Auton Res. 1998;8:221-30.
40. Timmers HJ, Wieling W, Soetekouw PM, Bleijenberg G, Van Der Meer JW, Lenders JW. Hemodynamic and neurohumoral responses to head-up tilt in patients with chronic fatigue syndrome. Clin Auton Res. 2002;12:273-80.
41. Wyller VB, Saul JP, Walløe L, Thaulow E. Sympathetic cardiovascular control during orthostatic stress and isometric exercise in adolescent chronic fatigue syndrome. Eur J Appl Physiol. 2008;102:623-32.
42. De Becker P, Dendale P, De Meirleir K, Campine I, Vandenborne K, Hagers Y. Autonomic testing in patients with chronic fatigue syndrome. Am J Med. 1998;105:22S-6.
43. Grouzmann E, Lamine F. Determination of catecholamines in plasma and urine. Best Pract Res Clin Endocrinol Metab. 2013;5:713-23.
44. Lazzeri C, La Villa G, Mannelli M, Janni L, Franchi F. Effects of acute clonidine administration on power spectral analysis of heart rate variability in healthy humans. J Auton Pharmacol. 1998;18:307-12.
45. Anavekar SN, Howes LG, Jarrott B, Syrjanen M, Conway EL, Louis WJ. Pharmacokinetics and antihypertensive effects of low dose clonidine during chronic therapy. J Clin Pharmacol. 1989;29:32.
46. Arndts D, Doevendans J, Kiersten R, Heintz B. New aspects of the pharmacokinetics and pharmacodynamics of clonidine in man. Eur J Clin Pharmacol. 1983;24:21-30.
47. Veith RC, Beset JD, Halter JB. Dose-dependent supression of norepineprhine appearance rate in plasma by clonidine in man. J Clin Endocrinol Metab. 1984;59:151.
48. Lazzeri C, La Villa G, Mannelli M, Janni L, Barletta G, Montano N, et al. Effects of clonidine on power spectral analysis of heart rate variability in mild essential hypertension. J Auton Nerv Syst. 1998;74:152-9.
49. Saul JP. Beat-to-beat variations of heart rate reflect modulation of cardiac autonomic outflow. News Physiol Sci. 1990;5:32-7.
50. Light AR, Bateman L, Jo D, Hughen RW, Vanhaitsma TA, White AT, et al. Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome. J Int Med. 2012;271:64-81.
51. Streeten DH, Anderson Jr GH. Mechanisms of orthostatic hypotension and tachycardia in patients with pheochromocytoma. Am J Hypertens. 1996;9:760-9.
52. Zhou Y, Xie G, Wang J, Yang S. Cardiovascular risk factors significantly correlate with autonomic nervous system activity in children. Can J Cardiol. 2012;28:477-82.
53. Hurum H, Sulheim D, Thaulow E, Wyller VB. Elevated nocturnal blood pressure and heart rate in adolescent chronic fatigue syndrome. Acta Paediatr. 2011;100:289-92.