 |
|
A Preliminary Placebo-Controlled Crossover Trial of Fludrocortisone for Chronic Fatigue Syndrome
Phillip K. Peterson, MD;
Alfred Pheley, PhD;
Jill Schroeppel, MD;
Carlos Schenck, MD;
Paul Marshall, PhD;
Allan Kind, MD;
J. Mark Haugland, MD;
Lawrence J. Lambrecht, PharmD;
Suzanne Swan, MD;
Steven Goldsmith, MD
Arch Intern Med. 1998;158:908-914.
Objective To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome.
Design A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone.
Setting An outpatient clinical trials unit.
Patients Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial.
Interventions All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment.
Main Outcome Measures Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits.
Results At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial.
Conclusion Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.
From the Departments of Medicine (Drs Peterson, Pheley, Schroeppel, Swan, and Goldsmith) and Psychiatry (Drs Schenck and Marshall) and the Drug Evaluation Unit (Drs Lambrecht and Swan), Hennepin County Medical Center, Minneapolis, Minn; Department of Medicine, Park Nicollet Clinic, St Louis Park, Minn (Drs Kind and Haugland); and the University of Minnesota Medical School, Minneapolis (Drs Peterson, Swan, Goldsmith, and Schenck).
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Qigong Ameliorates Symptoms of Chronic Fatigue: A Pilot Uncontrolled Study
Craske et al.
Evid Based Complement Alternat Med 2008;0:nem088v2-nem088.
ABSTRACT
| FULL TEXT
Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review.
Chambers et al.
JRSM 2006;99:506-520.
ABSTRACT
| FULL TEXT
Urinary Cortisol and Cortisol Metabolite Excretion in Chronic Fatigue Syndrome
Jerjes et al.
Psychosom. Med. 2006;68:578-582.
ABSTRACT
| FULL TEXT
The Placebo Response in the Treatment of Chronic Fatigue Syndrome: A Systematic Review and Meta-Analysis
Cho et al.
Psychosom. Med. 2005;67:301-313.
ABSTRACT
| FULL TEXT
Mineralocorticoid Receptor-Mediated Inhibition of the Hypothalamic-Pituitary-Adrenal Axis in Aged Humans
Otte et al.
J. Gerontol. A Biol. Sci. Med. Sci. 2003;58:B900-905.
ABSTRACT
| FULL TEXT
The Neuroendocrinology of Chronic Fatigue Syndrome
Cleare
Endocr. Rev. 2003;24:236-252.
ABSTRACT
| FULL TEXT
Chronic Fatigue Syndrome: A Review
Afari and Buchwald
Am. J. Psychiatry 2003;160:221-236.
ABSTRACT
| FULL TEXT
Interventions for the treatment and management of chronic fatigue syndrome/myalgic encephalomyelitis
Bagnall et al.
Qual Saf Health Care 2002;11:284-288.
ABSTRACT
| FULL TEXT
Interventions for the Treatment and Management of Chronic Fatigue Syndrome: A Systematic Review
Whiting et al.
JAMA 2001;286:1360-1368.
ABSTRACT
| FULL TEXT
Orthostatic Hypotension and Chronic Fatigue Syndrome
Baschetti et al.
JAMA 2001;285:1441-1443.
FULL TEXT
Fludrocortisone Acetate to Treat Neurally Mediated Hypotension in Chronic Fatigue Syndrome: A Randomized Controlled Trial
Rowe et al.
JAMA 2001;285:52-59.
ABSTRACT
| FULL TEXT
Extracts from "Clinical Evidence": Chronic fatigue syndrome
Reid et al.
BMJ 2000;320:292-296.
FULL TEXT
Treatment for Chronic Fatigue Syndrome
Baschetti et al.
Arch Intern Med 1998;158:2266-2267.
FULL TEXT
|
