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Rowe PC, Calkins H, DeBusk K, et al. Fludrocortisone Acetate to Treat Neurally Mediated Hypotension in Chronic Fatigue Syndrome: A Randomized Controlled Trial. JAMA. 2001;285(1):52–59. doi:10.1001/jama.285.1.52
Author Affiliations: Departments of Pediatrics and Medicine, Johns Hopkins University School of Medicine, Baltimore, Md (Drs Rowe and Calkins, Mss DeBusk, Snader, and Lucas); Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases , National Institutes of Health, Bethesda (Drs McKenzie, Sharma, Cuccherini, Soto, and Straus, and Ms Hohman); and the EMMES Corp, Potomac, Md (Drs Anand and Wolff).
Context Patients with chronic fatigue syndrome (CFS) are more likely than healthy
persons to develop neurally mediated hypotension (NMH) in response to prolonged
Objective To examine the efficacy of fludrocortisone acetate as monotherapy for
adults with both CFS and NMH.
Design Randomized, double-blind, placebo-controlled trial conducted between
March 1996 and February 1999.
Setting Two tertiary referral centers in the United States.
Patients One hundred individuals aged 18 to 50 years who satisfied Centers for
Disease Control and Prevention criteria for CFS and had NMH provoked during
a 2-stage tilt-table test. Eighty-three subjects had adequate outcome data
to assess efficacy.
Intervention Subjects were randomly assigned to receive fludrocortisone acetate,
titrated to 0.1 mg/d (n = 50) or matching placebo (n = 50) for 9 weeks, followed
by 2 weeks of observation after discontinuation of therapy.
Main Outcome Measure Proportion of subjects in each group with at least a 15-point improvement
on a 100-point global wellness scale.
Results Baseline demographic and illness characteristics between the groups
were similar; CFS had been present for at least 3 years in 71%. Using an intention-to-treat
analysis, 7 subjects (14%) treated with fludrocortisone experienced at least
a 15-point improvement in their wellness scores compared with 5 (10%) among
placebo recipients (P = .76). No differences were
observed in several other symptom scores or in the proportion with normal
follow-up tilt test results at the end of the treatment period.
Conclusions In our study of adults with CFS, fludrocortisone as monotherapy for
NMH was no more efficacious than placebo for amelioration of symptoms. Failure
to identify symptomatic improvement with fludrocortisone does not disprove
the hypothesis that NMH could be contributing to some of the symptoms of CFS.
Further studies are needed to determine whether other medications or combination
therapy are more effective in treating orthostatic intolerance in patients
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