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A Randomized Controlled Trial

Peter C. Rowe, MD; Hugh Calkins, MD; Karen DeBusk, RN; Robin McKenzie, MD; Ravinder Anand, PhD; Geetika Sharma, MD; Brenda A. Cuccherini, NP,PhD; Norberto Soto, MD; Patricia Hohman, RN; Sally Snader, RN; Katherine E. Lucas, MHS; Mark Wolff, PhD; Stephen E. Straus, MD

JAMA. 2001;285:52-59.

Context  Patients with chronic fatigue syndrome (CFS) are more likely than healthy persons to develop neurally mediated hypotension (NMH) in response to prolonged orthostatic stress.

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 with CFS.

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).

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