RANDOMIZED, DOUBLE-BLIND, CONTROLLED PLACEBO-PHASE IN TRIAL OF LOW-DOSE PHENELZINE IN THE CHRONIC FATIGUE SYNDROME

Because of the striking similarity of the clinical manifestations prod uced by use of the drug reserpine and seen in patients with the chroni c fatigue syndrome (CFS), we theorized that CFS was a disorder of redu ced central sympathetic drive. Because of the pharmacology of control of this central sympathetic system, we further postulated that CFS sym ptoms would respond quickly to low dose treatment with a monamine oxid ase inhibitor. To test these hypotheses, we designed a randomized, dou ble blind placebo controlled study using phenelzine. No patient in the trial had a diagnosis of lifetime or current psychiatric disorder and none had depressed mood in the range of clinically depressed patients on a paper and pencil test of depression. Patients in the placebo gro up received placebo for 6 weeks while those in the drug treatment grou p were treated in three 2-week segments - placebo, 15 mg phenelzine ev ery other day, and then 15 mg daily. This treatment regimen produced a significant pattern of improvement compared to worsening in 20 self r eport vehicles of CFS symptoms, illness severity, mood or functional s tatus, Thus the data support our hypothesis of reduced sympathetic dri ve, although an alternative hypothesis of pain alleviation is also pos sible. The study design also allowed us to evaluate patients for a pla cebo effect: no evidence for this was found, suggesting that CFS is no t an illness due to patients' being overly suggestible.