Double-blind placebo-controlled study of the efficacy of oral terfenadine in the treatment of Chronic Fatigue Syndrome (CFS)

BACKGROUND: There is no established treatment for chronic fatigue
syndrome (CFS), an illness characterized by disabling fatigue
exacerbated by physical activity. A variety of immunologic
abnormalities have been reported, including a high incidence
of atopy and hypoergy or anergy.

OBJECTIVE: Because of
anecdotal reports and uncontrolled trials showing
antihistamine efficacy in CFS, we evaluated the clinical
efficacy of the antihistamine terfenadine (60 mg twice daily)
in a placebo-controlled study.

METHODS: Thirty patients with
CFS were enrolled in a 2-month, double-blind,
placebo-controlled trial of terfenadine. Participants
underwent a battery of both immediate- and delayed-type
hypersensitivity skin tests and completed a self-assessment
questionnaire used to measure severity of symptoms, physical
and social functioning, health perceptions, and mental health
before each of six biweekly visits.

RESULTS: Twenty-eight
patients completed the trial. History of atopy and positive
immediate skin test results were prevalent, 73% and 53%,
respectively. No evidence for hypoergy or anergy after
delayed-type hypersensitivity skin testing was found. No
therapeutic benefit from terfenadine could be detected in
terms of symptom amelioration, improved physical or social
functioning, health perceptions, or mental health. A high
incidence of atopy in patients with CFS was confirmed.

CONCLUSION: Although this trial involved a small number of
patients, the results suggest that terfenadine is unlikely to
be of clinical benefit in treating CFS symptoms.

Steinberg P, McNutt BE, Marshall P, Schenck C, Lurie N, Pheley A,
Peterson PK

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