Double-blind placebo-controlled study of the efficacy of oral terfenadine in the treatment of chronic fatigue syndrome☆,☆☆,★,★★

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Abstract

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. (J ALLERGY CLIN IMMUNOL 1996;97:119-26.)

Section snippets

Patients

Thirty patients with CFS 18 years of age or older were recruited from the registry of the Minnesota Regional CFS Research Program established at Hennepin County Medical Center, Minneapolis, in 1988.2 Study volunteers were selected from patients who responded to a letter sent to all members of the registry. All patients lived in Minnesota or neighboring communities of Wisconsin or Iowa, and most had been referred by infectious disease specialists or rheumatologists. The study was conducted in

Demographics

The demographic features of the 30 study participants are shown in Table I. Two patients (one receiving treatment, one receiving placebo) were excluded from the evaluation of treatment efficacy because they withdrew from the study because of their perception of no improvement. Twenty-three of 30 (77%) were women. The 30 subjects ranged in age from 19 to 74 years (mean age, 36.2 years). There were no significant differences between the treatment and placebo groups with regard to age, sex,

DISCUSSION

The mean age (36 years) and female-to-male ratio (3:3) of the patients with CFS in this trial were similar to that of our entire CFS registry, 38 years and 3.7, respectively, and to that described in the literature.1, 31 The 90% with positive histories of allergy and/or positive immediate skin tests is also similar to the 83% observed in a CFS study group reported by Straus et al.4 The immediate cutaneous reactivity rate to selected allergens of 16 of 30 (53.3%) is similar to the 50% rate

Acknowledgements

We thank Stacey Larson for help with preparation of the manuscript and the staff of the Drug Evaluation Unit for care of the patients.

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    • Cited by (0)

    ☆

    From the Departments of aMedicine, cPsychiatry and the dProgram in Clinical Epidemiology, Effectiveness and Policy, Hennepin County Medical Center, Minneapolis; and b Marion Merrell Dow Inc., Kansas City, Mo.

    ☆☆

    Supported in part by a grant from Marion Merrell Dow Inc., Kansas City, Mo.

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    Reprint requests: Paul Steinberg, MD, Department of Internal Medicine, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415.

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    0091-6749/96 $5.00 + 0 1/1/65251

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