TY - JOUR
T1 - Double-blind placebo-controlled study of the efficacy of oral terfenadine in the treatment of chronic fatigue syndrome
AU - Steinberg, Paul
AU - McNutt, Bruce E.
AU - Marshall, Paul
AU - Schenck, Carlos
AU - Lurie, Nicole
AU - Pheley, Alfred
AU - Peterson, Phillip K.
N1 - Funding Information:
Supported in part by a grant from Marion Merrell Dow Inc., Kansas City, Mo.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1996
Y1 - 1996
N2 - 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.
AB - 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.
KW - Chronic fatigue syndrome
KW - antihistamines
KW - atopy
KW - delayed skin tests
KW - immediate skin tests
KW - terfenadine
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U2 - 10.1016/S0091-6749(96)70290-7
DO - 10.1016/S0091-6749(96)70290-7
M3 - Article
C2 - 8568124
AN - SCOPUS:0030026392
SN - 0091-6749
VL - 97
SP - 119
EP - 126
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 1 I
ER -