Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial.
OBJECTIVE
To evaluate the potential benefit of immunologic therapy with dialyzable leukocyte extract and psychologic treatment in the form of cognitive-behavioral therapy (CBT) in patients with chronic fatigue syndrome (CFS).


METHODS
Immunologic and psychologic treatments were administered to 90 adult patients who fulfilled diagnostic criteria for CFS in a double-blind, randomized, and placebo-controlled study. A four-cell trial design allowed the assessment of benefit from immunologic and psychologic treatment individually or in combination. Outcome was evaluated by measurement of global well-being (visual analogue scales), physical capacity (standardized diaries of daily activities), functional status (Karnofsky performance scale), and psychologic morbidity (Profile of Mood States questionnaire), and cell-mediated immunity was evaluated by peripheral blood T-cell subset analysis and delayed-type hypersensitivity skin testing.


RESULTS
Neither dialyzable leukocyte extract nor CBT (alone or in combination) provided greater benefit than the nonspecific treatment regimens.


CONCLUSIONS
In this study, patients with CFS did not demonstrate a specific response to immunologic and/or psychologic therapy. The improvement recorded in the group as a whole may reflect both nonspecific treatment effects and a propensity to remission in the natural history of this disorder.
Lloyd
A R
AR
Department of Immunology, Prince Henry Hospital, Sydney, Australia.
Hickie
I
I
Brockman
A
A
Hickie
C
C
Wilson
A
A
Dwyer
J
J
Wakefield
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D002457:Cell Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003956:Dialysis; D004311:Double-Blind Method; D005081:Exercise Therapy; D015673:Fatigue Syndrome, Chronic / Q000523:psychology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy; D007273:Injections, Intramuscular; D007962:Leukocytes / Q000737:chemistry*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
D002457:Cell Extracts; D010919:Placebos