Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome.
OBJECTIVE
To determine whether the reported therapeutic benefit of intravenous immunoglobulin in patients with chronic fatigue syndrome (CFS) is dose dependent.


METHODS
Ninety-nine adult patients, who fulfilled diagnostic criteria for CFS, participated in this double-blind, randomized, and placebo-controlled trial. Patients received intravenous infusions with either a placebo solution (1% albumin) or one of three doses of immunoglobulin (0.5, 1, or 2 g/kg) on a monthly basis for 3 months, followed by a treatment-free follow-up period of 3 months. Outcome was assessed by changes in a series of self-reported measures (quality-of-life visual analog scales, standardized diaries of daily activities, the profile of mood states questionnaire) and the Karnofsky performance scale. Cell-mediated immunity was evaluated by T-cell subset analysis and delayed-type hypersensitivity (DTH) skin testing.


RESULTS
No dose of intravenous immunoglobulin was associated with a specific therapeutic benefit. Adverse reactions, typically constitutional symptoms, were reported by 70% to 80% of patients, with no relationship to immunoglobulin treatment.


CONCLUSIONS
Intravenous immunoglobulin cannot be recommended as a therapy for the treatment of CFS. A better understanding of the pathophysiology of this disorder is needed before effective treatment can be developed.
Vollmer-Conna
U
U
Inflammation Research Unit, School of Pathology, University of New South Wales, Sydney, Australia.
Hickie
I
I
Hadzi-Pavlovic
D
D
Tymms
K
K
Wakefield
D
D
Dwyer
J
J
Lloyd
A
A
D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015673:Fatigue Syndrome, Chronic / Q000188:drug therapy* / Q000276:immunology / Q000523:psychology; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage*; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016176:T-Lymphocyte Subsets; D016896:Treatment Outcome
D016756:Immunoglobulins, Intravenous