title: Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome.
abstract: 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.
authors.affiliation: Inflammation Research Unit, School of Pathology, University of New South Wales, Sydney, Australia.
authors.forename: U
authors.initials: U
authors.lastname: Vollmer-Conna
authors.forename: I
authors.initials: I
authors.lastname: Hickie
authors.forename: D
authors.initials: D
authors.lastname: Hadzi-Pavlovic
authors.forename: K
authors.initials: K
authors.lastname: Tymms
authors.forename: D
authors.initials: D
authors.lastname: Wakefield
authors.forename: J
authors.initials: J
authors.lastname: Dwyer
authors.forename: A
authors.initials: A
authors.lastname: Lloyd
mesh_terms: 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
chemical_list: D016756:Immunoglobulins, Intravenous