INTRAVENOUS IMMUNOGLOBULIN IS INEFFECTIVE IN THE TREATMENT OF PATIENTS WITH CHRONIC-FATIGUE-SYNDROME

PURPOSE: TO determine whether the reported therapeutic benefit of intr avenous immunoglobulin in patients with chronic fatigue syndrome (CFS) is dose dependent. PATIENTS AND METHODS: Ninety-nine adult patients, who fulfilled diagnostic criteria for CFS, participated in this double -blind, randomized, and placebo-controlled trial. Patients received in travenous 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 bas is for 3 months, followed by a treatment-free follow-up period of 3 mo nths. Outcome was assessed by changes in a series of self-report measu res (quality-of-life visual analog scales, standardized diaries of dai ly activities, the profile of mood states questionnaire) and the Karno fsky 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 constitutio nal symptoms, were reported by 70% to 80% of patients, with no relatio nship to immunoglobulin treatment. CONCLUSIONS: Intravenous immunoglob ulin cannot be recommended as a therapy for the treatment of CFS. A be tter understanding of the pathophysiology of this disorder is needed b efore effective treatment can be developed. (C) 1997 by Excerpta Medic a, Inc.