Intravenous immunoglobulin is ineffective in the treatment of patients with Chronic Fatigue Syndrome (CFS)

PURPOSE: To determine whether the reported therapeutic benefit

of intravenous immunoglobulin in patients with chronic fatigue

syndrome (CFS) is dose dependent.


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


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.

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