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document
A double-blind , placebo-controlled trial of intravenous immunoglobulin therapy in patients with chronic fatigue syndrome . PURPOSE The chronic fatigue syndrome ( CFS ) is characterized by profound fatigue , neuropsychiatric dysfunction , and frequent abnormalities in cell-mediated immunity . No effective therapy is known . PATIENTS AND METHODS Forty-nine patients ( 40 with abnormal cell-mediated immunity ) participated in a randomized , double-blind , placebo-controlled trial to determine the effectiveness of high-dose intravenously administered immunoglobulin G. The patients received three intravenous infusions of a placebo solution or immunoglobulin at a dose of 2 g/kg/month . Assessment of the severity of symptoms and associated disability , both before and after treatment , was completed at detailed interviews by a physician and psychiatrist , who were unaware of the treatment status . In addition , any change in physical symptoms and functional capacity was recorded using visual analogue scales , while changes in psychologic morbidity were assessed using patient-rated indices of depression . Cell-mediated immunity was evaluated by T-cell subset analysis , delayed-type hypersensitivity skin testing , and lymphocyte transformation with phytohemagglutinin . RESULTS At the interview conducted by the physician 3 months after the final infusion , 10 of 23 ( 43 % ) immunoglobulin recipients and three of the 26 ( 12 % ) placebo recipients were assessed as having responded with a substantial reduction in their symptoms and recommencement of work , leisure , and social activities . The patients designated as having responded had improvement in physical , psychologic , and immunologic measures ( p less than 0.01 for each ) . CONCLUSION Immunomodulatory treatment with immunoglobulin is effective in a significant number of patients with CFS , a finding that supports the concept that an immunologic disturbance may be important in the pathogenesis of this disorder .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
intravenous immunoglobulin therapy
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
intravenously administered immunoglobulin G.
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Intervention_Control
placebo solution
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Intervention_Pharmacological
immunoglobulin
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Intervention_Pharmacological
Immunomodulatory treatment
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Intervention_Pharmacological
immunoglobulin
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Outcome_Other
substantial reduction in their symptoms
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Outcome_Other
recommencement of work
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Outcome_Physical
,
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Outcome_Other
leisure
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Outcome_Physical
, and
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Outcome_Mental
social activities
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Outcome_Other
effective
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Participant_Condition
chronic fatigue syndrome
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Participant_Sample-size
Forty-nine
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Participant_Sample-size
40
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Participant_Condition
abnormal cell-mediated immunity