Intravenous Immunoglobulin is Ineffective in the Treatment of Patients with Chronic Fatigue Syndrome

doi:10.1016/S0002-9343(97)90045-0

The American Journal of Medicine

Volume 103, Issue 1, July 1997, Pages 38-43

https://doi.org/10.1016/S0002-9343(97)90045-0 Get rights and content

Abstract

PURPOSE: To determine whether the reported therapeutic benefit of intravenous 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 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-report 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.

Section snippets

Patients

Ninety-nine patients with CFS were enrolled in the collaborating Australian institutions: 82 at the Prince Henry Hospital, Sydney, and 17 at the Woden Valley Hospital, Canberra. A diagnosis of CFS required that a medical and psychiatric history, a thorough physical examination, and laboratory assessment did not establish another explanation for chronic fatigue to meet diagnostic criteria for CFS, which were available at the time of enrollment for this study.18, 19The standardized investigation

Evaluation at Entry

The randomization code allocated 73 patients to receive immunoglobulin (22 received 0.5 g/kg, 28 1 g/kg, and 23 2 g/kg dosage) and 26 to receive placebo. The demographic, immunologic, and clinical data obtained on entry are shown in Table 1. There were no statistically significant differences between the treatment groups for these variables. Apparent between-group differences in the proportions of patients with abnormal DTH skin responses, the number of CD4 positive lymphocytes, and the POMS

Discussion

The results of this double-blind, placebo-controlled trial fail to demonstrate any significant benefit across several dosages of intravenous immunoglobulin in the treatment of CFS. Although some improvement in clinical symptoms (including functional capacity, subjective energy, QAL scores) were demonstrated, these improvements were not linked to a particular dosage of immunoglobulin. In fact, improvements occurred irrespective of whether patients received immunoglobulin or placebo infusions.

Acknowledgements

This study was supported by Commonwealth Serum Laboratories and the Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis Society of New South Wales.

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Similarly, although growth hormone therapy was found not to improve quality of life indices, 23% of patients so treated returned to work after long absences.151 There have been contradictory results with trials of IVIG in the treatment of CFS, although most studies indicate no benefit.152–154 CBT has consistently been found effective in CFS.155,156

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Intravenous Immunoglobulin is Ineffective in the Treatment of Patients with Chronic Fatigue Syndrome

Abstract

Section snippets

Patients

Evaluation at Entry

Discussion

Acknowledgements

Am J Med.

Am J Med.

Am J Med.

J Infect.

Lancet.

Lancet.

Am J Med.

The chronic fatigue syndrome: A comprehensive approach to its definition and study

Ann Intern Med.

Can the chronic fatigue syndrome be defined by distinct clinical features?

Psychol Med.

The economic impact of chronic fatigue syndrome

Med J Aust.

The chronic mononucleosis syndrome

J Infect Dis.

The existence of a fatigue syndrome after glandular fever

Psychol Med.

The validity and reliability of the fatigue syndrome which follows glandular fever

Psychol Med.