A controlled trial of intravenous immunoglobulin G in chronic fatigue syndrome.
ABSTRACT Currently, there is no established therapy for chronic fatigue syndrome (CFS), a recently defined illness that has been associated with a variety of immunologic abnormalities. Based on the hypothesis that a chronic viral infection or an immunoregulatory defect is involved in the pathogenesis of CFS, the therapeutic benefit of intravenous immunoglobulin G (IV IgG) was evaluated in a group of patients with CFS. Additionally, serum immunoglobulin concentrations and peripheral blood lymphocyte subset numbers were measured at the outset of the study, and the effect of IV IgG therapy on IgG subclass levels was determined.
Thirty patients with CFS were enrolled in a double-blind, placebo-controlled trial of IV IgG. The treatment regimen consisted of IV IgG (1 g/kg) or intravenous placebo (1% albumin solution) administered every 30 days for 6 months. Participants completed a self-assessment form prior to each of the six treatments, which was used to measure severity of symptoms, functional status, and health perceptions. Patients were also asked to report adverse experiences defined as worsening of symptoms occurring within 48 hours of each treatment.
Twenty-eight patients completed the trial. At baseline, all 28 patients complained of moderate to severe fatigue, and measures of social functioning and health perceptions showed marked impairment. Low levels of IgG1 were found in 12 (42.9%), and 18 (64.3%) had low levels of IgG3. At the end of the study, no significant therapeutic benefit could be detected in terms of symptom amelioration or improvement in functional status, despite restoration of IgG1 levels to a normal range. Major adverse experiences were observed in 20% of both the IV IgG and placebo groups.
The results of this study indicate that IV IgG is unlikely to be of clinical benefit in CFS. In addition to the ongoing need for placebo-controlled trials of candidate therapies for CFS, an expanded research effort is needed to define the etiology and pathogenesis of this disorder.
Article: Chronic Fatigue SyndromePharmacoEconomics 06/1994; 5(6). DOI:10.2165/00019053-199405060-00002 · 3.34 Impact Factor
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ABSTRACT: Centers for Disease Control criteria for chronic fatigue syndrome (CFS) specifically recognize that patients can have both CFS and depression. The clinician's challenge is to judge for each individual patient whether the complaint of fatigue is primarily depression, physical illness, such as CFS, or a combination of both. This review differentiates CFS and fibromyalgia, discussed as “chronic fatigue syndrome and related immune deficiency syndromes” (CFIDS), from depression in terms of physical signs, symptoms, biological parameters, brain imaging, immunology, and treatment. The review focuses on practical applications of research findings with a further focus on future ability to show clear biologic separation and specific treatment. When depressive symptoms exist with those of CFS, accurate differentiation can usually be accomplished by focusing on diagnostic criteria. Presence of multiple physical signs and symptoms of CFIDS may be of great value. In terms of laboratory testing, a single helpful test may be measuring the plasma cortisol, which is usually high in depression and low in CFS. Future research should focus on the combination of plasma cortisol with an index of serotonin function, which is high in CFIDS and low in depression. Additional research should focus on neuroimaging and immune differentiation. Combination of multiple tests should result in a significant and clinically useful separation between CFIDS and major depressive disorder (MDD). In treating patients with significant depression or MDD with CFIDS, one should think of the noradrenergic approach using bupropion or low-dose tricyclic antidepressants in combination with a selective serotonin reuptake inhibitor, especially sertraline, to aid improvement of global, pain, and immunologic parameters. Alternatively, serotonin norepinephrine reuptake inhibitors (venlafaxine and duloxetine) should be considered. Future treatment research should focus on larger placebo-controlled, double-blind trials of these and other antidepressants as well as the evaluation of psychostimulants, electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).Journal of Chronic Fatigue Syndrome 12/2011; 13(4).
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ABSTRACT: Chronic fatigue syndrome (CFS) is an illness characterised by incapacitating fatigue and a pattern of somatic complaints without known cause. It is a controversial illness in that symptoms are subjective and overlap with symptoms of primary emotional disturbance. The natural history of this illness is often characterised by spontaneous improvement, and a significant placebo response is frequently present. Therefore, results from poorly controlled trials may be misleading. Few adequate treatment trials have been done in patients with CFS, due to difficulties in case definition and the lack of definitive biological markers. However, numerous treatment regimens have been proposed over the last 30 years, the majority emphasising either psychotropic, immunological or antimicrobial therapy. While no single agent has been curative, benefit has been claimed for many agents. These include tricyclic antidepressants, the selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors fluoxetine and sertraline, amfebutamone (bupropion), immunoglobulin G, mismatched double-stranded RNA [Poly(I):Poly(C12U); ‘ampligen’] and essential fatty acids.CNS Drugs 05/1994; 1(5). DOI:10.2165/00023210-199401050-00005 · 4.38 Impact Factor