Trial Report Intravenous Immunoglobulin is Ineffective in the Treatment of Patients with Chronic Fatigue Syndrome, 1997, Vollmer-Conna et al

[Yann04]

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

Spoiler: Authors

Vollmer-Conna, Ute; Hickie, Ian; Hadzi-Pavlovic, Dusan; Tymms, Kathie; Wakefield, Denis; Dwyer, John; Lloyd, Andrew

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.

Web | DOI | The American Journal of Medicine

 

[Yann04]

1997, I wonder what criteria were used. I don’t have access to the paper (it’s paywalled it seems).

 

[TiredMathematician]

1997, I wonder what criteria were used. I don’t have access to the paper (it’s paywalled it seems).

From the paper:

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.

And cite this paper (1992): https://www.acpjournals.org/doi/10.7326/0003-4819-117-4-325

Seems to be a modified version of the 1988 CDC (Holmes) criteria.

 

[Utsikt]

It’s on SciHub.

The adverse events sound a lot like episodes of PEM:

Constitutional symptoms including headaches, worsened fatigue, malaise, and concentration im- pairment were commonly reported by all patients throughout the trial.

Of the patients receiving im- munoglobulin infusions, 18 of the 22 (88%) receiving low dose, 20 of the 28 (71%) receiving medium dose, and 18 of the 23 (78%) on high dose reported mod- erate to severe constitutional symptoms. Similar re- ports were made by 23 of the 26 (88%) placebo re- cipients.

These symptoms (in all of the groups) typically developed 12 to 24 hours after the comple- tion of the infusion and persisted for up to 10 days. There were no significant differences in the occur- rences of these symptoms between the different treatment groups (Fisher's exact test, P = 0.49).