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QJM Advance Access published online on June 29, 2006
QJM, doi:10.1093/qjmed/hcl063
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© The Author 2006. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: Journals.permissions@oxfordjournals.org
Received November 27, 2005
Accepted April 8, 2006

Original Papers

A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome

C. McDermott 1 *, S.C.M. Richards 2, P.W. Thomas 3, J. Montgomery 2, and G. Lewith 4

1 From the University of Southampton, UK; From the Dorset CFS Service, Wareham Community Hospital, Dorset, UK
2 From the Dorset CFS Service, Wareham Community Hospital, Dorset, UK
3 From the Dorset Research and Development Support Unit, Poole Hospital NHS Trust, Poole, UK; From the Institute of Health and Community Studies, Bournemouth University, Bournemouth, UK
4 From the University of Southampton, UK

* To whom correspondence should be addressed.
C. McDermott, E-mail: crm202{at}soton.ac.uk


  Abstract

Background: Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).

Aim: To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.

Design: Randomized, double-blind, placebo-controlled trial.

Methods: We recruited 71 patients with CFS (according to the Centers for Disease Control 1994 criteria) attending an out-patient specialist CFS service. Participants were given oral BioBran MGN-3 for 8 weeks (2 g three times per day) or placebo equivalent. The primary outcome measure was the Chalder physical fatigue score. Self-reported fatigue measures, self-assessment of improvement, change in key symptoms, quality of life, anxiety and depression measures were also included.

Results: Data were complete in 64/71 patients. Both groups showed marked improvement over the study duration, but without significant differences. Mean improvement in the Chalder fatigue score (physical scale) was 0.3 (95%CI -2.6 to 3.2) lower in the BioBran group.

Discussion: The findings do not support a specific therapeutic effect for BioBran in CFS. The improvement showed by both groups over time highlights the importance of placebo controls when evaluating interventions in CFS.


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