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QJM Advance Access originally published online on June 29, 2006
QJM 2006 99(7):461-468; 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

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

C. McDermott1,2,, S.C.M. Richards2, P.W. Thomas3,4, J. Montgomery2 and G. Lewith1

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

Address correspondence to Dr C. McDermott, Complementary Medicine Research Unit, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST. email: crm202{at}soton.ac.uk

Received 27 November 2005 and in revised form 8 April 2006

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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