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

A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome
A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome
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.
complications, depression, research, female, male, double-blind, treatment outcome, humans, adult, self disclosure, activity, England, time, methods, drug therapy, xylans, mental disorders, natural, killer cells, therapeutic use, patients, polysaccharides, quality of life, anxiety, design, disease, double-blind method, fatigue, syndrome, chronic, drug effects, fatigue syndrome
1460-2725
461-468
McDermott, C.
eec8423c-c503-43be-8f79-ee5728df4949
Richards, S.C.
a7a48a2d-78a1-4418-8f1d-442dee9fd5bc
Thomas, P.W.
7fb3690c-c304-4a3b-864e-bd2415f3db16
Montgomery, J.
9347f099-1aba-413e-906b-54a67df45f4c
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625
McDermott, C.
eec8423c-c503-43be-8f79-ee5728df4949
Richards, S.C.
a7a48a2d-78a1-4418-8f1d-442dee9fd5bc
Thomas, P.W.
7fb3690c-c304-4a3b-864e-bd2415f3db16
Montgomery, J.
9347f099-1aba-413e-906b-54a67df45f4c
Lewith, G.
0fc483fa-f17b-47c5-94d9-5c15e65a7625

McDermott, C., Richards, S.C., Thomas, P.W., Montgomery, J. and Lewith, G. (2006) A placebo-controlled, double-blind, randomized controlled trial of a natural killer cell stimulant (BioBran MGN-3) in chronic fatigue syndrome. QJM: An International Journal of Medicine, 99 (7), 461-468. (doi:10.1093/qjmed/hcl063).

Record type: Article

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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More information

Published date: 2006
Keywords: complications, depression, research, female, male, double-blind, treatment outcome, humans, adult, self disclosure, activity, England, time, methods, drug therapy, xylans, mental disorders, natural, killer cells, therapeutic use, patients, polysaccharides, quality of life, anxiety, design, disease, double-blind method, fatigue, syndrome, chronic, drug effects, fatigue syndrome

Identifiers

Local EPrints ID: 61984
URI: http://eprints.soton.ac.uk/id/eprint/61984
ISSN: 1460-2725
PURE UUID: 777f8d60-d5c2-48c1-b433-1bc879c573f9

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Date deposited: 10 Sep 2008
Last modified: 15 Mar 2024 11:28

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Contributors

Author: C. McDermott
Author: S.C. Richards
Author: P.W. Thomas
Author: J. Montgomery
Author: G. Lewith

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