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).


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


METHODS
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.


CONCLUSIONS
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.
McDermott
C
C
University of Southampton, UK. crm202@soton.ac.uk
Richards
S C M
SC
Thomas
P W
PW
Montgomery
J
J
Lewith
G
G
D000328:Adult; D004311:Double-Blind Method; D004739:England; D015673:Fatigue Syndrome, Chronic / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007694:Killer Cells, Natural / Q000187:drug effects*; D008297:Male; D001523:Mental Disorders / Q000150:complications; D011134:Polysaccharides / Q000627:therapeutic use*; D011788:Quality of Life; D012650:Self Disclosure; D016896:Treatment Outcome; D014990:Xylans / Q000627:therapeutic use*
D011134:Polysaccharides; D014990:Xylans; C419427:polysaccharide MGN3