McDermott C, Richards S C M, Thomas P W, Montgomery J, Lewith G
University of Southampton, UK.
QJM. 2006 Jul;99(7):461-8. doi: 10.1093/qjmed/hcl063. Epub 2006 Jun 29.
Previous research has suggested that natural killer (NK) cell activity may be reduced in patients with chronic fatigue syndrome (CFS).
To evaluate the effectiveness of a putative NK cell stimulant, BioBran MGN-3, in reducing fatigue in CFS patients.
Randomized, double-blind, placebo-controlled trial.
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.
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.
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.
先前的研究表明，慢性疲劳综合征（CFS）患者的自然杀伤（NK）细胞活性可能会降低。
评估一种假定的NK细胞刺激剂BioBran MGN-3减轻CFS患者疲劳的有效性。
随机、双盲、安慰剂对照试验。
我们招募了71名在门诊专科CFS服务机构就诊的CFS患者（根据疾病控制中心1994年标准）。参与者口服BioBran MGN-3 8周（每日三次，每次2克）或等效安慰剂。主要结局指标是查尔德身体疲劳评分。还包括自我报告的疲劳测量、自我改善评估、关键症状变化、生活质量、焦虑和抑郁测量。
71名患者中有64名的数据完整。两组在研究期间均有显著改善，但无显著差异。BioBran组的查尔德疲劳评分（身体量表）平均改善值低0.3（95%CI -2.6至3.2）。
研究结果不支持BioBran对CFS有特定治疗效果。两组随时间推移的改善突出了在评估CFS干预措施时安慰剂对照的重要性。
