Piatkowski Joachim, Kern Simone, Ziemssen Tjalf
Neurological Outpatient Center Reichenbachstrasse, Dresden, Germany.
J Altern Complement Med. 2009 May;15(5):507-11. doi: 10.1089/acm.2008.0501.
Electromagnetic field therapy has been reported to be beneficial in patients with multiple sclerosis (MS) with significant fatigue. This study was designed to evaluate the long-term effects of Bio-Electro-Magnetic-Energy-Regulation (BEMER) on MS-related fatigue.
This was a monocenter, patient- and rater-blinded, placebo-controlled trial.
There were 37 relapsing-remitting patients with MS with significant fatigue in the study.
The intervention consisted of BEMER magnetic field treatment for 8 minutes twice daily in comparison to placebo for 12 weeks.
The primary outcome criterion was change in the Modified Fatigue Impact Scale (MFIS) between baseline and 12 weeks. The secondary outcome criteria were changes of the Fatigue Severity Scale (FSS), a general depression scale-long version (ADS-L), Multiple Sclerosis Functional Scale (MSFC), and the Expanded Disability Status Scale (EDSS).
There was evidence of a significant difference of MFIS value (primary outcome criterion) after 12 weeks in favor of the verum group (26.84 versus 36.67; p = 0.024). In addition, FSS values were significantly lower in the verum group after 12 weeks (3.5 versus 4.7; p = 0.016). After 6 weeks' follow-up, verum and placebo groups did not differ in experienced fatigue (MFIS, FSS). Regarding the subscales of the MFIS, there was a significant decrease in physical (p = 0.018) and cognitive (p = 0.041), but not in psychologic subscales only in the verum group regarding the timepoints baseline and 12 weeks. BEMER therapy was well tolerated.
In this pilot study, we were able to demonstrate a beneficial effect of BEMER intervention on MS fatigue. As this was only a pilot study, trials with more patients and longer duration are mandatory to describe long-term effects.
据报道，电磁场疗法对患有严重疲劳的多发性硬化症（MS）患者有益。本研究旨在评估生物电磁能量调节（BEMER）对MS相关疲劳的长期影响。
这是一项单中心、患者和评估者双盲、安慰剂对照试验。
本研究中有37例复发缓解型MS患者伴有严重疲劳。
干预措施为与安慰剂相比，BEMER磁场治疗，每天两次，每次8分钟，持续12周。
主要观察指标为基线至12周期间改良疲劳影响量表（MFIS）的变化。次要观察指标为疲劳严重程度量表（FSS）、一般抑郁量表长版（ADS-L）、多发性硬化功能量表（MSFC）和扩展残疾状态量表（EDSS）的变化。
有证据表明，12周后MFIS值（主要观察指标）存在显著差异，真治疗组更优（26.84对36.67；p = 0.024）。此外，12周后真治疗组的FSS值显著更低（3.5对4.7；p = 0.016）。随访6周后，真治疗组和安慰剂组在经历的疲劳方面（MFIS、FSS）无差异。关于MFIS的子量表方面，仅真治疗组在基线和12周时间点时，身体（p = 0.018）和认知（p = 0.041）子量表有显著下降，心理子量表无显著下降。BEMER疗法耐受性良好。
在这项初步研究中，我们能够证明BEMER干预对MS疲劳有有益效果。由于这只是一项初步研究，因此需要进行更多患者参与、更长时间的试验来描述长期效果。
