Effect of bemer magnetic field therapy on the level of fatigue in patients with multiple sclerosis: a randomized, double-blind controlled trial

THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINEVolume 15, Number 5, 2009, pp. 507–511ª Mary Ann Liebert, Inc.
DOI: 10.1089=acm.2008.0501 Effect of BEMER Magnetic Field Therapy on the Level of Fatigue in Patients with Multiple Sclerosis: A Randomized, Double-Blind Controlled Trial Joachim Piatkowski, M.D.,1 Simone Kern, Ph.D.,2 and Tjalf Ziemssen, M.D.2 Objectives: 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.
Design: This was a monocenter, patient- and rater-blinded, placebo-controlled trial.
Patients: There were 37 relapsing-remitting patients with MS with significant fatigue in the study.
Intervention: The intervention consisted of BEMER magnetic field treatment for 8 minutes twice daily incomparison to placebo for 12 weeks.
Outcome measures: 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 ExpandedDisability Status Scale (EDSS).
Results: There was evidence of a significant difference of MFIS value (primary outcome criterion) after 12 weeksin favor of the verum group (26.84 versus 36.67; p ¼ 0.024). In addition, FSS values were significantly lower in theverum group after 12 weeks (3.5 versus 4.7; p ¼ 0.016). After 6 weeks’ follow-up, verum and placebo groups didnot differ in experienced fatigue (MFIS, FSS). Regarding the subscales of the MFIS, there was a significantdecrease in physical ( p ¼ 0.018) and cognitive ( p ¼ 0.041), but not in psychologic subscales only in the verumgroup regarding the timepoints baseline and 12 weeks. BEMER therapy was well tolerated.
Discussion: In this pilot study, we were able to demonstrate a beneficial effect of BEMER intervention on MSfatigue. As this was only a pilot study, trials with more patients and longer duration are mandatory to describelong-term effects.
with magnetic resonance imaging markers of disease activity,although it does seem to increase when the patient experi- Fatigue is among the most common symptoms of mul- encesrelapses.2,4Fatigueisamajorcauseofunemploymentin tiple sclerosis (MS), affecting at least 75% of patients,1 for patients with MS.5–7 The etiology and pathophysiology of many of whom it constitutes one of the worst and most dis- MS-related fatigue remain unknown. Studies have failed to tressing features.2 Fatigue is reported in all clinical pheno- demonstrate an association between MS-related fatigue and types of MS and affects patients of all ages.3 This symptom is the level of disability, clinical disease subtype, or gender.8 an integral part of the disease process that is usually present at Imaging studies using positron emission tomography suggest the time of diagnosis and in some cases represents one of the that fatigue in MS is related to hypometabolism of specific reasons for which patients originally consult a neurologist.
brain areas, including the frontal and subcortical circuits.9 Fatigue is not closely related to physical signs of disability or Different components of fatigue have been described such as 1Neurological Outpatient Center Reichenbachstrasse, Dresden, Germany.
2MS Center Dresden, Department of Neurology, University of Technology Dresden, Dresden, Germany.
motor and cognitive fatigue and lassitude. Management bo); all 4 had no time left for the two applications per day.
strategies include medications, exercise, and behavioral ther- Data analysis was therefore restricted to the remaining 37 apy.10 There have been reports on positive effects of immu- patients with complete data sets because for the lost 4 pa- nomodulatory drugs on fatigue.11 However, the efficacy of tients, no follow-up data were available. Female and male patients between 18 and 65 years were enrolled in the study In addition to pharmacological interventions, non- when they (1) had relapsing-remitting MS as defined by Poser pharmacological treatments including yoga, aerobic exer- et al.,19 (2) accepted the informed consent, and (3) had sig- cises, cooling therapy, and energy conservation techniques nificant fatigue as reported by the patient. Reasons to refuse have been used sucessfully. A recent meta-analysis summa- were (1) previous therapy with pulsed electromagnetic fields, rized promising data on electromagnetic field devices12: Ri- (2) acute relapse of MS within the last month as we were chards et al. and Lappin et al. demonstrated a positive effect interested in the effect of magnetic field therapy on chronic of low-level pulsed, electromagnetic field devices worn by fatigue that can be interfered with by an acute relapse, (3) the patients.13,14 Unfortunately, there were no long-term data psychiatric or neurological disorders other than multiple available. Although Mostert and Kesselring showed disap- sclerosis, (4) actual treatment with amantadine, aminopyr- pointing data on pulsed magnetic field therapy as an addi- idine, or modafinil as drug therapy for fatigue to avoid in- tional effect of a multimodal neurological rehabilitation terference of anti-fatigue effects of drugs and magnetic field program on fatigue,15 Sandyk documented improved phys- therapy or (5) pregnancy. Randomization to verum and pla- ical and cognitive fatigue in case studies of patients with MS cebo group was performed by block randomization. Patients after a course of treatment.16,17 It is only hypothetical why and physician=statistician were blinded. All patients were there is a positive impact of magnetic field therapy on MS told in the informed consent document that there was a 50% fatigue. Factors such as energy metabolism, oxygen supply, chance to receive placebo and verum treatment. All devices and microcirculation are discussed.12 The tendency for pos- looked identical and were numbered. The placebo-verum itive results warrants further investigation using a double- coding was only used for the final analysis. The success of blinded, controlled protocol. There are different patterns blinding was not evaluated, and patients were unblinded af- of pulsed magnetic field therapies available. Bio-Electro- Magnetic-Energy-Regulation (BEMER, Innomed Interna- The BEMER therapy was used to stimulate by extremely tional AG, Lichtenstein) therapy uses broadband, extremely weak, low-frequency pulsed electromagnetic fields (with weak, low frequent pulsed electromagnetic fields induced by mean of 14 mT) induced by flexible, flat electric coils. The flexible, flat electric coils.18 Although there have been sev- BEMER signal consists of a series of half-wave-shaped sinu- eral anecdotal positive reports with this device, no placebo- soidal intensity variations. Starting out with low values, the controlled, double-blinded study is currently available in the intensity initially increases slowly and then drops again to a value that, however, is located at a higher level within the Our study was designed to evaluate the long-term effect of impulse than the initial value. This sequence keeps repeating BEMER therapy in patients with MS with significant fatigue in itself, while the intensity variations gets denser and the drift a typical outpatient setting: Patients with relapsing-remitting from the zero line gradually increases. Correspondingly, the MS and significant fatigue were randomized to BEMER or ups and downs keep getting steeper. The intensity process placebo treatment and were evaluated after 6 and 12 weeks repeats itself 33.3 times per second. After 2 minutes, the using different fatigue scales. We hypothesize that patients magnetic field changes its polarity. The duration of the signal with relapsing-remitting MS who use the BEMER for 8 min- sequences was set empirically via a control device to a period utes twice a day for 12 weeks, will experience improvement in of 8 minutes. In this way, the magnetic field of the BEMER fatigue, compared to patients who use a placebo device.
3000 systems is, in the first approximation, a typical pulsingconstant electromagnetic direct current field that is asym-metrical to the zero line. The BEMER device includes a control device that produces the patented BEMER signal and that The present study was a randomized, patient- and rater- could be turned on=off by the patient. It is connected with an blinded, placebo-controlled trial conducted in a neurological all-metal mat that is hooked up to the control device via a outpatient center in Dresden. The study lasted 3 months and was performed between 2006 and 2007. The study protocol For this study, patients with MS were asked to lie down was approved by the international ethical committee Frei- on the mattress for 8 minutes twice every day at their private burg, Germany (EC 02=TS=06). It was conducted according home. Compliance of the patient was controlled by a special to the Declaration of Helsinki (Hong Kong Amendment) and diary. In the treatment group (verum), the BEMER mattress pertinent national legal and regulatory requirements. Prior to was activated whereas in the control group (placebo), no study entry, each patient provided written, informed consent magnetic field was generated although there was the typical and was free to withdraw from the study at any time for any reason without consequences on the care provided.
Patients were evaluated at inclusion and after 6 and 12 Forty-one (41) ambulatory patients with clinically definite, weeks of treatment at the same time of day (10 am). At each relapsing-remitting MS were randomly assigned to treat- visit, patients underwent a full neurologic assessment, any ment with BEMER or to sham therapy twice a day over 3 relapses occurring since the previous visit were ascertained, months. The sample size was calculated before using the and disability was assessed with the Expanded Disability software nQuery Advisor 6.0 (Statistical Solutions, Cork, Status Scale (EDSS).20 Multiple Sclerosis Functional Com- Ireland) with a power of 97% (two-sided test, a ¼ 0.05). A posite (MSFC) was performed each time. Fatigue was as- total of 4 patients were lost to follow-up (2 verum, 2 place- sessed by the patient using the fatigue severity scale (FSS), a Table 1. Demographic Characteristics of the Multiple At baseline, both groups did not differ in terms of EDSS Sclerosis Patients in the Verum and Placebo Group (Student’s test: t ¼ 1.21; not significant (n.s.)), MSFC (Stu-dent’s t-test: t ¼ 0.7; n.s.), duration of disease (Student’s t-test: t ¼ 1.10; n.s.) and ADS-L (Student’s t-test: t ¼ À1.23; n.s.).
Fatigue scores (MFIS, FSS) were slightly higher in the pla- cebo group compared to the verum group, but this effect did not reach statistical significance (Student’s t-test: MFIS: t ¼ À1.36; n.s.; FSS: t ¼ À1.15; n.s.) (Table 2).
Primary outcome criterion: MFIS baseline versus Regarding the primary endpoint of our study, there was evidence of a significant difference of MFIS value after 12 Data are presented as mean Æ standard deviation. EDSS, ex- weeks in favor of the verum group (26.84 versus 36.67; Stu- panded disability status scale; MSFC, Multiple Sclerosis Functional dent’s t-test for independent samples: MFIS12weeks: t ¼ À2.36; Scale; GA, glatiramer acetate; IFN, interferon-b.
visual analogue scale scored from 0 (no fatigue) to 10 Secondary outcome criteria: Baseline versus 6 weeks’ (maximum possible fatigue), and with the Modified Fatigue Impact Scale (MFIS)21 in its validated German translation.
This is a 21-item questionnaire that yields a total score After 6 weeks’ treatment, verum and placebo groups did ranging from 0 (no impact of fatigue) to 84 points (maximum not differ in experiencing fatigue (Student’s t-test for inde- impact of fatigue), as well as three subscales representing the pendent samples; MFIS6weeks: t ¼ À1.38; n.s.; FSS6weeks: physical (score range 0–36), cognitive (score range 0–40), and t ¼ À2.03; n.s.) (Table 2). However, looking at changes in fa- psychosocial (score range 0–8) dimensions of fatigue. De- tigue over time, there was a decrease in fatigue measured by pression was evaluated by the long German version of the the FSS in the verum but not the placebo group after 6 weeks Center for Epidemiologic Studies Depression Scale (CES-D) compared to baseline (paired t-test: FSS6weeks=verum: t ¼ 2.68; general depression scale–long version (ADS-L).22 p ¼ 0.015; FSS6weeks=placebo: t ¼ 0.98; n.s.) (Table 3). No differ- Group differences in MFIS, FSS, MSFC, EDSS, and ADS-L ences for the MFIS or MFIS subscales (physical, cognitive, scores between verum and placebo groups at the different psychologic) over time were observed for either group (paired timepoints were evaluated by Student’s t-test for indepen- t-test: MFIS6weeks=verum: t ¼ 1.14; n.s.; MFIS6weeks=placebo: dent samples. Changes in fatigue scores over time were statistically assessed by paired t-tests for the placebo and the Self-rated depressive symptoms by the CES-D did not dif- verum group, respectively. Differences in gender group fer between groups after 6 weeks’ treatment (Student’s t-test composition were assessed with a w2 test. All comparisons for independent samples: ADS-L6weeks: t ¼ À0.76; n.s.). There were two-tailed and a p value of <0.05 was taken as being was also no change in depressive symptoms expression over time in either group (paired t-test: ADS-L6weeks=verum: t ¼ 0.33; The BEMER devices were kindly supplied by Innomed n.s. = ADS-L6weeks=placebo: t ¼ 0.45; n.s.).
International AG, Lichtenstein. No additional support was Secondary outcome criteria: Baseline versus In addition to significant different fatigue ratings by MFIS between the verum and placebo groups, there was evidence Study population and baseline characteristics for a significant difference of FSS value after 12 weeks’ treat- Baseline demographic characteristics are presented in ment in favor of the verum group (Student’s t-test for inde- Table 1. Verum and placebo groups did not statistically differ pendent samples: FSS12weeks: t ¼ À2.53; p ¼ 0.016). In the in terms of age or gender group composition.
verum group but not in the placebo group, there was a Table 2. Changes of Modified Fatigue Impact Scale ( MFIS) Overall Score and as well as Physical, Cognitive, and Psychologic Subscores in Verum and Placebo Group at Baseline, 6 Weeks, and 12 Weeks Changes of MFIS overall score. Data are presented as mean Æ standard deviation (SD).
Table 3. Changes of MSFC, EDSS, MFIS, FSS, and ADS-L in Verum and Placebo Group at Baseline, Data are presented as mean Æ standard deviation (SD).
MSFC, Multiple Sclerosis Functional Scale; EDSS, Expanded Disability Status Scale; MFIS, Modified Fatigue Impact Scale; FSS, Fatigue Severity Scale; ADS-L, general depression scale–long version.
significant decrease in perceived fatigue over this 12-week following physical activity by extracranially applied elec- period (paired t-test; FSS12weeks=verum: 3.87; p ¼ 0.001; MFIS12weeks=verum: t ¼ 3.12; p ¼ 0.006; FSS12weeks=placebo: 1.50; A recent meta-analysis summarized beneficial effects of p ¼ n.s.; MFIS12weeks=placebo: t ¼ 0.53; p ¼ n.s.). Regarding the electromagnetic fields on MS fatigue, but recommended subscales of the MFIS, there was a significant decrease in physical (paired t-test: MFIS=phys12weeks=verum: t ¼ 2.6; p ¼ Other experiments have already investigated the effect of 0.018; MFIS=phys12weeks=placebo: t ¼ 0; n.s.) and cognitive electromagnetic fields on MS fatigue so far. Lappin et al.
demonstrated a reduction of MS fatigue by 0.5 points on a MFIS=cog12weeks=placebo: t ¼ 0.43; p ¼ n.s.) but not in psycho- modified five-item scale out of the MS Quality of Life In- logic subscales (paired t-test: MFIS=psy12weeks=verum: t ¼ 1.83; ventory by wearing a small portable pulsing electromagnetic n.s.; MFIS=psy12weeks=placebo: t ¼ 1.44; n.s.) only in the verum device next to the skin over the brachial plexus 24 hours a group regarding the timepoints baseline and 12 weeks’ day for 4 weeks.14 Expressed in relative terms, this was a decrement of fatigue by roughly 20%. The placebo effect of Self-rated depressive symptoms by CES-D did not differ the sham intervention in their study was 0.36 points (about between groups after 12 weeks’ treatment (Student’s t-test for 14%). A preliminary study of the same study group with 30 independent samples: ADS-L12weeks: t ¼ 1.35; n.s.). There was patients with the same device used 24 hours per day over a a tendency for decreased depressive symptoms compared to 2-month period also demonstrated a beneficial effect of baseline in the verum group, but this effect did not reach pulsed magnetic field therapy on a combined performance statistical significance (paired t-test: ADS-L12weeks=verum: scale rating for bladder control, cognitive function, fatigue t ¼ 2.03; (0.058=n.s.)=ADS-L12weeks=placebo: t ¼ 0.89; n.s.).
level, mobility, spasticity, and vision.13 There were no significant side-effects during verum and In contrast, Mostert and Kesselring used a device (mag- netic cell regeneration system by Santerra) that was compa-rable to the BEMER system as it was applied for 16 minutestwice daily. They were not able to demonstrate a beneficial effect of pulse electromagnetic field therapy as an additional Our study was focused on effects of a new type of pulsed component to a multimodal neurologic rehabilitation pro- low-frequency electromagnetic fields of the BEMER 3000 gram on fatigue.15 In comparison to our study, the level of device on MS fatigue after 6 weeks and 12 weeks. The pa- fatigue was slightly higher as measured by the FSS (5.5).
tients were evaluated by a panel of different questionnaires Unfortunately, other studies could not be compared re- (MFIS, FSS, ADS-L) in addition to MSFC and EDSS testing.
garding the baseline fatigue level because they used other Using a randomized placebo-controlled protocol, we were scales. Because Mostert and Kesselring described a wide able to demonstrate a modest, but statistically significant variability of measurements using the visual analogue scale, advantage for the verum treatment group concerning an ef- we decided to focus our evaluation of MS fatigue only on fect on the MFIS and FSS over a 3-month period. Although FSS and MFIS scales. In contrast to this study, we measured both groups showed a decrease of fatigue over the inter- fatigue level not directly after the application of electro- vention time, MFIS score was significantly lower in the magnetic field therapy, but in the study center always at 10 verum than in the placebo group 3 months later, which re- am. Our patients were not enrolled in a specific rehabilitation flects a statistical advantage of the BEMER treatment ac- program, which may have additional positive effects on MS cording the predefined primary outcome criteria.
fatigue that may be confounded in their study. Mostert and There is growing evidence in the literature of a beneficial Kesselring have already described that a special rehabilita- effect of magnetic field therapy on different MS symptoms tion program with short-time exercise treatment was able to such as fatigue, bladder control, spasticity, and quality of life.
reduce MS fatigue in a significant way.25 Nielsen and Sinkjaer reported a reduction of spasticity by Of course, there are statistical limitations of this study.
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confirm the findings from this pilot study. Again, it is not 13. Richards TL, et al. Double-blind study of pulsing magnetic possible to compare the different devices, as the physiology field effects on multiple sclerosis. J Altern Complement Med of magnetic field therapy is not well known. Magnetic field therapy is used in a lot of clinical settings. Unfortunately, 14. Lappin MS, Lawrie FW, Richards TL, Kramer ED. Effects of scientific data on mechanism and so on are still missing. We a pulsed electromagnetic therapy on multiple sclerosis fa- are beginning to investigate physiologic changes induced by tigue and quality of life: A double-blind, placebo controlledtrial. Altern Ther Health Med 2003;9:38–48.
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