Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial.
BACKGROUND
Multiple chemical sensitivity (MCS) is a chronic condition of unknown etiology. MCS is characterized by recurrent nonspecific symptoms from multiple organ systems in response to chemical exposures in concentrations that are normally tolerated by the majority of the population. The symptoms may have severe impact on patients' lives, but an evidence-based treatment for the condition is nonexisting. The pathophysiology is unclarified, but several indicators point towards abnormal processing of sensory signals in the central nervous system. Pulsed electromagnetic fields (PEMF) offer a promising new treatment for refractory depression and can be targeted at the brain, thereby activating biochemical cell processes.


METHODS
In a parallel, randomized, double-blind, placebo-controlled trial conducted at the Danish Research Centre for Chemical Sensitivities, the effects of PEMF in MCS patients will be assessed using the Re5 Independent System. Based on sample size estimation, 40 participants will be randomized to either PEMF therapy or placebo. The allocation sequence will be generated by computer. All involved parties (that is, participants, investigators, the research nurse, and the statistician) will be blinded to group allocation. The participants will receive PEMF therapy or placebo applied transcranially 30 minutes twice a day for 7 days a week over 6 consecutive weeks. Outcomes will be measured at baseline, once weekly during treatment, post treatment, and at 2.5-month and 4.5-month follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia, immunological markers in serum, and quality of life.


CONCLUSIONS
This trial will assess the effects of PEMF therapy for MCS. Currently, there is no treatment with a documented effect on MCS, and in terms of healthcare there is very little to offer these patients. There is thus a great need for well-conducted randomized trials aimed at assessing possible treatment effects. A positive outcome will pave the way for improved healthcare and understanding of this very disabling and overlooked condition.


BACKGROUND
ClinicalTrials.gov, NCT01834781.
The Danish Research Centre for Chemical Sensitivities, Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Ledreborg Allé 40, 2, th,, DK-2820 Gentofte, Denmark. marie.thi.dao.tran@regionh.dk
Marie Thi Dao
MT
Tran
Sine
S
Skovbjerg
Lars
L
Arendt-Nielsen
Karl Bang
KB
Christensen
Jesper
J
Elberling
D000203:Activities of Daily Living; D002985:Clinical Protocols; D017281:Cost of Illness; D003718:Denmark; D004311:Double-Blind Method; D006801:Humans; D018777:Multiple Chemical Sensitivity / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D050781:Transcranial Magnetic Stimulation; D016896:Treatment Outcome