The Danish Research Centre for Chemical Sensitivities, Department of Dermato-Allergology, Copenhagen University Hospital Gentofte, Ledreborg Allé 40, 2, th,, DK-2820 Gentofte, Denmark.
Trials. 2013 Aug 16;14:256. doi: 10.1186/1745-6215-14-256.
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/DESIGN: 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.
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.
ClinicalTrials.gov, NCT01834781.
多种化学敏感性（MCS）是一种病因不明的慢性疾病。MCS 的特征是在大多数人群可耐受的浓度下，多个器官系统出现反复的非特异性症状，对化学物质暴露产生反应。这些症状可能对患者的生活产生严重影响，但目前还没有针对这种疾病的循证治疗方法。其病理生理学尚未阐明，但有几个指标表明中枢神经系统对感觉信号的处理异常。脉冲电磁场（PEMF）为治疗难治性抑郁症提供了一种有前途的新方法，并且可以针对大脑，从而激活生化细胞过程。
方法/设计：在丹麦化学敏感性研究中心进行的一项平行、随机、双盲、安慰剂对照试验中，将使用 Re5 独立系统评估 PEMF 在 MCS 患者中的效果。根据样本量估算，将有 40 名参与者被随机分配到 PEMF 治疗组或安慰剂组。分配序列将通过计算机生成。所有相关方（即参与者、研究者、研究护士和统计学家）将对分组分配情况进行盲法。参与者将接受经颅 PEMF 治疗或安慰剂治疗，每天两次，每次 30 分钟，每周 7 天，持续 6 周。根据预定时间表，在基线、每周治疗一次、治疗后、2.5 个月和 4.5 个月随访时测量结果。主要结局是测量 MCS 对日常生活的影响。次要结局将测量 MCS 症状、心理困扰（压力、焦虑或抑郁症状）、辣椒素诱导的继发性点状痛觉过敏、血清中的免疫标志物以及生活质量。
这项试验将评估 PEMF 治疗 MCS 的效果。目前，尚无针对 MCS 的具有确切疗效的治疗方法，在医疗保健方面，对这些患者的治疗方法非常有限。因此，非常需要进行精心设计的随机试验，以评估可能的治疗效果。阳性结果将为改善医疗保健和对这种非常致残和被忽视的疾病的理解铺平道路。
ClinicalTrials.gov，NCT01834781。
