Retallick-Brown Hannah, Rucklidge Julia, Blampied Neville
Department of Psychology, College of Science, University of Canterbury, Private Bag 4800, Christchurch 8041, New Zealand.
Medicines (Basel). 2016 Dec 7;3(4):32. doi: 10.3390/medicines3040032.
The recent addition of Premenstrual Dysphoric Disorder (PMDD) to the Diagnostic and Statistical Manual (5th ed.) has highlighted the seriousness of this disorder. Many alternatives to psychoactive medication in the form of vitamins, minerals, and plant extracts have been trialled by women seeking a natural treatment approach. We plan to explore whether a well validated micronutrient formula, EMPowerplus Advanced, can outperform a recognized single nutrient treatment, vitamin B6, for the treatment of Premenstrual Syndrome (PMS). This will be a randomized treatment control study. Eighty women will be recruited and assigned to one of two treatment groups; EMPowerplus Advanced or vitamin B6. Baseline daily data will be collected for an initial two cycles, followed by three months of active treatment. A natural follow up will take place three cycles post treatment. The primary outcome measure will be PMS change scores as based on results from the Daily Record of Severity of Problems (DRSP). The number of treatment responders for each of the two groups will yield a comparison score between the two treatments, with participants deemed as a responder if they show a total PMS score improvement of 50% from their baseline scores on the DRSP. If a micronutrient formula proves more effective for treating PMS, not only does it give women suffering from the condition a viable treatment option, but it may also suggest one cause of PMS; that is insufficient minerals and vitamins.
经前烦躁障碍（PMDD）最近被纳入《诊断与统计手册》（第5版），这凸显了该疾病的严重性。许多寻求自然治疗方法的女性已经试用了维生素、矿物质和植物提取物等精神活性药物的替代物。我们计划探究一种经过充分验证的微量营养素配方——EMPowerplus Advanced，在治疗经前综合征（PMS）方面是否能优于公认的单一营养素疗法——维生素B6。这将是一项随机治疗对照研究。将招募80名女性并将她们分配到两个治疗组之一：EMPowerplus Advanced组或维生素B6组。在最初的两个周期收集基线每日数据，随后进行三个月的积极治疗。治疗后三个周期进行自然随访。主要结局指标将是基于问题严重程度每日记录（DRSP）结果的PMS变化分数。两组中每组的治疗有反应者数量将得出两种治疗方法之间的比较分数，如果参与者在DRSP上的PMS总分较基线分数提高50%，则被视为有反应者。如果一种微量营养素配方被证明对治疗PMS更有效，那么它不仅为患有该疾病的女性提供了一种可行的治疗选择，还可能暗示了PMS的一个病因，即矿物质和维生素不足。
