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. 2016 Dec 7;3(4):32.
doi: 10.3390/medicines3040032.

Study Protocol for a Randomized Double Blind, Treatment Control Trial Comparing the Efficacy of a Micronutrient Formula to a Single Vitamin Supplement in the Treatment of Premenstrual Syndrome

Hannah Retallick-Brown  1 , Julia Rucklidge  2 , Neville Blampied  3
Affiliations

Study Protocol for a Randomized Double Blind, Treatment Control Trial Comparing the Efficacy of a Micronutrient Formula to a Single Vitamin Supplement in the Treatment of Premenstrual Syndrome

Hannah Retallick-Brown et al. Medicines (Basel). .

Abstract

Background: 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). Methods: 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. Results: 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. Conclusion: 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.

Keywords: minerals; premenstrual dysphoric disorder; premenstrual syndrome; treatment; vitamins.

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Conflict of interest statement

The authors declare no conflict of interest

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Study Process.
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References

    1. Chavez-MacGregor M., van Gils C.H., van der Schouw Y.T., Monninkhof E., van Noord P.A., Peeters P.H. Lifetime cumulative number of menstrual cycles and serum sex hormone levels in postmenopausal women. Breast Cancer Res. Treat. 2008;108:101–112. doi: 10.1007/s10549-007-9574-z. - DOI - PMC - PubMed
    1. Lustyk M.K.B., Gerrish W.G. Premenstrual Syndrome and Premenstrual Disorder: Issues of Quality of Life, Stress and Exercise. Volume 115. Springer; London, UK: 2010. pp. 1952–1975.
    1. Rapkin A.J., Winer S.A. Premenstrual syndrome and premenstrual dysphoric disorder: Quality of life and burden of illness. Expert Rev. Pharmacoecon. Outcomes Res. 2009;9:157–170. doi: 10.1586/erp.09.14. - DOI - PubMed
    1. American Psychiatric Association . Diagnostic and Statisticl Manual of Mental Disorders. 5th ed. American Psychiatric Publishing; Arlington, VA, USA: 2013.
    1. American College of Obstetricians and Gynecologists . ACOG Practice Bulletin: Premenstrual Syndrome. National Guideline. Clearninghouse; Washington, DC, USA: 2000.