A Pilot Randomized Treatment-Controlled Trial Comparing Vitamin B6 with Broad-Spectrum Micronutrients for Premenstrual Syndrome
Publication: The Journal of Alternative and Complementary Medicine
Volume 26, Issue Number 2
Abstract
Objective: Premenstrual syndrome (PMS) affects 20%–30% of women but current medical treatments are limited in their efficacy. The objective of this study was to compare efficacy of a broad-spectrum micronutrient formula (consisting mainly of minerals and vitamins) to a single vitamin (B6) for treatment of PMS, for which B6 has already been shown to be efficacious.
Methods: This double-blind, randomized, treatment-controlled trial allocated 78 (72 completed) regularly menstruating women with PMS to consume micronutrients or vitamin B6 (80 mg/day) daily following a two-cycle baseline period, for three menstrual cycles. The primary outcome measure, Daily Record of Severity of Problems (DRSP), established PMS as well as tracked change in five PMS symptoms: psychological, somatic, total symptoms, impact ratings, and worst day ratings.
Results: Linear-mixed model analyses indicated both treatments produced comparable reduction in PMS symptoms with medium effect sizes (ES) across all PMS variables as measured by the DRSP (micronutrient ES = 0.50–0.56; B6 ES = 0.43–0.56), with 72% of the micronutrient and 60% of the vitamin B6 group identified as in full remission in PMS symptoms after three cycles. The micronutrient-treated participants showed greater improvement than the B6 group (between group d = 0.51, p < 0.05) in health-related quality of life. For those women (n = 28) who met criteria for premenstrual dysphoric disorder (PMDD), the DRSP ES were larger for those who had been in the micronutrient condition (ES = 1.28–1.67) as compared with those on B6 (ES = 0.50–0.75), although the group differences were not statistically reliable. There were no group differences in side effects, nor any serious adverse effects reported.
Conclusions: Both treatments provided similar benefit for reducing PMS symptoms, with greater effect of micronutrients on quality of life as well as potential clinical benefit of micronutrients for PMDD. This study provides further efficacy data on B6 and also identifies the nutritionally broader spectrum intervention as possibly having specific advantages for those whose symptoms are more severe. As this is the first study to investigate these treatments for PMDD, systematic replication is required.
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Disclaimer
The authors consider it would be premature to use the results of this study either to make clinical decisions regarding the treatment of PMS/PMDD or to influence the purchase of over-the-counter products.
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Information & Authors
Information
Published In
The Journal of Alternative and Complementary Medicine
Volume 26 • Issue Number 2 • February 2020
Pages: 88 - 97
PubMed: 31928364
Copyright
Copyright 2020, Mary Ann Liebert, Inc., publishers.
History
Published online: 4 February 2020
Published in print: February 2020
Published ahead of print: 10 January 2020
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Author Contributions
All authors were involved in the conception and design, analysis and interpretation of data, drafting the article and revising it critically for important intellectual content, and final approval of the submitted version.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This work was supported by the University of Canterbury, the UC Foundation, and the Ngāi Tahu Research Center. This study was funded by a grant provided as part of the first author's PhD enrolment at the University of Canterbury.
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