A Summary of a Magnesium and Vitamin B6 Clinical Study by Jadidi et al. (2023)

Reviewed by Tamberlyn Blinsink, ND, MPH | Research & Development

Overview

The following summary reviews a randomized controlled clinical trial examining the effects of oral magnesium and vitamin B6 supplementation on symptom severity and sleep quality in patients with Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED). RLS/WED is described in the study's introduction as a sensory-motor condition associated with aberrant sensations in the legs, sleep disturbance, and reduced quality of life. RLS/WED affects approximately 7–10% of the general population and is more prevalent in some subpopulations. The study sought to address contradicting evidence regarding the therapeutic utility of these supplements in this population.

Summary

Therapeutic Effects of Magnesium and Vitamin B6 in Alleviating the Symptoms of Restless Legs Syndrome: A Randomized Controlled Clinical Trial

Published in: BMC Complementary Medicine and Therapies

Study Design: Randomized, single-blind, placebo-controlled clinical trial

Participants: 75 adults (ages 15–50) diagnosed with RLS/WED for a minimum of three months.

Dose: 250 mg magnesium oxide once daily, or 40 mg vitamin B6 once daily, for two months (in addition to standard pramipexole therapy).

Outcome Measures: International Restless Legs Scale (IRLS); Pittsburgh Sleep Quality Index (PSQI)

What Was Studied: Researchers investigated whether supplementation with magnesium oxide or vitamin B6 could reduce the severity of RLS/WED symptoms and improve sleep quality in patients attending neurology clinics. Participants were randomly assigned to one of three groups — magnesium oxide, vitamin B6, or placebo — and all groups also received pramipexole as standard therapy. Symptom severity and sleep quality were assessed at baseline, one month, and two months post-intervention using validated questionnaires. Statistical analyses included ANOVA, t-tests, and repeated measures tests.

About the Reviewer

Name & Title: Tamberlyn Blinsink, Scientific Researcher at Solaray
Credentials: Naturopathic Doctor, Master of Public Health

Bio: Tamberlyn Blinsink, ND, MPH, a licensed naturopath who earned her Doctorate of Naturopathic Medicine from Bastyr University and her Master of Public Health from Purdue University. In addition to her experience in private practice, Dr. Blinsink, ND, MPH is a researcher in the natural products industry. She believes in giving back and has served as a lecturer at continuing education conferences and as a board member at Naturopaths Without Borders and NC Association of Naturopathic Physicians.

References

Jadidi A, Rezaei Ashtiani A, Khanmohamadi Hezaveh A, Aghaepour SM. Therapeutic effects of magnesium and vitamin B6 in alleviating the symptoms of restless legs syndrome: a randomized controlled clinical trial. BMC Complementary Medicine and Therapies. 2023;23(1):1. https://pubmed.ncbi.nlm.nih.gov/36587225/

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Frequently Asked Questions

What makes a study “double-blind”?

In double-blind studies, participants and researchers are
both unaware of which participants are in the group taking the active
investigational product and which are part of a control group.

What makes a study “placebo-controlled”?

When studies are placebo-controlled one group takes an active
investigational product and the other group takes an inactive product that has
the same general appearances as the active treatment.

What is a placebo?

Placebos are inactive treatments. Researchers include placebos that have the same general characteristics as an active treatment.

They try to make them indistinguishable from the active treatment regarding
qualities like appearance, taste, and smell.

Why is statistical significance important?

Quality scientific studies look for more than just a numerical difference between treated groups and control groups. These studies also check mathematically for the possibility that any difference between groups might
happen by chance. A difference that is statistically significant is one where the change is not likely to be due to a chance fluctuation within a normal variance.

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