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Therapeutic effects of magnesium and vitamin B6 in alleviating the symptoms of restless legs syndrome: a randomized controlled clinical trial.

  • 2022-12-31
  • BMC complementary medicine and therapies 23(1)
    • Ali Jadidi
    • Alireza Rezaei Ashtiani
    • Ali Khanmohamadi Hezaveh
    • Seyed Mohamad Aghaepour

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 75
Population
75 patients with RLS/WED for at least three months
Methods
Single-blind study, randomly assigned into three groups: magnesium, vitamin B6, and placebo; daily doses of 40 mg vitamin B6 or 250 mg magnesium oxide; evaluated at baseline, one month, and two months
Blinding
Single-blind
Duration
two months

Background and objective

Restless legs syndrome/Willis-Ekbom Disease (RLS/WED) is one of the most prevalent sleep disorders. There are contradicting data about the effectiveness of magnesium and vitamin B6 in alleviating the symptoms of this condition. Therefore, this study aimed to assess the efficacy of magnesium and vitamin B6 in alleviating the symptoms of RLS/WED.

Methods

A single-blind study was conducted on individuals with this illness for at least three months. Randomly, 75 patients were assigned into three groups: magnesium, vitamin B6, and placebo. The experimental group received daily doses of 40 mg vitamin B6 or 250 mg magnesium oxide. While others in the control group merely received a placebo. Patients' disease severity and sleep quality were evaluated three times using standard questionnaires (at the beginning of the study, one and two months after therapy). Utilizing SPSS22 software and the ANOVA, t-test, and repeated measure tests, statistical analysis was conducted.

Results

The mean and standard deviation of sleep quality and disease severity at the beginning of the trial and throughout the first month following the intervention did not differ statistically between the three groups. In the second month following the intervention, the mean and standard deviation of sleep quality and disease severity were significantly different (P = 0.001).

Conclusion

Taking magnesium and vitamin B6 supplements can reduce the severity of symptoms of RLS/WED patients and improve their sleep quality.

Research Insights

  • Vitamin B6→Improved Sleep Quality

    The mean and standard deviation of sleep quality and disease severity at the beginning of the trial and throughout the first month following the intervention did not differ statistically between the three groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    40 mg/day
  • Vitamin B6→Reduced Restless Legs Syndrome Severity

    The mean and standard deviation of sleep quality and disease severity at the beginning of the trial and throughout the first month following the intervention did not differ statistically between the three groups.

    Effect
    Neutral
    Effect size
    Small
    Dose
    40 mg/day
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