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Randomized Controlled Trial
. 2021 Dec;37(5):1000-1009.
doi: 10.1002/smi.3051. Epub 2021 May 6.

Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial

Affiliations
Randomized Controlled Trial

Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial

Lionel Noah et al. Stress Health. 2021 Dec.

Abstract

Magnesium status and vitamin B6 intake have been linked to mental health and/or quality of life (QoL). In an 8-week Phase IV randomised controlled study in individuals with low magnesemia and severe/extremely severe stress but who were otherwise healthy, greater stress reduction was achieved with magnesium combined with vitamin B6 than with magnesium alone. We present a previously unreported secondary analysis of the effect of magnesium, with and without vitamin B6, on depression, anxiety, and QoL. Adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 were randomised 1:1 to magnesium + vitamin B6 combination (Magne B6® ; daily dose 300 and 30 mg, respectively) or magnesium alone (Magnespasmyl® ; daily dose 300 mg). Outcomes included changes from baseline in DASS-42 depression and anxiety scores, and QoL (Short Form-36 Health Survey). DASS-42 anxiety and depression scores significantly improved from baseline to week 8 with both treatments, particularly during the first 4 weeks. Improvement in QoL continued over 8 weeks. Participants' perceived capacity for physical activity in daily life showed greater improvement with magnesium + vitamin B6 than magnesium alone (Week 4). In conclusion, magnesium supplementation, with or without vitamin B6, could provide a meaningful clinical benefit in daily life for individuals with stress and low magnesemia.

Keywords: anxiety; depression; magnesium supplementation; quality of life; stress; vitamin B6 supplementation.

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Conflict of interest statement

Lionel Noah, Béatrice Bois De Fer, and Etienne Pouteau are employees of Sanofi‐Aventis. Gisèle Pickering reports consultancy fees from Sanofi, unrelated to this publication. André Mazur reports consultancy fees from Sanofi, unrelated to this publication. Louise Dye has received research funding from Sanofi and consultancy payments unrelated to this publication.

Figures

FIGURE 1
FIGURE 1
DASS‐42 scores (adjusted means) for (a) anxiety and (b) depression by treatment and visit. *Statistically significant (p < 0.05) differences between baseline and a given post‐baseline visit using MMRM. Horizontal dashed lines represent the upper limit of each DASS‐42 category. Abbreviations: CI, confidence interval; DASS‐42, Depression Anxiety Stress Scales; MMRM, Model Mixed for Repeated Measures
FIGURE 2
FIGURE 2
SF‐36 scores for all domains at each visit (3 time points) among (a) patients treated with magnesium + vitamin B6; (b) patients treated with magnesium alone. Note: Means of SF‐36 scores are adjusted by sex and SF‐36 at baseline. Data calculated using MMRM including sex and visit as categorical fixed effects and SF‐36 score at baseline as continuous fixed effect and subject as random effect. For context, the red line shows reference data from a survey of a cross‐section of the French metropolitan population (Leplège et al., ; SF‐36 validation population in manual of SF‐36 in France) (see discussion). Abbreviations: MMRM, Model Mixed for Repeated Measures; SF‐36, Short Form‐36 Health Survey

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