Effect of vitamin B6 supplementation, in combination with magnesium, on severe stress and magnesium status: secondary analysis from an RCT
Abstract
Abstract Introduction Evidence from a recent randomised controlled trial1 suggests that in severely stressed subjects with low magnesemia, supplementation with magnesium (Mg) in combination with vitamin B6 (B6) provides greater benefits than Mg alone. B6 was reported to facilitate Mg absorption and its cellular uptake and to exert synergistic effect with Mg. The current secondary analysis explored the relationship between Mg-B6 combination and erythrocyte Mg concentration, used as a biomarker of body Mg status. Material and Methods An 8-week, Phase IV, controlled, single-blinded, parallel-group trial (EudraCT Number 2015-003749-24) stratified by sex was conducted in adults (n = 264) with a Depression Anxiety Stress Scales - stress subscale score (DASS-42SS) > 18 and serum Mg of 0.5–0.85mmol/L, randomised 1:1 to daily oral Mg-B6 (Magne B6®, Mg 300 mg; B6 30mg) or oral Mg alone (Magnespasmyl®, Mg 300mg). Outcomes were stress score, serum Mg (mmol/L), erythrocytes Mg (mmol/L), and serum B6 (nmol/L) from baseline to Week4 and Week8. Data are given as mean(SD) values. Results & Discussion Baseline characteristics. Baseline magnesemia was 0.80(0.04) for both groups. Erythrocyte Mg concentration for the lower quintile of the studied population (n = 53) was 0.73–1.62, below the normal range of 1.65–2.65 in general population. The mean stress score in this subgroup was higher [29.5(6.3)], but not significantly different from that in other quintiles [lowest value: 26.1(7.6)]. Baseline…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 264 participants or records.
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