Superiority of magnesium and vitamin B6 over magnesium alone on severe stress in healthy adults with low magnesemia: A randomized, single-blind clinical trial.
Study Goal
The researchers aimed to determine whether combining magnesium with vitamin B6 was more effective than magnesium alone in reducing stress in adults with low magnesemia and high stress levels.
Results Summary
Both magnesium alone and magnesium combined with vitamin B6 significantly reduced stress, with no statistical difference overall. However, in individuals with severe/extremely severe stress, the combination showed a 24% greater improvement compared to magnesium alone.
Population
Healthy adults with low magnesemia and high stress (DASS-42 stress subscale score >18).
Effective Dosage
30 mg vitamin B6 daily (combined with 300 mg magnesium).
Duration
8 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) | decrease | DASS-42 stress subscale score | healthy adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 and serum magnesium concentration 0.45 mmol/L-0.85 mmol/L | 44.9% | substantially reduced | #1 |
magnesium alone (Magnespasmyl [Mg]; daily dose 300 mg) | decrease | DASS-42 stress subscale score | healthy adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 and serum magnesium concentration 0.45 mmol/L-0.85 mmol/L | 42.4% | substantially reduced | #2 |
magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) | decrease | DASS-42 stress subscale score | adults with severe/extremely severe stress (DASS-42 stress subscale score ≥25) | 24% greater improvement (3.16 points, 95% CI 0.50 to 5.82) | had a 24% greater improvement | #3 |
magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) | neutral | AEs potentially treatment related | Mg-vitamin B6 treated subjects | 12.1% | experienced | #4 |
magnesium alone (Magnespasmyl [Mg]; daily dose 300 mg) | neutral | AEs potentially treatment related | Mg-treated subjects | 17.4% | experienced | #5 |
oral Mg supplementation | decrease | stress | healthy adults with low magnesemia | - | alleviated | #6 |
addition of vitamin B6 to Mg | no change | stress alleviation | healthy adults with low magnesemia | - | was not superior | #7 |
Mg combined with vitamin B6 | decrease | stress | subjects with severe/extremely severe stress | - | greater benefit | #8 |
INTRODUCTION: Animal and clinical studies suggest complementary effects of magnesium and high-dose pyridoxine (vitamin B6) on stress reduction. This is the first randomized trial evaluating the effects of combined magnesium and vitamin B6 supplementation on stress in a stressed population with low magnesemia using a validated measure of perceived stress. METHODS: In this Phase IV, investigator-blinded trial (EudraCT: 2015-003749-24), healthy adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 and serum magnesium concentration 0.45 mmol/L-0.85 mmol/L, were randomized 1:1 to magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) or magnesium alone (Magnespasmyl [Mg]; daily dose 300 mg). Outcomes included change in DASS-42 stress subscale score from baseline to Week 8 (primary endpoint) and Week 4, and incidence of adverse events (AEs). RESULTS: In the modified intention-to-treat analysis (N = 264 subjects), both treatment arms substantially reduced DASS-42 stress subscale score from baseline to Week 8 (Mg-vitamin B6, 44.9%; Mg 42.4%); no statistical difference between arms was observed (p>0.05). An interaction (p = 0.0097) between baseline stress level and treatment warranted subgroup analysis (as per statistical plan); adults with severe/extremely severe stress (DASS-42 stress subscale score ≥25; N = 162) had a 24% greater improvement with Mg-vitamin B6 versus Mg at Week 8 (3.16 points, 95% CI 0.50 to 5.82, p = 0.0203). Consistent results were observed in the per protocol analysis and at Week 4. Overall, 12.1% of Mg-vitamin B6 treated and 17.4% of Mg-treated subjects experienced AEs potentially treatment related. CONCLUSIONS: These findings suggest oral Mg supplementation alleviated stress in healthy adults with low magnesemia and the addition of vitamin B6 to Mg was not superior to Mg supplementation alone. With regard to subjects with severe/extremely severe stress, this study provides clinical support for greater benefit of Mg combined with vitamin B6.