Table 4. Change in DASS-42 stress subscale score from baseline to Week 4 by DASS-42 subscale subgroup score at baseline.
mITT population | Severe to extremely severe stress (N = 162) | Normal to moderate stress (N = 102) | ||
Mg–vit B6 combination (N = 78) | Mg (N = 84) | Mg–vit B6 combination (N = 54) | Mg (N = 48) | |
Baseline, adjusted mean (SE) | 32.67 (0.52) | 31.93 (0.47) | 20.53 (0.52) | 20.18 (0.58) |
Week 4, adjusted mean (SE) | 20.47 (0.96) | 23.10 (0.91) | 14.90 (0.87) | 13.33 (0.94) |
Change in adjusted mean (95% CI) | −12.21 (−13.90 to −10.51) | −8.83 (−10.47 to −7.20) | −5.63 (−7.35 to −3.91) | −6.85 (−8.68 to −5.03) |
Difference in change in adjusted mean between arms (95% CI) | 3.37 (1.02 to 5.73), p = 0.0053 | −1.22 (−3.73 to 1.29), p = 0.3354 | ||
PP population | Severe to extremely severe stress (N = 160) | Moderate stress (N = 73) | ||
Mg–vit B6 combination (N = 76) | Mg (N = 84) | Mg–vit B6 combination (N = 41) | Mg (N = 32) | |
Baseline, adjusted mean (SE) | 32.57 (0.53) | 31.92 (0.47) | 22.13 (0.34) | 21.94 (0.40) |
Week 4, adjusted mean (SE) | 20.25 (0.97) | 23.08 (0.91) | 15.88 (1.04) | 13.90 (1.18) |
Change in adjusted mean (95% CI) | −12.33 (−14.04 to −10.61) | −8.83 (−10.46 to −7.20) | −6.24 (−8.30 to −4.19) | −8.03 (−10.36 to −5.70) |
Difference in change in adjusted mean between arms (95% CI) | 3.50 (1.13 to 5.86), p = 0.0041 | −1.79 (−4.89 to 1.32), p = 0.2550 |
CI, confidence interval; DASS, Depression Anxiety Stress Scale; mITT, modified intention-to-treat; Mg, magnesium; PP, strict per protocol analysis; SE, standard error; Vit B6, vitamin B6. Standard error rather than standard deviation was calculated for subgroups to account for the means being adjusted.