Table 2.
Changes in outcome measures assessing secondary efficacy variables from baseline (BSL) to the last month of trimester (Τ3) of supplementation with in 113 patients comprising both the efficacy and intention to treat population.
Tools Assessing Secondary Endpoints | BSL | T3 | p Value |
---|---|---|---|
Mean ± SD Median |
Mean ± SD Median |
||
HIT-6 | 68.6 ± 5.7 69 |
63.8 ± 10.3 63 |
p < 0.001 |
MIDAS | 67.0 ± 43.8 58 |
49.5 ± 41.0 30 |
p < 0.001 |
MTAQ | 2.9 ± 1.1 3 |
3.2 ± 0.9 4 |
p < 0.001 |
MSQ-QOL total | 52.3 ± 15.4 52 |
71.3 ± 10.4 71 |
p < 0.001 |
HADS-A | 8.3 ± 5.8 6 |
8.3 ± 8.5 7 |
p = 0.923 |
HADS-D | 5.7 ± 3.7 5 |
6.1 ± 5.2 4 |
p = 0.216 |
Abbreviations: Headache Impact Test-6 (HIT 6); Migraine Disability Assessment questionnaire (MIDAS); Migraine Therapy Assessment questionnaire (MTAQ); Migraine-Specific Quality of life questionnaire (MSQ-QOL) and Hospital Anxiety and Depression Scale (HADS) anxiety (A) and depression (D).