Page 76 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Chapter 4
Table 2. Secondary outcomes.
Change in headache days1 Change in migraine days2
Change in moderate / severe headache days3
Change in hours of headache (cumulative)4
25% responder rate5 50% responder rate5
Succeeded to withdraw from medication (yes) 6 *
Medication overuse status (no overuse) 7 *
Change in SF-36 physical health8
Change in SF-36 mental health8
Change in HIT-6 9 ** Change in MIDAS10 ***
Botulinum toxin A (n=90)
-5.6 (0.8) -6.2 (0.8) -4.9 (0.7)
-20.8 (13.5)
48.3% 18.1%
89.7% 97.7%
-1.0 (1.9)
0.0 (2.0)
-0.8 (0.7) 18.7 (10.2)
Placebo (n= 89)
-4.4 (0.7) -7.0 (0.7) -5.4 (0.7)
-13.3 (13.5)
37.8% 20.4%
89.8% 97.7%
1.8 (1.8)
0.6 (2.0)
-0.8 (0.6) 24.0 (9.8)
Mean difference (95% CI)
-1.3 (-3.1 to 0.6) 0.8 (-1.0 to 2.7) 0.5 (-1.2 to 2.2)
-7.5 (-41.0 to 25.9)
10.5 (-3.9 to 24.9) -2.5 (-13.8 to 9.2)
-0.1 (-9.3 to 9.1) 0.0 (-4.4 to 4.4)
-2.8 (-7.1 to 1.4)
-0.6 (-5.4 to 4.1)
0.0 (-1.5 to 1.6) -5.3 (-19.0 to 29.6)
P value
.17 .38 .55
.66
.16 .69
.98 .99
.19 .79
.96 .67
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Data are least squares means (SE) or proportions. (Some scores do not add up due to rounding)
*N botulinum toxin A = 87; N placebo = 88; ** N botulinum toxin A = 76; N placebo = 79; *** N botulinum toxin A = 76; N placebo = 77
1 Day with a migraine or non-migraine headache of any duration; 2 Day with headache fulfilling migraine criteria or treated with acute anti-migraine medication; 3 Day with headache of moderate or severe intensity of any duration; 4 Cumulative duration in hours of any headache of any severity; 5 Proportion of participants with ≥ 25% or ≥ 50% reduction in headache days; 6 Proportion of participants who persevered successfully with medication withdrawal, defined as no more than two medication days per month; 7Proportion of participants without medication overuse, i.e. < 10 medication days per month; 8 Physical and mental health sum scores, range 0 - 100, a higher score corresponds to a higher quality of life; 9 Headache impact sum score, range 36 - 78, a higher score corresponds to a higher headache impact; 10 Sum of days with disability due to migraine, a higher score corresponds to a higher migraine disability.