Page 74 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Chapter 4
Results
Between December 2012 and February 2015, 721 patients with high frequent migraine were screened, of whom 221 were eligible and 179 included and randomly assigned to either BTA (n=90) or placebo (n=89) (Figure 1). The treatment groups were well balanced for age, gender, headache and migraine frequency, and psychiatric comorbidity (Table 1). Four participants discontinued the study in the double-blind phase, one in the placebo group because of lack of efficacy and three in the BTA group, because of lack of efficacy (n=2) or exacerbation of pre-existing depression (n=1). All 179 participants were included in the intention-to-treat analysis. Follow-up ended in January 2016. Discontinuation of participants until the end of follow-up is depicted in Figure 1.
Table 1: Baseline demographic and clinical characteristics
Botulinum toxin A
Placebo (n=89)
67 (75.3%) 46.7 ± 9.5
21.0 ± 4.8 15.3 ± 4.9 196.0 ± 148.2 14.9 ± 5.0
18.1 ± 9.5
65.0 ± 3.9 84 (94.4%)
16.4 ± 5.4
35 (39.3%) 81 (91.0%)
27 (30.3%) 34 (38.2%)
Gender, female Age (years)
Headache days
Moderate / severe headache days Headache duration (cumulative hours) Migraine days
Age of onset migraine (years)
HIT 61
Mean score
% severe (≥60)
Days using medication2 Prophylaxis3
Current use History of use4
Anxiety, % present (HADS-A ≥ 8)
Depression, % present (HADS-D ≥ 8) Values are means ± SD or n (%).
(n=90)
69 (76.7%) 43.7 ± 11.8
21.7 ± 4.7 16.1 ± 6.0 199.6 ± 156.6 15.5 ± 6.0
17.1 ± 9.7
65.0 ± 4.6 81 (90.0%)
16.5 ± 5.8
30 (33.3%) 82 (91.1%)
28 (31.1%) 32 (35.6%)
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1 N botulinum toxin A = 87, N placebo = 87; 2 Simple analgesics and/or triptans. 3Commonly used prophylaxis for migraine 4History of use: current or past use of at least one type of prophylaxis.
The primary outcome, mean percentage change in 4-weekly headache days from baseline to weeks 9-12 after therapy onset, did not differ between withdrawal