Page 78 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Chapter 4
Table 3. Unadjusted changes from baseline over 48 weeks, on most important secondary outcomes.
Headache days
Migraine days
Moderate / severe headache days
Headache duration (cumulative hours)
Medication days
Treatment
Double blind phase
Botulinum toxin A
Placebo
Botulinum toxin A
Placebo
Botulinum toxin A
Placebo
Botulinum toxin A
Placebo
Botulinum toxin A
Placebo
Baseline 12 weeks
Mean (95%CI)
21.7 -5.4 (-6.6 to -4.2)
21.0 -3.9 (-5.3 to -2.5)
15.5 -6.5 (-8.1 to -5.0)
14.9 -6.9 (-8.3 to -5.6)
16.1 -4.7 (-5.9 to -3.5)
15.3 -4.9 (-6.2 to -3.6)
199.6 -11.5 (-37.9 to 14.9)
196.0 -0.3 (-24.7 to 24.1)
16.1 -15.7 (-16.9 to 14.5)
15.3 -15.3 (-16.6 to 13.9)
Treatment
Open label phase
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
Botulinum toxin A Standard Care
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Shown are the crude data, derived without any modelling. The outcomes are subdivided in the four possible combinations for initial double-blind and subsequent open-label treatment (i.e. Botulinum toxin A + Botulinum toxin A, Botulinum toxin A + Standard Care, Placebo Botulinum toxin A, Placebo + Standard Care)
* Outcomes after 12 weeks are subdivided in the four treatment groups as well, to enable comparison for the open label and follow up phases.