Page 75 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Withdrawal and botulinum toxin A: a double blind RCT
plus BTA (-26.9%; 95% CI -19.9 to -34.0) versus withdrawal plus placebo (-20.5%; 95% CI: -13.5 to -27.6). The adjusted treatment difference was 6.4% (95% CI -2.4 to 15.2; p=.15; Figure 2).
Figure 2: Percentage change in 4-weekly headache days from baseline to the last four weeks of double- blind treatment (weeks 9-12) Depicted are unadjusted values and means.
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Likewise, there were no treatment differences after 12 weeks for any of the secondary outcome measures, including headache days or hours, migraine days, 50% and 25% responder rates, and measures of quality of life and (Table 2). The change in headache days was -5.6 for BTA versus -4.4 for placebo (mean difference -1.3; 95% CI: -3.1 to 0.6) and in migraine days was -6.2 for BTA versus -7.0 for placebo (mean difference 0.8; 95% CI: -1.0 to 2.7) (Table 2). Approximately 60% of participants had reverted back to episodic migraine, without any treatment differences (Table 2 and Fig. 3). BTA did also not increase the proportion of participants who managed to persevere with withdrawal. In both groups, 90% of participants withdrew successfully, defined as ≤2 medication days, and the proportions of participants still meeting the criteria for medication overuse at week 12 were negligible (2.3%; Table 2)
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