Abstract
BackgroundOnabotulinumtoxinA (OnabotA) is considered effective in in patients with chronic migraine (CM) who failed on traditional therapies. This study was designed to evaluate the effect of OnabotA injection series on migraine outcome, negative emotional states and sleep quality in patients with CM.MethodsA total of 190 patients with CM (mean (SD) age: 39.3 (10.2) years; 87.9% were female) were included. Data on Pittsburgh sleep quality index (PSQI), headache frequency and severity, number of analgesics used, Migraine Disability Assessment Scale.(MIDAS) scores and Depression, Anxiety and Stress Scale (DASS-21) were evaluated at baseline (visit 1) and 4 consecutive follow up visits, each conducted after OnabotA injection series; at week 12 (visit 2), week 24 (visit 3), week 36 (visit 4) and week 48 (visit 5) to evaluate change from baseline to follow up.ResultsFrom baseline to visit 5, significant decrease was noted in least square (LS) mean headache frequency (from 19.5 to 8.4, p = 0.002), headache severity (from 8.1 to 6.1, p = 0.017), number of analgesics (from 26.9 to 10.4, p = 0.023) and MIDAS scores (from 67.3 to 18.5, p < 0.001). No significant change from baseline was noted in global PSOI and DASS-21 scores throughout the study.ConclusionsOur findings revealed that OnabotA therapy was associated with significant improvement in migraine outcome leading to decrease in headache frequency and severity, number of analgesics used and MIDAS scores. While no significant change was noted in overall sleep quality and prevalence of negative emotional states, patients without negative emotional states at baseline showed improved sleep quality throughout the study.
Highlights
OnabotulinumtoxinA (OnabotA) is considered effective in in patients with chronic migraine (CM) who failed on traditional therapies
After baseline visit at study enrollment, patients were followed up for 48 weeks via 4 consecutive follow up visits each conducted after a new OnabotA injection series; at week 12, week 24, week 36 and week 48, respectively
Change from baseline to follow up was evaluated based on data from visit 1 to visit 3 (24 weeks) for Pittsburgh sleep quality index (PSQI), from visit 1 to visit 4 (36 weeks) for DASS-21 scores, while based on data from visit 1 to visit 5 (48 weeks) for headache frequency and severity, number of analgesics used and Migraine Disability Assessment Scale. (MIDAS) score
Summary
OnabotulinumtoxinA (OnabotA) is considered effective in in patients with chronic migraine (CM) who failed on traditional therapies. Recent studies indicate a higher prevalence of poor sleep quality in patients with than without migraine and association of frequency of migraine headache with poor sleep quality [17,18,19,20,21,22]. This seems notable given the association of comorbidities with increased burden of CM in terms of productivity loss, impaired HRQoL, healthcare utilization and emotional burden as well as treatment complications and poor clinical outcomes [13]. Development of new and effective therapeutic alternatives is of particular significance in the management of CM [24, 25]
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