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The study found "a significant decrease in headache severity in the capsaicin group," but not the placebo group.
Upon assessment of changes from baseline at 90 days, there was 37.75% reduction of headache days (in BTX-A) group versus 17.13% (in placebo) (Fig. 1), 43.68% decrease in headache severity as assessed by VAS (in BTX-A group) versus 17.98% (in placebo), and 40.57% decrease in HDI (in BTX-A group) versus 6.60% (in placebo group).
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A severity responder was defined as a patient who achieved a ≥ 1-grade improvement in average daily headache severity (ADHS) score across the assessment period (e.g., a reduction in headache severity from severe to moderate).
The mean reduction in headache severity was 30 and 38% in the physical therapy and relaxation groups.
Percentage of patients with a measurable change in headache severity among patients with <30% reduction in headache-day frequency.
Clinical effect was defined as >50% improvement in headache severity.
Our study showed significant improvement after 1 month of BTX-A injection regarding headache days/month, severity measured by VAS and HDI in headache severity.
Sample size calculation was based on improvements in headache severity going from baseline to post-intervention.
Patients had a significant decrease in headache days and headache severity, but side effects, weight gain and somnolence, were bothersome.
In conclusion, our findings in a cohort of chronic migraineurs revealed that OnabotA injection was associated with significant improvement in migraine outcome leading to decrease in headache frequency and severity, number of analgesics used and MIDAS scores.
Our 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.
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