Background: Current HIS-classification differentiates between chronic tension-type headaches with (cTTH+) and without (cTTH−) pericranial tenderness, however pharmacological treatment strategies don't.
Objective: To evaluate efficacy and tolerability of flupirtine modified release (FMR) — a muscle tone normalizing analgesic.
Patients and Methods: Patients with cTTH+/cTTH− received a 7 day open-label treatment with FMR (400 mg OD in the evening) during this non-interventional study. Pain intensity (NRS11), number of hours with pain, and pain-related restrictions in daily life activities were documented at baseline (prior FMR), and daily after treatment onset using standardized pain diaries. Adverse events (AE) were reported during the course of the study.
Results: Overall, 89 patients with cTTH (79 with/10 without PT) participated. 75.3% were female; mean age was 53.8 ± 14.1 years and 51.7% suffered for more than 6 months. With FMR, average number of daily TTH hours dropped for cTTH+/cTTH− from 11.3 ± 6.3/7.6 ± 3.4 h at baseline to 4.8 ± 3.9 (p < 0.001)/6.4 ± 2.8 (p = ns) at end-of-study. In parallel, average pain intensity dropped from 6.5 ± 1.9/5.3 ± 1.2 (95%-CI: 4.9–5.5) to 2.7 ± 1.7 (p < 0.001)/4.4 ± 1.3 (p = ns) NRS11, and average daily life restrictions improved from 5.8 ± 1.9/4.3 ± 1.7 to 2,3 ± 1,6 (p < 0.001)/3.4 ± 1.0 (p = ns) NRS11. No treatment emergent adverse events were reported.
Conclusions: Differential therapeutic benefits seen with FMR in patients suffering from cTTH+/− relate to its unique pharmacological (muscle tone normalizing) properties. The results of this naturalistic study focusing on patient-reported outcomes support taxonomic strategies to differentiate between cTTH with/without PT, and raises questions about current uniform recommendations for cTTH treatment.
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© 2015 Published by Elsevier Inc.
