BackgroundMigraine is included in the top-ten disabling diseases and conditions among the Western populations. Non-invasive neurostimulation, including the Cefaly® device, for the treatment of various types of pain is a relatively new field of interest. The aim of the present study was to explore the clinical experience with Cefaly® in a cohort of migraine patients previously refractory or intolerant to topiramate prophylaxis.MethodsA prospective, multi-center clinical study was performed in patients diagnosed with episodic or chronic migraine with a previous failure to topiramate treatment requiring prevention with Cefaly® according to the treating physician’s suggestion. A 1-month period of baseline observation was followed by a 3-month period of observation during the use of transcutaneous supraorbital nerve stimulation (t-SNS) with Cefaly® as the only preventive treatment.ResultsA small but statistically significant decline was shown over time in the number of days with headache (HA), the number of days with HA with intensity ≥5/10, and the number of days with use of acute medication after 3 months (p < 0.001 for all of the three changes). Twenty-three patients (65.7%) expressed their satisfaction and intent to continue treatment with Cefaly®. Compliance was higher among satisfied subjects compared to non-satisfied subjects. None of the explored factors were significantly associated with the reason for the failure of topiramate.ConclusionThree-months of preventive treatment for episodic or chronic migraine with t-SNS proved to be an effective, safe and well tolerated option for the treatment of patients with migraine who were intolerant or did not respond to topiramate.Trial registrationClinicalTrials NCT03125525. Registered 21 April 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-017-0869-3) contains supplementary material, which is available to authorized users.
BackgroundChronic migraine is a disabling condition, with limited treatment options. We conducted an open label, single arm, prospective clinical trial, to assess the efficacy and safety of onabotulinumtoxin-A in Greek patients with chronic migraine. Since recent evidence suggests that a meaningful clinical response may be delayed until after a third onabotulinumtoxin-A administration, we aimed at assessing outcomes at this time point.MethodsA total of 119 patients with CM, scheduled to be treated with Onabotulinumtoxin-A (Botox ®) every 3 months, according to the approved indication and standard clinical practice, were prospectively enrolled. Data documenting changes from baseline (T0—trimester before Onabotulinumtoxin-A first administration) to the period after its third administration (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >4/10 in a 0–10 numerical scale, and (iii) mean number of days with use of any acute headache medication, were collected from patients’ headache diaries at each visit.ResultsOf the 119 patients, a total of 81 received 3 courses of onabotulinumtoxin-A and were included in the efficacy population. In those 81 patients, there was a significant decrease in mean headache days/month between T0 and T3 (21.3 ± 5.4 vs 7.7 ± 4.8; P < 0.001); a significant decrease in days with peak headache intensity of >4/10 (11.9 ± 5.5 vs 3.7 ± 3.3; P < 0.001) and finally, the change in days using acute headache medications per month between was also significant (16.2 ± 7.8 vs 5.2 ± 4.3; P < 0.001). Adverse events were few and of non- serious nature.ConclusionOur results strongly support the use of onabotulinumtoxin-A for the prophylaxis of CM, as this intervention proved effective, safe and well tolerated in our cohort of Greek patients.
The long -term treatment with onabotulinumtoxinA proved effective, safe and well tolerated over three years. Our findings support the strategy to consistently deliver sessions of use of onabotulinumtoxinΑ over long time in CM patients (Trial registration NTC03606356, registered retrospectively, 28 July 2018).
The aim of this study was to record the demographic and epidemiological data on adult patients with headache who attend the emergency department (ED) and the diagnoses that made by the neurologists in the ED of a tertiary care hospital in metropolitan Thessaloniki (Greece). In an open prospective study, demographic and epidemiological data were collected on all patients who reported headache (as chief complaint or not) and presented to the ED of Papageorgiou Hospital between August 2007 and July 2008. Headache patients accounted for 1.3% of all ED patients and for 15.5% of patients primarily referred to the ED neurologist. Tension type headache was the most frequent diagnosis, followed by secondary headaches and migraine. The large number of patients without final ED diagnosis and ward admission for further evaluation sheds a light on the immense workload of Greek ED physicians. Furthermore, we found evidence for the misuse of Emergency Medical Services by chronic headache patients. These findings indicate shortcomings in the pre-hospital (primary care) management of headache patients in the Greek National Health System to an extent unreported so far.Electronic supplementary materialThe online version of this article (doi:10.1007/s10194-009-0178-3) contains supplementary material, which is available to authorized users.
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