Concurrent OnabotulinumtoxinA Treatment of Cervical Dystonia and Concomitant Migraine
Notice bibliographique
Résumé
OBJECTIVE: The objective of this study was to assess the clinical benefits of onabotulinumtoxinA (BOTOX®) treatment on the symptoms of cervical dystonia and the frequency, severity, and associated symptoms of migraine in patients with cervical dystonia and concurrent migraine. BACKGROUND: Botulinum toxin is established as first-line treatment of cervical dystonia. Recent clinical trials have shown onabotulinumtoxinA to be an effective prophylactic therapy for patients with chronic migraine, and onabotulinumtoxinA has been approved for use in this patient population by the Food and Drug Administration. Patients with headache associated with cervical dystonia have been identified as a specific subpopulation of patients in whom botulinum toxin treatment may be effective for controlling the symptoms of both conditions. METHODS: An open-label pilot study was conducted for 7.5 months in patients at least 18 years old with primary cervical dystonia of moderate severity (baseline rating of at least 20 on the Toronto Western Spasmodic Torticollis Rating Scale) complicated by migraine headache meeting the International Classification of Headache Disorders-II criteria for migraines with or without aura. Each patient received 2 cycles of treatment at Visit 3 (baseline) and Visit 6 (Day 90). For cervical dystonia, each patient was injected with a maximum of 175 units. At the same visit, a maximum of 125 units was also injected for migraine using a fixed-site, fixed-dose injection paradigm, with additional cervical dystonia injection-site treatment to a maximum dose of 300 units. Patients were assessed following onabotulinumtoxinA injection and at follow-up on Visit 4 (Day 30), Visit 5 (Day 60), Visit 6 (Day 90), and at Visits 7, 8, and 9 (Days 120, 150, and 180). The primary outcome measures for this study were change in Toronto Western Spasmodic Torticollis Rating Scale total score for cervical dystonia and frequency of headache episodes per 28-day period. Migraine episodes were defined as at least 4 hours of sustained pain with no upper limit. An episode was considered new if the patient was pain free for at least 24 hours. Secondary study end points included number of headache days per month, headache intensity, headache disability (assessed using Headache Impact Test-6 and the Migraine Disability Assessment score scales), acute headache medication use, resource utilization, and allodynia pain. Adverse events were reported. RESULTS: A total of 25 patients (24 women, mean age 50.5 years; mean age of disease onset 21.9 years) were enrolled in the study. Patients experienced improvement in cervical dystonia symptoms with significant reductions from baseline in Toronto Western Spasmodic Torticollis Rating Scale scores at 30, 60, 90, 120, 150, and 180 days (-9.84 ± 8.49, -12.67 ± 8.22, -13.63 ± 7.27, -14.92 ± 7.05, -14.76 ± 6.97, -14.49 ± 6.14, respectively, P < .0001 at all time points from a baseline of 31.03 ± 3.61). Changes from baseline were assessed using the t-test. Reductions in the number of headache episodes from baseline on concurrent onabotulinumtoxinA treatment for coexistent chronic migraine did not attain significance. However, patients experienced significant reductions from baseline in the number of headache days at 90, 120, and 180 days (-3.39 ± 6.78, P = .0289; -4.29 ± 7.94, P = .0194; -4.38 ± 7.99, P = .0178, respectively, from a baseline of 15.33 ± 6.76). Changes from baseline were assessed using the t-test. The change from baseline in Headache Impact Test-6 total scores was significant at 30, 60, 90, 150, and 180 days (3.21 ± 4.14, P = .0009; -3.04 ± 4.04, P = .0012; -2.41 ± 2.79, P = .0006; -2.59 ± 3.87, P = .0050; -3.09 ± 3.80, respectively, from a baseline of 22.68 ± 3.20). Changes from baseline were assessed using the t-test. The change from baseline in Migraine Disability Assessment was significant at 120, 150, and 180 days (-38.09 ± 47.87, P < .0001, Wilcoxon signed rank test; -16.91 ± 62.69, P = .0358, Wilcoxon signed rank test; -23.73 ± 40.57, P = .0122, t-test, respectively, from a baseline of 56.68 ± 50.41). There were no serious adverse events or treatment-related discontinuations. CONCLUSIONS: Concurrent treatment with onabotulinumtoxinA is effective and well tolerated in controlling the symptoms of cervical dystonia complicated by concurrent migraine.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».