Concurrent onabotulinumtoxinA treatment of cervical dystonia and concomitant migraine.

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.

Guía de práctica clínica para el diagnóstico y el tratamiento de la otitis media aguda en niños.

BACKGROUND: Acute otitis media (AOM) is one of the most prevalent acute conditions in the pediatric population worldwide. This work aimed to elaborate a Clinical Practice Guideline with clinical recommendations systematically developed to assist decision-making of specialists, patients, caregivers, and public policymakers involved in managing patients with AOM in children. METHODS: This document was developed by the College of Pediatric Otorhinolaryngology and Head, and Neck Surgery of Mexico (COPEME) in compliance with international standards. The SIGN quality of evidence classification was used. On behalf of the COPEME, the Guideline Development Group (GDG) was integrated, including otolaryngologists, infectologists, pediatricians, general practitioners, and methodologists with experience in systematic literature reviews and the development of clinical practice guidelines. RESULTS: A consensus was reached on 18 clinical questions, covering what was previously established by the GDG in the scope document of the guidelines. Scientific evidence answering each of these clinical questions was identified and critically evaluated. The GDG agreed on the final wording of the clinical recommendations using the modified Delphi panel technique. Specialists and patient representatives conducted an external validation. CONCLUSIONS: This Clinical Practice Guideline presents clinical recommendations for the prevention, diagnosis, and management of AOM to assist shared decision-making among physicians, patients, and caregivers and improve the quality of clinical care.

INTRODUCCIÓN: La otitis media aguda (OMA) es uno de los padecimientos agudos más prevalentes en la población pediátrica a escala global. El objetivo de este trabajo fue elaborar una guía de práctica clínica con recomendaciones para asistir la toma de decisiones de médicos especialistas, pacientes, cuidadores de pacientes y elaboradores de políticas públicas involucrados en el manejo de la OMA en niños. MÉTODOS: El documento ha sido desarrollado por parte del Colegio de Otorrinolaringología y Cirugía de Cabeza y Cuello Pediátricas de México (COPEME) en cumplimiento con los estándares internacionales. Se empleó la clasificación de calidad de la evidencia de SIGN. En representación del COPEME, se integró el Grupo de Desarrollo de la Guía (GDG), que incluyó otorrinolaringólogos, infectólogos, pediatras, médicos generales y metodólogos con experiencia en revisiones sistemáticas de la literatura y el desarrollo de guías de práctica clínica. RESULTADOS: Se consensuaron 18 preguntas clínicas que abarcaron lo establecido previamente por el GDG en el documento de alcances de la Guía. Se identificó la evidencia científica que responde a cada una de estas preguntas clínicas y se evaluó críticamente. El GDG acordó la redacción final de las recomendaciones clínicas mediante la técnica Delphi de panel. Se llevó a cabo una validación externa por colegas especialistas y representantes de pacientes. CONCLUSIONES: En esta Guía de Práctica Clínica se presentan recomendaciones clínicas para la prevención, el diagnóstico y el manejo de la OMA, con el fin de asistir la toma de decisiones compartidas entre médicos, pacientes y cuidadores con la intención de contribuir a mejorar la calidad de la atención clínica.

Guía de práctica clínica para el diagnóstico y el tratamiento de la otitis media aguda en niños / Clinical practice guidelines for diagnosis and management of acute otitis media in children

Resumen Introducción: La otitis media aguda (OMA) es uno de los padecimientos agudos más prevalentes en la población pediátrica a escala global. El objetivo de este trabajo fue elaborar una guía de práctica clínica con recomendaciones para asistir la toma de decisiones de médicos especialistas, pacientes, cuidadores de pacientes y elaboradores de políticas públicas involucrados en el manejo de la OMA en niños. Métodos: El documento ha sido desarrollado por parte del Colegio de Otorrinolaringología y Cirugía de Cabeza y Cuello Pediátricas de México (COPEME) en cumplimiento con los estándares internacionales. Se empleó la clasificación de calidad de la evidencia de SIGN. En representación del COPEME, se integró el Grupo de Desarrollo de la Guía (GDG), que incluyó otorrinolaringólogos, infectólogos, pediatras, médicos generales y metodólogos con experiencia en revisiones sistemáticas de la literatura y el desarrollo de guías de práctica clínica. Resultados: Se consensuaron 18 preguntas clínicas que abarcaron lo establecido previamente por el GDG en el documento de alcances de la Guía. Se identificó la evidencia científica que responde a cada una de estas preguntas clínicas y se evaluó críticamente. El GDG acordó la redacción final de las recomendaciones clínicas mediante la técnica Delphi de panel. Se llevó a cabo una validación externa por colegas especialistas y representantes de pacientes. Conclusiones: En esta Guía de Práctica Clínica se presentan recomendaciones clínicas para la prevención, el diagnóstico y el manejo de la OMA, con el fin de asistir la toma de decisiones compartidas entre médicos, pacientes y cuidadores con la intención de contribuir a mejorar la calidad de la atención clínica.

Abstract Background: Acute otitis media (AOM) is one of the most prevalent acute conditions in the pediatric population worldwide. This work aimed to elaborate a Clinical Practice Guideline with clinical recommendations systematically developed to assist decision-making of specialists, patients, caregivers, and public policymakers involved in managing patients with AOM in children. Methods: This document was developed by the College of Pediatric Otorhinolaryngology and Head, and Neck Surgery of Mexico (COPEME) in compliance with international standards. The SIGN quality of evidence classification was used. On behalf of the COPEME, the Guideline Development Group (GDG) was integrated, including otolaryngologists, infectologists, pediatricians, general practitioners, and methodologists with experience in systematic literature reviews and the development of clinical practice guidelines. Results: A consensus was reached on 18 clinical questions, covering what was previously established by the GDG in the scope document of the guidelines. Scientific evidence answering each of these clinical questions was identified and critically evaluated. The GDG agreed on the final wording of the clinical recommendations using the modified Delphi panel technique. Specialists and patient representatives conducted an external validation. Conclusions: This Clinical Practice Guideline presents clinical recommendations for the prevention, diagnosis, and management of AOM to assist shared decision-making among physicians, patients, and caregivers and improve the quality of clinical care.