INTRODUCTION: Pain, along with clicking, sub-luxation, and blocking, is one of the main symptoms for patients presenting with temporomandibular joint disorders. We assessed the effectiveness of botulinum toxin A (BOTOX(®), Allergan) as analgesic treatment for temporomandibular joint disorders.
PATIENTS AND METHOD: Twenty-six patients with chronic pain linked to temporomandibular joint disorders were prospectively assessed. Botulinum toxin A was injected in masseter and temporalis muscles. Follow-up parameters, at one and three months, were: measuring mouth opening and diduction, muscle tenderness and pain using a visual analogue scale.
RESULTS: There was a significant (P<0.0001) decrease of pain, an increased mouth opening, and diduction at three months. Seventy percent of the patients felt less muscle tenderness. The patient felt his psychological state had improved and so did his family.
DISCUSSION: Botulinum toxin A significantly decreases pain and improves movements of patients presenting with temporomandibular joint disorders. The effects are prolonged three months after the injection.
OBJECTIVE: Botulinum toxin is a widely accepted, effective treatment for Frey's syndrome. While some patients need only one injection, others require repeated treatments. We aimed to describe the clinical features of patients with a more challenging treatment course.
DESIGN: Literature review and retrospective analysis of eight consecutive patients treated at a university hospital.
SUBJECTS: These patients' treatment responses were categorised (using our own system) and compared with those of 25 published cases.
RESULTS: Combined analysis identified no significant correlation between treatment response and age, gender or the extent of primary salivary gland surgery. There was no significant correlation between botulinum toxin dosage and time between treatments.
CONCLUSION: Frey's syndrome should be viewed as a dynamic process in which the stimulus for aberrant reinnervation of parasympathetic nerve fibres can be reduced, in some patients, with higher botulinum toxin dose injections to the treated areas. However, responses are unpredictable, and relapses may occur at different time points and in different areas.
OBJETIVO: La toxina botulínica tipo A (BTX-A) se ha utilizado para tratar la migraña y la neuralgia occipital. Presentamos los resultados preliminares de un estudio en curso que evalúa la eficacia de BTX-A en la neuralgia del trigémino (TN) pacientes refractarios al tratamiento médico.
Diseño del estudio: Se han tratado 15 pacientes (8 hombres y 7 mujeres) entre 28 y 67 años de edad que sufrían de TN refractaria a las drogas de febrero 2008 a enero de 2010. Los síntomas, incluyendo la duración del dolor, factores que provocan, rama del nervio afectado, la frecuencia de los ataques de TN y severidad del dolor justo antes de las inyecciones, se evaluaron 1 semana, 1 mes y 6 meses después de la inyección. Hemos inyectado 50 T reconstituido BTX-A solución a las zonas de activación. La respuesta global al tratamiento se evaluó a través de una escala de evaluación global del paciente de 9 puntos y se compara con los valores basales. El análisis estadístico se realizó mediante el análisis de la prueba de varianza (ANOVA) para la frecuencia de los ataques TN, la prueba de Friedman para la intensidad del dolor y el signo de Wilcoxon-rank test para PGA, y todo con el uso de software SPSS.
RESULTADOS: Ocho hombres y 7 mujeres de 28 a 67 años (media 48,9 y) que sufre de TN de 6 meses a 24 años, todos mejoraron con respecto a la frecuencia y severidad de los ataques de dolor; en 7 pacientes, el dolor era completamente erradicados y no hubo necesidad de más medicación. En 5 pacientes, los fármacos antiinflamatorios no esteroides fueron suficientes para aliviar los ataques de dolor, y 3 pacientes respondieron nuevamente a los medicamentos anticonvulsivos después de la inyección. Todos los pacientes presentaron mayores umbrales de dolor después de las inyecciones. La prueba de ANOVA mostró una diferencia significativa en la frecuencia de los ataques antes de la inyección ya 1 semana, 1 mes y 6 meses después de la inyección (P <0,001). Prueba de Friedman y la comparación par de las puntuaciones de gravedad del dolor con ajuste de corrección de Bonferroni mostraron una diferencia significativa (p <0,001) entre la intensidad del dolor antes y después de la inyección. Prueba de los rangos con signo de Wilcoxon mostró una mejoría significativa en todos los pacientes hasta 6 meses después de la inyección (P <0,001). Las complicaciones incluyen paresia transitoria de la rama bucal del nervio facial en 3 pacientes.
CONCLUSIÓN: Este estudio apoya otros estudios similares y demuestra que la BTX-A es un método mínimamente invasivo que puede desempeñar un papel en el tratamiento de TN antes de que otros tratamientos más invasivos, es decir, la radiofrecuencia y la cirugía.
PURPOSE: To assess the effect and efficacy of botulinum toxin type A (BTX-A) in reducing synkinesis in aberrant facial nerve regeneration (following facial paralysis).
METHOD: A total of 55 sessions of BTX-A (Botox) infiltration were performed on 30 patients (23 female) with synkinesis after facial palsy. Each subject was injected with 2.5 units of BTX-A in each injection site (the sites were chosen on a case-by-case basis). The synkinetic muscles targeted include: orbicularis oculi, zygomaticus major, depressor labii inferioris, platysma, healthy frontalis and healthy corrugator supercilii. The patients were examined using the Sunnybrook Facial Grading System, both before the BTX-A treatment and after an average of 35 days.
RESULTS: All 30 patients experienced improvement to the synkinesis after treatment. Total scores: median pre-BTX-A: 40; post 53 p = 0.004. Resting symmetry scores: mean pre-BTX-A -7.1; post: -3.5; median pre -5 [interquartile range (IQR) -10 to -5]; post: -5 (IQR -5 to 0); p = 0.0001. Symmetry of voluntary movement median pre-BTX-A: 56 post 60 p = 0.10. Synkinesis scores: median pre-BTX-A: -9 post -3 p < 0.0001. Mean duration of improvement was 4 months.
CONCLUSIONS: BTX-A injection treatment was effective in reducing facial synkinesis, thus improving facial expression symmetry both at rest and in voluntary movements.
( Headache 2010;50:921-936) Objective.- To assess the efficacy, safety, and tolerability of onabotulinumtoxinA (BOTOX<sup>(R)</sup>) as headache prophylaxis in adults with chronic migraine. Background.- Chronic migraine is a prevalent, disabling, and undertreated neurological disorder. Few preventive treatments have been investigated and none is specifically indicated for chronic migraine. Methods.- The 2 multicenter, pivotal trials in the PREEMPT: Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy clinical program each included a 24-week randomized, double-blind phase followed by a 32-week open-label phase (ClinicalTrials.gov identifiers NCT00156910, NCT00168428). Qualified patients were randomized (1:1) to onabotulinumtoxinA (155-195 U) or placebo injections every 12 weeks. Study visits occurred every 4 weeks. These studies were identical in design (eg, inclusion/exclusion criteria, randomization, visits, double-blind phase, open-label phase, safety assessments, treatment), with the only exception being the designation of the primary and secondary endpoints. Therefore, the predefined pooling of the results was justified and performed to provide a complete overview of between-group differences in efficacy, safety, and tolerability that may not have been evident in individual studies. The primary endpoint for the pooled analysis was mean change from baseline in frequency of headache days at 24 weeks. Secondary endpoints were mean change from baseline to week 24 in frequency of migraine/probable migraine days, frequency of moderate/severe headache days, total cumulative hours of headache on headache days, frequency of headache episodes, frequency of migraine/probable migraine episodes, frequency of acute headache pain medication intakes, and the proportion of patients with severe (>=60) Headache Impact Test-6 score at week 24. Results of the pooled analyses of the 2 PREEMPT double-blind phases are presented. Results.- A total of 1384 adults were randomized to onabotulinumtoxinA (n = 688) or placebo (n = 696). Pooled analyses demonstrated a large mean decrease from baseline in frequency of headache days, with statistically significant between-group differences favoring onabotulinumtoxinA over placebo at week 24 (-8.4 vs -6.6; P < .001) and at all other time points. Significant differences favoring onabotulinumtoxinA were also observed for all secondary efficacy variables at all time points, with the exception of frequency of acute headache pain medication intakes. Adverse events occurred in 62.4% of onabotulinumtoxinA patients and 51.7% of placebo patients. Most patients reported adverse events that were mild to moderate in severity and few discontinued (onabotulinumtoxinA, 3.8%; placebo, 1.2%) due to adverse events. No unexpected treatment-related adverse events were identified. Conclusions.- The pooled PREEMPT results demonstrate that onabotulinumtoxinA is an effective prophylactic treatment for chronic migraine. OnabotulinumtoxinA resulted in significant improvements compared with placebo in multiple headache symptom measures, and significantly reduced headache-related disability and improved functioning, vitality, and overall health-related quality of life. Repeat treatments with onabotulinumtoxinA were safe and well tolerated.
OBJECTIVES: This is the second of a pair of studies designed to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) for prophylaxis of headaches in adults with chronic migraine. METHODS: PREEMPT 2 was a phase 3 study, with a 24-week, double-blind, placebo-controlled phase, followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections of onabotulinumtoxinA (155U–195U; <i>n</i> = 347) or placebo (<i>n</i> = 358) every 12 weeks for two cycles. The primary efficacy endpoint was mean change in headache days per 28 days from baseline to weeks 21–24 post-treatment. RESULTS: OnabotulinumtoxinA was statistically significantly superior to placebo for the primary endpoint, frequency of headache days per 28 days relative to baseline (–9.0 onabotulinumtoxinA/–6.7 placebo, <i>p</i> < .001). OnabotulinumtoxinA was significantly favoured in all secondary endpoint comparisons. OnabotulinumtoxinA was safe and well tolerated, with few treatment-related adverse events. Few patients (3.5% onabotulinumtoxinA/1.4% placebo) discontinued due to adverse events. CONCLUSIONS: The results of PREEMPT 2 demonstrate that onabotulinumtoxinA is effective for prophylaxis of headache in adults with chronic migraine. Repeated onabotulinumtoxinA treatments were safe and well tolerated. (PsycINFO Database Record (c) 2016 APA, all rights reserved)
OBJECTIVES: This is the first of a pair of studies designed to assess efficacy, safety and tolerability of onabotulinumtoxinA (BOTOX®) as headache prophylaxis in adults with chronic migraine. METHODS: The Phase III REsearch Evaluating Migraine Prophylaxis Therapy 1 (PREEMPT 1) is a phase 3 study, with a 24-week, double-blind, parallel-group, placebo-controlled phase followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections every 12 weeks of onabotulinumtoxinA (155 U–195 U; <i>n</i> = 341) or placebo (<i>n</i> = 338) (two cycles). The primary endpoint was mean change from baseline in headache episode frequency at week 24. RESULTS: No significant between-group difference for onabotulinumtoxinA versus placebo was observed for the primary endpoint, headache episodes (-5.2 vs. -5.3; <i>p</i> = 0.344). Large within-group decreases from baseline were observed for all efficacy variables. Significant between-group differences for onabotulinumtoxinA were observed for the secondary endpoints, headache days (<i>p</i> = .006) and migraine days (<i>p</i> = 0.002). OnabotulinumtoxinA was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. CONCLUSIONS: There was no between-group difference for the primary endpoint, headache episodes. However, significant reductions from baseline were observed for onabotulinumtoxinA for headache and migraine days, cumulative hours of headache on headache days and frequency of moderate/severe headache days, which in turn reduced the burden of illness in adults with disabling chronic migraine. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
Chemodervation with abobotulinum toxin A (Dysport) and botulinum toxin type A (Botox) is finding an expanding role in functional and cosmetic cases. We describe the use of chemodenervation with abobotulinum toxin A for functional corneal protection in two cases and botulinum toxin type A for facial symmetry after Bell's palsy in one patient. The first case is a 75-year-old female with a nonhealing corneal erosion in her right eye secondary to epithelial basement membrane corneal dystrophy who underwent injection of 24 units of abobotulinum toxin A to the right Muller's muscle and levator palpebrae superioris to induce a protective ptosis. The second case is a 40-year-old male with corneal decompensation in the right eye after penetrating keratoplasty who underwent similar injection at both sites. The third case is a 46-year-old Asian female with history of Bell's palsty affecting her right side and causing mild left eyelid retraction who was injected 3 units of botulinum toxin type A to her Muller's muscle for lid positioning. Chemodenervation is used in these cases to purposefully induce ptosis by careful injection to Muller's muscle and the levator palpebrae superioris for functional and cosmetic purposes.
OBJECTIVE: Frey's syndrome is a frequent sequela of parotidectomy, causing facial sweating and flushing because of gustatory stimuli. Although botulinum toxin type A has become first-line therapy for Frey's syndrome, some patients become resistant. In this study, we investigated whether another serotype, botulinum toxin type B, might be an effective alternative.
STUDY DESIGN: Case series with planned data collection.
SETTING: Otolaryngology department in a university hospital.
SUBJECTS AND METHODS: Seven patients aged 30 to 68 years, with severe Frey's syndrome, underwent the Minor test and had 80 U of botulinum toxin type B per cm(2) (mean total dose, 2354 U) injected intracutaneously in the mapped area of gustatory sweating. All patients were followed up for 12 months.
RESULTS: One month after treatment, six of the seven patients reported that gustatory sweating and flushing had resolved, and, in the remaining patient, these symptoms had decreased. The Minor test confirmed a significant improvement. The subjective benefits remained stable for six months in four patients and for nine months in the remaining three patients; 12 months after treatment, all patients still reported some improvement.
CONCLUSION: Botulinum toxin type B afforded symptomatic relief in a small sample of patients with Frey's syndrome and might be considered a potential alternative to botulinum toxin type A.
Pain, along with clicking, sub-luxation, and blocking, is one of the main symptoms for patients presenting with temporomandibular joint disorders. We assessed the effectiveness of botulinum toxin A (BOTOX(®), Allergan) as analgesic treatment for temporomandibular joint disorders.
PATIENTS AND METHOD:
Twenty-six patients with chronic pain linked to temporomandibular joint disorders were prospectively assessed. Botulinum toxin A was injected in masseter and temporalis muscles. Follow-up parameters, at one and three months, were: measuring mouth opening and diduction, muscle tenderness and pain using a visual analogue scale.
RESULTS:
There was a significant (P<0.0001) decrease of pain, an increased mouth opening, and diduction at three months. Seventy percent of the patients felt less muscle tenderness. The patient felt his psychological state had improved and so did his family.
DISCUSSION:
Botulinum toxin A significantly decreases pain and improves movements of patients presenting with temporomandibular joint disorders. The effects are prolonged three months after the injection.
