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 tinnitus can have many different etiologies, palatal myoclonus being one of the less frequent. This type of tinnitus is generated by involuntary rhythmic contraction of the soft palate, which generates an audible click for the patient and for the explorer. Botulinum toxin achieves temporary muscle paralysis through presynaptic inhibition of the acetylcholine level at the neuromuscular union. We present a patient with long-term objective tinnitus, along with this patient's response to botulinum toxin 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.
We evaluated the efficacy of Botulinum toxin type A (BTXA) as an alternative to surgical intervention to facilitate phonation in 34 laryngectomized patients (31 males and 3 women) who were unable to produce tracheoesophageal voice because of spasm of the middle and inferior pharyngeal constrictor muscles (PCM). EMG was recorded to confirm activity in these muscles during attempted vocalization. Parapharyngeal nerve block (Carbocaine 2%, 5 cc) was used to demonstrate short-term fluent voice after relaxation of the pharyngeal constrictor muscle. At a later occasion, 100 U of Botox (Allergan) in ten patients and 50 U in two patients were injected unilaterally at one location in the PCM percutaneously under EMG guidance. All patients then underwent a voice therapy program. In 11 out of 12 patients an improvement of phonation was evident after 24-48 h and it was long lasting. This result was also seen in a patient previously myotomized without improvement. Only one patient needed to be reinjected every 3 months. At a follow-up after 3 months the EMG recorded in four patients showed a low-amplitude or complete absence of activity in the treated muscle. No side effects developed. BTX therapy, especially when associated with the speech therapy, is efficacious in restoring voice to laryngectomees who are unable to voice because of spasm of the PCMs. Our results confirm previous reports. This method is our approach of choice in managing PCM spasm because it is non-invasive, not painful, has few or no side effects, and is frequently long-lasting.
OBJECTIVE: Botulinum toxin type A (BTX-A) has been used to treat migraine and occipital neuralgia. We report preliminary results of an ongoing study that assesses the efficacy of BTX-A on trigeminal neuralgia (TN) patients refractory to medical treatment.
STUDY DESIGN: We treated 15 patients (8 men and 7 women) between 28 and 67 years of age who were suffering from drug-refractory TN from February 2008 to January 2010. Symptoms, including pain duration, provoking factors, affected nerve branch, frequency of TN attacks, and severity of pain just before injections, were evaluated 1 week, 1 month, and 6 months after injection. We injected 50 U reconstituted BTX-A solution at the trigger zones. The overall response to treatment was assessed via a 9-point patient global assessment scale and compared with values at baseline. Statistical analysis was performed by the analysis of variance (ANOVA) test for frequency of TN attacks, the Friedman test for severity of pain, and the Wilcoxon signed-rank test for PGA, and all with the use of SPSS software.
RESULTS: Eight men and 7 women aged 28-67 years (mean 48.9 y) suffering from TN from 6 months to 24 years all improved regarding frequency and severity of pain attacks; in 7 patients, pain was completely eradicated and there was no need for further medication. In 5 patients, nonsteroidal antiinflammatory drugs were enough to alleviate pain attacks, and 3 patients again responded to anticonvulsive drugs after injection. All patients developed higher pain thresholds after injections. The ANOVA test showed a significant difference in frequency of attacks before injection and at 1 week, 1 month, and 6 months after injection (P < .001). Friedman test and pair comparison of pain severity scores with Bonferroni correction adjustment showed a significant difference (P < .001) between severity of pain before and after injection. Wilcoxon signed-rank test showed significant improvement in all patients up to 6 months after injection (P < .001). Complications included transient paresis of the buccal branch of the facial nerve in 3 patients.
CONCLUSION: This study supports other similar studies and shows that BTX-A is a minimally invasive method that can play a role in treating TN before other more invasive therapies, i.e., radiofrequency and surgery.
OBJECT: To explore the feasibility of using botulinum toxin type A (BTXA) to treat tinnitus due to stapedius myoclonus.
METHOD: A piece of gelfoam containing BTXA (25 U/ml) was placed, through a perforation in tympanic membrane, into the middle ear cavity of a patient suffering from tinnitus due to stapedius myoclonus.
RESULTS: The tinnitus disappeared on the second day after the BTXA treatment. The patient was free of symptoms during a 3-month follow-up period. Tinnitus reappeared at 4 months, and disappeared after second BTXA local treatment.
CONCLUSION: Local BTXA treatment may be considered as a treatment for tinnitus caused by stapedius myoclonus.
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.
<b>OBJECTIVES: </b>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.<b>METHODS: </b>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; n = 347) or placebo (n = 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.<b>RESULTS: </b>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, p < .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.<b>CONCLUSIONS: </b>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.
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.
