Rev Clin Esp. Indicaciones y resultados. Rev Neurol. Focal dystonias and their treatment with dysport botulinum toxin type A. Dressler D. Clinical applications of botulinum toxin.
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Aetna considers onabotulinumtoxinA Botox medically necessary for any of the following conditions:. Aetna considers abobotulinumtoxin A Dysport medically necessary for the treatment of any of the following indications:.
Aetna considers incobotulinumtoxinA Xeomin medically necessary for the treatment of any of the following indications:. Aetna considers botulinum toxin types A or type B experimental and investigational for all other indications, including any of the following conditions:. Aetna considers testing for neutralizing antibodies to botulinum toxin experimental and investigational.
Fuentes: Allergan, ; Ipsen Biopharmaceuticals, Inc. El estrabismo puede ser horizontal, vertical o torsional. El entrecruzamiento puede ocurrir de forma predominante con un ojo o puede alternarse entre los dos. En algunos pacientes, las dos enfermedades pueden coexistir Comella, Los pacientes no pueden reprimir los movimientos.
A diferencia de otros trastornos del movimiento, este puede continuar mientras se duerme. The American Academy of Neurology AAN 's assessment on the use of botulinum neurotoxin in the treatment of movement disorders Simpson et al, b stated that while botulinum neurotoxin is probably effective for the treatment of adductor type laryngeal dystonia, there is insufficient evidence to support a conclusion of effectiveness for botulinum neurotoxin in patients with abductor type of laryngeal dystonia.
The assessment also stated that while many clinicians utilize electromyographic targeting for laryngeal injections, the utility of this technique is not established in comparative trials. Botox has been evaluated in various spastic disorders.
Botox can be used to reduce spasticity or excessive muscular contractions to relieve pain; to assist in posturing and walking; to allow better range of motion; to permit better physical therapy; and to reduce severe spasm in order to provide adequate perineal hygiene. Botox has been shown to improve gait patterns in patients with cerebral palsy with progressive dynamic equinovarus or equinovalgus foot deformities.
Treatment of children with cerebral palsy during the early years when functional skills in walking are being developed improves the outcome and may help to avoid surgery for contracture and bony torsion. In multiple sclerosis, Botox can relieve contractions of thigh adductors that interfere with sitting, positioning, cleaning, and urethral catheterization.
These researchers conducted a randomized, double-blind, placebo-controlled, parallel-group study of Botox for leg spasticity in 64 children with CP. There were no differences in adverse events. The authors concluded that there was no evidence of cumulative or persisting benefit from repeated Botox at the injection cycle troughs at 1 year or 2 years. The dose was not enough to change spasticity measures and thus GMFM in this heterogeneous group.
This finding does not deny the value, individually, of single injection cycles or prove that repeating them is unhelpful. In this regard, Botox therapy can be viewed in the same light as other temporary measures to relieve spasticity, such as oral or intra-thecal agents: there is no evidence of continuing benefit if the treatment ceases.
The study provided long-term, fully controlled adverse event data and has not revealed any long-term adverse effects. Treatment with Botox has been shown to be safe and effective in the jaw-closing variant of oromandibular dystonia. Injections of Botox into the masseter, temporalis, and internal pterygoid muscles result in reduction in the oromandibular and lingual spasms and an improvement in chewing and speech. Treatment with Botox has been shown to be safe and effective for writer's cramp local and segmental limb dystonia.
This dystonia can be incapacitating and has been exceptionally resistant to treatment with oral medications. The AAN's assessment on the use of botulinum neurotoxin in the treatment of movement disorders Naumann et al, stated that while many clinicians advocate electromyography or nerve stimulation guidance to optimize needle localization for injection, further data are needed to establish this recommendation.
Botox has also been shown to be effective in the treatment of achalasia. There is some question whether Botox treatments are as good as or better than conventional therapy, pneumatic dilation, or myotomy. Botox has been shown to be a promising alternative to sphincterotomy in patients with chronic anal fissures. Study subjects were assessed at 1, 2 and 3 months. The U botulinum toxin group had no statistically significant reduction in migraine frequency at any assessment Silberstein et al, A commentary on this study Bandolier, noted that, because of significant flaws in the design of the study by Silberstein et al, "[t]he trial would score 2 out of a possible 5 points on a common quality scoring scale in which trials scoring 2 or less may be subject to bias.
It does not inspire confidence, especially as this is the only randomised controlled trial for this intervention in this indication and the quality of reporting allows for the possibility of bias, as well as it being financed by the manufacturer.
Eligible patients were injected with Botox at U, U, 75 U, or placebo and returned for additional masked treatments at day 90 and day Patients were assessed every 30 days for 9 months.
The primary efficacy end point was the mean change from baseline in the frequency of headache-free days at day for the placebo non-responder group. The primary efficacy end point was not met. Mean improvements from baseline at day of 6. An a priori-defined analysis of headache frequency revealed that Botox at U or U had significantly greater least squares mean changes from baseline than placebo at day Only 27 of patients 3.
These investigators concluded that although the primary efficacy end point was not met, all groups responded to treatment. The U and U groups experienced a greater decrease in headache frequency than the placebo group at day The placebo response was higher than expected.
The authors stated that onabotulinumtoxinA was safe and well-tolerated. The authors noted that further study of Botox prophylactic treatment of CDH appears warranted. The findings of this study were in agreement with those of Mathews et al An assessment on use of botulinum toxin in pain associated with neuromuscular disorders, prepared for the Minnesota Health Technology Advisory Committee , concluded that there is insufficient evidence to support the use of botulinum toxin in the treatment of migraine.
A review of the literature on treatments for migraine concluded that "botulinum toxin A ha[s] recently been suggested to be effective [for treatment of migraine]; however, at present, there are insufficient rigorous and reliable controlled data on these drugs for them to be indicated for such use" Krymchantowski et al, The AAN's assessment on the use of botulinum neurotoxin in the treatment of autonomic disorders and pain Naumann et al, stated that botulinum neurotoxin is probably ineffective in episodic migraine and chronic tension-type headache.
Also, there is currently no consistent evidence or strong evidence to allow drawing conclusions on the effectiveness of botulinum neurotoxin in chronic daily headache. The assessment also noted that the evidence for botulinum neurotoxin in gustatory sweating is suboptimal. In a meta-analysis, Shuhendler et al evaluated the effectiveness of botulinum toxin type A in lowering the frequency of migraine headaches in patients with episodic migraines.
PubMed, Google Scholar, and the Cochrane Library were searched from inception to October in order to locate randomized, double-blind, placebo-controlled trials that compared the effectiveness of peri-cranial botulinum toxin A injections with placebo in the prevention of migraines in patients with a history of episodic migraine headaches.
A random effects model was used to combine study results, and the standardized mean difference Cohen's d in migraine frequency between the placebo and botulinum toxin A groups was reported. Effect sizes d less than 0. Quality assessment was performed by using the Downs and Black scale. Eight randomized, double-blind, placebo-controlled clinical trials 1, patients presented a quantitative assessment of the effectiveness of botulinum toxin A versus placebo. The overall treatment effect size of botulinum toxin A over placebo for 30, 60, and 90 days after injection was d The authors concluded that botulinum toxin A for the prophylactic treatment of episodic migraine headaches was not significantly different from placebo, both from a clinical and statistical perspective.
Aurora and colleagues evaluated the safety, effectiveness, and tolerability of Botox as headache prophylaxis in adults with chronic migraine. The primary end point was mean change from baseline in headache episode frequency at week Large within-group decreases from baseline were observed for all efficacy variables.
Botox was safe and well-tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. The authors concluded that there was no between-group difference for the primary end point, headache episodes. Dodick et al evaluated the efficacy, safety, and tolerability of Botox as headache prophylaxis in adults with chronic migraine.
The 2 multi-center, pivotal trials in the PREEMPT clinical program each included a week randomized, double-blind phase followed by a week open-label phase. Qualified patients were randomized to Botox U to U or placebo injections every 12 weeks. Study visits occurred every 4 weeks. These studies were identical in design e.
Thus, the pre-defined 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 end point for the pooled analysis was mean change from baseline in frequency of headache days at 24 weeks.
Adverse events occurred in Most patients reported adverse events that were mild-to-moderate in severity and few discontinued Botox, 3. No unexpected treatment-related adverse events were identified. Botox 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.
Overall, results from the clinical trials are mixed. In part this reflects the inherent difficulties in study design such as defining different sub-populations of migraine sufferers and trial end points that are meaningful to patient populations.
Recent studies of subjects with chronic migraine appear to have positive results. If confirmed this would be the first preventive medication indicated specifically for chronic migraine. In October , the FDA approved Botox injection onabotulinumtoxinA to prevent headaches in adult patients with chronic migraine more than 14 days per month with headaches lasting 4 hours a day or longer.
To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections -- a total of 31 injections into 7 specific head and neck sites for a total of U per treatment session. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.
On behalf of the AAN, Silberstein et al provided updated evidence-based recommendations for the preventive treatment of migraine headache. The clinical question addressed was: What pharmacologic therapies are proven effective for migraine prevention? The authors analyzed published studies from June to May using a structured review process to classify the evidence relative to the efficacy of various medications available in the United States for migraine prevention. The author panel reviewed abstracts, which ultimately yielded 29 Class I or Class II articles that were reviewed.
Divalproex sodium, sodium valproate, topiramate, metoprolol, propranolol, and timolol are effective for migraine prevention and should be offered to patients with migraine to reduce migraine attack frequency and severity Level A. Frovatriptan is effective for prevention of menstrual migraine Level A. Lamotrigine is ineffective for migraine prevention Level A. Delayed-release capsule of valproic acid, immediate-release topiramate, propranolol excluding Innopran XL and timolol are FDA-approved for migraine prophylaxis.
According to the FDA, "[u]nits of biologic activity of Botox cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other assay method.
Botox is not indicated in patients receiving aminoglycosides, which may interfere with neuromuscular transmission. The AAN's assessment on the use of botulinum neurotoxin in the treatment of spasticity Simpson et al, a recommended botulinum neurotoxin as a treatment option to reduce muscle tone and improve passive function in adults with spasticity.
2014, Número 2