Safety Of Botox Research Articles

A Systematic Review and Comparative Analysis of Botox Treatment in Aesthetic and Therapeutic Applications: Advantages, Disadvantages, and Patient Outcomes.

The objective of this review article is to comprehensively analyze Botox treatment, emphasizing its aesthetic and therapeutic applications, along with the associated advantages, disadvantages, and patient outcomes. By reviewing current literature, the article evaluates Botox's efficacy and safety in various clinical settings, including cosmetic procedures and medical treatments for conditions such as chronic migraines and excessive sweating, while also exploring patient satisfaction and potential risks. This review article provides a comprehensive analysis of Botox treatment, focusing on its aesthetic and therapeutic applications, as well as the associated advantages, disadvantages, and patient outcomes. Botulinum toxin, derived from Clostridium botulinum, is widely recognized for its ability to induce temporary muscle paralysis, leading to significant improvements in both cosmetic and medical conditions. The article reviews findings from recent clinical trials, case reports, and observational studies, highlighting the efficacy and safety of Botox in treating various conditions such as chronic migraines, excessive sweating, and muscle spasticity, alongside its cosmetic use in wrinkle reduction. While the benefits of Botox are substantial, including its minimally invasive nature and high patient satisfaction rates, potential risks and complications, including rare adverse events, are also discussed.

Comparison of Safety and Efficacy of Botox and Neuronox in the Management of Benign Essential Blepharospasm: A Split-face Study.

PurposeTo compare the efficacy and safety of Botox and Neuronox in the management of benign essential blepharospasm (BEB).MethodsWe performed a triple-masked, randomized control study to compare Botox and Neuronox in 48 eyes of 24 patients with BEB. All 24 patients randomly received Botox or Neuronox in the periorbital region in a masked, randomized split-face manner, keeping the injection sites and doses uniform. The toxin preparation, injection, and clinical evaluations were done by three independent observers. Objective outcome measures included improvement in the severity of spasm, grading of the functional visual status, changes in palpebral fissure height, lagophthalmos, superficial punctate keratitis and Schirmer's test at 2 weeks, 6 weeks, and upon conclusion of the effect of the toxin. Subjective outcome measures included duration of the effect and a forced choice stating which half of the face was better. Evaluations were performed through clinical measurements, external digital photography, and high-definition videography.ResultsThe mean duration of relief from spasms was 3.78 months (standard deviation, 1.58 months; range, 1 to 6 months). The improvement in the objective parameters like severity of spasm and functional visual status was statistically significant at the 2-week and 6-week follow-up visits (p < 0.001). The changes in palpebral fissure height, lagophthalmos, and superficial punctate keratitis were equally observed in both groups. At 2 and 6 weeks, three of 24 (12.5%) and one of 24 (4%) patients, respectively, reported an unequal effect between the two sides of the face, but this difference was not statistically significant. At final follow-up (conclusion of the toxin effect), patients reported equal effect with no preference for either hemiface. No statistically significant differences were found in the comparative analysis between the Neuronox and Botox groups.ConclusionsNeuronox and Botox are comparable in terms of their safety and efficacy in the management of BEB.

Efficacy of Onabotulinum Toxin A (Botox) versus Abobotulinum Toxin A (Dysport) Using a Conversion Factor (1 : 2.5) in Treatment of Primary Palmar Hyperhidrosis

Background. Two preparations of botulinum A toxin (BTX-A) are commercially available for the treatment of palmar hyperhidrosis (PPH): Botox (Allergan; 100 U/vial) and Dysport (Ipsen Limited; 500 U/vial), which are not bioequivalent. Results regarding an appropriate conversion factor between them are controversial. Objectives. This paper aims to compare the efficacy of Botox and Dysport in PPH using a conversion factor of 1 : 2.5. Methods. Eight patients with severe PPH received intradermal injections of Botox in one palm and Dysport in the other in the same session. Clinical assessment was performed at baseline and posttreatment for 8 months using Minor's iodine starch test, Hyperhidrosis Disease Severity Scale (HDSS), and Dermatology Life Quality Index (DLQI) test. Results. At 3 weeks, a significant decrease in sweating for both preparations was noted which was more pronounced with Dysport compared with Botox. At 8 weeks, this difference turned insignificant. Continued evaluation showed similar improvement in both palms with a nonsignificant difference. Patients with longer disease duration were more liable to relapse. Conclusion. The efficacy and safety of Botox and Dysport injections were similar using a conversion factor of 1 : 2.5. There was a trend towards a more rapid action after Dysport treatment but without significant importance.

Botulinum toxin-A (Botox®) intradetrusor injections in children with neurogenic detrusor overactivity/neurogenic overactive bladder: A systematic literature review

Describe and discuss the efficacy and safety of botulinum toxin type A (BTX-A) intradetrusor injections in children with neurogenic detrusor overactivity (NDO) and urinary incontinence or overactive bladder symptoms of neurogenic origin (NOAB). A MEDLINE and EMBASE search for clinical studies involving BTX-A injected into the detrusor of children with NDO or NOAB was performed, prior to data analysis. A total of six articles evaluating the efficacy and safety of Botox in patients with NDO and incontinence/NOAB were selected. The underlying neurological disease was myelomeningocele in 93% of patients. Most were over 2 years of age. The most common amount of Botox injected was 10-12 U/kg with a maximal dose of 300 U, usually as 30 injections of 10 U/ml in the bladder (excluding the trigone) under cystoscopic guidance and general anaesthesia. Most of the studies reported a significant improvement in clinical (65-87% became completely dry) as well as urodynamic (in most studies mean maximum detrusor pressure was reduced to <40 cm H(2)O and compliance was increased >20 ml/cm H(2)O) variables, without major adverse events. Botox injections into the detrusor provide a clinically significant improvement and seem to be very well tolerated in children with NDO and incontinence/NOAB refractory to antimuscarinics.

Outcome predictors, efficacy and safety of Botox and Dysport in the long‐term treatment of hemifacial spasm

To review the clinical characteristics and the long-term outcome of patients with hemifacial spasm (HFS) who received botulinum neurotoxin (BoNT) over the past 10 years. A total of 108 patients received 665 treatments. Mean latency of clinical effect was 5.4 +/- 5.3 days for Botox and 4.9 +/- 4.6 days for Dysport (P > 0.05). Mean duration of clinical improvement was higher after the injection of Dysport than Botox: 105.9 +/- 54.2 and 85.4 +/- 41.6 days respectively (P < 0.01). The percentage of treatment failures was 6.5% for Botox and 4.6% for Dysport (P > 0.05). The doses of Botox significantly increased over time (beta = 0.35, P < 0. 001) whilst Dysport dose remained unchanged (beta = 0.16, n.s.). The duration of clinical benefit slightly increased with Botox (beta = 0.12; P < 0.01), but remained constant for Dysport. Side effects occurred in 17.4% of treatments: 16.7% of patients who had received Botox, and in 19.7% who had received Dysport (P > 0.05). The most common side effects were palpebral ptosis and lacrimation; ptosis and lagophtalmos was more common in Dysport treatments (P < 0.005). Both brands are effective and safe in treating HFS; efficacy is long-lasting. The differences in outcome and side effects confirm that, albeit the active drug is the same, Botox and Dysport should be considered as two different drugs.

Safety of Botulinum toxin a in cerebral palsy

The use of Botulinum toxin (BoNT) in the treatment of focal spasticity in adults and children has become well established worldwide. Since the first use of BoNT in children with spastic equinus over 10 years ago, there have been no serious or unexpected safety concerns for this indication. However, within the last year, there has been media attention as well as reviews by European and US regulatory agencies about the safety of all marketed Botulinum toxin products for the way in which they are used currently. Following the pioneering studies by Koman in the US and Graham in Europe, the initial publications recommended utilizing doses of 1–4 U BOTOX/kg body weight (BW) per muscle in the gastrocnemius and soleus and a total dose of not more than 8 units BOTOX/kg BW. For Dysport, the recommended dosing was up to 30 U/kg BW up to a maximum of 1000 U. In a consensus statement published in 2000, Graham and colleagues recommended a maximum dose of 50 U of the BOTOX formulation in any one site, a maximum total dose of 12 U/kg BW or 400 units at an injection session. This was based on clinical experience current at that time. Recognizing the multilevel nature of spasticity in children with spastic diplegia, firstly Graham and colleagues, followed by Molenaers and colleagues, extended existing protocols to expand the muscle groups injected to include the hamstrings, adductors and iliopsoas. Although the dose per muscle was not altered, this resulted in a stepwise increase in total dose administered. Subsequently, there have been numerous publications on outcomes and safety of BOTOX when used in a multi-level approach. The most common, obvious treated related side effects are pain at the site of injection, excess weakness of the targeted muscle, and weakness of adjacent muscle. The 2000 consensus statement anticipated that the risk of adverse events in children with cerebral palsy could be related to the type of cerebral palsy than the dose of toxin administered. Specifically, it is anticipated that children at GMFCS level V, who are non-ambulatory and often debilitated with impaired attention and cognition; have comorbidities of epilepsy and other cardiac, pulmonary or neurologic conditions; and have symptoms of pseudo-bulbar palsy, might be specifically at risk for complications of BoNT and/or the procedure including the use of sedative agents and anaesthesia. In a recent randomized trial, Graham and colleagues carefully studied adverse events in a large number of children with cerebral palsy treated with an average dose of 14 U BOTOX/kg BW. There was evidence of possible systemic spread and adverse events in some children, but no fatalities directly related to the administration of the toxin. This experience is consistent with the literature. In a recent review of our BoNT database, we have identified the following risk factors for adverse events in the administration of BoNT. In order of importance these are: (1) the child's GMFCS level; (2) the total dose administered; (3) method of sedation/anaesthesia. Secondary factors for further investigation include: (1) current and past medical history, specifically dysphagia, aspiration, cardiopulmonary events, concomitant medications; (2) reconstitution volume; (3) total number of muscles injected; (4) single or divided dose per muscle; (5) method of muscle targeting, e.g. muscle stimulation versus ultrasound.