Toxin Injection Research Articles

Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation

BackgroundPostoperative atrial fibrillation (POAF) is associated with increased morbidity and mortality. Epicardial injection of botulinum toxin may suppress POAF. ObjectivesThis study sought to assess the safety and efficacy of AGN-151607 for the prevention of POAF after cardiac surgery. MethodsThis phase 2, randomized, placebo-controlled trial assessed the safety and efficacy of AGN-151607, 125 U and 250 U vs placebo (1:1:1), for the prevention of POAF after cardiac surgery. Randomization was stratified by age (<65, ≥65 years) and type of surgery (nonvalvular/valve surgery). The primary endpoint was the occurrence of continuous AF ≥30 seconds. ResultsAmong 312 modified intention-to-treat participants (placebo, n = 102; 125 U, n = 104; and 250 U, n = 106), the mean age was 66.9 ± 6.8 years; 17% were female; and 64% had coronary artery bypass graft (CABG) only, 12% had CABG + valve, and 24% had valve surgery. The primary endpoint occurred in 46.1% of the placebo group, 36.5% of the 125-U group (relative risk [RR] vs placebo: 0.80; 95% CI: 0.58-1.10; P = 0.16), and 47.2% of the 250-U group (RR vs placebo: 1.04; 95% CI: 0.79-1.37; P = 0.78). The primary endpoint was reduced in the 125-U group in those ≥65 years of age (RR: 0.64; 95% CI: 0.43-0.94; P = 0.02) with a greater reduction in CABG-only participants ≥65 years of age (RR: 0.49; 95% CI: 0.27-0.87; P = 0.01). Rehospitalization and rates of adverse events were similar across the 3 groups. ConclusionsThere were no significant differences in the rate of POAF with either dose compared with placebo; however, there was a lower rate of POAF in participants ≥65 years undergoing CABG only and receiving 125 U of AGN-151607. These hypothesis-generating findings require investigation in a larger, adequately powered randomized clinical trial. (Botulinum Toxin Type A [AGN-151607] for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery [NOVA]; NCT03779841); A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A [AGN 151607] Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery; 2017-004399-68)

Vocal Fold Motion Impairment in Neurodegenerative Diseases.

Vocal fold motion impairment (VFMI) is the inappropriate movement of the vocal folds during respiration, leading to vocal fold adduction and/or abduction problems and causing respiratory and vocal impairments. Neurodegenerative diseases (NDDs) are a wide range of disorders characterized by progressive loss of neurons and deposition of altered proteins in the brain and peripheral organs. VFMI may be unrecognized in patients with NDDs. VFMI in NDDs is caused by the following: laryngeal muscle weakness due to muscular atrophy, caused by brainstem and motor neuron degeneration in amyotrophic lateral sclerosis; hyperactivity of laryngeal adductors in Parkinson's disease; and varying degrees of laryngeal adductor hypertonia and abductor paralysis in multiple system atrophy. Management of VFMI depends on whether there is a presence of glottic insufficiency or insufficient glottic opening with/without severe dysphagia. VFMI treatment options for glottic insufficiency range from surgical interventions, including injection laryngoplasty and medialization thyroplasty, to behavioral therapies; for insufficient glottic opening, various options are available based on the severity and underlying cause of the condition, including continuous positive airway pressure therapy, botulinum toxin injection, tracheostomy, vocal fold surgery, or a combination of interventions. In this review, we outline the mechanisms, clinical features, and management of VFMI in NDDs and provide a guide for physicians who may encounter these clinical features in their patients. NDDs are always progressive; hence, timely evaluation, proper diagnosis, and appropriate management of the patient will greatly affect their vocal, respiratory, and swallowing functions as well as their quality of life.

Modelling long-term outcomes and mortality risk in patients with post-stroke spasticity during abobotulinum toxin injections as part of rehabilitation

To date, there are no Russian or international studies investigating the long-term efficacy of botulinum therapy (abobotulinum toxin injections – AboBTX) during rehabilitation in patients with post-stroke spasticity in terms of its impact on the risk of death from all causes and the development of cardiovascular complications. A 10-year study conducted in the United Kingdom analyzed the effects of AboBTX injections in patients with post-stroke spasticity on long-term clinical (all-cause mortality, cardiovascular events, length and quality of life) and economic (direct medical costs) outcomes. For the first time ever, a model was developed to evaluate the clinical (quality-adjusted life expectancy) and economic benefits of AboBTX injections in the structure of rehabilitation compared to rehabilitation without botulinum therapy in patients with post-stroke spasticity. It was shown that the inclusion of regular injections of AboBTX in the rehabilitation process resulted in an 8.8% reduction in the risk of death from all causes, a 13% increase in life expectancy (and by 59% in quality-adjusted terms compared to rehabilitation without botulinum therapy) and proved to be cost-effective. The use of AboBTX injections in patients with post-stroke spasticity as part of rehabilitation is cost-effective in the long term and improves long-term outcomes, including post-stroke survival.

Botulinum Toxin in Chronic Lateral Epicondylitis, from Tendon to Muscle Approach-A Review.

Chronic lateral epicondylitis challenges the therapeutical approach; underlying mechanisms are incompletely understood; neuropathic pain and central and peripheral sensitization may explain the fact that botulinum toxin has been found to play a role in pain and function management. We searched the literature for MeSH terms: lateral epicondylitis or synonyms and botulinum toxin. We found 14 papers containing trials on botulinum toxin injection into the tendon or into the extensor muscles (specifically, extensor carpi radialis brevis and extensor communis digitorum). We followed the administration pathways, doses, timing, and side effects. With a chronic course, the focus of the therapy shifts from the afflicted tendon to the inserting muscles, as muscle contracture may create a vicious loop to perpetuate and aggravate the disease. Doses, timing, and side effects are discussed.

Botulinum toxin in modern cosmetology practice: from high efficiency to the problem of complications (analysis of clinical observation)

At the present stage, there has been an increase in the popularity of wrinkle correction using botulinum toxin, which is largely due to the quick and long-lasting result of this procedure. The accumulated scientific and practical experience shows that cosmetic injections of botulinum toxin are rarely accompanied by complications. However, due to the high demand for procedures and the significant commercialization of this area, cases of its implementation by persons without proper professional education and using non-certified injectables have become more frequent. This often leads to undesirable consequences of the procedure and late treatment of such patients in specialized medical institutions. The article focuses on the fact that a prerequisite for this procedure is a high level of qualification of a dermatocosmetologist, the obligatory observance of the injection technique and the use of only certified medical preparations. In order to inform healthcare professionals about this problem, we present our own clinical observations of patients with complications after botulinum toxin injections performed by non-medical personnel.

Effectiveness of Extracorporeal Shock Wave Therapy after Botulinum Toxin Injection for Post-Stroke Upper Extremity Spasticity: A Randomized Controlled Study.

Post-stroke spasticity is a common complication that limits the functional performance of patients. Botulinum toxin (BTx) is an effective treatment for spasticity. Numerous researchers have applied extracorporeal shock wave therapy (ESWT) to address post-stroke spasticity, yielding positive clinical outcomes. We aimed to clarify the add-on effects of ESWT on BTx therapy for spasticity in patients with post-stroke. Sixteen eligible patients with upper extremity spasticity after stroke were recruited for this study. They were randomized to either a BTx with focused ESWT treatment group or a BTx alone group. Spasticity, measured using the modified Ashworth score (MAS) and modified Tardieu scale (MTS), showed statistically significant improvements in the elbow and wrist flexor muscles in both BTx + ESWT group and BTx alone groups. However, no significant differences were observed between the two groups with time flow. The BTx + ESWT group showed significantly decreased MAS of the finger flexors at follow-up and increased R1 (MTS) of the finger flexors at 3 weeks after treatment, which was not observed in the BTx alone group. This is the first study to identify the add-on effect of ESWT on BTx injections to improve post-stroke upper limb spasticity.

Identifying Levels of Competency in Aesthetic Medicine: A Questionnaire-based Study.

In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amid an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by nonacademic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. The aim of this study was to identify levels of competency for the aesthetic practitioner and necessary achievement milestones during the educational path from novice to expert injector. A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection, and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. Regardless of medical specialty and experience level, averages of 3.85 (1.8) years, 786.4 (2628) filler injections and 549.9 (1543) toxin injections were estimated to progress from novice to advanced injector, while averages of 6.10 (3.7) years, 1842.2 (4793) filler injections, and 1308.5 (3363) toxin injections were estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions where it is most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. In this study we establish an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1840 filler and 1310 neuromodulator injections for expertise. We also identify critical facial regions for targeted treatments by different expertise levels.

Distal renal tubular acidosis as a rare complication of vesicoureteral reflux in children: a case report and literature review.

Distal renal tubular acidosis (dRTA) is a clinical picture of hyperchloremic hypokalemic metabolic acidosis with a normal anion gap. It can be caused by a variety of conditions including obstructive uropathy such as vesicoureteral reflux (VUR). We report a rare case of dRTA secondary to VUR in a 4-year-old girl with a history of meningomyelocele, neurogenic bladder and recurrent urinary tract infections. She was admitted to the hospital with complaints of polydipsia, polyuria, and inability to gain weight for the last 1year. She was on prophylactic antibiotic treatment with clean intermittent catheterization and anticholinergic drug. She had a history of subureteral injection of various agents and botulin toxin injection into the bladder. Her voiding cystourethrogram revealed grade 5 VUR in the left kidney, tortuosity in the left ureter, and the bladder had a dome-like appearance and was trabeculated. When all laboratory values of the patient since birth were examined, it was observed that urine pH was high despite hypokalemic hyperchloremic metabolic acidosis for the last year; these abnormalities became more severe in the last few months. In conclusion, the development of hypokalemia and nephrolithiasis/nephrocalcinosis along with metabolic acidosis in a patient diagnosed with VUR should be considered as an indicator of impaired tubular functions. Also, the possibility of an underlying VUR in the presence of recurrent urinary tract infection in a patient diagnosed with dRTA should not be ignored.

CGRP Released by Corneal Sensory Nerve Maintains Tear Secretion of the Lacrimal Gland.

This study aims to elucidate the calcitonin gene-related peptide (CGRP) mediation and primary mechanism of corneal sensory nerves on tear production of the lacrimal gland. Mouse corneal denervation models were constructed through surgical axotomy, pharmacologic treatment with capsaicin or resiniferatoxin, and Trpv1-Cre/DTR mice with diphtheria toxin injection. The capsaicin-treated mice received subconjunctival injection of CGRP or substance P, while the normal C57BL/6J mice were administered with CGRP receptor antagonist BIBN-4096. Furthermore, double immunostaining of c-FOS+ and choline acetyltransferase was used to evaluate the activation of the superior salivatory nucleus (SSN). Mouse lacrimal glands were collected for transcriptomic sequencing and subsequent RNA and protein expression analysis. The corneal denervated mice exhibited a significant reduction in corneal sensitivity and tear secretion. In capsaicin-treated mice, tear secretion decreased to 2.5 ± 0.5mm compared to 6.3 ± 0.9mm in control mice (P < 0.0001). However, exogenous administration of CGRP in capsaicin-treated mice increased tear secretion from 2.6 ± 0.5mm to 4.5 ± 0.5mm (P = 0.0009), while BIBN-4096 treatment reduced tear secretion to 3.4 ± 0.5mm when compared to 7.3 ± 0.7mm in control mice (P = 0.0022). Furthermore, c-FOS+ cell number in the SSN increased by twofold (P = 0.0168) after CGRP administration compared with capsaicin-treated mice. In addition, the expressions of CCNA2, Ki67, PCNA, and CDK1 in acinar cells of the lacrimal gland were impaired by corneal denervation and alleviated by CGRP administration. CGRP released by corneal sensory nerves mediates tear secretion of the lacrimal gland, providing a new strategy for improving tear secretion in patients with neurotrophic keratitis.

Facial Painting and 3D Stereophotogrammetric Analysis of Facial Dynamics: A Reliable Anatomical Educational Method.

(1) Background: Accurate knowledge of the dynamic anatomy of facial muscles is crucial for the use of functional and aesthetic botulinum toxin injections. We studied the reliability and relevance of facial painting as a pedagogic tool for the dynamic anatomy of facial muscles. (2) Methods: Different facial expressions were performed by a female model after a professional makeup artist applied makeup to the various facial muscles on her left hemiface. A 3D photograph was taken at the beginning and end of each movement using the VECTRA H2 Imaging System device. Cutaneous movements were visualized using displacement vectors. The correlation between the theoretical and dynamic positions of the makeup-muscle was assessed by two facial anatomy experts, thanks to a correlation scale. (3) Results: The overall average score for the 11 analyzed muscles or muscle groups was 3.36 out of 4, indicating a "strong" to "very strong" estimated correlation. There was a moderate agreement between Evaluator 1 and Evaluator 2 (ICC: 0.64; 95%CI: [0.244; 0.852]; p-value: 0.005). (4) Conclusions: The educational model with facial makeup provides an indirect but nonetheless precise and reliable representation of all facial muscles on the skin's surface. It is presented as a reliable and reproducible method, which exhibits great potential as a teaching tool.

Botulinum Toxin Injections for Psychiatric Disorders: A Systematic Review of the Clinical Trial Landscape.

Botulinum toxin type A (BONT-A) has shown promise in improving the mood-related symptoms of psychiatric disorders by targeting muscles linked to the expression of negative emotions. We conducted a systematic review of past and ongoing efficacy trials of BONT-A therapy for psychiatric disorders to identify relevant trends in the field and discuss the refinement of therapeutic techniques. A comprehensive search for published clinical trials using BONT-A injections for psychiatric disorders was performed on 4 May 2023 through OVID databases (MEDLINE, Embase, APA PsycINFO). Unpublished clinical trials were searched through the ClinicalTrials.gov and International Clinical Trial Registry Platform public registries. The risk of bias was assessed using the JBI Critical Appraisal tools for use in systematic reviews. We identified 21 studies (17 published, 4 unpublished clinical trials) involving 471 patients. The studies focused on evaluating the efficacy of BONT-A for major depressive, borderline personality, social anxiety, and bipolar disorders. BONT-A was most commonly injected into the glabellar area, with an average dose ranging between 37.75 U and 44.5 U in published studies and between 32.7 U and 41.3 U in unpublished trials. The results indicated significant symptom reductions across all the studied psychiatric conditions, with mild adverse effects. Thus, BONT-A appears to be safe and well-tolerated for psychiatric disorders of negative affectivity. However, despite the clinical focus, there was a noted shortage of biomarker-related assessments. Future studies should focus on pursuing mechanistic explorations of BONT-A effects at the neurobiological level.

Parietal abdominal pain with lower leg discrepancy: a case report

BackgroundThis report involves the first publication describing a case of parietal abdominal pain due to lower limb length discrepancy.Case presentationA Caucasian male patient in his 50s was referred to our rehabilitation department with chronic abdominal pain that began in childhood. This chronic pain was associated with episodes of acute pain that were partially relieved by grade 3 analgesics. The patient was unable to sit for long periods, had recently lost his job, and was unable to participate in recreational activities with his children. Investigations revealed contracture and hypertrophy of the external oblique muscle and an limb length discrepancy of 3.8 cm (1.5 inches) in the left lower limb. The patient was effectively treated with a heel raise, physiotherapy, intramuscular injection of botulinum toxin, and lidocaine. The patient achieved the therapeutic goals of returning to work, and reducing analgesic use.ConclusionsStructural misbalances, as may be caused by lower leg discrepancy, may trigger muscular compensations and pain. Complete anamnesis and clinical examination must not be trivialized and may reveal previously ignored information leading to a proper diagnosis.

Inability to belch syndrome: what the gastroenterologist needs to know.

To review recent publications on the inability to belch syndrome. Five recent retrospective case series indicate that the inability to belch syndrome usually starts in early childhood and is often accompanied by gurgling noises in the chest, pain in the chest or upper abdomen, bloating, and excessive flatulence. Currently, the vast majority of patients who have been identified with inability to belch have self-diagnosed the syndrome on the basis of information available on the internet. A favorable response to injection of botulinum toxin in the cricopharyngeus muscle is regarded as confirmation of the diagnosis. In a mechanistic study in eight patients, absence of reflexogenic relaxation of the upper esophageal sphincter upon rapid gaseous esophageal distension was confirmed to play a pivotal role in the pathogenesis of the syndrome. The inability to belch syndrome, caused by failure of the upper esophageal sphincter to relax when the esophageal body is distended, clearly exists and may not be as rare as thought hitherto. However, overdiagnosis is also likely to occur because the diagnosis is usually made on the basis of symptoms only. The efficacy of botulinum toxin injection in the upper sphincter needs to be assessed in double-blind placebo-controlled studies.

Botulinum Toxin Injection under Electromyography Guidance for the Treatment of Primary Dysfunction of Cricopharyngeal Muscle

Botulinum Toxin Injection under Electromyography Guidance for the Treatment of Primary Dysfunction of Cricopharyngeal Muscle

Functional Goal Setting for Botulinum Toxin Injections in People with Cerebral Palsy (P10-8.005)

Functional Goal Setting for Botulinum Toxin Injections in People with Cerebral Palsy (P10-8.005)

Upper Limb Casting Application Post-Botulinum Toxin Injection for Elbow Spasticity: A Guided Casting Protocol.

Casting is an effective adjunctive treatment, which increases the effects of botulinum toxin on patients with spasticity. The evidence for casting as an adjunctive therapy post-botulinum toxin has been well documented in the literature. However, standardized casting protocols are lacking, with no published descriptions of upper limb casting application post-botulinum toxin injection for spasticity. In this article, we will describe our experience regarding the application of upper limb casting as an adjunctive therapy for elbow spasticity, detailing indications, contraindications, and description of our protocol (materials required and technique).

Factors affecting the effectiveness of intravesical injection of botulinum toxin A in females with overactive bladder

Factors affecting the effectiveness of intravesical injection of botulinum toxin A in females with overactive bladder

Is bulbospongiosus muscle botox injection safe and effective in treating lifelong premature ejaculation? Randomized controlled study

PurposeTo evaluate the safety and efficacy of botulinum-A toxin injections into the bulbospongiosus muscle for cases of lifelong drug-resistant premature ejaculation (PE).MethodsNinety-eight outpatients diagnosed with lifelong PE were randomly assigned to two groups: the botulinum-A toxin group comprising forty-nine patients and the placebo (saline) group also consisting of forty-nine patients. A 100 U botulinum-A toxin was diluted into 10 cc of saline, with 5 cc injected into one side of the muscle (botulinum-A toxin group) guided by ultrasound to distribute across most muscle fibers. The same technique was applied using the same volume of saline injected into the bulbospongiosus muscle. Intravaginal ejaculatory latency time (IELT), scores from the premature ejaculation profile (PEP), Premature Ejaculation Diagnostic Tool (PEDT), International Index of Erectile Function (IIEF), and recording of any complications were obtained. Follow-ups occurred at 1-, 3-, and 6-month post-procedure.ResultsCases receiving injections of botulinum-A toxin into the bulbospongiosus muscle showed notably extended intravaginal ejaculatory latency times compared to their initial performance after treatment. In addition, there were enhancements in PEP scores, and notably, no significant complications were reported. Conversely, the bilateral injection of saline into the bulbospongiosus muscle did not demonstrate any impact on ejaculation latencies.ConclusionOur study demonstrated that the injection of botulinum-A toxin into the bulbospongiosus muscle can serve as a safe and effective option for treating PE. Nonetheless, its clinical application warrants further studies involving larger sample sizes and longer follow-up periods.

Botulinum toxin and hyperhidrosis of the amputation stump in war amputees.

Stump hyperhidrosis is a common condition after lower limb amputation. It affects the prosthesis use, and the quality of life of patients. Several case reports tried to prove benefit of using Botulinum toxin in its treatment. This study was to conduct a larger workforce clinical trial and to demonstrate benefits of botulinum toxin injection in the treatment of stump hyperhidrosis. A prospective study was conducted. War amputees who complained of annoying excessive sweating of the stump were included. They received intradermal injection of botulinum toxin A in the residual limb area in contact with prosthetic socket. Abundance of sweating and degree of functional discomfort associated with it were assessed before, after 3 weeks, 6 and 12 months. Seventeen male patients, followed for post-traumatic limb amputation were included in the study. Discomfort and bothersome in relation to Hyperhidrosis did decrease after treatment (p<0,001). Reported satisfaction after 3 weeks was 73,33%. Improvement of prothesis loosening up after 3 weeks was 72,5% [±15,6]. Mean injection-induced pain on the visual analogue scale was 5.17/10 (±1.58). The mean interval after the onset of improvement was 5.13 days [min:3, max:8]. The mean time of improvement was 10.4 months after the injection [min:6, max:12]. No major adverse events were reported following treatment. Intradermal injections of botulinum toxin in the symptomatic treatment of stump hyperhidrosis are effective and have few adverse effects. It improves the quality of life of our patients thanks to a better tolerance of the prosthesis.

Effects of onabotulinum toxin type A injections in patients with Meige's syndrome.

Meige's syndrome is a type of facial dystonia characterized by the simultaneous occurrence of blepharospasm and oromandibular dystonia. Although botulinum toxin type A (OBTA) injections are the standard treatment, evidence of their effectiveness and safety in this scenario is still lacking. Our research aimed to evaluate the improvement and occurrence of side effects following injections of onabotulinum toxin type A (OBTA) in patients with Meige's syndrome. Patients with Meige's syndrome undergoing botulinum toxin injections were enrolled in this study. We assessed dystonia intensity before and 14 days after OBTA injection using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) to measure the response of symptoms in the eyes (blepharospasm) and mouth (oromandibular dystonia). Other variables, such as dosage, side effects, and demographic data, were also recorded. The study included 41 participants, with a mean age of 67.7 years and a female-to-male ratio of 3.5:1. The mean BFMDRS score before the injections was 8.89, and after 14 days, it was 2.88. The most reported side effect was ptosis, with a 7.3% incidence. OBTA significantly reduced dystonia severity (p < 0.0001). The clinical response for the blepharospasm component was superior to the oromandibular dystonia component. Our results support that OBTA seems to be an effective and safe therapeutic option for treating Meige's syndrome. The effect of OBTA was more pronounced in the treatment of blepharospasm than in oromandibular dystonia.