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Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial.
Lindsay, C, Ispoglou, S, Helliwell, B, Hicklin, D, Sturman, S, Pandyan, A
Clinical rehabilitation. 2021;(3):399-409
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Abstract
OBJECTIVE Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function. DESIGN Randomised placebo-controlled-trial. SETTING Specialised stroke-unit. PARTICIPANTS & INTERVENTION Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). OUTCOME-MEASURES Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection. RESULTS Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively. CONCLUSION BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function. TRIAL REGISTRATION EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.
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Overactive Bladder in Frail Older Adults.
Shaw, C, Wagg, A
Drugs & aging. 2020;(8):559-565
Abstract
Overactive bladder (OAB) and frailty are multidimensional syndromes, and the prevalence of both increases with age. Little evidence exists for a direct association between OAB and frailty, but urinary urgency may well be a precursor of frailty in older people. Frail older adults are no less deserving of treatment than fit older adults, and lifestyle, behavioral, and pharmacological interventions remain the primary options for treatment, with some evidence for efficacy. Data on onabotulinumtoxinA therapy or percutaneous tibial nerve stimulation in frail older adults are sparse. Frail older adults are often excluded from drug trials, but evidence is accumulating that antimuscarinics and, to a lesser extent, beta-adrenergic agonists are safe, well-tolerated, and effective in older adults. Cognitive impairment associated with frailty should not be used as justification for avoiding the use of antimuscarinics. More studies are required to better understand the association between OAB and frailty, as both are associated with poor outcomes and may be amenable to intervention. Drug trials for OAB treatments should be encouraged to include frail older adults, as this population is highly affected yet often excluded.
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Iron Deposits in Periaqueductal Gray Matter Are Associated with Poor Response to OnabotulinumtoxinA in Chronic Migraine.
Domínguez Vivero, C, Leira, Y, Saavedra Piñeiro, M, Rodríguez-Osorio, X, Ramos-Cabrer, P, Villalba Martín, C, Sobrino, T, Campos, F, Castillo, J, Leira, R
Toxins. 2020;(8)
Abstract
Previous studies have reported increased brain deposits of iron in patients with chronic migraine (CM). This study aims to determine the relation between iron deposits and outcome after treatment with OnabotulinumtoxinA (OnabotA). Demographic and clinical data were collected for this study through a prospective cohort study including 62 CM patients treated with OnabotA in the Hospital Clínico Universitario de Santiago de Compostela (Spain). Demographic and clinical variables were registered. Selected biomarkers in plasma during interictal periods (calcitonin gene-related peptide (CGRP) and pentraxin-3 (PTX3)) and neuroimaging changes (iron deposits in the red nucleus (RN), substantia nigra (SN), globus pallidus (GP), and periaqueductal gray matter (PAG), and white matter lesions (WML)) were determined. Subjects were classified in responders (≥50% reduction in headache days) or non-responders (<50%). Responders to treatment were younger (mean age difference = 12.2; 95% confidence interval (CI): 5.4-18.9, p = 0.001), showed higher serum levels of CGRP (≥50 ng/mL) and PTX3 (≥1000 pg/mL) and smaller iron deposits in the GP and PAG (mean difference = 805.0; 95% CI: 37.9-1572.1 μL, p = 0.040 and mean difference = 69.8; 95% CI: 31.0-108.6 μL, p = 0.008; respectively). Differences in PAG iron deposits remained significant after adjusting for age (mean difference = 65.7; 95% CI: 22.8-108.6 μL, p = 0.003) and were associated with poor response to OnabotA after adjustment for clinical and biochemical variables (odds ratio (OR) = 0.963; 95% CI: 0.927-0.997, p = 0.041). We conclude that larger PAG iron deposits are associated with poor response to OnabotA in CM.
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Vibration Versus Ice to Reduce Cosmetic Botulinum Toxin Injection Pain-A Randomized Controlled Trial.
Chorney, SR, Villwock, JA, Suryadevara, AC
Ear, nose, & throat journal. 2019;(6):351-355
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Abstract
Botulinum toxin is the most commonly performed facial cosmetic procedure and pain at the injection site is a frequent patient concern. While various topical interventions have been described for analgesia, there have not been any studies comparing different techniques. We compared the use of a vibratory stimulus, ice pack application, and no intervention on injection site pain for cosmetic botulinum toxin injection. A prospective-, randomized-, individual-controlled study was conducted using a visual analog scale to assess pain. Patients received bilateral glabellar injections, with randomization into unilateral vibration, unilateral ice application, or vibration and ice on either side. We analyzed 88 injections on 22 patients. Mean visual analog scores were 26.5 (standard deviation [SD]: 23.1) among injections with vibration, 24.4 (SD: 22.9) with ice, and 29.4 (SD: 27.1) without analgesia. There was no significant difference in pain scale scores with the use of vibration, ice, or no topical anesthesia (P = .737). Further, pain scale scores did not differ significantly between medial and lateral injections nor did patients have a reduction in pain on either side of the forehead regardless of which method was used. While there may be a role for topical interventions to improve injection site analgesia, we maintain that consistently proper technique plays a greater role in improving patient tolerance. Future studies will continue to investigate the role of topical anesthesia in cosmetic facial injections and address patient-specific factors contributing to discomfort.
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Temporary autonomic modulation with botulinum toxin type A to reduce atrial fibrillation after cardiac surgery.
Waldron, NH, Cooter, M, Haney, JC, Schroder, JN, Gaca, JG, Lin, SS, Sigurdsson, MI, Fudim, M, Podgoreanu, MV, Stafford-Smith, M, et al
Heart rhythm. 2019;(2):178-184
Abstract
BACKGROUND Postoperative atrial fibrillation (POAF) frequently complicates cardiac surgery and is associated with worse outcomes. The cardiac autonomic nervous system is implicated in the pathogenesis of POAF. OBJECTIVE The purpose of this study was to determine the efficacy and safety of selective cardiac autonomic modulation in preventing POAF. METHODS In this randomized, double-blind, placebo-controlled trial, adults undergoing cardiac surgery were randomized 1:1 to intraoperative injection of 250 units onabotulinumtoxinA (botulinum toxin type A [BoNTA]) or placebo into epicardial fat pads. The study was powered to detect a 40% reduction in relative risk of POAF. Time to first episode of in-hospital POAF was the primary outcome, evaluated in patients receiving injection. Additionally, incidence of POAF, length of stay (LOS), and adverse events were examined. RESULTS The trial assigned 145 patients to injection, 15 of whom were dropped before treatment, leaving 130 patients for analysis. Overall, 36.5% (23/63) of BoNTA-treated patients developed POAF compared with 47.8% (32/67) of placebo-treated patients. The time-to-event analysis revealed a hazard ratio of 0.69 (95% confidence interval 0.41-1.19; P = .18) for the BoNTA vs placebo arm. There were no significant differences in postoperative hospital LOS (median [interquartile range] 6.0 [3.4] vs 6.2 [3.7] days; P = .51) or adverse events prolonging LOS (27/63 [42.9%] vs 30/67 [44.8%]; P = .83) in patients receiving BoNTA vs placebo. CONCLUSION Epicardial injection of onabotulinumtoxinA was without discernible adverse effects, but we failed to detect a significant difference in risk of POAF. Future large-scale studies of epicardial onabotulinumtoxinA injection as a potential POAF prevention strategy should be designed to study smaller, but clinically meaningful, treatment effects.
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Botulinum toxin injection to improve functional independence and to alleviate parenting stress in a child with advanced pantothenate kinase-associated neurodegeneration: A case report and literature review.
Lin, CI, Chen, KL, Kuan, TS, Lin, SH, Lin, WP, Lin, YC
Medicine. 2018;(20):e10709
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RATIONALE Pantothenate kinase-associated neurodegeneration (PKAN) is a rare autosomal recessive disease. Progressive motor symptoms such as dystonia and spasticity begin in childhood and relentlessly become incapacitating later in life. Treatments including anticholinergics and iron chelation are usually ineffective. Botulinum toxin type A (BoNT-A) is effective for adult patients with dystonia or spasticity. PATIENT CONCERNS We reported a 10-year-old female patient with advanced PKAN, manifesting as generalized dystonia and spasticity. DIAGNOSIS The patient was diagnosed with PKAN by a pediatric neurologist. INTERVENTIONS The patient received BoNT-A injection. OUTCOMES The effect was obvious at four weeks after the injection, with an improvement of 25% in Barry-Albright Dystonia Scale and 4% in Functional Independence Measure for Children score. Furthermore, there was a 3.8% reduction in Parenting Stress Index Short Form score and 8.3% improvement in Pain and Impact of Disability domain in the score of Cerebral Palsy Quality of Life for Children. LESSONS BoNT-A injection was effective to improve functional independence and to alleviate stress of caregivers in the patient with advanced PKAN.
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Foodborne botulism due to ingestion of home-canned green beans: two case reports.
Hellmich, D, Wartenberg, KE, Zierz, S, Mueller, TJ
Journal of medical case reports. 2018;(1):1
Abstract
BACKGROUND Foodborne botulism is a life-threatening, rapidly progressive disease. It has an incidence of less than 10 cases per year in Germany and mostly affects several previously healthy people at the same time. The only specific treatment is the administration of botulism antitoxin. According to the German guidelines administration of antitoxin is recommended only in the first 24 hours after oral ingestion of the toxin. CASE PRESENTATION A 47-year-old white woman and her 51-year-old white husband presented with paralysis of multiple cranial nerves and rapidly descending paralysis approximately 72 hours after ingestion of home-canned beans. The disease was complicated by autonomic changes like hypertension, febrile temperatures, and a paralytic ileus. The diagnosis was confirmed by identification of botulinum neurotoxin type A in the serum of the woman. In accordance with the German guidelines, antitoxin was not given due to the prolonged time interval at diagnosis. Both patients had a long intensive care unit course requiring ventilation for approximately 5 months. Finally they recovered completely. CONCLUSIONS A full recovery from foodborne botulism is possible even in patients with intensive care lasting several months. There are only case reports indicating that administration of antitoxin may shorten the course of the disease, even if given later than 24 hours after intoxication. Due to the rarity of the disease and its rapid course there are no randomized controlled trials. Thus, evidence of the superiority of this treatment is lacking. However, the prevailing view according to the German guidelines to administer antitoxin only within 24 hours after ingestion of the toxin should be questioned in the case of progression of the disease with proof of remaining toxin in the blood.
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Differential effect of Incobotulinumtoxin A on pain, neurogenic flare and hyperalgesia in human surrogate models of neurogenic pain.
Diener, SA, Breimhorst, M, Vogt, T, Krämer, HH, Drummond, PD, Geber, C, Birklein, F
European journal of pain (London, England). 2017;(8):1326-1335
Abstract
BACKGROUND The effectiveness of Botulinum-neurotoxin A (BoNT/A) to treat pain in human pain models is very divergent. This study was conducted to clarify if the pain models or the route of BoNT/A application might be responsible for these divergent findings. METHODS Sixteen healthy subjects (8 males, mean age 27 ± 5 years) were included in a first set of experiments consisting of three visits: (1) Visit: Quantitative sensory testing (QST) was performed before and after intradermal capsaicin injection (CAPS, 15 μg) on one thigh and electrical current stimulation (ES, 1 Hz) on the contralateral thigh. During stimulation pain and the neurogenic flare response (laser-Doppler imaging) were assessed. (2) Four weeks later, BoNT/A (Xeomin® , 25 MU) was injected intracutaneously on both sides. (3) Seven days later, the area of BoNT/A application was determined by the iodine-starch staining and the procedure of the (1) visit was exactly repeated. In consequence of these results, 8 healthy subjects (4 males, mean age 26 ± 3 years) were included into a second set of experiments. The experimental setting was exactly the same with the exception that stimulation frequency of ES was increased to 4 Hz and BoNT/A was injected subcutaneously into the thigh, which was stimulated by capsaicin. RESULTS BoNT/A reduced the 1 Hz ES flare size (p < 0.001) and pain ratings (p < 0.01), but had no effect on 4 Hz ES and capsaicin-induced pain, hyperalgesia, or flare size, regardless of the depth of BoNT/A injection (i.c./s.c). Moreover, i.c. BoNT/A injection significantly increased warm detection and heat pain thresholds in naive skin (WDT, Δ 2.2 °C, p < 0.001; HPT Δ 1.8 °C, p < 0.005). CONCLUSION BoNT/A has a moderate inhibitory effect on peptidergic and thermal C-fibers in healthy human skin. SIGNIFICANCE The study demonstrates that BoNT/A (Incobotulinumtoxin A) has differential effects in human pain models: It reduces the neurogenic flare and had a moderate analgesic effects in low frequency but not high frequency current stimulation of cutaneous afferent fibers at C-fiber strength; BoNT/A had no effect in capsaicin-induced (CAPS) neurogenic flare or pain, or on hyperalgesia to mechanical or heat stimuli in both pain models. Intracutaneous BoNT/A increases warm and heat pain thresholds on naïve skin.
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Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke.
Morel, C, Hauret, I, Andant, N, Bonnin, A, Pereira, B, Coudeyre, E
BMJ open. 2016;(11):e011751
Abstract
INTRODUCTION Botulinum toxin injections are an effective treatment for limb spasticity following stroke. Different tracking techniques are used for this purpose: palpation, electrostimulation, electromyography and ultrasound. Yet very few studies have compared these different techniques, and none has successfully proved the superior efficacy of ultrasound-guided injections compared to another tracking method. The primary objective of our study was therefore to compare the efficacy of botulinum toxin injections depending on the tracking technique used: ultrasound versus electrostimulation. METHODS AND ANALYSIS This is a clinical, single-centre, prospective, interventional, single-blind, crossover, randomised trial. In total, 30 patients aged between 18 and 80 years presenting with triceps surae spasticity (evaluated >1 on the modified Ashworth scale) associated with hemiplegia sequelae due to stroke will be included. The patients will be selected among those who attend for consultation the Physical Medicine and Rehabilitation Department of the Clermont-Ferrand University Hospital. One group will receive the abobotulinumtoxinA (BoNT-A) injection guided by electrostimulation then ultrasound, and the second group's botulinum toxin injections will be guided by ultrasound then electrostimulation. For each patient, the duration of study participation is 5 months. The primary end point is variation in passive ankle dorsiflexion range of motion at slow and high speeds (Tardieu scale) with the knee straight. ETHICS AND DISSEMINATION This study received ethics approval form the CPP of Rhônes-Alpes region. Results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT01935544; pre-results.
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The Efficacy and Safety of Fractional CO₂ Laser Combined with Topical Type A Botulinum Toxin for Facial Rejuvenation: A Randomized Controlled Split-Face Study.
Zhu, J, Ji, X, Li, M, Chen, XE, Liu, J, Zhang, JA, Luo, D, Zhou, BR
BioMed research international. 2016;:3853754
Abstract
OBJECTIVE We evaluated synergistic efficacy and safety of combined topical application of Botulinum Toxin Type A (BTX-A) with fractional CO2 laser for facial rejuvenation. METHODS Twenty female subjects were included for this split-face comparative study. One side of each subject's cheek was treated with fractional CO2 plus saline solution, and the other side was treated with fractional CO2 laser plus topical application of BTX-A. Patients received one session of treatment and evaluations were done at baseline, one, four, and twelve weeks after treatment. The outcome assessments included subjective satisfaction scale; blinded clinical assessment; and the biophysical parameters of roughness, elasticity, skin hydration, transepidermal water loss (TEWL), and the erythema and melanin index. RESULTS BTX-A combined with fractional CO2 laser sides showed higher physician's global assessment score, subject satisfaction score, roughness, skin hydration, and skin elasticity compared to that of fractional CO2 plus saline solution side at 12 weeks after treatment. TEWL and erythema and melanin index showed no significant differences between two sides at baseline, one, four, and twelve weeks after treatment. CONCLUSION Topical application of BTX-A could enhance the rejuvenation effect of fractional CO2 laser.