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Objective To estimate differences in botulinum toxin type A (BoNT-A) treatment costs per patient for spasticity-injecting physicians, with a focus on physicians’ use of alternative BoNT-A agents other than onabotulinumtoxinA. Design Retrospective Cohort Study Setting 2017 National Medicare data for fee for service beneficiaries Participants Physicians who use BoNT-A treatments predominantly for spasticity chemodenervation, along with their patients Interventions Type of BoNT-A selected by physicians was the independent variable of interest. Included physicians were separated into two groups: (1) onabotulinumtoxinA only injectors; and (2) abobotulinumtoxinA and/or incobotulinumtoxinA injectors (may still utilize onabotulinumtoxinA). Main Outcome Measure Average cost per patient per year Results A total of 116 physicians, 6,829 BoNT-A procedures, and 3,051 patients were included in this analysis. Most physicians were physiatrists (84%) and utilized onabotulinumtoxinA only (82%). Total average BoNT-A cost per patient per year was significantly less for physicians who utilized abobotulinumtoxinA and/or incobotulinumtoxinA versus onabotulinumtoxinA-only physicians ($3,684 vs $4,739; p=0.01). Patients’ average annual out-of-pocket costs also reflected a similar difference ($855 vs $1,082; p=0.02) between the groups. Doses utilized and numbers of injections per patient per year were not significantly different between groups. Conclusions The present analysis demonstrated lower cost per patient for both the payer and patient when physicians utilized types of BoNT-A other than onabotulinumtoxinA for spasticity. Nevertheless, most physicians in this spasticity-focused study utilized exclusively onabotulinumtoxinA, the most expensive BoNT-A available. Reasons for this are complex and include history on the market and approved indications beyond those associated with spasticity; however, future research should continue to identify such issues with a goal of finding solutions to improve cost inefficiencies.

Introduction Osteoarthritis (OA) of the hip is a low-grade inflammatory disease of multiple etiology that has a limited conservative management and insufficiently explored. The application of botulinum toxin type A (BoNT-A) produces in the applied muscle a temporary, delimitable and reversible flaccid paralysis, which applied in a strategic way achieves to reduce mechanical stress and pain. Objective To evaluate the effect on pain perception, functionality and rigidity and changes in flexibility, internal and external rotation, before and 90 days after the application of BoNT-A. Methods Clinical, experimental, longitudinal, open study, with a total of 35 patients and 45 hips treated. BoNT-A of 500 U was applied in iliac, adductor brevis and longus muscles. Results The Wilcoxon test was used to compare the evaluation scores on days 0-90, observing the decrease in referred pain (p < 0.0001), rigidity (p < 0.002), improved perceived function (p < 0.001) and mobility arcs: flexion, internal and external rotation (p < 0.0001). Conclusions The treatment with BoNT-A provides a conservative and safe option for the management of symptoms and physical restraint caused by hip OA.

The purpose of this study was to explore the treatment efficacy of botulinum-A (BTX-A) in nocturnal bruxism. Five electronic databases (PubMed, Web of Science, Cochrane, Embase and Clinical Trials) were searched to identify related randomised controlled trials up to September 1, 2020. Five evaluation indices were extracted, namely, the pain at rest and at chewing (PR and PC), the number of bruxism events (NBE) and the self-assessment by patients (SA), to assess the treatment efficacy of BTX-A in bruxism. All data analyses were conducted using Review Manager (Version 5.3; The Cochrane Collaboration, London, United Kingdom). Six studies were included in this review. The sample was composed of 148 participants. Compared with the placebo group, the BTX-A group showed the significantly improved the PR index scores (MD, 1.16 cm; 95%CI, 0.65 to 1.67 cm; p0.00001), slightly improved the PC index scores (SMD, 0.25; 95%CI -0.14 to 0.64; p = 0.21), and the NBEs were significantly decreased in the before-injection group compared with that in the after-injection group (MD, 1.72; 95%CI, 0.60 to 2.85; p = 0.003). The results of this study suggest that BTX-A possesses significant therapeutic efficiency for the relief of pain and events of bruxism. However, whether the events of bruxism would recur or rebound after botulinum toxin injection needs more follow-up clinical evidence.

The aim of this study is to compare the efficacy of single-point injection of botulinum toxin A versus multi-point operative protocols found in the literature in reducing hypertrophy in patients with masticatory muscle hypertrophy. A systematic review was performed in accordance with the Park et al., 2018 guidelines, selecting articles from PubMed, Google Scholar, Web of Science and Ovid databases up to July 8, 2020.28 studies met the eligibility criteria. 748 patients were treated for masseter hypertrophy (MH) and 4 patients for temporal muscle hypertrophy. As for MH: in 45.2% of cases 3 injection sites (IS) were used, in 18.8% 1 IS, in 16.2% 2 IS, in 13% 5 IS, in 4.1% 6 IS, 2.7% 4 IS. At three months, the mean reduction in masseter muscle thickness is 26–31% when 1 IS was used, 28% in 2 IS, 12–27% in 3 IS and 22–30% in 6 IS. Heterogeneity of results, high bias level and selective reports led to a difficult efficacy comparison of the injection techniques described. Data suggest that the lowest number of IS possible should be used until stronger evidences are presented. Homogeneity in pre- and post-operative protocols is needed to establish a reliable setting for the condition under study.

Summary Background Botulinum toxin A (BoNT-A) injection is one of the most frequently undertaken procedures in aesthetic medicine. The Medicines & Healthcare products Regulatory Agency (MHRA) is the government body in the United Kingdom (UK) mandated to ensure that the provision and administration of medicines is safe. We analyzed adverse events of facial cosmetic BoNT-A injections reported to the MHRA and assessed whether the incidence of reported adverse events in this government registry is comparable to published retrospective and prospective studies. Methods A freedom of information (FOI) request was submitted to the MHRA to obtain recorded complications of BoNT- A. Complications reported to the MHRA between 1991 and 2020 were analyzed. Only cases with BoNT-A where the indication was specified as for facial cosmetics were included in the analysis. Additionally, the literature was reviewed on adverse events of facial cosmetic BoNT- A injections, and a statistical meta-analysis of complication rates was carried out. Results A total of 188 adverse events of aesthetic BoNT-A injections were reported to the MHRA. The literature search resulted in 30 studies and a total of 17,352 injection sessions, where the complication rate was 16% (95% CI = 8% to 25%). Frequent adverse events included localized skin reactions such as bruising with an incidence of 5% (95% CI = 3% to 7%), headache in 3% (95% CI = from 1% to 5% ), and facial paresis in 2% (95% CI = 1% to 3%) of injection sessions. Conclusions This is the first paper to obtain and evaluate data on adverse events of BoNT-A from the MHRA. An estimate of the likely complication rate of aesthetic BoNT-A in the UK, according to the MHRA database, is significantly lower than the rate recorded from our meta-analysis of the international literature. This suggests that the MHRA may be underestimating the adverse events of aesthetic BoNT-A treatment, which would have implications for patient safety and informed consent. Therefore, legislative changes may be required to ensure more robust reporting of aesthetic BoNT-A in the UK.

Summary Introduction Facial palsy (FP) is one of the most common neuropathies. Overall, 15%-30% of patients develop chronic sequelae. Several studies support the use of botulinum toxin A (BoNT-A) in the treatment of FP sequelae. No studies have analyzed the cost of treating FP with BoNT-A. Methods A retrospective review of data from all clinical records of consultations and procedures that took place at the FP Treatment Unit clinic throughout 2017. Type of BoNT-A used, total dose used, unilateral or bilateral injection, date of consultation, and gender were collected. The price of expendable materials, BoNT-A, and the 2017 salary scale was obtained to establish costs. Results During 2017, 605 clinical procedures were conducted in 240 patients. The mean number of procedures was 2.5 (0.80). The average time between procedures was 124(28.72) days. The total annual cost was 34.155,10€. The average annual cost of BoNT-A for each procedure was 39,93€, and the total annual cost of BoNT-A was 24.160,58€. On average, more units of IncotoxA were injected. This difference is not reflected in the final cost of each BoNT-A. For patients who achieved treatment stability, the average annual cost per patient was 106,6€ (OnatoxA) and 100,6€ (IncotoxA). Conclusion In our unit, treatment with BoNT-A in FP sequelae had an average annual cost of 124,31€ per patient, requiring a visit to the hospital to receive treatment every 124 days. Given the functional and quality of life improvements, we should consider that it is a beneficial treatment at an acceptable cost.

Purpose To systematically review technical aspects and treatment regimens of botulinum toxin A (BTA) injections in the lateral abdominal wall musculature. We also investigated the effect of BTA on abdominal muscle- and hernia dimensions, and clinical outcome. Methods PubMed, EMBASE, CENTRAL, and CINAHL were searched for studies that investigate the injection of BTA in the lateral abdominal wall muscles. Study characteristics, BTA treatment regimens, surgical procedures, and clinical outcomes are presented descriptively. The effect of BTA on muscle- and hernia dimensions is analyzed using random-effects meta-analyses, and exclusively for studies that investigate ventral incisional hernia patients. Results We identified 23 studies, comprising 995 patients. Generally, either 500 units of Dysport® or 200–300 units of Botox® are injected at 3–5 locations bilaterally in all three muscles of the lateral abdominal wall, about 4 weeks prior to surgery. No major procedural complications are reported. Meta-analyses show that BTA provides significant elongation of the lateral abdominal wall of 3.2 cm per side (95% CI 2.0–4.3, I2 = 0%, p I2 = 94%, p = 0.04). Furthermore, meta-analysis shows that BTA pretreatment in ventral hernia patients significantly increases the fascial closure rate [RR 1.08 (95% CI 1.02–1.16, I2 = 0%, p = 0.02)]. Conclusion The injection technique and treatment regimens of botulinum toxin A as well as patient selection require standardization. Bilateral pretreatment in hernia patients significantly elongates the lateral abdominal wall muscles, making fascial closure during surgical hernia repair more likely. Study registration A review protocol for this meta-analysis was registered at PROSPERO (CRD42020198246).

Summary Background Botulinum toxin (BT-A) chemodenervation has been proved to significantly improve the physical and psychological well-being of patients suffering from facial synkinesis. Despite this, a cohort of patients has persistent tightness and discomfort around the angle of the jaw, which may be caused by synkinesis within the posterior belly of digastric (PBD) muscle. This study was designed to evaluate the benefits of ultrasound-guided BT-A injections into the PBD. Methods Thirty-three patients with recalcitrant tightness and discomfort around the angle of the jaw, despite maximal facial therapy and platysmal chemodenervation were selected for inclusion. Patients underwent ultrasound-guided BT-A injection into the ipsilateral PBD muscle (skin puncture site 1 cm inferior and posterior to the angle of mandible). Outcomes consisted of the Facial Disability Index (FDI), Synkinesis Assessment Questionnaire (SAQ), and a visual analogue scale (VAS) designed to assess tightness and pain around the PBD when moving the jaw, swallowing, and masticating. Questionnaires were completed two weeks before and postinjection. Statistical analysis was performed using a paired t-test. Results Nineteen patients completed the post-treatment outcome questionnaire. A statistically significant improvement was noted in the physical and social function aspects of the FDI and all aspects of the patient-reported VAS scores apart from tightness and pain on jaw retrusion and swallowing. There was no significant difference in the SAQ. Conclusion This study has demonstrated the patient-perceived benefit of ultrasound-targeted BT-A chemodenervation of PBD. This represents a low-risk treatment option that can be easily added to the repertoire of treatments offered to patients with post paralysis facial synkinesis.

Background and Purpose: This study aimed to assess the efficacy of an ultrasound-guided lateral approach for BoNT-A (botulinum toxin A) injections into the subscapularis in patients with hemiplegic shoulder pain. Methods: This single-center trial used a randomized, double-blind, placebo-controlled design. The key inclusion criteria were a visual analogue scale score of ≥4 cm and a modified Ashworth scale score of ≥1+. The patients were randomized to receive either BoNT-A injections or a placebo. The outcomes included the visual analogue scale score, modified Ashworth scale score, pain-free passive range of motion of the hemiplegic shoulder, Fugl-Meyer assessment score for the upper extremities, and Stroke-Specific Quality-of-Life score. Results: A total of 49 hemiplegic shoulder pain patients were screened, and 36 were included. The participants receiving the BoNT-A injection reported a significant decrease in pain (visual analogue scale, −1.39 [95% CI, −2.41 to −0.36]; P =0.002) and spasticity (modified Ashworth scale score for shoulder internal rotation, −0.72 [95% CI, −1.10 to −0.35]; P =0.001; modified Ashworth scale score for shoulder abduction, −0.44 [95% CI, −0.90 to −0.01]; P =0.026) and improved pain-free passive shoulder internal rotation range of motion (14.56 [95% CI, 6.70–21.41]; P P =0.025) compared with those receiving the placebo at the end point. The shoulder abduction range of motion did not significantly improve after the BoNT-A injection at the end point ( P =0.127). In addition, the patients in the BoNT-A group showed significant improvements in the visual analogue scale score and shoulder external rotation range of motion at the 12-week follow-up. No injection-related adverse events were observed during or after the interventions in either group. Conclusions: The ultrasound-guided lateral approach for BoNT-A injections into the subscapularis is a precise and reliable method for reducing pain and spasticity and improving quality of life in stroke survivors with hemiplegic shoulder pain. Registration: URL: https://www.chictr.org.cn ; Unique identifier: ChiCTR1900023513.

BACKGROUND: This is the first large study of onabotulinumtoxinA as treatment for pediatric upper limb spasticity. OBJECTIVE: Evaluate efficacy and safety of a single treatment with onabotulinumtoxinA plus occupational therapy (OT). METHODS: In this registrational phase III, multinational study (NCT01603602), participants were randomized 1:1:1 to onabotulinumtoxinA 3 U/kg/OT, 6 U/kg/OT, or placebo/OT. Primary endpoint was average change from baseline at weeks 4 and 6 in Modified Ashworth Scale-Bohannon (MAS) score. Secondary endpoints included Modified Tardieu Scale (MTS), Clinical Global Impression of Change (CGI) and functional Goal Attainment Scale (GAS). RESULTS: 235 participants were randomized. At weeks 4 and 6, onabotulinumtoxinA groups had greater mean reductions in MAS (both –1.9; p

While acute anal fissures can be treated with topical therapy to reduce sphincter hypertonia (e.g., isosorbide dinitrate, glyceryl trinitrate, diltiazem), chronic fissures may require more invasive instrumental therapy. Currently, the golden standard remains lateral internal sphincterotomy; however, this carries the long-term risk of faecal incontinence. Fissurectomy can be a valuable alternative, but is less efficient because of absence of correction of underlying hypertonia. In this study, we aim to evaluate the additional effect of injection of botulinum toxin during fissurectomy in the treatment of chronic anal fissures. A single-centre retrospective analysis of 293 isolated superficial fissurectomies with or without injection of botulinum toxin was performed, with pain relief as primary endpoint. The majority of patients undergoing fissurectomy were women (65%, mean age 45.0 years vs. 35% men, mean age 48.3 years), often because of ventral fissures (30% in women vs. 8% in men). Fissurectomy resulted in resolution of complaints in 81.1%, while additional injection of botulinum toxin resulted in resolution in 90.1% (p

The aim of this study is to investigate the efficacy of treatment-combined electrocauterization after removal of apocrine sweat glands with ultrasound-guided (BOTOX) injection for adolescents with axillary bromhidrosis. From January 2015 to January 2018, 90 adolescents with axillary bromhidrosis were recruited and randomly divided into three groups (group A, B, and C). Patients in group A underwent electrocauterization after removal of apocrine sweat glands, patients in group B received ultrasound-guided BOTOX injection, and patients in group C had electrocauterization after the removal of apocrine sweat glands followed by ultrasound-guided BOTOX administration after two weeks. All patients were followed up for one year. The percentages of axillary malodor score at twelve months after treatments compared with pre-operation for group A, group B, and group C were 20.2%, 27.5%, and 12.5%, respectively. Significant statistical differences were observed in changes of axillary malodor score among the three groups at three, six, nine and twelve months postoperatively. Satisfaction rates of group A, group B, and group C were 90.0%, 93.3%, and 96.7%, respectively. The side effects after surgery in group A were similar to group C, and no side effect was observed in group B. One-year postoperative scar formation rate of group A was 16.7%, which was significantly higher than that of group B (0) and group C (6.66%). Combination of electrocauterization after removal of apocrine sweat glands with ultrasound-guided BOTOX injection showed better treatment effects.

Botulinum toxin type A (BoNTA) products are widely used for therapeutic and aesthetic indications, but there is a need for longer-lasting treatments that maintain symptom relief between injections and reduce the frequency of re-treatment. DaxibotulinumtoxinA for Injection (DAXI) is a novel BoNTA product containing highly purified 150-kDa core neurotoxin and is the first to be formulated with a proprietary stabilizing excipient peptide (RTP004) instead of human serum albumin. The positively charged RTP004 has been shown to enhance binding of the neurotoxin to neuronal surfaces, which may enhance the likelihood of neurotoxin internalization. DAXI produces robust, extended efficacy across both aesthetic and therapeutic indications. In an extensive glabellar lines clinical program, DAXI showed a high degree of efficacy, a consistent median time to loss of none or mild glabellar line severity of 24 weeks, and median time until return to baseline of up to 28 weeks. In adults with cervical dystonia, DAXI at 125 U and 250 U significantly improved Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total scores, with a median duration of efficacy of 24 and 20 weeks, respectively, which compares favorably with the 12–14 weeks’ duration reported for approved BoNTA products. Overall, DAXI was well tolerated, and the consistent extended duration of effect suggests that DAXI has the potential to improve the management of both aesthetic and therapeutic conditions., Plain Language Summary Botulinum toxin is used to block the nerve signals that cause muscles to contract. Products containing botulinum toxin are commonly given by injection to treat muscle spasms (such as cervical dystonia, a painful condition where the neck muscles contract involuntarily) and for cosmetic treatment of frown lines. However, the effects of the currently approved botulinum toxin products typically wear off about 3–4 months after injection and so the injections must be repeated regularly. A new product called DAXI (DaxibotulinumtoxinA for Injection) has been developed. In this product, the botulinum toxin is formulated with a unique protein (called RTP004) that has been designed to help deliver the botulinum toxin to the nerve cells. Research suggests that the RTP004 protein in DAXI adheres the botulinum toxin to the nerves close to the injection site, potentially making its effect last longer. To date, DAXI has been studied in over 3800 patients. The studies have shown that DAXI is effective for treating neck spasms (cervical dystonia) and for reducing the appearance of frown lines. Importantly, the effects of DAXI lasted up to 6 months, which is longer than seen with other botulinum toxin products. The side effects seen with DAXI are consistent in nature and frequency with those seen with other botulinum toxin products. These findings suggest that DAXI can improve both medical and cosmetic treatments due to its longer-lasting effect.

The aim of the study is to evaluate the evidence supporting the efficacy of botulinum toxin type A (BTA) injections in lower limb of hemiplegic patients, after stroke or cerebrovascular accident, and their gait analysis. This study included: randomized controlled trials (RCTs), non-randomized or controlled clinical trials (CCTs) or cluster trials, clinical trials of various phases (I-III), interrupted time series (ITS) studies with at least three data points before and after the intervention, controlled before and after (CBA) studies, prospective and retrospective comparative cohort studies, case-control and multicentred studies. The patients included in these studies had similar characteristics: age over 18 years, history of stroke and following hemiplegia, minimum modified Ashworth scale (MAS) score of 2 and duration since stroke over 6 months. The number of studies included in this review was 21. A meta-analysis was performed on a fraction of them depending on the reported index and the methodology as reported in detail in the results section. MAS score, following BTA injections, was significantly improved (Hedges' g: -1.17; 95% CI: -1.66, 0.67; p 0.001). The same applied for the 10 Meter Walk Test (MWT) (-0.35; 95% CI: -0.68, -0.02; p = 0.016). The gait velocity showed improvement, yet without statistical significance (0.27; 95% CI: -0.09, 0.63; p = 0.285). We concluded that botulinum toxin injections showed effectiveness on lower limb hypertonia reduction of hemiplegic patients after stroke. Apart from significantly reducing the MAS scores, 10 MWT was also improved. However, more research is required in order to determine the advancement in specific gait and posture parameters.

This study evaluated the efficacy of botulinum toxin A (BTX A) in improving the aesthetic appearance of lips. Twenty-four outpatients with clinical evidence indicating decreased fullness of lips or gummy smile were selected and received BTX A injection on the orbicularis oris. We observed a significant decrease in wrinkles and improvement in gummy smile in all patients 4 weeks after the injection. Aesthetic lines also changed significantly. Local injection of BTX A on the orbicularis oris could simultaneously achieve mild lip enhancement, improvement in fine wrinkles around lips, and mild gummy smile.

To assess the efficacy and safety of intradetrusor botulinum toxin type A injections (IBTI) for idiopathic overactive bladder (iOAB) in non-neurological adults with an artificial urinary sphincter (AUS). We retrospectively selected, in the 11 French centers, members of a collaborative network (GENULF (Groupe d’etude de neuro-urologie de langue francaise)), the patients who had had an artificial urinary sphincter implantation and who had subsequently developed iOAB requiring IBTI. This study was approved by the French association of urology ethics committee (no 2018012). Between 2006 and 2020, 33 patients were included from 5 French centers. Mean follow-up after the first IBTI was 47 months. The average age of the studied population was 68 years, with 70% of females. A complete resolution of symptoms at optimal IBTI dose was experienced by 21 (64%) patients. Seven (21%) patients had partial improvement. Five non-responder patients (15%) had no improvement at all. Maximum cystometric bladder capacity was 240 ml pre-IBTI and 335 ml post IBTI. Discontinuation free survival at 60 months was 50%. Two erosions occurred during the 6 months following an IBTI both in male patients with a perineal implantation. There were four AUS balloon perforations that occurred during the 6 months following an IBTI, all of them in female patients. IBTI has a good efficacy for the treatment of iOAB in patients with an AUS. However, both patients and practicians must be aware of the risk of rare and usually mild complications.

Background Botulinum toxin (BT), a potent neurotoxin, has been used in clinical medicine since the 1970s for cosmetic and therapeutic purposes. Studies have consistently shown positive outcomes with a very limited adverse effect profile and a conventional understanding that results dissipate after 3 to 5 months. However, more recent evidence suggests that changes in muscle composition, function, and appearance persist for much longer, even years. To examine the potential implications of these findings on cosmetic use of BT injections in reduction of skin lines and wrinkles, we first needed to further our understanding of the current literature on long-term outcomes after repeated BT injections. Methods A comprehensive review of the literature on long-term outcomes after repeated BT injections for cosmetic indications was performed. We evaluated the study designs, and results were compared. Results A total of 22 publications met our inclusion criteria, of which 14 were clinical trials. Few studies extended outcome measurement past 6 months postinjection, and many were funded or supported by industry. However, the studies that extended follow-up saw persistent changes after BT injection, in some cases as far as 4 years postinjection. Conclusion The current body of knowledge on the long-term results after repeated cosmetic BT injections is very limited, and the available literature provides insufficient evidence on how prolonged effects could alter clinical use of BT. Further clinical studies with extended follow-up periods with inclusion of both subjective and objective measured outcomes of appearance and muscle function are required to better understand the long-term impacts of repeated BT injections.

One of the most common dysfunction is overactive bladder. The clinical symptoms are associated with an involuntary contraction of the detrusor muscle of the urethra. Drugs are the basis of overactive bladder therapy. However, the duration of drug therapy is limited due to the frequent development of side effects. The study aimed to examine the efficacy of using botulinum toxin type A (BTX-A) in patients with overactive bladder. A total of 90 patients with overactive bladder (mean age 39.86 ± 3.47 years; 59 (65.6%) women and 31 (34.4%) men) divided into two groups (45 patients each) were examined: Group 1 included patients without imperative urinary incontinence, and Group 2 included patients with imperative urinary incontinence. Patients in both groups underwent intravesical injection of 200 units of botulinum toxin type A (Xeomin). The BTX- A for treating patients with overactive bladder reduces clinical symptoms, increases the functional volume of the bladder, and facilitates an improvement in the life quality of patients. The use of BTX-A in patients suffering from overactive bladder and not responding to drug therapy with m-cholinolytics is effective and safe, which allows recommending this treatment method to correct the studied bladder dysfunction in such patients.

The intramuscular injection of botulinum toxin is one of the most efficient ways to treat localized spasticity in patients suffering from Central Nervous System lesions like stroke, cerebral palsy and multiple sclerosis. The gait analysis based on kinetics and kinematics is a recognized way of measurement of the effect of intramuscular injection of botulinum toxin in spastic patients suffering from chronic stroke. The aim of this study is to provide evidence of the beneficial effect of botulinum toxin on characteristics of gait pattern on patients suffering from chronic stroke. So, thirteen patients with spasticity due to chronic stroke were included in the protocol and were treated by botulinum toxin injections in the lower extremity. All patients were evaluated before the injection as well as one month after the botulinum injection on a foot pressure sensitive walkway with a power plate and by the readings of seven inertial measurements units which recorded spatio-temporal specific parameters during walking, and the spasticity was measured according to modified Ashworth Scale. While all spatio-temporal parameters of motion analysis and balance improved for most of the patients after botulinum toxin injection, only one parameter, the normal to hemiplegic step length, reached statistical significant improvement (p 0.03). Moreover the modified Ashworth score was statistically improved post injection (p 0.001). In conclusion the use of botulinum toxin injections is beneficial in post stroke patients as this is depicted in gait parameters improvement which accompanies the spasticity reduction.

Introduction The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking. Methods DIRECTION is an international, randomized, double-blind, crossover study comparing the safety and efficacy of abobotulinumtoxinA with onabotulinumtoxinA in the management of upper limb spasticity at doses at or near maximum recommended in product labelling. Participants (18–75 years) will be randomized (1:1) to either one cycle of abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa. To maintain blinding, a fixed volume (3.6 ml) will be injected into the target upper limb muscles (four wrist and finger flexors and biceps brachii). The second treatment cycle will begin at Week 12 if retreatment criteria are fulfilled, and if not, they will be reassessed every 4 weeks until they meet retreatment parameters. Planned Outcomes The primary hypothesis is that there is comparable safety between products; non-inferiority will be tested based on treatment-emergent adverse event (TEAE) rates from injection to Week 12. A secondary hypothesis is that abobotulinumtoxinA has longer duration of effect than onabotulinumtoxinA. This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment. Trial Registration EudraCT (http://eudract.ema.europa.eu): 2021-000161-32 and Clinicaltrials.gov (http://clinicaltrials.gov): NCT04936542. Overview of the study protocol by the principal investigator (MP4 185265 KB) Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01896-3.

Objective To evaluate the effectiveness of botulinum toxin A (BTX-A) in the treatment of hemiplegic shoulder pain. Data Sources PubMed, EMBASE, Elsevier, Springer, Cochrane Library, Physiotherapy Evidence Database, CNKI, and VIP were researched from the earliest records to September 1, 2020. Study Selection Randomized controlled trials that compared shoulder BTX-A injections vs a control intervention in patients with a history of hemiplegic shoulder pain after stroke were selected. Among the 620 records screened, 9 trials with 301 eligible patients were included. Data Extraction Outcome data were pooled according to follow-up intervals (1, 2, 4, and 12 wk). The primary evaluation indices were pain reduction (visual analog scale [VAS] score) and range of motion (ROM) improvement. The second evaluation indices were upper limb functional improvement, spasticity improvement, and incidence of adverse events. Cochrane risk-of-bias was used to assess the methodological quality of studies independently by 2 evaluators. Data Synthesis Meta-analysis revealed a statistically significant decrease in the VAS score in the BTX group vs the control group at 1, 4, and 12 weeks postinjection (wk 1: standardized mean difference [SMD], 0.91; 95% confidence interval [CI], 0.27 to 1.54; wk 4: SMD, 1.63; 95% CI, 0.76 to 2.51; wk 12: SMD, 1.96; 95% CI, 1.44 to 2.47). Furthermore, the meta-analysis demonstrated a statistically significant increase in abduction at 1, 4, and 12 weeks postinjection (wk 1: SMD, 3.71; 95% CI, 0 to 7.41; wk 4: SMD, 8.8; 95% CI, 2.22 to 15.37; wk 12: SMD, 19.59; 95% CI, 9.05 to 30.13) and external rotation at 1, 2, 4 weeks postinjection (wk 1: SMD, 5.67; 95% CI, 0.88 to 10.47; wk 2: SMD, 9.62; 95% CI, 5.57 to 13; wk 4: SMD, 6.89; 95% CI, 2.45 to 11.33) in the BTX group. Conclusions BTX-A injection provided greater analgesic effects and increased shoulder abduction and external rotation ROM compared with steroid or placebo injection for the treatment of HSP.

Introduction Fascial closure during complex abdominal wall reconstruction (AWR) improves recurrence and wound infection rates. To facilitate fascial closure in massive ventral hernias preoperative Botulinum Toxin A (BTA) injection can be used. Methods 2:1 propensity-scored matching of patients undergoing AWR with and without BTA was performed based on BMI, defect width, and loss of domain using CT-volumetric analysis. Results 145 patients without BTA and 75 with BTA were comparable on hernia size (240vs251cm2, p = 0.589) and hernia volume (1405vs1672cm3, p = 0.243). Patients with BTA had higher wound class (CDC≥3 37%vs13%, p Conclusion In patients with massive ventral hernias and severe loss of domain, preoperative BTA-injection improves fascial closure rates during AWR.

Blepharospasm is a focal dystonia whereby excessive eyelid muscle contractions cause involuntary eye closure. Botulinum neurotoxin type A (BoNT-A) injections are an approved treatment. This randomized placebo-controlled trial (NCT01896895; EudraCT number 2012-004821-26) assessed the efficacy, safety, and treatment effect duration of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH), a BoNT-A formulation without complexing proteins, in BoNT-A-naïve adults with blepharospasm.Subjects received incobotulinumtoxinA 50 U, 25 U (total dose) or placebo during a main study period (MP; 6-20 weeks). Patients needing a second injection received incobotulinumtoxinA ≤70 U in an open-label extension period (EP; 6-20 weeks). Treatment effect durations were time from first injection to EP injection or final MP visit and from EP injection to end-of-study visit. Times to effect onset and to waning of effect (MP) were time from injection to first subject-assessed onset effect and time from injection to subject-reported waning of effect, respectively.Of 61 subjects, 39 entered the EP. During the MP, median duration of treatment effect was longer with incobotulinumtoxinA 50 U (20 weeks) versus incobotulinumtoxinA 25 U (11 weeks) or placebo (6 weeks). Median duration of treatment effect was 20 weeks during the EP. Median time to effect onset was 5, 7, and 14 days with 50 U, 25 U, and placebo, respectively (Subjects reported an effect onset from 5 days after injection lasting up to 20 weeks (maximum observation period). Data indicate that incobotulinumtoxinA re-treatment of blepharospasm may not be required at fixed 12-week intervals and provide evidence for a patient-tailored approach.PLAIN LANGUAGE SUMMARYBlepharospasm is a condition in which involuntary contractions of the eyelid muscles cause the eye to close. The condition can be treated with botulinum neurotoxin type A (BoNT-A) injections. This study assessed the duration of effect and time to onset of effect for the BoNT-A formulation incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) in adults with blepharospasm. Subjects received a single injection of one of two doses of incobotulinumtoxinA (total dose 25 or 50 U) or placebo and received a second injection of incobotulinumtoxinA only (total dose ≤70 U; the second injection was not compared with placebo) if needed 6–20 weeks after the first injection. After the first injection, the median (mid-point of values from all subjects) duration of treatment effect was longer with the higher incobotulinumtoxinA dose (20 weeks) than with the lower dose (11 weeks) and was longer with both incobotulinumtoxinA doses than with placebo (6 weeks). After the second incobotulinumtoxinA injection, the median duration of treatment effect was 20 weeks. The time to onset of effect was quicker with both incobotulinumtoxinA doses (5 and 7 days for the higher and lower doses, respectively) than with placebo (14 days) and the difference was statistically significant for the higher incobotulinumtoxinA dose compared with placebo. The time to waning of treatment effect was similar for the two incobotulinumtoxinA doses and placebo. This study shows that incobotulinumtoxinA is an effective treatment for blepharospasm, with a fast onset of action. In addition, the effects of one injection can last for up to 20 weeks.

Background Botulinum toxin A (BoNT-A) has grown tremendously in aesthetic dermatology since 2002 when the United States Food and Drug Administration (FDA) first approved its use for treating moderate-to-severe glabellar lines. Blepharoptosis, due to local spread of toxin, is a reported side effect of BoNT-A which, although rare, more frequently occurs among inexperienced practitioners. Objectives The purpose of this review is to highlight the causes and management of eyelid ptosis secondary to BoNT-A administration including new anatomic pathways for BoNT-A spread from the brow area to the levator palpebrae superioris muscle. Methods A literature search was conducted using electronic databases (PubMed, Science Direct, MEDLINE, Embase, CINAHL, EBSCO) regarding eyelid anatomy and the underlying pathogenesis, presentation, prevention, and treatment of eyelid ptosis secondary to BoNT-A. Anatomic dissection has been performed to assess the role of neurovascular pedicles and supraorbital foramen anatomic variations. Results Blepharoptosis occurs due to weakness of the levator palpebrae superioris muscle. Mean onset is 3-14 days after injection and eventually self-resolves after the paralytic effect of BoNT-A wanes. Administration of medications, such as oxymetazoline hydrochloride or apraclonidine hydrochloride eye drops, anticholinesterase agents, or transdermal BoNT-A injections to the pre-tarsal orbicularis, can at least partially reverse eyelid ptosis. Anatomic study shows that a supraorbital foramen may be present in some patients and constitutes a shortcut from the brow area directly into the orbital roof, following the supraorbital neurovascular pedicle. Conclusion Providers should understand the anatomy and be aware of the causes and treatment for blepharoptosis when injecting BoNT-A for the reduction of facial wrinkles. Thorough anatomic knowledge of the supraorbital area and orbital roof is paramount to preventing incorrect injection into "danger zones," which increase the risk of eyelid ptosis.

Background Facial nerve injury after facelift is rare; hence, its treatment is poorly established. Botulinum toxin type A (BTXA) can be employed to resolve the asymmetry. To our knowledge, there is no protocol in the literature about the best timing for this treatment, injection sites, or recommended dose. Objectives The authors sought to propose a protocol to guide the management of asymmetries post-facelift. Methods Fifteen patients with post-rhytidectomy facial palsies were treated in the non-paralyzed side with BTXA. After analysis of the smile deviation vectors, it is possible to identify the muscles that should be treated. The dose varied from 1 to 2 volume-unit per point. Patients were examined after 15 days for outcomes evaluation and touch-up if needed. Patients were re-treated after 5 to 6 months in case of asymmetry recurrence. Results Symmetry was achieved in all cases. Six patients had definitive nerve lesions and required treatment every 6 months after the first session. Five patients had lesions affecting the upper third of the face; 4 of them were definitive nerve lesions. Two of the 4 patients who were treated less than 2 weeks after surgery recovered early from the post-facelift paralysis and developed reversed asymmetry due to the BTXA. In 7 patients, the post-facelift asymmetry was due to neuropraxis: the recovery from the nerve injury and BTXA treatment occurred symmetrically on both sides of the face in the following months after 1 single session. Conclusions Asymmetries post-facelift were successfully managed with the proposed protocol. The best time for injection was 2 to 4 weeks after surgery. Level of Evidence: 4

Supplemental Digital Content is Available in the Text., BACKGROUND DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin in development that has demonstrated efficacy on dynamic glabellar lines. OBJECTIVE To evaluate the effect of repeated DAXI treatment on static glabellar lines. METHODS This post hoc analysis included adults with moderate or severe dynamic glabellar lines who were treated with 40U DAXI in the SAKURA clinical program. Glabellar line severity was evaluated through validated subject and investigator scales. RESULTS Overall, 568 subjects received 3 DAXI treatments. Most subjects were White (92.3%) and female (85.7%). At baseline, 9.0% and 27.3% of subjects had no static glabellar lines based on subject and investigator assessment, respectively. Four weeks after DAXI Treatment Cycle 1, the proportion of subjects with no static glabellar lines increased to 57.9% and 64.8% based on subject and investigator assessment, respectively. At Week 4 after DAXI Treatment Cycles 2 and 3, the proportion further increased to 68.7% and 71.5%, respectively, based on subject assessment and 75.0% and 77.6% based on investigator assessment. CONCLUSION Subjects who received repeated DAXI treatment showed progressive improvement in their static glabellar lines. The extended duration of therapeutic benefit with DAXI on dynamic glabellar lines likely provides a long period of muscle inactivity/hypoactivity, during which dermal remodeling can occur.

This review aims to determine the analgesic efficacy of botulinum toxin (BTX) for the management of pain in children with cerebral palsy (CP). During July and August 2020, a systematic literature search was performed using a mixture of subject headings and free text. The eligibility criteria for inclusion in the review were: (1) interventional studies, (2) participants: children aged 0-18 with CP, (3) participants were treated with BTX, (4) an outcome measure of pain or satisfaction with pain management, and (5) published in an English-language peer-reviewed journal. Eleven studies met the eligibility criteria; nine studies explored analgesic effects of BTX for hypertonia related pain and two for postoperative pain. The studies were of level II to level IV evidence. We identified one high-quality study, which provides level II evidence, and two observational studies that supported BTX therapy for muscle hypertonia related pain in non-ambulant children with CP (GMFCS levels IV and V). For children in GMFCS levels I to III, the evidence for the analgesic effects of BTX was contradictory possibly due to the heterogeneity of the studies and/or weak study design. Mixed evidence for the use of BTX to reduce pain after hip surgery was found likely due to differences in the surgical method, injection protocols, and outcome measures.

Background Onabotulinum toxin Ars (BoNTArs) popularity is centered on its quick, predictable, and safe ability to improve clinically apparent rhytides. While this remains the only FDA indication for BoNTA, recent research suggests that BoNTA may have a much wider use for the improvement of overall skin quality. Objective This review will focus on the various evidence and uses of BoNTA for improvement of skin quality. Materials and methods This review considered published journal articles (clinical trials, case studies, scientific reviews). Studies were identified by searching the PubMed database and reference lists of respective articles. Only articles available in English were considered for this review. Results Intramuscular and intradermal injections of BoNTA decrease sebum production, pore size, facial erythema and flushing, and resting lines. BoNTA induces neocollagenesis and restores the extracellular matrix. Conclusion The literature provides both in vivo and in vitro evidence that BoNTA enhances skin quality beyond its well-studied neuromuscular effect. J Drugs Dermatol. 2021;20(9):958-962. doi:10.36849/JDD.6038.

BACKGROUND Hyperfunction of the muscles of the upper lip is considered as the most common cause of excessive gingival display (EGD). The aim of this study was to demonstrate the effectiveness of botulinum toxin (BT) injection as a conservative treatment for EGD due to muscular hyperfunction and to compare the outcome of 2 injection methods. MATERIAL AND METHODS This study included 40 participants who were randomly assigned into 2 groups of 20 each, The first group received 2.5IU BT injection at 1 point per side (2-points group), while the second group received a total of 5 IU of BT at 2 points per side (4-points group). The outcome variables were the reduction in the central and lateral gingival display expressed as the difference between the pre- and post-injection measurements and the degree of satisfaction of the participants. The follow up visits were at 2- and 12-weeks postinjection. The study variables were statistically analyzed and probability values of

Summary Objective To assess botulinum toxin treatment for buccinator muscle synkinesis including: how often the synkinesis was troublesome; who benefitted and how from the treatment; and what were the adverse effects, ideal dosage, and injection site. Subjects and Methods Facial palsy (FP) patients and patients with hemifacial spasms who were attending for multiple site botulinum-toxin treatment for facial sequelae were assessed for buccinator synkinesis. The study group comprises those experiencing buccinator synkinesis with associated bothering symptoms who were willing to try injection also to the buccinator muscle. Results During 9/2017–12/2019, 126 different patients with facial sequelae were treated with multiple-site botulin-toxin injections by the author. Of them, 83 (66%) received injection also for buccinator synkinesis and 66/82 (80%) wanted to continue with the buccinator injections. The most remarkable results were seen with FP patients biting the mucus membrane of their cheek: usually the biting ceased totally. Patients with powerful hemifacial cheek spasms also experienced cessation of the spasms, contrasting any previous treatments. Adverse effects were mostly mild: slight weakness of the corner of the mouth or additional leakage of saliva or liquids. Only a few patients experienced more pronounced adverse effects. The most posterior contracting part of the buccinator muscle proved to be the best site for the injection. Conclusions Buccinator synkinesis was very common and its treatment gave many patients additional relief from facial sequelae symptoms. Professionals treating patients with synkinesis and hemifacial spasms should add well-tolerated buccinator injections to their repertoire of injection sites.

Statement of problem Botulinum toxin has been used for various therapeutic and esthetic purposes for nearly 4 decades and has shown positive outcomes in patients with bruxism. However, the effectiveness of botulinum toxin injections as an alternative to traditional therapies in the management of primary bruxism is still unclear. Purpose The purpose of this systematic review was to analyze the clinical outcomes of the use of botulinum toxin type A injections in the management of primary bruxism in adults. Material and methods Databases such as PubMed, Web of Science, Scopus, LILIACS, Cochrane Library, and Open Grey Literature were searched without language or date restrictions until October 6, 2019. Using Mendeley Desktop software to organize the references, 2 independent researchers selected the published clinical studies (Study type) on the improvement of symptoms (Outcome) in human adults with primary bruxism (Participants/Population) who received botulinum toxin type A injections (Intervention), placebo injections, saline injections, no injections, or other treatments (Comparator(s)/Control) for the management of bruxism. Results A total of 601 references were initially obtained from the 6 databases. Six randomized clinical trials and 4 case series were selected and critically appraised according to the Fowkes and Fulton guidelines. Heterogeneity among the studies did not allow for a meta-analysis. All studies supported the efficacy and safety of botulinum toxin injections in reducing the symptoms of primary bruxism. Conclusions Botulinum toxin type A injections are effective in the treatment of the symptoms of primary bruxism in adults. Randomized clinical trials are still needed to establish a protocol for using botulinum toxin as an alternative to traditional therapies in the management of primary bruxism.

Early postoperative injection of botulinum toxin type A (BTxA) can reduce surgical scar hypertrophy. BTxA injection at different time points is associated with different levels of efficacy, but the efficacy of different doses of BTxA for scar management has not investigated. The purpose of this study was to investigate the effect of different doses of BTxA administered early after surgery on scar improvement through a split-scar experiment. The study included 22 patients who underwent surgery between September 2019 and October 2020. High- and low-dose BTxA was randomly administered into each half of the surgical wound closure immediately after surgery. One half of the incision was injected with a low dose (4 U) of BTxA, and the other half was injected with a high dose (8 U). The scars were then evaluated at postoperative 6 months using the modified Stony Brook Scar Evaluation Scale (mSBSES), and patient satisfaction was evaluated using the Visual Analogue Scale (VAS). The occurrence of complications or adverse events was also recorded. Twenty patients completed the study and were analyzed. Compared with the low-dose sides, the high-dose sides had significantly better mSBSES scores and significantly higher VAS scores (p

Background Over the years, botulinum toxin has found its place as a neuromuscular blocking agent in numerous medical fields. Since the approval of botulinum toxin by the FDA for cosmetic indications in 2002, it had become the most commonly performed esthetic procedure worldwide, with ever-growing demand. The characteristics of the toxin, along with the facial areas it is injected to, could possibly account for a wide array of complication. Methods The authors conducted a literature search for reported cases of ophthalmic adverse events following Botulinum toxin facial injections in the electronic databases of PubMed and Cochrane Library databases. Results The authors found 25 publications, reporting 49 cases of ophthalmic adverse events following botulinum toxin injections. Injections for cosmetic indications accounted for 51% of all injections, treatment of blepharospasms for 22% of cases, protective ptosis for 11% of cases, and treatment of hemifacial spams for 8% of cases. The average quantity of botulinum toxin injected to a single patient ranged between 1.25 and 75 units, with a median of 13.75 units.Majority of injections for cosmetic indications were performed to the lateral canthal area (56%), followed by the glabella (28%) and the forehead (20%).Adverse events following injections included diplopia (64%), ptosis (14%), and decrease in visual acuity or vision loss (8%). Conclusions Botulinum toxin is gaining extreme popularity in the management of a wide area of diseases and for cosmetic indications. Proper knowledge of potential adverse events is crucial for the clinician in attempt to decrease complications.

BACKGROUND Persistent pelvic pain (PPP) remains an important cause of morbidity. Pelvic floor muscle spasm is an important contributor to PPP. AIMS The study's primary aim was to assess if botulinum toxin (BoNT) injection to pelvic floor muscles altered pain scores or quality of life (QoL) at six, 12 and 26 weeks. Secondary aims included investigating the impact of BoNT on opiate usage, examining the role of pain catastrophising, and assessing for complications. MATERIALS AND METHODS A single-centre prospective cohort study enrolled 21 patients with PPP who had failed physiotherapy techniques. Each participant underwent BoNT injection to muscles of the pelvic floor and pudendal nerve block. Questionnaires and digital vaginal examinations were conducted at baseline, six, 12 and 26 weeks. Pain score quantification used visual analogue scales (VAS) and numerical rating scales (NRS). Other outcome assessments included The World Health Organization Quality of Life instrument (WHOQoL-BREF), Pain Catastrophising Scale (PCS), and modified Australian Pelvic Floor Questionnaire (APFQ). ACTRN12620000067976. RESULTS Following BoNT injection, median VAS scores decreased for all domains at six and 12 weeks, with VAS for dyspareunia significant at six weeks (P = 0.026). Scores returned to baseline by 26 weeks. Opiate usage was significantly less following BoNT injection, with a percentage reduction of 23.8% (95% CI -48.3 to 0.7, P = 0.06). Sexual function improved significantly (P

Summary Background In this study we have based our research on botulinium toxin injection via targeted neuromuscular end plate zones, specifically in muscles with diffuse distribution of the latter. The muscular surface anatomical variety was also taken into consideration with thorough pre-injection examination of every subject. Method With consideration of the facial muscles anatomical variation and neuromuscular bundle distribution, we have applied the method of retrograde botulinium toxin injection on a series of 10 patients on the right side of the face with the left side as a control side, it was injected in a regular perpendicular manner in order to conclude the efficacy of targeted motor end zone injection. Using an auto-injecting syringe, we have delivered 6 Allergan units per zone (frontalis, glabellar lines of corrugator supercilii and orbicularis oculi crow's feet). Results On control day 8 we have noticed a more prominent effect mainly on the level of the orbicularis oculi muscle and the corrugator supercilii muscle on 9 out of 10 patients. Nine patients out of 10 needed the delivery of an additional 6 Allergan units per zone on the control side's glabellar lines and crow's feet rhytids. Where 1 out of 10 patients needed the reinjection of the control side on the glabellar lines zone. Conclusion The musculature of the face varies when it comes to neuromuscular plate distribution. Muscles with scattered distribution patterns show an optimal response to botulinum toxin injections when delivered in a retrograde manner. This has allowed us to achieve of optimal results while minimizing injection sites and hence pain, the use of lower dosage and hence treatment cost, as well as lowering the unwanted product dissemination to the neighboring mimic muscles.

Botulinum toxin is a protease used by the bacterium Clostridium botulinum that causes chemical denervation of skeletal muscles, producing a temporary weakening of muscle activity. Despite having a transitory effect, the application of botulinum toxin has been identified as an alternative for correcting an excessive gingival display (EGD). However, studies evaluating the maintenance of long-term results of botulinum toxin remain scarce. This study aimed to evaluate the effectiveness and duration of botulinum toxin type A in the treatment of anterior EGD. Botulinum toxin Type A was applied to 15 patients with EGD. The measurement was performed in triplicate, using a Castro Viejo dry point compass, between the central cervical portion of the upper lateral incisors to the lower portion of the upper lip, bilaterally. The measurements were performed before the application of the toxin and repeated on days 7, 14, 90, 120, and 180 after the procedure. The data were analyzed using repeated-measures ANOVA, followed by a Bonferroni. There was a statistically significant reduction between the measurements performed on the Baseline and seven days after the application of the botulinum toxin. After 180 days, approximately one-quarter of the patients in the sample did not presented EGD. Mild adverse effects were reported by 46.7% of the patients. The use of botulinum toxin type A was effective to treat EGD. After 180 days, it was still possible to observe a significant effect compared to the initial gingival exposure.

Objective To assess the efficacy and safety of botulinum toxin treatment (onabotulinumtoxinA 200 units) for Japanese patients with neurogenic detrusor overactivity caused by spinal cord injury or multiple sclerosis. Methods Patients with urinary incontinence refractory to pharmacological treatment were enrolled and randomized in a phase III trial. A single dose of onabotulinumtoxinA (n = 11) or placebo (n = 10) was given in the double-blind phase, and repeat injections of onabotulinumtoxinA were given in the subsequent open-label phase. Outcomes included urinary incontinence episodes, urodynamics, patient-reported outcomes and adverse events. Results The onabotulinumtoxinA group showed a numerically greater reduction in the number of urinary incontinence episodes per day than the placebo group, with the difference between the groups at week 6 of -3.02 (95% confidence interval -5.85 to -0.19). The onabotulinumtoxinA group also showed greater improvements in urodynamic assessments. Adverse events related to onabotulinumtoxinA injections were hematuria, urinary retention, urinary bladder hemorrhage, autonomic dysreflexia and epididymitis. Most events were deemed mild or moderate. Conclusions Intradetrusor injections of onabotulinumtoxinA are efficacious and tolerable for Japanese patients with neurogenic detrusor overactivity-related symptoms that are difficult to manage with anticholinergics and/or β3 -adrenergic receptor agonists.

To identify the most common type and timing of interventions used to initially manage patellofemoral pain (PFP), and whether exercise therapy as an initial treatment was associated with a decreased likelihood of recurrence of PFP.Retrospective cohort.Active-duty military service members (n = 74 408) aged 18 to 50 years and diagnosed with PFP between 2010 and 2011 were included. We identified the type and timing of interventions from electronic medical records and insurance payer claims, and studied the influence of early exercise therapy use on injury recurrence rates.In this cohort of patients with PFP, 62.3% (n = 46 338) sought no additional care after the initial visit. The most common initial pharmacological interventions were nonsteroidal anti-inflammatory drugs (4.1%), corticosteroid injections (0.4%), and muscle relaxers (0.3%). The most common initial nonpharmacological treatments were exercise therapy (7.6%), passive modalities (eg, hot packs, electrical stimulation, ultrasound; 0.6%), and manual therapy (joint manipulation and mobilization; 0.5%). Common specialty referrals were to physical therapy (3.3%) and orthopaedic providers (0.8%). If patients received at least 6 exercise therapy visits during the initial episode of care, they were less likely to have a recurrence of knee pain (odds ratio = 0.46; 95% confidence interval: 0.42, 0.49).Two in every 3 patients did not seek additional care after PFP diagnosis. For those who sought additional care, exercise therapy was the most common intervention, and higher doses of exercise therapy were associated with a reduced likelihood of having a recurrent episode of knee pain.

Objectives We aimed to evaluate the safety and efficacy of botulinum toxin type A (BoNTA) injections for the treatment of sialadenosis. Methods We retrospectively reviewed 20 patients treated with intraglandular BoNTA injections. Patient satisfaction was assessed using Likert scales: a three-point scale to evaluate improvement in the sense of parotid distention and a five-point scale to assess improvement in cosmesis. Complications, such as salivary dysfunction and facial weakness, were monitored during follow-up after injections. Results Patients received a median of two injections (range, one to five injections) of BoNTA (40-50 U/mL per injection) into each parotid gland. Three months after treatment, five (25%), 11 (55%), and four (20%) patients experienced complete, partial, and no relief of salivary gland distention with discomfort, respectively. For esthetic scoring, two (10%), five (25%), 10 (50%), three (15%), and no patients were assigned scores of 3, 2, 1, 0, and -1, respectively. Salivary gland scintigraphy was performed for 14 patients before injection. Ten and four patients showed normal and increased uptake by the salivary glands, respectively. At 3 months after injection, salivary gland scintigraphy showed that maximum salivary secretions significantly decreased, whereas salivary flow did not significantly differ between pre- and post-injection. No patient complained of dry mouth or facial weakness during follow-up. Conclusions Intraglandular BoNTA injections might be an alternative option for treating symptomatic sialadenosis, although it is only partially effective for alleviating parotidomegaly and often requires repeated injections. Long-term prospective studies are needed to optimize the dosage and treatment intervals of BoNTA injection.

Aim To describe current rehabilitation paediatricians' use of intramuscular botulinum toxin-A (BoNT-A) to manage hypertonicity. Methods Cross-sectional survey. Results In late 2019, 32 of the 35 identified Australian rehabilitation paediatricians who use BoNT-A to manage paediatric hypertonicity completed the survey. Annually, they administer just over 3750 courses of BoNT-A to manage hypertonicity with a mean of 11 years of clinical experience. Sedation was used by all but 1 clinician who used a number of other strategies during the procedure. Mean (and median) maximum dose of OnabotulinumtoxinA (Botox) was 400 Units (range 300–450 Units). Only three clinicians indicated that they used AbobotulinumtoxinA (Dysport) – the other BoNT-A preparation approved for children available in Australia; analysis of its use was not performed. Dose modifications were made by clinicians according to a patient's response to a previous course of BoNT-A (88% of respondents); patient experience of a previous adverse event (78%); history of aspiration or dysphagia (65 and 63%, respectively); and the presence of dystonia; and where the patient was GMFCS level V (53% each). Intervals between courses ranged from 3 to 24 months with the variation due to clinical circumstances. Conclusion Clinical practice in BoNT-A management of paediatric hypertonicity was largely consistent in regard to maximum doses of OnabotulinumtoxinA (Botox) used. Dose modification and time between injection courses varied according to individual clinical presentation. Procedural sedation was used extensively.

SUMMARY A mere serendipitous finding has culminated in a life-changing development for patients and a colossally fulfilling field for many surgeons. The surgical treatment of migraine headaches has been embraced by many plastic surgeons after numerous investigations ensuring that the risks are minimal and the rewards inestimable. Seldom has a plastic surgery procedure been the subject of such scrutiny. Through retrospective, prospective pilot, prospective randomized, prospective randomized with sham surgery, and 5-year follow-up studies, the safety, efficacy, and longevity of the given operation have been confirmed. Although the first decade of this journey was focused on investigating effectiveness and risk profile, the second decade was largely devoted to improving results, reducing invasiveness, and shortening recovery. Multiple publications in peer-reviewed journals over the past 20 years, several independent studies from reputable surgeons at recognized centers, and over 40 studies from the author's center have established the surgical treatment of headaches as a standard practice.

Background Botulinum neurotoxin is one of the most versatile and widely used medical products in the world. Aims The review's focus is the plastic and dermatologic uses of botulinum neurotoxin currently supported by published data. Methods Relevant clinical articles regarding botulinum neurotoxin use in plastic surgery, dermatology, and general aesthetic literature were searched and reviewed. Results The search yielded 258 studies. Two hundred articles were excluded following title and abstract review. Twenty-one studies were excluded following full-text screening. A total of 37 studies remained and were discussed in this review. Conclusions Botulinum neurotoxin is widely used for numerous off-label indications from head to toe. Some uses are well documented, and their safety has been demonstrated in controlled trials, yet most remain poorly researched.

OBJECTIVES Sialocele and salivary fistula are not serious but troublesome complications after parotidectomy. Various modalities have been introduced to prevent postoperative saliva-related complications. However, clinical trials assessing the prophylactic use of botulinum toxin (BTX) for parotidectomy have not been conducted yet. Herein, we report a pilot study investigating the safety and efficacy of intraoperative BTX (iBTX) injection in partial superficial parotidectomy (PSP). PARTICIPANTS Patients with benign parotid tumour were prospectively recruited for this clinical trial from 2017 to 2019. The study participants underwent PSP with iBTX injection. We retrospectively reviewed the clinical information of all the consecutive patients who underwent PSP without iBTX from 2013 to 2019. These patients were divided into two groups: the iBTX group (n = 36) and the control group (n = 54). RESULTS Permanent facial palsy was not observed in either group. Two patients (3.7%) had transient marginal palsy in the control group but none had it in the iBTX group. The incidence of sialocele was significantly lower in the iBTX group than in the control group (2.8% vs. 20.4%, P

BACKGROUND/AIMS: The aim of this study is to share the results of gastric botulinum toxin (BTX) application in individuals who are overweight or type 1 obese without comorbidity. MATERIALS AND METHODS: In this study, 13 patients were included who were enrolled for gastric BTX application for the first time. A total of 300 U of BTX-A (Allergan Botox (®)1 vial 100 U) was diluted with 8 mL of 0.9% NaCl saline, and antrum (100 U to 8 spots), corpus (100 U to 8 spots), and fundus (100 U to 8 spots) regions were injected intramuscularly. Patients were given a 1200-calorie low-carb diet and this was followed for 6 months. RESULTS: Gastric BTX application was applied to 13 patients with a mean age of 40.9 ± 5.2 (85% female), a mean body mass index (BMI) of 28.41 ± 1.4 kg/m(2) (26-31.6) and a mean excess weight of 10.1 ± 3.6 kg. As a result of the 6-month follow-up, only four patients (30.8%) were able to lose more than 50% of their excess weight (6-15 kg). Six patients (46.2%) could not lose any weight. There was an average decrease of 3.3 kg in the weight of patients before and after BTX application (P = .03). A mean decrease of BMI was detected, 1.17 kg/m(2) (P = .032). CONCLUSION: It was concluded that the application of gastric BTX for weight loss does not provide effective results.

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) is the single largest payer for health care in the United States and the largest payer by spending globally. Medicare Part B, with more than 50 million beneficiaries, currently has no broad mechanisms in place for promoting cost-effective care of injectable drugs. OBJECTIVE: To conduct a real-world utilization and cost analysis comparing botulinum toxins in movement disorders. METHODS: The 2017 Medicare Provider Utilization and Payment Data: Physician and Other Supplier dataset from CMS was used for this claims level analysis. Neurologists, ophthalmologists, or physiatrists who injected predominantly for movement disorders (defined as blepharospasm, cervical dystonia, sialorrhea, and/or spasticity) were included along with their patients. Botulinum toxins with FDA indications spanning these 3 specialties were included. RESULTS: A total of 891 physicians (406 ophthalmologists, 338 neurologists, and 147 physiatrists) along with their 29,954 botulinum toxin (27,441 onabotulinumtoxinA and 2,513 incobotulinumtoxinA) patients were included in the analysis. The average total drug cost per patient per year (PPPY) was significantly lower for incobotulinumtoxinA versus onabotulinumtoxinA ($2,099 vs. $3,115; P < 0.001), for an average savings of 32.6%. Annual average out-of-pocket costs were also significantly less expensive for incobotulinumtoxinA versus onabotulinumtoxinA ($486 vs. $719; P < 0.001), for an average savings of 32.4%. Across 74,346 total injection visits, there was no significant difference in dosing between the agents, with an average dosing ratio of 0.94 incobotulinumtoxinA to 1.0 onabotulinumtoxinA. Injections PPPY were 2.42 for onabotulinumtoxinA and 2.29 for incobotulinumtoxinA. Average reported wastage was 64% higher for onabotulinumtoxinA than it was for incobotulinumtoxinA. A budget impact analysis estimated that increasing incobotulinumtoxinA use in the movement disorder space to attain an overall 20% botulinum toxin market share would save Medicare $32.9 million over a 3-year period versus current use. CONCLUSIONS: IncobotulinumtoxinA was shown to be a less costly alternative than onabotulinumtoxinA with similar dosing in real-world practice in this large national Medicare population. Policies to increase use of agents that promote cost-effective evidence-based care should be further explored and implemented for this fundamental federal payer. DISCLOSURES: This research received no external funding. Kazerooni was an employee of Merz Pharmaceuticals at the time of the analysis. Watanabe received no compensation or funding for this research project. Watanabe is a member of the National Academies of Sciences, Engineering, and Medicine Forum on Drug, Discovery, Development, and Translation. This information, content, and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government or the National Academies of Sciences, Engineering.

Aim To evaluate the effect of repeated onabotulinum neurotoxin A injections for the treatment of drooling in children with neurodisabilities. Method This was a retrospective cohort study, in which the first, second, and third onabotulinum neurotoxin A injection were compared within children treated between 2000 and 2020. Primary outcomes included drooling quotient, visual analogue scale (VAS), and treatment success defined as ≥50% reduction in drooling quotient and/or VAS 8 weeks after treatment. Each outcome was obtained at baseline and 8 weeks posttreatment. Results Seventy‐seven children were included (mean age at first injection: 8y 3mo, SD 3y 7mo, range 3–17y; 44 males, 33 females; 51.9% with cerebral palsy, 45.5% wheelchair‐bound). The objective (drooling quotient) and subjective (VAS) effect after the second injection was lower compared to the first injection. The third injection showed less objective and significantly less subjective effect compared to the first injection. An overall success rate of 74.0%, 41.6%, and 45.8% were found for the first, second, and third injection respectively. Interpretation Although onabotulinum neurotoxin A remained effective throughout the entire treatment course, there is less effect of subsequent onabotulinum neurotoxin A injections compared to the first. Although there might be a loss of effect after repeated injections, there is continued improvement for most children. What this paper adds Repeated injections show a diminished treatment effect after the second injection.A continued improvement is seen in most patients., What this paper adds Repeated injections show a diminished treatment effect after the second injection.A continued improvement is seen in most patients. This article's abstract has been translated into Spanish and Portuguese. Follow the links from the abstract to view the translations.

Background: OnabotulinumtoxinA is a novel therapeutic intervention whose mechanism of action is believed to modify the negative facial feedback, thus abating symptoms of depression. This putative new antidepressant agent offers minimal systemic side effects and negligible risk of pharmacological interactions. We set out to examine the evidence for the use of onabotulinumtoxinA in major depression. Methods: A systematic search of the literature identified double-blind randomised controlled trials (RCTs) investigating the use of onabotulinumtoxinA in the treatment of major depression versus placebo. Data, reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA), was combined in meta-analyses (PROSPERO registration ID: CRD42020183538). Results: The search identified five RCTs (four double-blind) comparing onabotulinumtoxinA to placebo. OnabotulinumtoxinA was more effective than placebo when administered within the 20–40 IU dose range in double-blind RCTs. The analysis was free of publication bias and significantly heterogeneous. Meta-regression analyses indicated that onabotulinumtoxinA was more efficacious in women and in higher doses in female patients and less effective with polypharmacy, especially when an increasing number of antidepressants were prescribed. The effectiveness of onabotulinumtoxinA was higher in more recently published double-blind RCTs. Conclusion: The meta-analysis supports the efficacy of the intervention with the results being highly heterogeneous across studies. In view of the heterogeneity of the findings and the significant moderators of benefit (sex, year of study completion and the interaction between sex and dose), more research is required to better understand the role of onabotulinumtoxinA in the treatment of depression.

Background Sugammadex binds progesterone with high affinity and may interfere with hormonal contraceptive effectiveness. The clinical, economical, and ethical implications of unintended pregnancy should prompt anesthesiologists to actively consider and manage this pharmacologic interaction. We surveyed anesthesiology providers at our institution about knowledge of this potential adverse drug interaction, how they manage it clinically, and the extent to which they involve patients in shared decision-making regarding choice of neuromuscular blocker antagonist. Methods A survey instrument was distributed to anesthesiology providers at a large, tertiary-care medical center. The survey explored prior experience using neostigmine and sugammadex, knowledge about potential sugammadex interference with hormonal contraception, pre-/postoperative counseling practices, clinical management, and shared decision-making regarding potential use of neostigmine in lieu of sugammadex to avoid this drug-drug interaction. Results Of 259 surveys distributed, 155 were fully completed, and 10 were partially completed. Overall response rate was 60% (residents 85%, student nurse anesthetists 53%, certified registered nurse anesthetists 58%, attendings 48%). All but 1 respondent recognized the potential for sugammadex interference with oral hormonal contraception. Far fewer accurately identified potential interference with hormonal intrauterine devices (44%) and hormonal contraceptive implants (55%). The manufacturer's recommended 7-day duration of alternative contraception was correctly identified by 72% of respondents; others (22%) reported longer durations (range 10-30 days). Most (78% overall) agreed/strongly agreed that potential interference with contraceptive effectiveness should be discussed with patients preoperatively. Despite the majority (86% overall) that endorsed shared decision-making and inviting patient input regarding choice between sugammadex and neostigmine, many respondents reported "rarely/never" having discussed this drug interaction with patients in actual clinical practice, either preoperatively (67%) or postoperatively (80%). Furthermore, most respondents (79%) reported "rarely/never" administering neostigmine to intentionally avoid this drug interaction. Conclusions Two years after designating sugammadex as antagonist of choice, physician and nurse anesthesia providers reported seldom inquiring about contraceptive use among women of childbearing potential and rarely discussing potential risk of contraceptive failure from sugammadex exposure. Most lack accurate knowledge of sugammadex interference with hormonal intrauterine and subcutaneous contraceptive devices. Although most endorse preoperative counseling and support patient autonomy or shared decision-making regarding choice of reversal agent, the same respondents report rarely, if ever, actualizing these positions in clinical practice. These conflicting findings highlight the need for education regarding residual neuromuscular block versus adverse drug interactions, collaboration among providers involved in patient counseling, and intentional mindfulness of reproductive justice when caring for women of childbearing potential.

Objective To examine the prevalence and duration of skeletal muscle relaxant (SMR) treatment among commercially insured adults in the United States. Methods We used the MarketScan Research Database to identify a cohort of adults 18 to 64 years who had ≥2-year continuous enrollment between 2005 and 2018. We estimated the prevalence of SMR treatment using a repeated cross-sectional design and derived treatment duration using the Kaplan-Meier method. Analyses were stratified by age group, sex, geographic region, individual SMR agent, and musculoskeletal disorder. Results 48.7 million individuals were included. Treatment prevalence ranged from 61.5 to 68.3 per 1,000. About one-third of users did not have a preceding musculoskeletal disorder diagnosis. Cyclobenzaprine was the dominant agent accounting for >50% of prescriptions. The considerable growth in the use of baclofen, tizanidine, and methocarbamol paralleled with a decline in carisoprodol and metaxalone use. The prevalence was highest in the South while lowest in the Northeast. The median treatment duration was 14 days with 4.0%, 1.9%, and 1.0% of individuals using SMRs for more than 90, 180, and 365 days, respectively. Compared with cyclobenzaprine, patients initiating baclofen, tizanidine, and carisoprodol had longer treatment duration. Conclusions SMRs are widely used in the United States. Their use slightly increased in recent years, but trends varied among individual agents, patient groups, and geographic regions. Despite limited evidence to support efficacy, a sizable number of U.S. adults used SMRs for long-term and off-label conditions. Further study is needed to understand determinants of treatment as well as outcomes associated with such use.