Safety Of Botulinum Toxin Type Research Articles

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

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

A Phase III Clinical Study of the Efficacy and Safety of Botulinum Toxin Type A (MASPORT) with DYSPORT for the Treatment of Glabellar Lines.

Botulinum toxin type A is a widely used treatment of facial wrinkles. The objective of this study was to compare the efficacy and safety of a new botulinum toxin type A (Masport [abobotulinum toxin A], MasoonDarou Co) with DYSPORT® for the treatment of glabellar lines. 262 subjects with moderate-to-severe glabellar lines received either a fixed dose of 50 units of MASPORT® or DYSPORT® (Ipsen Company, England). Subjects were followed up at 14, 30, 60, 90 and 120 days after injection. Efficacy was assessed by investigator at maximum frown and rest and also by Subject Global Assessment of Change (SGA). The responders were defined as persons with +2 grade improvement from baseline for both investigator and patient assessment. The occurrence and duration of adverse effects were recorded up throughout the study. According to the investigator evaluations, the responder rate at maximum frown were 94.5% for MASPORT and 95.6% for DYSPORT group on day 30 and at rest were 85.45% and 85.68% for MASPORT and DYSPORT group, respectively. According to the subject self-assessment, the proportion of responders in MASPORT group at day 30 was 95.28% versus 97.04% for DYSPORT group. No serious drug related adverse effect was recorded in either study groups, and the rates of adverse effects were similar for both groups. Abobotulinum toxin A [MASPORT] is equally safe and effective as commercial product [DYSPORT] for the treatment of glabellar lines with the dose of 50 units, up to 120 days. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Abstract 11520: Safety and Efficacy of Botulinum Toxin Type A for Prevention of Postoperative Atrial Fibrillation in Cardiac Surgery Patients: Pulmonary Function Test Results From the Phase 2 NOVA Study

Background: Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Autonomic neuromodulation, including injection of botulinum toxin into epicardial fat pads, may suppress and/or attenuate atrial fibrillation. The respiratory safety of a potential preventative treatment for AF is critical. Aim: To assess efficacy and pulmonary safety of botulinum toxin type A (BoNT/A; AGN-151607) 125U and 250U vs placebo for prevention of POAF after coronary artery bypass graft and/or valve surgery. Methods: NeurOtoxin for the PreVention of post-operative Atrial fibrillation (NOVA; NCT03779841) was a phase 2, international, multicenter, randomized, placebo-controlled trial. The primary endpoint was proportion of patients with continuous AF ≥30 seconds within the first 30 days. Respiratory function was assessed via pulmonary function tests (PFTs) performed at baseline and day 30 after treatment. Adverse events (AEs), serious adverse events (SAEs), and time to extubation were recorded. Results: A total of 323 patients were randomized: BoNT/A 125U (n=106), 250U (n=109), placebo (n=108). The primary endpoint occurred in 46.1% of the placebo group, 36.5% of the 125U group (relative risk [RR] vs placebo, 0.80 [95% CI: 0.58, 1.10]; P =0.16), and 47.2% of the 250U group (RR vs placebo, 1.04 [95% CI: 0.79, 1.37]; P =0.78). Baseline, day 30, and change from baseline PFT results were similar for active treatment vs placebo ( Table ). Median time to extubation was 9.7, 9.6, and 9.6 h in the placebo, 125U, and 250U groups, respectively. Respiratory AEs were reported in 42.9%, 38.1%, and 50.5% of patients, and respiratory SAEs in 11.4%, 6.7%, and 5.5% of patients in the placebo, 125U, and 250U groups, respectively. Conclusion: In this analysis of respiratory function, there appeared to be no detrimental effect of AGN-151607 compared with placebo, as evidenced by similar outcomes in PFT parameters and respiratory AE/SAE incidences among treatment arms.

Abstract 13435: The Efficacy and Safety of Botulinum Toxin Type A to Prevent Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Meta-Analysis of Randomized Controlled Trials

Background: Postoperative atrial fibrillation (POAF) is prevalent in about 30 to 60 percent of patients undergoing cardiac surgery leading to worse outcomes. However, effective POAF therapies are lacking. Botulinum toxin type A (BTX) epicardial injection can prevent POAF by impairing cholinergic signaling. Methods: We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching: PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through November 23 rd , 2022. RevMan version 5.4 software was used to pool dichotomous outcomes using risk ratio (RR) and continuous outcomes using mean difference (MD) presented with the corresponding confidence interval (CI). Results: Three RCTs with a total of 509 patients (308 in the BTX group and 205 in the placebo group) were included in our analysis. Two RCTs included patients undergoing open-chest cardiac surgery, including coronary artery bypass graft (CABG) and/ or valve surgery, while one RCT included patients undergoing CABG only. There was no difference between BTX and placebo regarding POAF incidence (RR: 0.81 with 95% CI [0.65, 1.00], P= 0.05), postoperative hospital length of stay in days (MD: -0.03 with 95% CI [-0.54, 0.49], P= 0.91), all-cause mortality, (RR: 1.64 with 95% CI [0.22, 12.17], P= 0.63), any adverse event (RR: 1.03 with 95% CI [0.94, 1.12], P= 0.51), and any serious adverse event (RR: 0.89 with 95% CI [0.68, 1.15], P= 0.36). Conclusion: There was no difference between epicardial fat injection of BTX versus placebo for preventing POAF; however, BTX showed a similar safety profile compared to placebo and our analysis can be underpowered to detect a significant effect. Hence, further large-scale RCTs are warranted to investigate BTX for POAF, especially in high-risk cohorts.

Study of the Effectiveness and Safety of Botulinum Toxin Type- A for Treatment of Androgenetic Alopecia in men

Study of the Effectiveness and Safety of Botulinum Toxin Type- A for Treatment of Androgenetic Alopecia in men

Systematic evaluation of the efficacy and safety of botulinum toxin type A in the treatment of spastic cerebral palsy

Systematic evaluation of the efficacy and safety of botulinum toxin type A in the treatment of spastic cerebral palsy

Efficacy and Safety of Botulinum Toxin Type A for Treatment of Glabellar Lines: A Network Meta-Analysis of Randomized Controlled Trials.

Botulinum toxin type A (BoNT/A) has been used in aesthetic applications worldwide, including glabellar lines. Currently, four BoNT/A preparations were approved for the improvement of moderate-to-severe glabellar lines: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, and prabotulinumtoxinA. DaxibotulinumtoxinA is a new form of BoNT/A drug that is developed in clinical application. We performed this network meta-analysis (NMA) to assess the efficacy and safety of all these different BoNT/A formulations for treating glabellar lines. The investigators searched randomized controlled trials (RCTs) using the Medical Subject Headings (MeSH) terms "botulinum toxin" and "glabellar lines." We searched the relevant studies in electronic databases as following: PubMed, Elsevier, EMBASE and the Cochrane Library. The end points included the percentage of subjects with a glabellar line severity (GLS) score of none (0) or mild (1), and the percentage of subjects achieving ≥ 1-point and 2-point improvement in glabellar line severity at maximum frown at approximately month 1 by the investigators' assessment. All formulations of BoNT/A were far superior to placebo in efficacy. DaxibotulinumtoxinA was the only treatment that significantly increased the proportion of subjects achieving ≥ 1 point improvement in GLS score compared with other BoNT/A formulations. Moreover, daxibotulinumtoxinA was ranked the highest for the proportion of subjects achieving ≥ 2-point improvement in GLS score. No significant differences were revealed for the incidence of any adverse events (AEs) that related to treatment or drug among all BoNT/A preparations. The overall results of this NMA suggested that daxibotulinumtoxinA is a new BoNT/A preparation that may be not only more effective but also well-tolerated for the treatment of glabellar lines. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Efficacy and Safety of Botulinum Toxin Type A (NABOTA) for Post-stroke Upper Extremity Spasticity: A Multicenter Phase IV Trial.

ObjectiveTo evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.MethodsThis prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.ResultsThere was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (−0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.ConclusionNABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.

Efficacy and Safety of Botulinum Toxin Type A in the Treatment of Benign Parotid Hypertrophy: A Prospective Study.

Benign parotid hypertrophy makes the earlobe area appear swollen and weakens the lateral facial contour and aesthetics. Efficacious treatment for benign parotid hypertrophy is not available. The authors evaluated the efficacy and safety of botulinum toxin type A for benign parotid hypertrophy treatment. Thirty-six participants with benign parotid hypertrophy were enrolled and treated with botulinum toxin type A injection. After 6 months of follow-up, changes in the thickness and length of the superficial lobe of the parotid gland were assessed. Analyses of patient subgroups and image analyses were also undertaken to assess improvement. Thirty-three participants completed this study. Superficial lobe of the parotid gland thickness was reduced significantly after botulinum toxin type A injection, but the longitudinal diameter of the parotid gland was not changed significantly ( p < 0.001 and p = 0.146, respectively). Subgroup analyses showed that the degree of parotid gland hypertrophy affected treatment efficacy and degree of improvement, but age and sex did not ( p < 0.001, p = 0.137, and p = 0.138, respectively). Image analyses showed improvement in the facial contour ( p < 0.05). Serious adverse reactions or complications were not observed. Botulinum toxin type A can be used to treat benign parotid hypertrophy, reduce parotid gland volume, and improve the facial contour. Therapeutic, IV.

Influence of COVID-19 mRNA vaccination on the efficacy and safety of Botulinum toxin type A injections.

BackgroundConcerns have been raised recently regarding the efficacy and safety of Botulinum toxin type A (BTA) injections following COVID‐19 vaccination.AimsTo assess the influence of BNT162b2 mRNA vaccine on the safety and efficacy of BTA injections performed for aesthetic indications.MethodsA retrospective cohort study followed patients undergoing periodic BTA treatments who completed two doses of BNT162b2 vaccine. The latency between BTA injections before and after getting vaccinated was assessed for all study participants. Efficacy and longevity of BTA was reflected and evaluated by the latency between BTA injections. Patients were longitudinally monitored for the development of adverse events.ResultsForty‐five patients were eligible for inclusion in the current study. The mean (standard deviation [SD]) age of patients was 48.3 (8.9) years and 40 (88.9%) patients were females. The mean (SD) number of pre‐ and post‐ COVID‐19 vaccination BTA injections was 5.1 (2.6) and 3.1 (0.4), respectively. The average (SD) interval between BTA injections after COVID‐19 vaccination (96.0 [12.3] days) was significantly shorter than before it (118.6 [22.7]; P<0.001). No severe BTA‐associated adverse events were registered after the administration of BNT162b2 vaccine.ConclusionsOur findings indicate that BTA might be less effective after COVID‐19 vaccination. Further research is required to delineate the pathomechanism underlying this observation.

Efficacy and Safety of Botulinum Toxin A and Pulsed Radiofrequency on Postherpetic Neuralgia: A Randomized Clinical Trial.

This study evaluated the effectiveness and safety of botulinum toxin type A (BoNT-A) and pulsed radiofrequency (RF) in the clinical treatment of postherpetic neuralgia (PHN). A total of 100 patients with PHN were randomly divided into two groups (n = 50 per group): RF group and BoNT-A group. Based on conventional drug treatment, patients were treated with either a single nerve root pulsed radiofrequency therapy or a single local subcutaneous injection of BoNT-A in the lesion area. All the patients were followed up for 24 weeks on pain scores, sleep quality, anxiety, and depression scores, etc. In the last follow-up at the end of 24 weeks postoperation, the pain scores of patients in both groups were significantly lower than those before the operation (P < 0.05), indicating that both treatments were effective against PHN; however, there was no significant difference between these two groups (P > 0.05). It is noteworthy that the subcutaneous injection of BoNT-A is relatively easy to administer and less expensive compared to RF. Therefore, we believe that the subcutaneous injection of BoNT-A is an effective and safe method for the treatment of PHN.

The Efficacy and Safety of Botulinum Toxin Type A Injections in Improving Facial Scars: A Systematic Review and Meta-Analysis

Background: Botulinum toxin type A (BTA) has a wide range of clinical applications, and its use in improving aesthetics is one of them. The aim of this study was to better assess the efficacy and safety of BTA in patients with facial scars. Summary: We extracted the data of the visual analog scale (VAS) score, Vancouver scar scale (VSS) score, scar width, observer scar assessment scale (OSAS), patient scar assessment scale (PSAS), and/or drug-related adverse events. Five studies provided the data of VAS score, and the results showed that the VAS score in the BTA group was significantly higher than that in the control group. Three randomized controlled trials (RCTs) reported the VSS score. A statistically significant difference exists between the BTA group and the control group. Three RCTs reported the scar width after BTA treatment. A more favorable change was found in the BTA group with scar width even without statistical significance. Data about the OSAS and PSAS scores were available in two trials. There was no significant difference in OSAS and PSAS scores between the BTA group and the control group. Only three studies recorded three slight adverse events. There were no reports of severe complications. In conclusions, this study demonstrated that BTA has the potential to improve facial scars with an acceptable safety profile.

Efficacy and safety of botulinum toxin type A in distraction osteogenesis of the lower extremities: a meta-analysis of randomized controlled trials

BackgroundTo explore the efficacy and safety of botulinum toxin in patients who received distraction osteogenesis of the lower extremities.MethodsWe searched the PubMed, Medline, Cochrane Library, and Web of Science databases for randomized controlled trials that administered botulinum toxin to individuals who underwent distraction osteogenesis of the lower limbs. The final search was conducted on July 6, 2021. Quality assessments were conducted using the Cochrane risk of bias tool and the Jadad scale. We performed random-effects meta-analysis to calculate the standardized mean differences (SMDs) and confidence intervals (CIs) of the pooled effect sizes, and subgroup analysis and meta-regression were performed for potential moderators.ResultsOur analysis of four randomized controlled trials, which enrolled a total of 257 participants, revealed that the difference in pain during the distraction phase was not statistically significant between groups (SMD, − 0.165; 95% CI, − 0.379 to 0.050, p = 0.133, I2 = 0.0%). The meta-regression analyses did not find any influence on the effect size, considering age (β = − 0.0092; p = 0.61) and the amount of lengthening (β = 0.0023; p = 0.99). Subgroup analysis did not reveal difference between different doses of botulinum toxin and single or multi-site study design. An analysis of two randomized controlled trials enrolling a total of 177 individuals demonstrated a limited effect of botulinum toxin in reducing postoperative pain (SMD, − 0.239; 95% CI, − 0.641 to 0.162, p = 0.24, I2 = 37.6%), total adverse events (SMD, − 0.207; 95% CI, − 0.505 to 0.090, p = 0.17, I2 = 0.0%), and infection of pin site (SMD, − 0.131; 95% CI, − 0.428 to 0.165, p = 0.39, I2 = 0.0%). No botulinum toxin–related adverse events were reported.ConclusionsThe current evidence does not support the administration of botulinum toxin in patients who receive distraction osteogenesis of the lower limbs. However, we were unable to draw decisive conclusions because of the limitations of our meta-analysis. Future well-designed, large-scale randomized controlled trials are necessary to confirm our conclusions.

Efficacy and safety of botulinum toxin type A for postoperative scar prevention and wound healing improvement: A systematic review and meta-analysis.

Botulinum toxin type A (BTXA) has shown underlying effects for wound healing improvement. New small clinical trials keep emerging every year and updated evidence-based information is warranted. This study aimed to evaluate the efficacy and safety of BTXA for preventing scarring. Four databases were searched to recruit randomized clinical trials (RCTs) which compared the surgical wounds treated with BTXA vs. those treated with placebo or blank control. The outcomes were primarily quantified by measures including the Vancouver Scar Scale (VSS), Visual Analog Scale (VAS), Stony Brook Scar Evaluation Scales (SBSES), modified SBSES (mSBSES), and scar width. Patients' satisfaction and adverse events were also reported. In total, 16 RCTs involving 671 cases (510 patients) were included. The outcome showed significant superiority of BTXA in VSS (mean difference [MD]=-1.32, 95% confidence interval [CI]: -2.00 to -0.65, p=0.0001), VAS (MD=1.29, 95% CI: 1.05-1.52, p<0.00001), SBSES or mSBSES (MD=-0.18, 95% CI: -0.27 to -0.10, p<0.0001), scar width (MD=-0.18, 95% CI: -0.27 to -0.10, p<0.0001), and patients' satisfaction (risk ratio [RR]=1.25, 95% CI: 1.06-1.49, p=0.01). No significant difference of adverse events incidence was observed (RR=1.46 95% CI: 0.64-3.33, p=0.36). Botulinum toxin type A is effective and safe for postoperative scar prevention and wound healing improvement, especially for facial wounds of Asians. Further studies should manage to standardize the treatment algorithm, while mSBSES is recommended for scar assessment.

Botulinum Toxin Injections for Treatment of Drooling in Children with Cerebral Palsy: A Systematic Review and Meta-Analysis.

Background: We aimed to review and analyse the effectiveness and safety of botulinum toxin type A (BoNT-A) injections for drooling in children with cerebral palsy. Data sources: We searched the EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) databases from inception to January 2020. Methods: We included randomized controlled trials and observational studies which (1) involved children with cerebral palsy, (2) used BoNT-A for control of drooling, and (3) provided quantitative evaluations of drooling before and after intervention with BoNT-A. Results: Twenty-one trials met the inclusion criteria. Most studies showed that BoNT-A injections are safe and efficacious as a treatment for drooling in children with cerebral palsy. Four trials had sufficient data to pool the results for the meta-analysis. Both the drooling quotient (p = 0.002) and drooling Ffrequency and severity scale (p = 0.004) supported this conclusion. Conclusion: BoNT-A injections are a safe, reversible, effective treatment for drooling control in children with cerebral palsy that can offer effectiveness for more than 3 months with few side effects. The dosage of BoNT-A should not exceed 4 units/kg. Further studies are required to determine the optimal dosage and target glands.

Effectiveness and Safety of Botulinum Toxin Type A in Treatment of Restless Legs Syndrome: A Systematic Review and Meta-Analysis.

Our study aimed to investigate the effectiveness and safety of botulinum toxin type A in patients with restless legs syndrome. We searched electronic databases, including PubMed, Cochrane Library, and Web of Science, up to 12 June 2021, for published articles. We enrolled randomized controlled clinical trials and non-randomized controlled studies involving patients with restless legs syndrome who were treated with botulinum toxin. Quality assessment was performed using the Cochrane risk of bias tool and Joanna Briggs Institute Critical Appraisal Checklist for Quasi-Experimental Studies. As for the results, we included four articles comprising 62 participants, two studies were randomized controlled trials. Improvement in International Restless Legs Syndrome Study Group (IRLSSG) rating scale was observed in three studies. Adverse events were temporary and self-limited. Meta-analyses were performed, including the two randomized controlled trials with 27 participants. Compared with placebo, botulinum toxin injection significantly reduced scores of IRLSSG rating scale (SMD, −0.819, 95% confidence interval [CI], −1.377 to −0.262). A total of 11.8% (95% CI, 0.7–72.4%) of patients reported at least one adverse event. In conclusion, botulinum toxin injection may relieve restless legs syndrome related symptoms. However, decisive conclusions cannot be drawn because of the small number of patients included in our meta-analysis. Large-scale, randomized controlled trials are warranted to discover the optimal dose, safety, and long-term effect of intervention with botulinum toxin type A for patients with restless legs syndrome.

Botulinum toxin type A therapy for hemifacial spasm.

This is an update of a Cochrane Review, first published in 2005. Hemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA). To compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS. We searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS. Two review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event. We found no parallel-group randomised controlled trials comparing BtA and placebo in HFS. We did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.).

Efficacy and safety of IncobotulinumtoxinA in the treatment of lower limb spasticity in Japanese subjects

Objective: To confirm the efficacy and safety of botulinum toxin type A (BoNT-A) treatment incobotulinumtoxinA (INCO; Xeomin®, Merz Pharmaceuticals GmbH) in Japanese subjects from study sites in Japan with post-stroke spasticity in the lower limb (LL), using the Modified Ashworth Scale (MAS) spasticity score for the plantar flexors.

Efficacy and Safety of Botulinum Toxin Type A in Preventing Postoperative Scars and Improving the Cosmetic Appearance of Scars: A Systematic Review and Meta-Analysis.

Scars with poor cosmesis that develop after wound healing may affect normal life. To assess the efficacy and safety of botulinum toxin type A (BTXA) in preventing postoperative hypertrophic scars or keloids. A systematic review was performed by searching the PubMed, Cochrane Library, and EMBASE databases from their inception date up to February 2020 for randomized controlled trials (RCTs) evaluating the efficacy of BTXA in preventing hypertrophic scars or keloids. The primary outcome measures included the Vancouver Scar Scale (VSS) score, Visual Analog Scale (VAS) score, scar width, patient satisfaction, and adverse events. Twelve RCTs involving 497 cases (372 patients) were included. The meta-analysis showed significant differences in the VAS score (weighted mean difference [WMD] = 1.31, 95% CI = 1.06 to 1.55, P < .00001), VSS score (WMD = -1.02, 95% CI = -1.72 to -0.32, P = .004), scar width (WMD = -0.18, 95% CI = -0.29 to -0.08, P = .0008), and patient satisfaction (relative risk = 1.25, 95% CI = 1.06-1.49, P = .01). Four studies reported trivial adverse events. This meta-analysis showed that BTXA was more effective than the control treatment in preventing postoperative scars and improving the cosmetic appearance of facial scars for East Asians, and no serious adverse events were found during the follow-up period. However, there was insufficient evidence to support the use of BTXA for the prevention of scars in patients from other ethnic groups and regions or scars in non-facial areas.

The efficacy and safety of Botulinum Toxin Type A in painful knee osteoarthritis: a systematic review and meta-analysis.

ObjectiveA systematic review and meta-analysis was carried out to evaluate the efficacy and safety of Botulinum Toxin Type A in painful knee osteoarthritis.MethodsThe EMBASE and MEDLINE databases were searched to identify randomized controlled trials (RCTs) of Botulinum Toxin Type A in the treatment of painful knee osteoarthritis. The references of included literature were also searched.ResultsFive articles involving 5 RCTs including 314 patients were included in this analysis. There was a significant difference between Botulinum Toxin Type A and placebo in the visual analog scale (VAS) pain scale and Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) questionnaire score in both the short-term (≤4 weeks) and long-term (≥8 weeks) treatment period. There were no serious adverse events in the Botulinum Toxin Type A groups.ConclusionsThis meta-analysis suggests that Botulinum Toxin Type A is effective and safe in the painful knee OA treatment. However, high-quality randomized controlled studies are still needed to further confirm our findings.