Search Results (79)

Background: Patient care following botulinum toxin injections has long been guided by anecdotal instructions, often based on theoretical considerations. This study evaluates the necessity of extended post-treatment instructions by analyzing outcomes and satisfaction in patients who followed only a 10 min precaution protocol. Materials and Methods: A retrospective, multicentric study was conducted across six Italian centers, analyzing 5014 patients treated with botulinum toxin for upper facial wrinkles between 2015 and 2020. Outcomes included adverse effects—particularly upper eyelid ptosis—and patient satisfaction. Follow-up was performed at two weeks. Results: No cases of upper eyelid ptosis were observed. Among 4000 patients who attended follow-up, adverse effects occurred in only 5.99%, notably lower than rates reported in the literature. Of the 2010 patients who completed the satisfaction questionnaire, 90% reported being very satisfied. These findings support the safety of limiting post-treatment instructions to 10 min. Conclusions: Our findings indicate that omitting extended post-injection instructions does not negatively impact patient satisfaction or complication rates. Given the toxin’s rapid internalization and localized effect, extended behavioral restrictions may be redundant. However, the absence of a control group and lack of statistical analyses limit the strength of these conclusions. In addition, this is a short-term study. Future prospective, randomized trials are needed to develop evidence-based post-care protocols to optimize esthetic outcomes, patient safety, and long-term efficacy. Full article

Background/Objectives: Temporomandibular disorders (TMDs) are the most common cause of non-dental pain in the orofacial region. Due to the complex and multifactorial nature of TMD, a multidisciplinary approach is often required. The objective of this narrative review is to evaluate the effectiveness of multimodal therapies in the management of TMD. Methods: A literature search was performed using a combination of keywords: “TMD”, “TMJ”, “disorders”, “manual therapy”, “physical therapy”, “dry needling”, “botulinum toxin”, “Botox”, “splint”, and “psychotherapy”. The search was conducted in the PubMed, Google Scholar, and Scopus databases, focusing on studies involving human subjects. Results: The included studies reported that the use of multimodal approaches—such as physiotherapy, botulinum toxin injections, occlusal splints, and/or psychotherapy—led to symptom improvement or complete resolution in patients with TMD. Conclusions: Temporomandibular disorders are complex conditions with a multifactorial etiology involving both somatic and psychological components. Given the wide range of symptoms and the functional connections of the temporomandibular joint with the nervous, muscular, and skeletal systems—including the cervical spine—effective treatment of TMD requires a multidisciplinary strategy. Full article

Biomimetic peptides represent a growing class of active ingredients in modern cosmeceuticals, designed to mimic the function of the naturally occurring peptides involved in skin homeostasis, repair, and regeneration. Among them, acetyl hexapeptide-8 (AH-8), often referred to as a “botox-like” peptide, has received considerable attention for its potential to dynamically reduce wrinkles through the modulation of neuromuscular activity. AH-8 is widely used in topical formulations intended for anti-aging effects, scar treatment, and skin rejuvenation. This review provides a comprehensive overview of the structure and proposed mechanisms of action of AH-8, with particular focus on its efficacy and skin penetration properties. Due to its hydrophilic nature and relatively large molecular size, AH-8 faces limited permeability through the lipophilic stratum corneum, making effective dermal delivery challenging. Formulation strategies such as oil-in-water (O/W) and multiple water-in-oil-in-water (W/O/W) emulsions have been explored to enhance its delivery, but the ability of AH-8 to reach neuromuscular junctions remains uncertain. Preclinical and clinical studies indicate that AH-8 may reduce wrinkle depth, improve skin elasticity, and enhance hydration. However, the precise biological mechanisms underlying these effects—particularly the peptide’s ability to inhibit muscle contraction when applied topically—remain incompletely understood. In some studies, AH-8 has also shown beneficial effects in scar remodeling and sebum regulation. Despite promising cosmetic outcomes, AH-8’s low skin penetration limits its bioavailability and therapeutic potential. This review emphasizes the need for further research on formulation science and delivery systems, which are essential for optimizing the effectiveness of peptide-based cosmeceuticals and validating their use as non-invasive alternatives to injectable treatments. Full article

Objective: The objective of this study was to examine 7 years of clinical physical therapy measures in a child with spastic diplegic cerebral palsy (CP) who received multiple botulinum toxin type A (BoNT-A) injections. Methods: A boy diagnosed with spastic diplegic CP, Gross Motor Function Classification System level II, received four episodes of BoNT-A from ages 4 to 10 years. Serial clinical measures of muscle strength, spasticity, lower extremity passive range of motion, gait kinematics, and gross motor function were collected in the gait analysis lab from age 3 to 10 years. Results: After improvements from ages 3 to 7 years, gait and motor function declined from ages 8 to 10 years with no improvement in spasticity or range of motion measurements. Muscle testing and gait kinematics defined a loss of plantarflexion strength. Conclusions: A decline in gross motor skills and gait is not typical for a child with spastic diplegia at age 8 years and its association with BoNT-A injections needs to be considered. This case demonstrates the importance of evaluating treatment outcomes for youth with spastic CP utilizing a set of reliable, and clinically useful measures of strength, spasticity, contracture, gait, and motor function. Critical examination of impairment and functional level measures defines goals, guides treatment, and evaluates outcomes. With this approach, pediatric therapists can empower families to make well-informed decisions. Full article

OnabotulinumtoxinA is an FDA-approved treatment for adults with overactive bladder (OAB) who have an inadequate response to, or are intolerant of, oral pharmacotherapies including anticholinergics or beta-3 agonists. However, procedural practices of onabotulinumtoxinA intradetrusor injection vary among practitioners and can affect patient experience. To address this, a panel of six high-volume intravesical onabotulinumtoxinA providers with 100 years of combined experience convened to discuss the best office practices when treating patients with OAB. These key best practices include counseling patients on available OAB therapies, including onabotulinumtoxinA, at the initial consultation in accordance with established AUA and SUFU guidelines in a way that is easily understood. An office setting is preferred over a hospital or surgery center when performing the procedure. Staff involvement, from scheduling to post-procedure, is essential for establishing the relationships necessary to optimize patient experience and encourage compliance and retreatment. Experts generally recommend using a viscous lidocaine bladder instillation for an anesthetic 15 min prior to the reconstitution of onabotulinumtoxinA with 5 to 10 mL of normal saline. A range of one to 20 injection sites is acceptable, with a smaller number preferred. Starting in the lower bladder, experts recommend using a slower speed of injection to improve distribution and decrease patient discomfort. Subsequent treatments should be regularly scheduled at six-month intervals with the option of re-treating earlier if symptoms return, but no sooner than 12 weeks. For office intravesical onabotulinumtoxinA procedures, optimization of the patient experience by the physician and their staff, starting with the initial visit through the post-treatment follow-up, is key to long-term patient compliance. Full article

Background: Spasticity is a muscle stiffness issue often caused by spinal cord or cerebral diseases, notably impairing stroke patients. This study aims to evaluate the long-term effectiveness of repeated Botulinum Toxin A injections on spasticity and arm function, to understand if the treatment’s effects accumulate or diminish over time. Methods: This study examines 85 stroke patients treated with one or five sessions of BTX-A injections between 2013 and 2019. Patients were divided into two groups based on the number of sessions and evaluated using Modified Ashworth Scores, Brunnstrom Stage, and Frenchay Arm Test. Results: This study includes 85 hemiplegic patients with an average age of around 50, and various muscle groups were treated with BTX-A injections. Group 2, who received five sessions, showed significantly greater improvement in MAS scores for certain muscle groups and had higher FAT scores compared to Group 1, who received just one session. Overall, BTX-A treatment led to significant improvements in MAS, Brunnstrom, and FAT scores across all patients. Conclusions: Our findings corroborate existing literature by affirming that Botox injections effectively mitigate spasticity and enhance arm functionality. Notably, our data reveal that repeated Botox treatments yield significantly greater benefits in reducing spasticity in the elbow pronators, wrists, and finger flexors compared to a single session. This study uniquely demonstrates the cumulative benefits of multiple BTX-A sessions, highlighting that repeated applications not only sustain but also amplify functional improvements over time. These results advocate for the feasibility and augmented effectiveness of administering a series of five Botox injections in the management of post-stroke spasticity. Full article

Botulinum toxin (BoNT) is well-recognized throughout dermatology for its cosmetic indications and growing therapeutic value. Recent studies have trialed BoNT in the treatment of hair and scalp disorders, many of which lack long-term effective treatments and significantly impact quality of life. In this review, we summarize the current clinical literature on this topic to comprehensively evaluate the efficacy, safety, and clinical value of BoNT in treating hair and scalp conditions. A literature search on PubMed/MEDLINE and Scopus identified 40 articles reporting the use of 25–200 units of BoNT-A or B in 689 patients with hair loss (79.5%), scalp seborrheic dermatitis/hyperseborrhea (10%), craniofacial hyperhidrosis (9%), folliculitis decalvans/dissecting folliculitis (0.86%), scalp pain (0.43%), or linear scleroderma (0.29%). Most studies on BoNT therapy for androgenetic alopecia (AGA) reported mild or non-significant hair growth; however, considerable variability in outcome measures complicates the ability to draw definitive conclusions or justify the use of BoNT over established AGA therapies. BoNT-A and B showed consistent efficacy in treating craniofacial hyperhidrosis with minimal side effects. Additional scalp conditions may benefit from BoNT therapy, but the evidence is limited, and larger, controlled studies are needed to better understand BoNT’s clinical value in these conditions. Full article

This retrospective study investigates botulinum toxin changes in 206 patients with spasticity, following reimbursement adjustments in France. The main objective was to evaluate the tolerance and efficacy of these changes, a topic underexplored due to the common practice of maintaining the same toxin brand. The majority of patients switched from Botox to Xeomin (73.66%), while others switched from Botox to Dysport (14.63%) or from Xeomin to Dysport (11.71%). Dose adjustments varied depending on the switch, with the change from Botox to Xeomin showing the greatest diversity in adjustments. Overall, tolerance was good, with few adverse effects reported, primarily fatigue. Perceived efficacy fluctuated, with some patients noting improvement while others experienced deterioration, but the median remained stable. A majority of patients (57.06%) chose to continue with their new treatment, indicating general satisfaction, though 42.93% preferred to return to their initial treatment. This study highlights the importance of an individualized approach and careful monitoring during toxin changes. The results suggest that toxin switches can be made without an increase in adverse effects. While differences between groups were observed, they were not statistically significant. Placebo and nocebo effects may influence perceptions of efficacy and side effects during treatment changes. Full article

Introduction: Overactive bladder (OAB) is a syndrome of the lower urinary tract characterized by urinary urgency, frequency, and nocturia, with or without urgency urinary incontinence. OAB significantly impacts all aspects of life—social, psychological, physical, professional, domestic, and sexual—for both women and men. The aim of this study was to investigate sexual dysfunction in both women and men with OAB treated with intravesical onabotulinumtoxinA (Botox) injections using the Sexual Quality of Life questionnaire in two versions: female (SQoL-F) and male (SQoL-M). Methods: Forty sexually active patients (thirty women and ten men) with idiopathic OAB were recruited. Patients completed the SQoL-F or SQoL-M questionnaire before treatment, and again at 3 and 6 months after treatment with intravesical onabotulinumtoxinA injections. Results: All 40 patients completed the study (30 women and 10 men). There were no statistically significant differences in SQoL results before the procedure or at 3- and 6-months post-treatment. Conclusions: OAB treatment with onabotulinumtoxinA did not significantly affect the quality of sexual life in either women or men. Further research is needed using questionnaires specifically designed to assess the sexual life of patients with OAB, especially in men. Full article

Background: Sleep apnea and nocturnal bruxism belong to sleep disorders that can affect the quality of life. The aim of this study was to investigate the effects on patients with moderate sleep apnea and nocturnal bruxism of Botox injection as monotherapy or associated with wearing thermoformed occlusal splints and to determine the patients’ satisfaction degree after the applied treatments. Methods: The selected patients for study were divided into two groups: in the first group, the patients (n = 18) treatment consisted of injecting Botox (Allergan) into the masseter muscle as monotherapy; in the second group, the patients (n = 18) benefited from associated therapy, Botox injections in masseter muscle, and the wear of thermoformed occlusal splints. At baseline, at three weeks, at three months, and six months after the effectuation of therapies, the monitoring sessions were realized. Results: The associated therapy presented better results in decreasing the studied symptoms than the monotherapy. Both therapies improved patient satisfaction. Conclusions: The applied therapies for treating the specific symptomatology in moderate sleep apnea and sleep bruxism were efficacious. Patient satisfaction was very good in both groups after the applied treatments, but the associated therapy presented better results than monotherapy. Full article

Cerebral palsy (CP) is a common neurodevelopmental disorder characterized by pronounced motor dysfunction and resulting in physical disability. Neural precursor cells (NPCs) have shown therapeutic promise in mouse models of hypoxic-ischemic (HI) perinatal brain injury, which mirror hemiplegic CP. Constraint-induced movement therapy (CIMT) enhances the functional use of the impaired limb and has emerged as a beneficial intervention for hemiplegic CP. However, the precise mechanisms and optimal application of CIMT remain poorly understood. The potential synergy between a regenerative approach using NPCs and a rehabilitation strategy using CIMT has not been explored. We employed the Rice–Vannucci HI model on C57Bl/6 mice at postnatal day (PND) 7, effectively replicating the clinical and neuroanatomical characteristics of hemiplegic CP. NPCs were transplanted in the corpus callosum (CC) at PND21, which is the age corresponding to a 2-year-old child from a developmental perspective and until which CP is often not formally diagnosed, followed or not by Botulinum toxin injections in the unaffected forelimb muscles at PND23, 26, 29 and 32 to apply CIMT. Both interventions led to enhanced CC myelination and significant functional recovery (as shown by rearing and gait analysis testing), through the recruitment of endogenous oligodendrocytes. The combinatorial treatment indicated a synergistic effect, as shown by newly recruited oligodendrocytes and functional recovery. This work demonstrates the mechanistic effects of CIMT and NPC transplantation and advocates for their combined therapeutic potential in addressing hemiplegic CP. Full article

Urgency urinary incontinence (UUI) refractory to medical treatment poses significant challenges despite advancements. This study evaluates the efficacy of intravesical botulinum toxin for UUI and identifies factors influencing treatment outcomes. Among 368 women receiving botulinum toxin injections, 74.5% achieved a complete discontinuation of pad usage. Predictors of efficacy included lower pre-treatment pad usage and the absence of prior sling placement. Patients often required repeat injections (60.3%), with younger age and satisfaction correlating with treatment repetition. The interval between injections averaged 18 months, influenced by logistical challenges and patient preferences. Despite concerns about diminishing efficacy, subjective perceptions did not align with objective findings. Limitations include retrospective analysis and heterogeneous clinical records. In conclusion, intravesical botulinum toxin is effective for UUI, with pre-treatment pad usage and sling placement history influencing outcomes and patient characteristics influencing treatment repetition. Full article

Dynamic wrinkle reduction continues to challenge aesthetic dermatology, predominantly addressed through Botulinumtoxin (Botox) injections. Despite Botox’s robust efficacy with up to an 80% reduction in wrinkle visibility within just one week, its invasive administration and specific mechanism of soluble N-ethylmaleimide-sensitive factor attachment protein receptor (SNARE) complex inhibition prompt the exploration of safer, non-invasive alternatives. This review critically assesses recent innovations in non-invasive effects, with a focus on peptides and botanical extracts that exhibit a diverse array of mechanisms including SNARE complex inhibition, modulation of calcium and sodium channels, and interactions with acetylcholine receptors, contributing to their effectiveness in muscle relaxation on dynamic wrinkle approaches. Noteworthy peptides such as Argireline and SYN-Ake replicate the neuromodulatory effects of Botox, achieving up to a 52% reduction in wrinkles within four weeks without injections. Moreover, botanical extracts meet the rising demand for clean beauty solutions by enhancing skin elasticity and health through gentle yet potent mechanisms. However, the main concern with peptides is their low absorption rate, with only six clinical validations regarding Botox-like peptide anti-wrinkle efficacy available. These advancements not only deepen our understanding of cosmetic dermatology but also significantly influence market dynamics and consumer behavior, underscoring their pivotal role in redefining the future landscape of anti-aging effects. Full article

(1) Background: At present, the only potency assay approved in China for the in-country testing of botulinum toxin type A for injection products is the mouse bioassay (MBA). The Chinese market for neurotoxin products is rapidly expanding, but MBAs are subject to high variability due to individual variations in mice, as well as variations in injection sites, in addition to the limited number of batches tested for one MBA. Compared with the mLD₅₀ method, the cell-based potency assay (CBPA) developed for the potency testing of onabotulinumtoxinA (BOTOX) by AbbVie not only does not use any experimental animals but also allows for significant time and cost savings. Due to the significant benefits conferred by the replacement of the mLD₅₀ assay with CBPA in China, the CBPA method has been transferred, validated, and cross-validated to demonstrate the equivalence of the two potency methods. (2) Methods: The differentiated SiMa cells were treated with both BOTOX samples and the reference standard, and the cleaved SNAP25₁₉₇ in the cell lysates was quantified using Chemi-ECL ELISA. A 4-PL model was used for the data fit and sample relative potency calculation. The method accuracy, linearity, repeatability, and intermediate precision were determined within the range of 50% to 200% of the labeled claim. A statistical equivalence of the two potency methods (CBPA and mLD₅₀) was initially demonstrated by comparing the AbbVie CBPA data with NIFDC mLD₅₀ data on a total of 167 commercial BOTOX lots (85 50U lots and 82 100U lots). In addition, six lots of onabotulinumtoxinA (three 50U and three 100U) were re-tested as cross-validation by these two methods for equivalence. (3) Results: The overall assay’s accuracy and intermediate precision were determined as 104% and 9.2%, and the slope, R-square, and Y-intercept for linearity were determined as 1.071, 0.998, and 0.036, respectively. The repeatability was determined as 6.9%. The range with the acceptable criteria of accuracy, linearity, and precision was demonstrated as 50% to 200% of the labeled claim. The 95% equivalence statistic test using margins [80%, 125%] indicates that CBPA and mLD₅₀ methods are equivalent for both BOTOX strengths (i.e., 50U and 100U). The relative potency data from cross-validation were within the range of ≥80% to ≤120%. (4) Conclusions: The CBPA meets all acceptance criteria and is equivalent to mLD₅₀. The replacement of mLD₅₀ with CBPA is well justified in terms of ensuring safety and efficacy, as well as for animal benefits. Full article

Sleep bruxism, characterized by involuntary grinding or clenching of teeth during sleep, poses significant challenges in management due to its potential to induce temporomandibular joint disorders (TMDs) and other related symptoms. The use of Botulinum toxin Type A (BoNT-A), also known as Botox^®, has been proposed as a therapeutic intervention. This systematic review aims to evaluate the efficacy and safety of BoNT-A in the management of sleep bruxism, focusing on pain reduction, improvement in jaw function, reduction in bruxism episodes, and the incidence of adverse effects. An exhaustive search was conducted across PubMed, Scopus, and Embase databases up to January 2024, adhering to the PRISMA guidelines. Nine randomized clinical trials (RCTs) involving 137 participants were analyzed for efficacy and safety outcomes. The studies demonstrated a significant reduction in mean pain scores (from 7.1 to 0.2 at 6 months and 1 year post-treatment in one study) and a notable decrease in the number of bruxism events (from 4.97/h to 1.70/h in the BoNT-A group in another study). Additionally, improvements were observed in jaw stiffness and total sleep time. Adverse effects varied but were generally mild and transient, including injection site pain in 20% of participants in one study and cosmetic changes in smile in 15.4% of patients in another. These findings suggest that BoNT-A injections may provide some benefits for treating nocturnal bruxism, potentially reducing TMD symptoms like pain and improving jaw function. However, these findings are preliminary due to variability in study designs and the absence of detailed statistical analysis. Full article