Effect Of Botulinum Toxin Type Research Articles

Effects of botulinum toxin type A in patients with painful temporomandibular joint disorders: A systematic review and meta-analysis

Objective: To assess the therapeutic efficacy of botulinum toxin type A (BTX-A) for managing myofascial pain related to temporomandibular disorders (TMDs). Methods: This study was conducted according to the PRISMA 2020 statement guidelines. The PubMed, Embase, and Cochrane Library databases were searched. Only randomized controlled trials (RCTs) were included. The primary outcome was pain score on the visual analogue scale (VAS), and the secondary outcomes were maximum mouth opening (MMO) and adverse effects. The Cochrane risk of bias tool was used to assess risk bias. A meta-analysis of studies with the same interventions, controls, assessment methods and follow-up durations was performed. Results: A total of 519 studies were retrieved, of which 20 RCTs were included in the qualitative analysis and 6 were included in the meta-analysis. The results showed that, compared with placebo, BTX-A injection was more effective at relieving myofascial pain, and its effect was similar to that of conventional methods. However, there was no difference in MMO between the two groups. After study assessment with the RoB 2.0 tool, six studies showed a low risk of bias, 13 studies showed some concerns regarding the reported results, and only one study showed a high risk of bias. Adverse effects of BTX-A injection were observed in four studies. Conclusions: In conclusion, BTX-A is effective at relieving pain in TMD patients but does not improve mouth opening. To minimize adverse effects, we recommend a low dose of BTX-A for TMD patients who do not experience complete pain relief from conservative treatments.

Clinical Application of Botulinum Toxin A on Nasal Reconstruction with Expanded Forehead Flap for Asian Patients.

Because of its unique advantages, frontal expansion has become a common tool for Asian nasal reconstruction, but it has the limitations of prolonging the duration and pain in the expansion area. Based on the fact that the denervation effect of botulinum toxin type A (BTX-A) has been widely used in the reconstruction of superficial organs, we hypothesized that BTX-A would shorten the length of nasal reconstruction sequence and alleviate the discomfort of patients. A comparative retrospective study was conducted of consecutive patients underwent sequential treatment of nasal reconstruction between June 2010 and July 2012. Data on demographics, BTX-A injection plan and expansion duration were collected and analyzed. Phased pain intensity outcomes were evaluated by visual analogue scale (VAS). Photographs were collected during the follow-up period. Thirty patients were enrolled in the study; 15 (50%) with and 15 (50%) without BTX-A pre-injection. Demographic data were homogeneous. The duration of the observation group (BTX-A pretreated) (133.87 ± 13.64 days) was significantly shortened versus the control group (164.27 ± 14.08 days, P<0.001). At the initial stage, no significant difference was found in the VAS scores (P=0.64). At the medium stage, the VAS score of the observation group (2.07 ± 0.80) was significantly lower than the control group (3.00 ± 0.53, P<0.01). At the terminal stage, the VAS score of the observation group (1.93 ± 0.59) was significantly lower than the control group (2.73 ± 0.70) but with a narrower disparity. Pre-injection of BTX-A is effective in shortening the duration of the expansion phase, as well as relieving the pain associated with expansion. The journal asks authors to assign a level of evidence to each article. For a complete description of Evidence-Based Medicine ratings, see the Table of Contents or the online Instructions for Authors at www.springer.com/00266 .

Botulinum toxin type A inhibits M1 macrophage polarization by deactivation of JAK2/STAT1 and IκB/NFκB pathway and contributes to scar alleviation in aseptic skin wound healing

The non-neuronal and non-muscular effects of botulinum toxin type A (BTXA) on scar reduction has been discovered. This study was designed to investigate the effects of BTXA on macrophages polarization during the early stage of skin repair. A skin defect model was established on the dorsal skin of SD rats. BTXA was intracutaneous injected into the edge of wound immediately as the model was established. Histological examinations were performed on scar samples. Raw 264.7 was selected as the cell model of recruited circulating macrophages, and was induced for M1 polarization by LPS. Identify the signaling pathways that primarily regulated M1 polarization and respond to BTXA treatment. Application of BTXA at early stage of injury significantly reduced the scar diameter without delaying wound closure. BTXA treatment improved fiber proliferation and arrangement, and inhibited angiogenesis in scar granular tissue. The number of M1 macrophages and the levels of pro-inflammation were decreased after treated with BTXA in scar tissues. LPS activated JAK2/STAT1 and IκB/NFκB pathways were downregulated by BTXA, as well as LPS induced M1 polarization. At early stage of skin wound healing, injection of BTXA effectively reduced the number of M1 macrophages and the levels of pro-inflammatory mediators which contributes to scar alleviation. BTXA resisted the M1 polarization of macrophages induced by LPS via deactivating the JAK2/STAT1 and IκB/NFκB pathways.

Effects of botulinum toxin type A in the prevention and treatment of facial hypertrophic scars: A meta-analysis.

A meta-analysis was conducted to comprehensively evaluate the prophylactic and therapeutic efficacy of botulinum toxin type A (BTX-A) in the treatment of facial hypertrophic scars. Computerised searches were performed in databases, from their inception to November 2023, including Embase, Google Scholar, Cochrane Library, Wanfang, PubMed and China National Knowledge Infrastructure databases, focusing on randomised controlled trials (RCTs) that investigated the use of BTX-A for treating facial hypertrophic scars. Two researchers independently screened the literature, extracted data and conducted quality assessments. Stata 17.0 software was employed for data analysis. Seventeen RCTs were ultimately included, involving 1605 patients who underwent facial cosmetic surgery. The analysis revealed that compared with conventional treatments, BTX-A significantly reduced visual analogue scale (VAS) scores (standardized mean difference [SMD]: -3.50, 95% confidence interval [CI]: -5.16 to -1.84, p < 0.001) and Vancouver scar scale (VSS) scores (SMD: -2.86, 95% CI: -4.03 to -1.68, p < 0.001), and narrowed scar width (SMD: -1.80, 95% CI: -2.48 to -1.13, p < 0.001), while also enhancing the overall effectiveness of the treatment. This study indicates that BTX-A is an effective modality in the prophylaxis and treatment of facial hypertrophic scars, significantly alleviating scar-related pain and preventing scar widening, and is thus worthy of broader clinical application.

The application and therapeutic effect of botulinum toxin type a (BTX-A) in the treatment of patients with pain after cancer treatment: a systematic review and meta-analysis.

Botulinum toxin type A (BTX-A) is a potential treatment for cancer pain. This study aimed to analyze the effectiveness and safety of BTX-A in the treatment of pain after cancer treatment. Systematic searches of PubMed, Cochrane Library, and Embase databases were conducted. Randomized controlled trials evaluating the efficacy and safety of BTX-A compared with either placebo or active treatment in patients with pain after cancer treatment were included. The outcomes included pain intensity, quality of life, and adverse events. This systematic review included four studies of which two were included in the meta-analysis. Compared with a placebo, BTX-A injection in patients with pain after cancer treatment had a clinically meaningful reduction in self-reported pain post-treatment [mean difference=-1.79 (95% CI: -2.14--1.43), P <0.00001, I ²=0%]. This systematic review and meta-analysis demonstrated that BTX-A is safe and effective for pain relief in patients with pain after cancer treatment.

Effect and mechanism of action of botulinum toxin type A on hypertrophic scar &lt;i&gt;in vitro&lt;/i&gt;

Purpose: To examine the effect of botulinum toxin type A (BTXA) on the formation of hypertrophic scar and to unravel its mechanism of action.&#x0D; Methods: HSF cells were isolated from hypertrophic scars and cultured. Immunohistochemistry (IHC) assays were performed to determine TGF-β1, FN, and Col1 expressions in hypertrophic scar and normal tissues while the expressions and phosphorylation of p38, ERK, JNK, as well as the expressions of α-SMA, Col1 and FN1 in HSF cells were evaluated by immunoblot techniques. CCK-8 and Transwell assays were used to assess the effect of BTXA on the viability and motility of HSF cells.&#x0D; Results: BTXA suppressed MAPK pathway in hypertrophic scar fibroblasts (p &lt; 0.01). It also suppressed excessive collagen deposits in hypertrophic scar through MAPK pathway (p &lt; 0.01), and restrained HSF growth and motility via MAPK pathway (p &lt; 0.01).&#x0D; Conclusion: BTXA suppresses hypertrophic scarring via MAPK pathway and thus, can potentially be developed as a drug for the treatment of hypertrophic scarring.

Effect of botulinum toxin type A on muscular temporomandibular disorder: A systematic review and meta-analysis of randomized controlled trials.

Botulinum toxin type A (BTX-A) is increasingly used to manage painful temporomandibular disorders (TMD). However, the effect of BTX-A on muscular TMD remains unclear. To assess the efficacy, safety and optimal dose of BTX-A for treating TMD. We conducted systematic literature searches in MEDLINE, Embase, Web of Science, ClinicalTrials.gov and Cochrane Library until March 2023. We extracted data from randomized controlled trials (RCTs) that evaluated the efficacy and safety of BTX-A in treating muscular TMD. We performed a meta-analysis using a random-effects model. Fifteen RCTs involving 504 participants met the inclusion criteria. BTX-A was significantly more effective than placebo in reducing pain intensity, as measured on a 0-10 scale, at 1 month (MD [95% CI] = -1.92 [-2.87, -0.98], p < .0001) and 6 months (MD [95% CI] -2.08, [-3.19 to -0.98]; p = .0002). A higher dosage of BTX-A (60-100 U bilaterally) was associated with a greater reduction in pain at 6 months (MD [95% CI] = -2.98 [-3.52, -2.44]; p < .001). BTX-A also resulted in decreased masseter muscle intensity (μV) (MD [95% CI] = -44.43 [-71.33, -17.53]; p = .001) at 1 month and occlusal force (kg) at 3 months (MD [95% CI] = -30.29 [-48.22 to -12.37]; p = .0009). There was no significant difference in adverse events between BTX-A and placebo. BTX-A is a safe and effective treatment for reducing pain and improving temporomandibular muscle and joint function in muscular TMD patients. A bilateral dose of 60-100 U might be an optimal choice for treating muscular TMD pain.

The Therapeutic Effect of Botulinum Toxin Type A on Trigeminal Neuralgia: Are There Any Differences between Type 1 versus Type 2 Trigeminal Neuralgia?

Botulinum toxin type A is an effective treatment for trigeminal neuralgia. Moreover, its efficacy in type 2 trigeminal neuralgia and comparative studies between type 1 and type 2 trigeminal neuralgia (TN) still need to be improved. We treated 40 TN patients with onabotulinumtoxinA; 18 had type 1 TN, and 22 had type 2 TN. We compared the baseline pain score with the Visual Analogue Scale (VAS) and paroxysm frequency (number per week) at the baseline with those obtained at 1-month and 3-month follow-ups. Nonetheless, we compared the baseline Penn Facial Pain Scale with the scores obtained at the 1-month follow-up. BoNT/A effectively reduced pain intensity and frequency at the 1-month and 3-month follow-ups. Moreover, the type 1 TN and type 2 TN groups had baseline pain scores of 7.8 ± 1.65 and 8.4 ± 1.1, respectively. Pain significantly improved (p < 0.001) in both groups to 3.1 ± 2.3 (type 1 TN) and 3.5 ± 2.3 (type 2 TN) at the 1-month follow-up and to 3.2 ± 2.5 (type 1 TN) and 3.6 ± 2.5 (type 2 TN) at the 3-month follow-up. There was no difference between the two groups (p 0.345). The baseline paroxysm frequencies (number per week) were 86.7 ± 69.3 and 88.9 ± 62.2 for the type 1 and type 2 TN groups, respectively; they were significantly reduced in both groups at the 1-month and 3-month follow-ups without significant differences between the two groups (p 0.902). The Pain Facial Pain Scale improved at the 1-month follow-up, and no significant differences were found between the two groups. There was a strong correlation between background pain and paroxysm pain intensity (r 0.8, p < 0.001). Botulinum toxin type A effectively reduced the pain, paroxysm frequency, and PFPS scores of type 1 and type 2 trigeminal neuralgia patients without statistically significant differences. Facial asymmetry was the only adverse event.

Botulinum toxin type A outcomes in infants with refractory congenital muscular torticollis.

The aim of this study was to determine the effectiveness of botulinum toxin type A (BoNT-A) injections in infants with congenital muscular torticollis (CMT) who were refractory to conservative management. This was a retrospective study in which all subjects included were seen between 2004 and 2013 and were deemed appropriate for BoNT-A injections. A total of 291 patients were reviewed for inclusion in the study, and 134 patients met the inclusion criteria. Each child was injected with 15-30 units of BoNT-A into each of the following muscles: ipsilateral sternocleidomastoid, upper trapezius, and scalene muscles. The key outcome and variable measurements analyzed included age at time of diagnosis, age at time of initiation of physical therapy, age at time of injection, total number of injection series utilized, muscles injected, and degrees of active and passive cervical rotation and lateral flexion pre- and post-injection. A successful outcome was documented if a child could achieve 45° of active lateral flexion and 80° of active cervical rotation post-injection. Secondary variables including sex, age at time of injection, number of injection series utilized, surgery required, adverse effects of botulinum toxin, presence of plagiocephaly, side of torticollis, orthosis used, presence of hip dysplasia, skeletal anomalies, complications during pregnancy or birth, and any other pertinent information regarding the delivery were also measured. Based on this criteria, 82 children (61%) had successful outcomes. However, only four of the 134 patients required surgical correction. BoNT-A may be an effective and safe method for treatment in refractory cases of congenital muscular torticollis.

Comparison research on the therapeutic effects of botulinum toxin type A and stromal vascular fraction gel on hypertrophic scars in the rabbit ear model

Background and objectivesBotulinum toxin type A (BTA) is often used for wrinkles and muscle convulsive diseases due to its blocking of the transmission of nerve impulses. Stromal vascular fraction gel (SVF-gel) prepared from adipose tissue has novel effects on skin depression and poor texture. Both BTA and SVF-gel are proved to possess anti-scar potential. This study aimed to assess and compare their therapeutic effects on hypertrophic scars. Materials and methodsThe rabbit ear scar model was established and treated with BTA and SVF-gel, alone or in combination. Gross evaluation using Manchester Scar Scale (MSS) was conducted immediately, 4 and 8 weeks after initial treatment. After tissue sample harvest, histological and Western blot analyses were performed. ResultsAll the treatments alleviated scar hyperplasia in different degrees by inhibiting fibroblast activation (Ki-67, α-SMA), tissue inflammation (CD45, IL-1β) and the transforming growth factor-β1 (TGF-β1)/Smad3 pathway. Despite an excellent anti-inflammatory effect, improvement of scar appearance and pathological characteristics in SVF-gel-contained groups was not as good as that in BTA-only group, which might be related to the retention of M2-type macrophages (CD163 +) and partial maintenance of TGF-β1 expression. ConclusionOur data suggest that BTA has better anti-scar efficacy than SVF-gel, and the combination of these two treatments shows no obvious combinatorial effect.

The Effect of Botulinum Toxin Type A Injection in the Rectus Femoris in Stroke Patients Walking With a Stiff Knee Gait: A Randomized Controlled Trial

Background Over activity of the rectus femoris is often cited as a main cause for stiff knee gait (SKG). Botulinum toxin (BoNT) can be used to reduce this over activity. Inconsistent results for the effect of BoNT injections were found in literature which can possibly be explained by the study design as these were uncontrolled or non-randomized studies. Objective To conduct a randomized controlled trial (RCT) to investigate the effect of botulinum toxin type A (BoNT-A) injections in the rectus femoris on gait kinematics and functional outcome in adult stroke patients. Methods Twenty-six participants were included in this triple-blind cross-over RCT. The intervention consisted of an injection with BoNT-A. Placebo is an injection with saline. Besides knee and hip kinematics, functional outcomes were measured. Results Comparison of the effect of BoNT-A injection to placebo injection showed a significant increase in peak knee flexion and knee range of motion of 6.7° and 4.8° respectively. There was no difference in hip kinematics. In functional outcomes, only the 6 Minute Walking Test showed a significant increase of 18.3 m. Conclusions BoNT-A injections in the rectus femoris is a valuable treatment option for stroke patients walking with a SKG to improve knee kinematics. To study the effect on functional outcome more research is necessary with different functional outcome measures that can capture the effect in kinematics. It is important to use kinematic measurements to demonstrate effects in quality of movement that are not captured by commonly used functional outcome measurements post stroke. Clinical Trial Registration: https://trialsearch.who.int/Trial2.aspx?TrialID=NTR2169

Effects of botulinum toxin type A in Meige's syndrome

Effects of botulinum toxin type A in Meige's syndrome

Effects of Botulinum Toxin Type A Injection in Patients with Bruxism and Masseter Muscle Hypertrophy

Effects of Botulinum Toxin Type A Injection in Patients with Bruxism and Masseter Muscle Hypertrophy

Clinical efficacy of botulinum toxin type A in the treatment of fasciitis pain: A systematic review and meta-analysis.

The purpose of this meta-analysis was to assess the effectiveness of botulinum toxin type A (BoNT-A) in reducing pain associated with fasciitis. By synthesizing the findings from multiple studies, we aimed to provide a comprehensive evaluation of the current evidence regarding the efficacy of BoNT-A in the treatment of fasciitis pain. To identify studies for our report, we conducted electronic database searches of Embase, PubMed, Web of Science, and the Cochrane Library from their inception to November 20, 2022. We included only randomized controlled trials that examined the therapeutic effects of BoNT-A on fasciitis pain, with the primary outcome measure being the visual analog scale. We conducted statistical analyses using RevMan 5.4 software. Our final meta-analysis comprised 14 randomized controlled trials involving 537 participants, with 271 patients in the BoNT-A group and 266 patients in the control group. The overall effectiveness of BoNT-A in reducing fasciitis pain was significant, with a mean difference (MD) in visual analog scale score of -2.59 (95% confidence interval [CI], -3.36, -1.82); P < .00001; I2 = 88%. Subgroup analysis revealed that BoNT-A was particularly effective in treating plantar fasciitis (MD = -3.34 [95% CI, -4.08, -2.78]; P < .00001; I2 = 75%), lumbar back fasciitis (MD = -2.17 [95% CI, -3.82, -0.52]; P = .001; I2 = 93%), and neck and shoulder fasciitis (MD = -1.49 [95% CI, -2.76, -0.22]; P = .02; I2 = 61%). BoNT-A has a significant analgesic effect on fasciitis pain. Therefore, BoNT-A presents a promising alternative treatment option for fasciitis (PROSPERO 2022: CRD42022382805).

High Levels of Physical Activity Reduce the Esthetic Durability of Botulinum Toxin Type A: A Controlled Single-Blind Clinical Trial.

The present study aimed to evaluate the influence of physical activity on the durability of the esthetic effect of botulinum toxin type A (BoNT-A). Sixty female patients were allocated to three groups (n = 20) according to their physical activity level (PA): Low PA, Moderate PA, and High PA. All groups received a single injection of onabotulinumtoxinA, considering standardized doses in the frontalis (12U), corrugator supercilia (7U, each), and procerus muscles (4U). Outcomes were measured using electromyography (EMG), Merz 5-point scales, and Face-Q scales (perceived age and lines between eyebrows). A follow-up occurred after 30, 60, and 90 days. EMG results showed a significant decrease in muscle activity in the Low-PA group at all follow-ups compared with the other groups (p < 0.001). The Merz scale scores showed that the severity of forehead and glabellar lines significantly improved in the Low-PA group throughout this study compared with the other groups (p < 0.001). No significant differences between groups were found in the Face-Q scale for perceived age, while the Face-Q scale for lines between eyebrows showed better results for Low-PA (p < 0.01) and Moderate-PA (p < 0.01) groups compared to the High-PA group at the 30- and 90-day follow-ups. The durability of the esthetic effect of BoNT-A seems to be negatively influenced by the level of physical activity.

Botulinum toxin in the treatment of sialorrhea in severe neurological patients with tracheotomy.

To observe the clinical effect of botulinum toxin type A (BTA) injection into the salivary glands of the severe neurological patients with tracheotomy METHODS: Seven patients with severe neurological disorders after tracheotomy and obvious drooling symptoms were enrolled. BTA was injected into bilateral parotid glands and submandibular glands under the guidance of ultrasound. Unstimulated salivary flow rate (uSFR) and Drooling Severity and Frequency Scale (DSFS) were used to evaluate drooling before injection, 1 week, and 4 weeks after injection. We compared the extubation time, time of changing from balloon cannula to metal cannula, hospitalization time and incidence of recurrent pulmonary infection between these patients and other patients accepted conventional curation. (1) The drooling severity scale (DSFS-S), the drooling frequency scale (DSFS-F), the drooling frequency and severity scale total score (DSFS-T) were significantly lower at 4 weeks after BTA injection compared to prior-treatment (p<.001). (2) uSFR of 1 week and 4 weeks were both statistically decreased than the untreated condition (p<.001). (3) Compared with the conventional group, the time of changing from balloon cannula to metal cannula was shortened obviously (p<.05) and incidence of recurrent pulmonary infection was clearly decreased (p<.05) after BTA treatment CONCLUSION: Ultrasound-guided BTA injection into salivary glands can effectively reduce saliva secretion. We also found that the time of changing cannula was shortened obviously and the incidence of recurrent pneumonia infection was reduced. BTA injection of salivary glands to cure drooling could advance to the clinical therapy in severe neurological patients after tracheotomy.

Effect of botulinum toxin type A in functionality, synkinesis and quality of life in peripheral facial palsy sequelae

ObjectivesThis study aimed to assess the effects of botulinum toxin A (BTX-A) infiltration on face muscle function, synkinesis, and quality of life in patients with sequelae of peripheral facial palsy (PFP). Material and methodsWe present the results of a prospective study including a sample of 20 patients with sequelae of PFP (15 women, 5 men) who underwent BTX-A (Botox© or Xeomin©) infiltration. All patients had previously received personalised treatment with neuromuscular retraining. A clinical assessment was performed before BTX-A infiltration and 4 weeks after treatment. The effect of BTX-A on face muscle function, quality of life, and synkinesis was evaluated using the Sunnybrook Facial Grading System (SFGS), the Facial Clinimetric Evaluation (FaCE) questionnaire, and the Synkinesis Assessment Questionnaire (SAQ), respectively. ResultsMean SFGS scores increased from 64.8 to 69.9 after BTX-A infiltration (P=.004). Increases were also observed in mean total FaCE scores (from 52.42 to 64.5; P<.001) and the mean score on the FaCE social function subscale (from 61.15 to 78.44; P<.001). Mean SAQ scores decreased from 46.22 to 37.55 after BTX-A infiltration (P=.001). ConclusionsBTX-A infiltration increases face muscle function, improves quality of life, and reduces synkinesis in patients with sequelae of PFP.

Comparison of the effects of botulinum toxin type A hamstring muscle injection combined with periarticular injection and simple periarticular injection on early pain and functional recovery after total knee arthroplasty

Objective: This study was designed to compare the effects of hamstring muscle injection of botulinum toxin type A (BoNT/A) combined with periarticular injection to those of simple periarticular injection alone, in terms of early pain reduction and functional recovery following total knee arthroplasty (TKA).&#x0D; Methods: This study included 40 patients who underwent elective unilateral TKA at our hospital from February 2021 to December 2021. The patients were randomly assigned to either the experimental group (BoNT/A injection into the hamstring muscle + periarticular injection, n = 20 cases) or the control group (0.9% normal saline injection into the hamstring muscle + periarticular injection, n = 20 cases). The preoperative and postoperative 3-day HSS scores were compared between the two groups. Postoperative visual analog scale (VAS) pain scores were observed and compared between the two groups. The Lovett grading method was used to evaluate the postoperative muscle strength of both groups. Additionally, postoperative knee joint pain scores, maximum active flexion angle, and any postoperative adverse reactions were observed and compared between the two groups.&#x0D; Results: The experimental group showed significantly lower VAS pain scores than the control group at 24 h, 48 h, and 72 h after the operation, with a statistically significant difference (P &lt; 0.05). Furthermore, compared to the control group, the patients in the experimental group exhibited larger knee joint active flexion angles at 1 day, 3 days, and 5 days post-operation, also demonstrating a statistically significant difference (P &lt; 0.05). These findings hold scientific significance (P &lt; 0.05). Additionally, the combined administration of BoNT/A hamstring muscle injection with periarticular injection exhibited a low incidence of adverse reactions during the perioperative period and had no significant effect on quadriceps muscle strength.&#x0D; Conclusion: The combination of BoNT/A hamstring muscle injection with periarticular injection effectively alleviates early postoperative pain following TKA and promotes early functional recovery of the knee joint.

P.021 Botulinum toxin type a for Parkinson’s Disease - related painful foot dystonia

Background: Pain is a frequent symptom in Parkinson’s disease (PD), and the therapeutic alternatives are scarce. The goal of this trial was to assess the effects of botulinum toxin type A (BTXA) in the treatment of foot dystonia in PD. Methods: Randomized placebo-controlled trial (RCT) (double-blind parallel-group study) evaluating the safety and efficacy of BTXA for PD-related painful foot dystonia using 100 units of BTXA/placebo, followed by an open-label phase. The primary outcome was a change in pain on the King’s Parkinson’s disease Pain scale and on a visual analogue scale at 6, 12 and 24 weeks. Secondary outcomes included the percentage of responders, clinical global impression, MDS-UPDRS, PDQ-39 scores, and adverse events. Results: 40 subjects were screened and 33 were enrolled. The RCT blind will be opened in March 2023 after the final study visit and data will be available for presentation at the June 2023 conference. The current open-label phase has revealed a preliminary that the toxin is safe and effective in reducing pain in PD-related foot dystonia with 84% of participants noticing a significant benefit. Conclusions: According to our preliminary data, targeted BTXA injections are a safe and effective treatment in patients with foot dystonia and PD.

The Effect of Botulinum Toxin Injection in Cleft Lip Repair

Background &amp; Objectives: Cleft lip and palate are common congenital anomalies that require precise management with main component of repairing lip is the aesthetic outcome. Using botulinum toxin is new method to optimize the resultant scar. The aim of this study is to evaluate the effect of botulinum toxin type A following cleft lip repair on resultant quality of scar. Methods: This is a comparative study conducted in Rizgary teaching hospital and private hospitals in Erbil – Kurdistan region/Iraq between July 2018 and April 2021. A total of 38 patients with cleft lip were included; bilateral and unilateral, complete and incomplete, isolated cleft lip and cleft lip and palate, 20 of them received botulinum toxin injection. Preoperative and postoperative photos were documented. Scars were analysed one year following repair. Results: Among 38 patients, in comparison of outcome of using botulinum toxin (31.6%) following cleft lip repair to patients did not receive the injection (68.4%), the scar quality was better; linear scar in botox group 100%, non-botox group 80.8%, complications were less; early complications in botox group 8.3%, non-botox group 11.5% and late complications in botox group 0% non-botox 7.7% and satisfaction was better; parents of botox group were 100% highly satisfied while for those of non-botox group 84.6% highly satisfied, 7.7% satisfied and 7.7% unsatisfied. There was significant difference between the two groups but statistically not significant. Conclusion: Botulinum toxin injections into the subjacent orbicularis oris muscle following cleft lip repair produced better appearing and narrower cheiloplasty scars.