Safety Of Botulinum Toxin Type Research Articles

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.

The efficacy and safety of botulinum toxin type A in treatment of trigeminal neuralgia and peripheral neuropathic pain: A meta-analysis of randomized controlled trials.

BackgroundAlthough recent studies have shown that botulinum toxin‐A (BTX‐A) has a good analgesic effect on trigeminal neuralgia (TN) and peripheral neuropathic pain (PNP), the quality of evidence is low due to limited data. This meta‐analysis is used to synthesize existing evidence for the treatment of these conditions with BTX‐A.MethodsRelevant trials were accessed by using an electronic search in databases (Web of Science, PubMed, EMBASE, Cochrane Library, and http://ClinicalTrials.gov). Data from included randomized controlled trials (RCTs) on the efficacy and safety of BTX‐A in treating TN and PNP were extracted for meta‐analysis.ResultsFinally, 10 RCTs (n = 391) were included in this meta‐analysis. The pooled effect of BTX‐A was superior to placebo based on pain intensity (SMD = −0.48, 95% CI [−0.74, 0.23] at 1 month, SMD = −0.58, 95% CI [−0.91, −0.24] at 2 months, and SMD = −0.55, 95% CI [−0.87, −0.22] at 3 months). Number needed to treat (NNT) for 50% pain intensity reduction showed better effect of BTX‐A on TN and postherpetic neuralgia (PN). Adverse events associated with BTX‐A were similar to placebo (OR = 1.58, 95% CI [0.51, 4.87], p = .424).ConclusionPooled data from our meta‐analysis suggest that BTX‐A is efficacious and safe in treating TN and PNP. However, due to the limited sample size and heterogeneity, further larger and well‐designed RCTs are imperative to validate these findings.

Efficacy and safety of botulinum toxin a injection into urethral sphincter for underactive bladder

BackgroundThe aim of this retrospective study was to evaluate the clinical efficacy and safety of botulinum toxin type A (BTX-A) injection into the urethral sphincter to treat patients with underactive bladder (UAB).MethodsFrom September 2012 to December 2018, 35 patients with UAB who presented with dysuria were treated with BTX-A (Prosigne®, Lanzhou Biological Products, Lanzhou, China). All patients were evaluated using the International Continence Society standard for video-urodynamic examination before and 1 month after treatment. The index includes maximum urinary flow rate, detrusor leak point pressure, and maximum urethral pressure. Post-voiding residual urine volume was measured using ultrasound before, one and 3 months post injection.ResultsAfter 1 month of treatment, the maximum flow rate increased from 2.5 ± 1.1 ml/s to 6.6 ± 1.7 ml/s (P < 0. 05). The maximum urethral pressure decreased from 73.5 ± 5.8 cmH2o to 45.6 ± 4.3cmH2O (P < 0. 05). The detrusor leak point pressure decreased from 69.9 ± 20.7cmH2O to 26.3 ± 7.4cmH2O (P < 0. 01). Post-voiding residual urine decreased from 282.8 ± 134.2 ml to 125.0 ± 92.1 ml (P < 0. 01) but increased to 270.1 ± 129.0 ml 3 months post injection. Of the 35 patients, 57.1% (20/35) relied on clean intermittent catheterization (CIC) before injection, but 75.0% (15/20) of them could partly void 1 month after injection, and 25%(5/20) could void without CIC. Eight patients showed hydronephrosis before treatment; in three of them, hydronephrosis decreased slightly, while it resolved in two. All patients were followed for three to 6 months, and the effect lasted for about two to 3 months. No serious adverse events occurred in any patient.ConclusionsThe results suggest that Prosigne® injection into the urethral sphincter is an effective, safe, and inexpensive way to treat UAB.

Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.

Background Inconsistent data have been reported for the effectiveness of intramuscular botulinum toxin type A (BTXA) in patients with limb spasticity after stroke. This meta-analysis of available randomized controlled trials (RCTs) aimed to determine the efficacy and safety of BTXA in adult patients with upper and lower limb spasticity after stroke. Methods An electronic search was performed to select eligible RCTs in PubMed, Embase, and the Cochrane library through December 2018. Summary standard mean differences (SMDs) and relative risk (RR) values with corresponding 95% confidence intervals (CIs) were employed to assess effectiveness and safety outcomes, respectively. Results Twenty-seven RCTs involving a total of 2,793 patients met the inclusion criteria, including 16 and 9 trials assessing upper and lower limb spasticity cases, respectively. For upper limb spasticity, BTXA therapy significantly improved the levels of muscle tone (SMD=-0.76; 95% CI -0.97 to -0.55; P<0.001), physician global assessment (SMD=0.51; 95% CI 0.35-0.67; P<0.001), and disability assessment scale (SMD=-0.30; 95% CI -0.40 to -0.20; P<0.001), with no significant effects on active upper limb function (SMD=0.49; 95% CI -0.08 to 1.07; P=0.093) and adverse events (RR=1.18; 95% CI 0.72-1.93; P=0.509). For lower limb spasticity, BTXA therapy was associated with higher Fugl-Meyer score (SMD=5.09; 95%CI 2.16-8.01; P=0.001), but had no significant effects on muscle tone (SMD=-0.12; 95% CI -0.83 to 0.59; P=0.736), gait speed (SMD=0.06; 95% CI -0.02 to 0.15; P=0.116), and adverse events (RR=1.01; 95% CI 0.71-1.45; P=0.949). Conclusions BTXA improves muscle tone, physician global assessment, and disability assessment scale in upper limb spasticity and increases the Fugl-Meyer score in lower limb spasticity.

Effectiveness and Safety of Botulinum Toxin Type A Injection for Scar Prevention: A Systematic Review and Meta-analysis

The role of active scar prevention in postoperative scar management is important. Botulinum toxin type A (BTXA) has been shown to improve postoperative scars in the past decades. The aim of this systematic review and meta-analysis was to evaluate the effectiveness and safety of BTXA injection for scar prevention. The authors searched the databases of Medicine, Embase, the Cochrane Library, Web of Science, and CINAHL from inception through November 2018 for randomized controlled trials (RCTs) reporting the use of BTXA in scar prevention. The outcomes were the visual analogue scale (VAS) score, Vancouver Scar Scale score, scar width, patient satisfaction and adverse events. A total of nine RCTs were identified in this systematic review and meta-analysis. The VAS score was significantly higher in the BTXA group than in the control group (weighted mean difference (WMD) = 1.32, 95% confidence interval (CI) = 1.06-1.58, P < 0.00001). The Vancouver Scar Scale score was significantly lower in the BTXA group (WMD = - 1.25, 95% CI = - 2.23 to - 0.26, P = 0.01). The scar width was also significantly smaller in the BTXA group (WMD = - 0.18, 95% CI = - 0.24 to - 0.12, P < 0.00001). There was a significant difference in terms of patient satisfaction between the BTXA group and the control group (relative risk (RR) = 1.38, 95% CI = 1.09-1.74, P = 0.007). Only two studies reported complications, and other studies reported no complications during the follow-up period. This systematic review and meta-analysis demonstrates that BTXA injection can reduce scar width in wounds and improve the overall appearance of postoperative scars and suggests that BTXA may be a safety therapy for scar prevention. 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 .

The Masseter Muscle and Its Role in Facial Contouring, Aging, and Quality of Life: A Literature Review.

Masseter muscle hypertrophy manifests itself as enlargement of the masseter muscle. It can be associated with a square-angled lower face, pain, dental attrition, maxillary and mandibular bone resorption, and accelerated aging process of the lower face. The objective of this study was to assess the efficacy and safety of botulinum toxin type A in contouring the masseter and its impact on quality of life and the aging process of the lower face, and its role in full face rejuvenation. A PubMed search was conducted for articles on masseter treatment with botulinum toxin type A, masseter muscle hypertrophy, and the aging process of the lower face. Key studies are reviewed and findings are summarized. Botulinum toxin type A can be injected into the lower posterior aspect of the masseter muscle. Treatment decreases muscle bulk and reshapes the lower face. Furthermore, patient quality-of-life measures, including pain and symptoms of grinding and clenching, are improved. Treatment can decrease shear stress on maxillary and mandibular bones and can possibly prevent tooth loss and progressive bone resorption of the lower face. Adverse effects are minimal and short lasting. Botulinum toxin type A is a safe and effective treatment of masseter hypertrophy. The treatment results in improvement of functionality and cosmesis, and restoration of facial harmony.

Efficacy and Safety of Botulinum Toxin Type A in Spasticity Caused by Spinal Cord Injury: A Randomized, Controlled Trial.

BackgroundBaclofen is approved by the US FDA to treat spasticity, but its sustained use may cause drug addiction. The objective of this study was to compare the efficacy and safety of botulinum toxin type A versus baclofen in spasticity.Material/MethodsA total of 336 patients who had spasticity caused by spinal cord injury were enrolled in a randomized (in 1: 1: 1: ratio) for placebo, controlled trial. Patients had received baclofen (BA group, n=112), local intramuscular injection of 500 U Botulinum toxin type A (BTI group, n=112), or physical therapies alone (placebo group, n=112). Modified Ashworth scale (mAS) score, disability assessment scale (DAS) score, modified medical research council (mMRC) score, the Barthel Index (BI) score, and treatment-emergent adverse effects were evaluated during the follow-up period. Wilcoxon test or one-way ANOVA/Tukey post hoc tests were performed at 95% of confidence level.ResultsBaclofen (1.504±0.045 vs. 1.53±0.06, p=0.003, q=4.068) and botulinum toxin type A (1.49±0.09 vs. 1.528±0.15, p=0.0224, q=3.5541) had improved mAS scores after 2 weeks. Baclofen had a more strongly improved DAS score than botulinum toxin type A at 4 (p=0.0496, q=3.48) and 6 (p<0.0001, q=6.48) weeks. Baclofen and botulinum toxin type A had consistently improved BI scores. Baclofen caused asthenia and sleepiness, while botulinum toxin type A caused bronchitis and elevated blood pressure.ConclusionsBotulinum toxin type A may be an effective therapeutic option for spasticity caused by spinal cord injury.

Botulinum toxin type A in the treatment of sialorrhea - Our experience

Sialorrhea consists of an involuntary loss of saliva, and is considered pathological after 4YO. The aim of this study is to describe our methodology and evaluate the efficacy and safety of Botulinum Toxin Type A (BTX-A) in sialorrhea in children and adults with cerebral palsy (CP) or cognitive deficit, referenced to PMR consultation between 2002–2017. Longitudinal descriptive study with clinical records analysis and consultation of drooling rate scale (DRS) and teacher drool scale (TDS) prior to BTX-A injections and 1-month after. Injection of BTX-A performed with ultrasound and sedation. Total of 104 patients, 86 patients selected, 32 female (37.21%), 54 male (62.79%), current ages 7–29YO (mean 18), age of the 1st application 3–22YO (mean 9.76), age of last application 4–23YO (mean 11.83). Fifty patients (58.14%) diagnosed with CP. Two hundred and three total applications (average 2.36), maximum 10 applications. Parotids (55.56%), submandibular (9.09%) or both (35.35%), mean periodicity of 11.81 months. Sedation: 49.38% midazolam, 41.36% nitrogen protoxide, 0.62% Chloral-Hydrate and 8.64% without. Surveys: mean pre-application-DRS of 33.98 (minimum 19, maximum 58), mean post-application-DRS of 28.46 (min 15, max 54), with P = 6.48–5, average difference 4.28 points in DRS (min −27, max 22). Mean pre-application-TDS of 4.04 (min 2, max 5), mean post-applicantion-TDS of 3.38 (min 1, max 4), with P = 2.80–5, average difference of 0.69 points in TDS (min −1, max 3). Difference in DRS and TDS of 0.76 and 0.24 respectively in the parotids, 6.33 and 0.83 in the submandibular and 8.52 and 1.43 in both. Improvements were statistically significant. Surgery: 6 (6.98%). Side effects: 5 children (5.81%) insomnia/vomiting. No complications related to the administration technique. The application of BTX-A in the treatment of sialorrhea is a safe, easy-to-apply technique, with statistically significant improvement in QoL and severity. Benefit in the application of BTX-A in both glands treatment is shown.

Botulinum toxin type A in the treatment of sialorrhea - Our experience

Sialorrhea consists of an involuntary loss of saliva, and is considered pathological after 4YO. The aim of this study is to describe our methodology and evaluate the efficacy and safety of botulinum toxin type A (BTX-A) in sialorrhea in children and adults with cerebral palsy (CP) or cognitive deficit, referenced to PMR consultation between 2002–2017. Longitudinal descriptive study with clinical records analysis and consultation of Drooling Rate Scale (DRS) and Teacher Drool Scale (TDS) prior to BTX-A injections and 1-month after. Injection of BTX-A performed with ultrasound and sedation. Total of 104 patients, 86 patients selected, 32 female (37.21%), 54 male (62.79%), current ages 7–29YO (mean 18), age of the 1st application 3–22YO (mean 9.76), age of last application 4–23YO (mean 11.83). Fifty patients (58.14%) diagnosed with CP. Two hundred and three total applications (average 2.36), maximum 10 applications. Parotids (55.56%), submandibular (9.09%) or both (35.35%), mean periodicity of 11.81 months. Sedation: 49.38% midazolam, 41.36% nitrogen protoxide, 0.62% chloral-hydrate and 8.64% without. Surveys: mean pre-application-DRS of 33.98 (minimum 19, maximum 58), mean post-application-DRS of 28.46 (min 15, max 54), with P = 6.48–5, average difference 4.28 points in DRS (min −27, max 22). Mean pre-application-TDS of 4.04 (min 2, max 5), mean post-applicantion-TDS of 3.38 (min 1, max 4), with P = 2.80–5, an average difference of 0.69 points in TDS (min −1, max 3). Difference in DRS and TDS of 0.76 and 0.24 respectively in the parotids, 6.33 and 0.83 in the submandibular and 8.52 and 1.43 in both. Improvements were statistically significant. Surgery: 6 (6.98%). Side effects: 5 children (5.81%) insomnia/vomiting. No complications related to the administration technique. The application of BTX-A in the treatment of sialorrhea is a safe, easy-to-apply technique, with statistically significant improvement in QoL and severity. Benefit in the application of BTX-A in both glands treatment is shown.

The efficacy and safety of botulinum toxin type A injection for cervical dystonia in adults with athetoid cerebral palsy

The main purpose of this study is to evaluate the efficacy and safety of injecting botulinum toxin A (BoNT-A) into the neck muscles to treat cervical dystonia (CD) in patients with dyskinetic cerebral palsy (CP). This is a randomized, double-blinded, placebo-controlled trial with cross-over design. We prospectively enrolled adults with dyskinetic CP who were over 20 years old and had been clinically diagnosed with CD for more than one year. Patients were assessed using the Toronto western spasmodic torticollis rating scale (TWSTRS) and the numerical rating scale (NRS). Seventeen patients were initially enrolled, but one patient was excluded after the final evaluation because of a violation of the study protocol. At 4 weeks, the BoNT-A injections showed significant improvement in TWSTRS total scores compared to the saline injections ( P = 0.0286 for ANCOVA). At 12 weeks, the BoNT-A injections resulted in greater improvements in TWSTRS total scores than the saline injections but this difference was not statistically significant ( P = 0.0783 for ANCOVA). Dysphagia occurred in 3 out of 16 patients; 2 after BoNT-A and 1 after saline. The dysphagia was transient and improved naturally within 2 weeks without any special treatment. Botulinum toxin injection for cervical dystonia in adults with dyskinetic cerebral palsy is relatively safe and improves pain and disability. This study was funded by Seoul National University Hospital Grant No. 0620131320 (2012-1185).

Efficacy and Safety of Botulinum Toxin Type A in Treating Patients of Advanced Age with Idiopathic Trigeminal Neuralgia.

Objective To assess the therapeutic efficacy and safety of botulinum toxin type A (BTX-A) for treating idiopathic trigeminal neuralgia (ITN) in patients ≥80 years old. Methods Selected patients (n=43) with ITN, recruited from the neurology clinic and inpatient department of the Second Affiliated Hospital of Soochow University between August 2008 and February 2014, were grouped by age, one subset (n=14) ≥80 years old and another (n=29) <60 years old. Each group scored similarly in degrees of pain registered by the visual analogue scale (VAS). Dosing, efficacy, and safety of BTX-A injections were compared by group. Results Mean dosages of BTX-A were 91.3 ± 25.6 U and 71.8 ± 33.1 U in older and younger patients, respectively (t=1.930, p=0.061). The median of the VAS score in older patients at baseline (8.5) declined significantly at 1 month after treatment (4.5) (p=0.007), as did that of younger patients (8.0 and 5.0, resp.) (p=0.001). The median of the D values of the VAS scores did not differ significantly by group (older, 2.5; younger, 0; Z=−1.073, p=0.283). Two patients in each group developed minor transient side effects (p=0.825). Adverse reactions in both groups were mild, resolving spontaneously within 3 weeks. Conclusions BTX-A is effective and safe in treating patients of advanced age (≥80 years old) with ITN, at dosages comparable to those used in much younger counterparts (<60 years old).

Botulinum toxin treatment for hypersalivation in anti-NMDA receptor encephalitis.

Hypersalivation is one of the intractable symptoms of anti‐N‐methyl‐d‐aspartate receptor (NMDAR) encephalitis. While anticholinergic medications partially improve the hypersalivation, they can aggravate the autonomic dysfunctions associated with anti‐NMDAR encephalitis. Thus, we investigated the efficacy and safety of botulinum toxin type A injection on hypersalivation refractory to anticholinergics in six patients with anti‐NMDAR encephalitis. Hypersalivation was well‐controlled without remarkable adverse reaction over 16 weeks after botulinum toxin type A, although two patients were reinjected at 12 weeks due to reaggravation of hypersalivation. Our findings suggest that botulinum toxin type A might be a better choice than anticholinergics for management of hypersalivation in patients with anti‐NMDAR encephalitis.

Poster 137: Incidence and Safety of Botulinum Toxin Type A Injections for Pediatric Patient with Cerebral Palsy

Poster 137: Incidence and Safety of Botulinum Toxin Type A Injections for Pediatric Patient with Cerebral Palsy

The course of cervical dystonia with head tremor during botulinum toxin type A treatment

Objective : to evaluate the efficacy and safety of botulinum toxin type A (BTA) injections into the neck muscles to reduce dystonic postures, head tremor, and pain syndrome in patients with cervical dystonia (CD) within the first 8 cycles of treatment. Patients and methods. The investigation included 76 patients (26 (34%) men and 50 (66%) women) with CD and dystonic head tremor, who were given BTA injections into the neck muscles for the first time. All the 76 patients received at least one cycle of BTA therapy. At the same type, 18 of these patients received 4 cycles of injections and 36 patients had 8 cycles. Injections were given when the symptoms of CD recurred or increased and the patient needed to be retreated. The interval between the injection cycles was arbitrary, but not less than 12 weeks. The doses of BTA agents per treatment cycle were as follows: Dysport was 400 to 1000 U, xeomin was 50 to 300 U, and Botox 200 to 300 U. The symptoms of CD were assessed using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and the Tsui scale before the first injection of BTA and injection cycles 4 and 8; the presence or absence of head tremor was recorded. Results. The TWSTRS severity of CD symptoms decreased from 38 [36; 41] to 30 [27; 33] scores by injection cycle 4 (p &lt; 0.001) and to 26 [23; 27] scores by cycle 8 (p&lt;0.01). The Tsui severity of CD reduced from 9.3 [9; 10] to 7.2 [7; 8] scores by injection cycle 4 (p&lt;0.001) and to 6.7 [6; 7] scores by cycle 8. The Tsui tremor scores decreased from 1.9 [1.6; 2.1] to 1.4 [1.1; 1.6] scores by injection cycle 4 and to 1.1 [0.9;1.4] scores by cycle 8 (p&lt;0.01). Tremor completely disappeared in 6 (11%) of patients by injection cycle 4 and in 6 (18%) patients by cycle 8. According to Section 3 of the TWSTRS, pain intensity was reduced from 9.9 [8.9; 11.0] to 5.0 [3.3; 6.6] scores by injection cycle 4 (p&lt;0.001) and to 2.1 [0.7; 3.6] scores by cycle 8 (p &lt; 0.01); pain regressed completely in 12 (41%) and 9 (64%) patients by cycles 4 and 8, respectively. Conclusion. BTA injections into the neck muscles are an effective treatment for CD symptoms, such as dystonic tremor, posture, and pain. Successive injection cycles have a cumulative effect that is more marked by injection cycle 8. It is appropriate to prescribe longer treatment cycles to patients with CD and head tremor. Dystonic head tremor, unlike dystonic postures, may regress fully after BTA injections

Therapeutic Outcome of Botulinum Toxin Type A for Patients with Low Bladder Compliance Secondary to Spinal Cord Injury

Objective: To evaluate the efficacy and safety of botulinum toxin type A (BTX-A) in treating patients with low bladder compliance (BC) secondary to spinal cord injury (SCI). Methods: From 2011 to 2016, we retrospected patients who received BTX-A injections for LBC secondary to SCI. The primary outcomes were urodynamic parameters including maximum detrusor pressure (Pdetmax), bladder compliance (BC). Related adverse events were recorded. Results: 72 SCI patients were selected (62 males, 10 females, age range 18 - 52 years; mean age 28.5 years). 12 weeks after BTX-A injection, Pdetmax decreased from 51.02 cmH2O to 28.31 cmH2O. BC increased from 3.64 ml/cmH2O to 10.08 ml/cmH2O. 12 patients had mild transient haematuria for 1 - 2 days. Conclusion: Intradetrusor BTX-A injection was effective and safe for patients with low BC secondary to SCI.

Efficacy and safety of botulinum toxin type A for upper limb spasticity after stroke or traumatic brain injury: a systematic review with meta-analysis and trial sequential analysis.

Muscle spasticity is a positive symptom after stroke and traumatic brain injury. Botulinum toxin type A (BoNT-A) injection is widely used for treating post stroke and traumatic brain injury spasticity. This study aimed to evaluate efficacy and safety of BoNT-A for upper limb spasticity after stroke and traumatic brain injury and investigate reliability and conclusiveness of available evidence for BoNT-A intervention. We searched electronic databases from inception to September 10 of 2016. Randomized controlled trials comparing the effectiveness between BoNT-A and placebo in stroke or traumatic brain injury adults with upper limb spasticity were included. Reliability and conclusiveness of the available evidence were examined with trial sequential analysis. From 489 citations identified, 22 studies were included, reporting results for 1804 participants. A statistically significant decrease of muscle tone was observed at each time point after BoNT-A injection compared to placebo (SMD at week 4=-0.98, 95% CI: -1.28 to -0.68; I2=66%, P=0.004; SMD at week 6=-0.85, 95% CI: -1.11 to -0.59, I2=1.2%, P=0.409; SMD at week 8=-0.87, 95% CI: -1.15 to -0.6, I2=0%, P=0.713; SMD at week 12=-0.67, 95% CI: -0.88 to -0.46, I2=0%, P=0.896; and SMD over week 12=-0.73, 95% CI: -1.21 to -0.24, I2=63.5%, P=0.065).Trial sequential analysis showed that as of year 2004 sufficient evidence had been accrued to show significant benefit of BoNT-A four weeks after injection over placebo control. BoNT-A treatment also significantly reduced Disability Assessment Scale Score than placebo at 4, 6 and 12-week follow-up period (WMD=-0.33, 95% CI: -0.63 to -0.03, I2=60%, P=0.114; WMD=-0.54, 95% CI: -0.74 to -0.33, I2= 0%, P=0.596 and WMD=-0.3, 95% CI: -0.45 to -0.14, I2=0%, P=0.426 respectively), and significantly increased patients' global assessment score at week 4 and 6 after injection (SMD=0.56, 95% CI: 0.28 to 0.83; I2=0%, P=0.681 and SMD=1.11, 95% CI: 0.4 to 1.77; I2=72.8%, P=0.025 respectively). No statistical difference was observed in the frequency of adverse events between BoNT-A and placebo group (RR=1.36, 95% CI [0.82, 2.27]; I2=0%, P=0.619). As compared with placebo, BoNT-A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with upper limb spasticity post stroke or traumatic brain injury.

Long-term effects and safety of botulinum toxin type A in facial beauty

Objective To explore the long-term efficacy of botulinum toxin type A injections on facial beauty and its long-term safety. Methods A total of 33 beauty-seekers with botulinum toxin type A treatment for more than five years were reviewed as observation group, using digital muscle palpation meter (Myoton PRO) for the determination of the orbicularis oculi muscle and masseter muscle tension (F), the muscle characteristic parameters, such as muscle hardness (S) using a homemade facial questionnaire test for satisfactory rate of beauty from both beauty-seekers and physicians. At sametime, 33 normal adults that never accepted botulinum toxin injection with matched age and gender were collected as control group. The same-sex indicators were dtermined and compared with using statistic analysisttest. Results The pairwised parameters of the same sex and site were comparied between the two groups; average F and S values in the observation group were lower than those of the control group, but no statistically significant difference were observed between the two groups (P>0.05); in the observation group, average appearance age was 7.3 years younger than the control group, and the facial shape improved significantly. Conclusions Long-term and repeated application of botulinum toxin A is able to remove crow's feet and decrease the masseter and so the injection is safe with high satisfaction to beauty-seekers. Key words: Botulinum toxin type A; Facial beauty; Safety; Satisfaction

Efficacy and safety of botulinum toxin injection for interstitial cystitis/bladder pain syndrome: a systematic review and meta-analysis.

To investigate the overall treatment efficacy and safety of botulinum toxin type A (BoNTA) injections compared with placebo in interstitial cystitis/bladder pain syndrome (IC/BPS). We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and EMBASE on BoNTA use in IC/BPS. Outcome measures included changes of OLS, ICSI, ICPI, VAS, frequency, nocturia, FBC, Qmax, and PVR from baseline and also included adverse events. A total of five studies were included, with a total sample size of 252 subjects (133 subjects in the experimental group and 119 subjects in the control group). The duration of follow-up ranged from 8 to 12weeks. The BoNTA dosage was from 50 to 200U. The pooled overall SMD in the mean change of VAS for the BoNTA group versus the placebo group was -0.49 (95% CI -0.74, -0.23). There were also significant improvements in ICPI and frequency. The other outcomes (ICSI, nocturia, Qmax, and FBC) were not statistically different between the two groups. Although BoNTA is not regulatory approved indication, this first evidence-based systematic review and meta-analysis of BoNTA injection for IC/BPS showed significant differences in efficacy of treatment compared with placebo, especially for pain control, and also showed no differences in the rate of procedure-related adverse events.

Efficacy and safety of botulinum toxin in treatment of anismus: A systematic review.

To evaluate the efficacy and safety of botulinum toxin type A (BTX-A) in the management of patients with anismus. An organized search of published literature was conducted using electronic databases including: PubMed/MEDLINE, and Cochrane Central Register of Controlled Trials, also an internet-based search using "Google Scholar" service was conducted. Both comparative and observational studies were included. We excluded irrelevant articles, editorials, case reports, reviews, and meta-analyses. The studies that followed the patients less than 6 mo were excluded. Variables collected were demographic data of the patients, technique of BTX-A injection and number of sessions, short-term and long-term clinical improvement, post-injection changes in electromyography (EMG), defecography, manometry, and balloon expulsion test, and complications recorded after BTX-A injection. Seven studies comprising 189 patients were included in the review. The median age of the patients was 41.2 years and female-to-male ratio was 1.3:1. The median dose of BTX-A injected per procedure was 100 IU (range, 20-100 IU). Lateral injection was done in five trails and combined lateral and posterior injections in two trials. Three studies used endorectal ultrasonography-guided technique, one study used EMG-guided technique, whereas the remaining three studies used manual palpation with the index finger. The median percentage of patients who reported initial improvement of symptoms was 77.4% (range 37.5%-86.7%), this percentage declined to a median of 46% (range 25%-100%) at 4 mo after injection of BTX-A. Rates of improvement evaluated by balloon expulsion test, EMG, and defecography ranged between (37.5%-80%), (54%-86.7%), and (25%-86.6%), respectively. Fourteen (7.4%) patients developed complications after injection of BTX-A. Complication rates across the studies ranged from 0% to 22.6%. Initial satisfactory improvement of symptoms after BTX-A injection remarkably deteriorated after 3 mo of the procedure. However, repeated injection may provide better sustained results with no additional morbidities. Further analysis of more patients is necessary to conclude the safety of BTX-A for the treatment of anismus.

Efficacy and safety of botulinum toxin injection for benign prostatic hyperplasia: a systematic review and meta-analysis.

The aim of this study was to overcome the limitation of overlooking the placebo effect in previous studies and to demonstrate the overall treatment efficacy and safety of botulinum toxin type A (BTX-A) compared with placebo. We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and Embase reporting on BTX use in lower urinary tract symptoms (LUTS)/benign prostate hyperplasia (BPH). Single-group analysis for the placebo effect and meta-regression analysis for the moderator effect were performed with high-quality RCTs compared with placebo. A total of three studies were included, with a total sample size of 522 subjects (260 subjects in the experimental group and 262 subjects in the control group). Study duration ranged from 8 to 24 weeks. The pooled overall SMD in the mean change in IPSS for the BTX-A group versus the placebo group was -1.02 (95 % CI -1.97, -0.07). The other outcomes (Q max, prostate volume, and post-voided residual volume) were not statistically different between the two groups. The placebo effect in single-group analysis ranged from 0 to 27.9 % for IPSS, and from -1.1 to 28.7 % for Q max (lowest to highest, respectively). This evidence-based systematic review and meta-analysis of the BTX-A injection for LUTS/BPH showed no differences in efficacy compared with placebo and also showed no difference in procedure-related adverse events occurred. Thus, the results of this study do not provide evidence of clinical benefits of using the BTX-A injection for LUTS/BPH in real clinical practice.