Safety Of Botulinum Toxin Type Research Articles

Efficacy and safety of botulinum toxin type A for treatment of Frey's syndrome: evidence from 22 published articles.

Frey’s syndrome (FS) is an unavoidable sequela following the surgery of the parotid gland. Although several treatment methods are available, their efficacy is short term or accompanied by unacceptable complications. In the past two decades, botulinum toxin type A (BTXA) has been widely used to treat FS. Although several systematic reviews have been reported recently, they were conflicting and with obvious deficiencies. Thus, we performed an objectively systematic review to determine whether BTXA is an effective and safe treatment for FS. A literature retrieval covering PubMed, Web of Science, Ovid, Embase and Cochrane library was performed on 16 January, 2015. Proportion meta-analysis and corresponding 95% confidence interval (CI) were performed to evaluate the efficacy and safety of BXTA in treatment of FS. A total of 499 records were retrieved and 22 articles with 23 studies were included after scrutiny by two independent authors. Statistical analyses regarding the effective rate, incidence of complications were used to estimate the efficacy and safety of BTXA. Our results suggested that the effective rate of BTXA for treatment of FS is 98.5% (95% CI = 0.971–0.994) and the incidence of complication is 3.6% (95% CI = 0.017–0.061). In conclusion, our study supports that BTXA produces meaningful benefits on the treatment of patients with FS. However, owing to lack of strong evidence, future studies with well-designed inclusion criteria and multicenter randomized controlled trials are needed to give more credible evidence, if possible.

Evaluation of therapeutic effectiveness and safety of botulinum toxin type A in the treatment of idiopathic trigeminal neuralgia in patients older than 70 years

To evaluate therapeutic effectiveness and safety of botulinum toxin type A in the treatment of idiopathic trigeminal neuralgia in patients older than 70 years. The total 64 patents were involved from neurology clinic and inpatient department from Aug 2008 to Sep 2013. They were divided into two groups according to the age (older than 70 years versus younger than 60 years. The therapeutic dose, safety, effectiveness were compared between two groups. Visual analog scores were employed to measure the degree of pain. The mean dosage was (88 ± 30) U in the group aged above 70 years old, and (72 ± 33) U in the group aged below 60 years old respectively. There was no significant difference of dosage between the two groups. The average visual analog score of all patients was (7.7 ± 2.2) before the treatment and decreased to (4.4 ± 2.9) one month after the treatment. To be precise, the average visual analog score of the group aged above 70 years old was (8.2 ± 1.9) before and (4.5 ± 3.2) after the treatment, and the visual analog score of the group aged below 60 years old was (7.2 ± 2.4) before and (4.4 ± 2.5) after the treatment. The effect of botulinum toxin type A in the treatment of idiopathic trigeminal neuralgia was considered statistically significant. The D-value of visual analog score in the elderly group was (3.5 ± 3.6), and (2.8 ± 3.5) in the younger group. There was no significant difference in the D-value between the two groups. Five patients had transient minor side effects in the former group and two patients had transient minor side effects in latter group. There was no significant difference in the incidence rate of side effects between the two groups (P > 0.05). Botulinum toxin type A is safe and effective in the treatment of idiopathic trigeminal neuralgia for the patients older than 70 years and the dosages of it are approximate to the patients under 60 years old.

Experience of botulinum toxin in treatment of writer's cramp

To evaluate the efficacy and safety of botulinum toxin type A (BTA) injections in patients with writer's cramp (WC). We treated 29 patients, in general, 49 BTA injections were performed. To determine points for the injections, we used ultrasound examination of the forearm including the time of writing. Patients reported subjective improvement in 75.9% after the first injection. Positive results as assessed with the WCRS were seen in 82.7% of the patients. We observed muscle weakness in the hands of 17.2% of the patients. Most of the patients were satisfied with the result of the injection and agreed on the need to re-injection when clinical effect of BTA had decreased. To determine the indications for BTA injections in PS, an individual approach to the development of schemes of injections and calculation of dose is needed. Treatment of BTA should be used in severe forms of WC with social significance to the patients.

Comparative efficacy and safety of botulinum toxin type A and B in treating Parkinson's disease-related sialorrhea: A pre-test post-test study

Comparative efficacy and safety of botulinum toxin type A and B in treating Parkinson's disease-related sialorrhea: A pre-test post-test study

Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: Results of the German–Austrian open-label post-marketing surveillance prospective study

The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale (‘no goal achievement’, ‘goal achievement’, ‘good goal achievement’, ‘best goal achievement’). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728U and an inverse dose–response relationship was observed. Treatment was well tolerated. 500–1000U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation.

Efficacy, safety, and predictors of response to botulinum toxin type A in refractory chronic migraine: A retrospective study

BackgroundDue to its persistent and debilitating nature, refractory chronic migraine (RCM) can cause significant socioeconomic burden. This study retrospectively reviewed the efficacy and safety of botulinum toxin type A (BoNT-A) in the treatment of RCM. Predictors of treatment response were also investigated. MethodsWe enrolled 94 patients in this study after reviewing the records of those patients who received BoNT-A injections ≥75 U in our headache clinic, and who fulfilled the criteria for RCM established by Schulman et al. The outcome variables included headache frequency, migraine disability assessment score, and adverse events recorded in headache diaries. Treatment response was defined as ≥30% reduction in headache frequency from baseline at 12 weeks. Potential predictors of treatment response were evaluated, including patient demographics, headache directionality, ocular-type headache, medication overuse, BoNT-A dosage, body mass index, and Beck depression inventory score. ResultsFor the 94 patients with RCM who were enrolled, their mean baseline headache frequency was 23.9 days/28 days. At 12 weeks after BoNT-A injection, the mean reduction in headache frequency was 6.5 days/28 days (p < 0.001), and the median migraine disability assessment score decreased from 60.0 to 30.0 (p < 0.001). Thirty-seven (39.4%) patients responded to treatment, and only ocular-type headache was associated with a higher response rate (ocular vs. nonocular, 54.8% vs. 31.7%; p = 0.031). The most common adverse event was lateral eyebrow elevation (19.1%), followed by neck soreness (5.3%). ConclusionAbout 40% of patients with RCM obtained ≥30% reduction in headache frequency at 12 weeks after BoNT-A injection, and treatment-related adverse events were transient and acceptable. Ocular-type headache may predict treatment response.

Botulinum toxin for masseter hypertrophy

Benign masseter muscle hypertrophy is an uncommon clinical phenomenon of uncertain aetiology which is characterised by a soft swelling near the angle of the mandible. The swelling may on occasion be associated with facial pain and can be prominent enough to be considered cosmetically disfiguring. Varying degrees of success have been reported for some of the treatment options for masseter hypertrophy, which range from simple pharmacotherapy to more invasive surgical reduction. Injection of botulinum toxin type A into the masseter muscle is generally considered a less invasive modality and has been advocated for cosmetic sculpting of the lower face. Botulinum toxin type A is a powerful neurotoxin which is produced by the anaerobic organism Clostridium botulinum and when injected into a muscle causes interference with the neurotransmitter mechanism producing selective paralysis and subsequent atrophy of the muscle.This review is an update of a previously published Cochrane review. To assess the efficacy and safety of botulinum toxin type A compared to placebo or no treatment, for the management of benign bilateral masseter hypertrophy. We searched the following databases from inception to April 2013: the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (via PubMed); EMBASE (via embase.com); Web of Science; CINAHL; Academic Search Premier (via EBSCOhost); ScienceDirect; LILACS (via BIREME); PubMed Central and Google Scholar (from 1700 to 19 April 2013). We searched two bibliographic databases of regional journals (IndMED and Iranmedex) which were expected to contain relevant trials. We also searched reference lists of relevant articles and contacted investigators to identify additional published and unpublished studies. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing intra-masseteric injections of botulinum toxin versus placebo administered for cosmetic facial sculpting in individuals of any age with bilateral benign masseter hypertrophy, which had been self-evaluated and confirmed by clinical and radiological examination were considered for inclusion. We excluded participants with unilateral or compensatory contralateral masseter hypertrophy resulting from head and neck radiotherapy. Two review authors independently screened the search results. For future updates, two authors will independently extract data and assess trial quality using the Cochrane risk of bias tool. Risk ratios (RR) and corresponding 95% confidence intervals (CI) will be calculated for all dichotomous outcomes and the mean difference (MD) and 95% CI will be calculated for continuous outcomes. We retrieved 683 unique references to studies. After screening these references 660 were excluded for being non-applicable. We assessed 23 full text articles for eligibility and all of these studies were excluded from the review. We were unable to identify any RCTs or CCTs assessing the efficacy and safety of intra-masseteric injections of botulinum toxin for people with bilateral benign masseter hypertrophy. The absence of high level evidence for the effectiveness of this intervention emphasises the need for well-designed, adequately powered RCTs.

Therapeutic efficacy and safety of botulinum toxin type A in trigeminal neuralgia: a systematic review

Trigeminal neuralgia is a common disorder caused mainly by compression of the trigeminal nerve root by an overlying blood vessel. Pharmacotherapy and surgery are ineffective or unsuitable in many patients. Therefore, other therapeutic modalities have been tried, including injection of botulinum toxin type A (BTX-A). This study aims to systematically review the therapeutic efficacy and safety of BTX-A in trigeminal neuralgia. PubMed, EMBASE, Cochrane Library Clinical Trials and Web of Science from January 1966 to March 2013 were searched with the terms of “botulinum toxin” AND “trigeminal neuralgia”, and references of related articles were traced. Data on the efficacy and safety of BTX-A in this disorder were extracted and analyzed by at least 2 reviewers. Data for individual studies were reported, and pooled data were analyzed if appropriate. Five prospective studies and one double-blind, randomized, placebo-controlled study were identified. Response was achieved in approximately 70-100% of patients, and the mean pain intensity and frequency were reduced by approximately 60-100% at 4 weeks after treatment in most studies. Major adverse events were not reported. Available studies show BTX-A may be effective in treatment of trigeminal neuralgia. However, well-designed randomized, controlled, double-blinded trial is still lacking. Future BTX-A treatment studies on optimal dose, duration of the therapeutic efficacy, common AEs, and the time and indications for repeat injection would be promising.

Evaluation of the Efficacy and Safety of Botulinum Toxin Type A to Induce Temporary Ptosis in Dogs

To verify the safety and efficacy of botulinum toxin type A (BoNT/A) to promote protective ptosis in dogs. In this prospective interventional study, a total of 10 dogs underwent transcutaneous anterior chemodenervation of levator palpebral superioris with 15 U of BoNT/A. The systemic changes, ocular mobility, visual function, intraocular pressure (IOP), tear production, and the onset, degree, and duration of ptosis were evaluated on a daily basis during the first 7 days and on days 14, 21, and 28 after application. The onset of the clinical effect was observed between 2 and 3 days after application of the toxin; the time taken for maximum ptosis to develop varied from 4 to 7 days (mean 5 days) and the average duration of the toxin effect was 21 days. The mean percentage reduction in palpebral fissure height was 42.859% (SD±35.714%-59.821%). There was not a statistically significant difference in IOP before and after the BoNT/A application (P=0.974), or lacrimal production evaluation (P=0.276). There was no change in ocular mobility and no other adverse effect was observed in association with the administration of the study drug. The application of BoNT/A into the levator palpebral superioris muscle in dogs was effective and safe to promote protective ptosis with a temporary covering of the cornea.

原発性腋窩多汗症患者に対する A 型ボツリヌス毒素製剤の治療評価

原発性腋窩多汗症患者に対する A 型ボツリヌス毒素製剤の治療評価

Treatment of Primary Axillary Hyperhidrosis with Botulinum Toxin Type A: Our Experience in 50 Patients from 2007 to 2010

Background. Local injections of Botulinum toxin type A (BTX-A) are an effective and safe solution for primary bilateral axillary hyperhidrosis. Traditional treatments are often ineffective and difficult to tolerate. This study was performed to assess the efficacy and safety of Botulinum toxin type A in the treatment of these diseases and to evaluate the reliability of patient's subjective rating in the timing of repeat injections. Methods. From 2007 to 2008, we included in the study and treated a total of 50 patients, and we used the Minor's iodine test and the hyperhidrosis diseases severity scale as initial inclusion criteria and also for evaluating the followup, comparing to patient's subjective rating. We used also a specific questionnaire to evaluate the level of pain, the onset of the effect, any eventual adverse effect of the treatment, the onset of compensatory hyperhidrosis, and the global grade of satisfaction. The data were analyzed using standard statistical methods. Results. 88% of patients were totally satisfied and all patients repeated the treatment during all the study. The symptom-free interval was in median 6 months with an average improving of HDSS of 1.5 points. In 86%, there was a complete accordance between the subjective patient's demand of the repetition of the treatment and the positivity to Minor test and HDSS. No major side effects happened. Conclusion. Local injections of Botulinum toxin type A (BTX-A) result in an effective and safe solution for bilateral axillary primary hyperhidrosis for the absence of significant morbidity, side effects, and lack of efficacy or duration. The only defects are the need of repetition of the treatment and relative costs.

Severe Nervous System Complications After Botulinum Type A Therapy: Three Case Reports With Reviews of FDA-Reported Nervous System Adverse Effects

The short-term safety of botulinum toxin type A (BoNT/A) has been established in numerous double-blind trials, but as many authors have pointed out, long-term drug safety is an unresolved issue [1-3]. We report 3 cases of central nervous system complications with encephalitic clinical features that occurred shortly after treatment of focal dystonia with BoNT/A. The goal of this study is to raise awareness and increase the vigilance of health care providers regarding the possible occurrence of adverse events that may be related not directly to the toxin but to other mechanisms that have not yet been well studied. We suggest an algorithm for safer toxin use until further research is conducted. We also offer a summary of toxin-related nervous system adverse events reported to the U.S. Food and Drug Administration (FDA) between September 1992 and May 2009.

Open-label, Multicenter, Randomized Study Investigating the Efficacy and Safety of Botulinum Toxin Type A in the Treatment of Myofascial Pain Syndrome in the Neck and Shoulder Girdle

ObjectivesTo evaluate two doses of botulinum toxin A [BoNT-A] for the treatment of chronic myofascial pain syndrome [MPS].MethodsA 12-week, open-label, randomized study in which patients [N = 163] with MPS in the neck and shoulder girdle muscles were treated with intramuscular injections of 200 U [25 U/trigger point [TrP]] or 320 U [40 U/TrP] BoNT-A.ResultsAt Week 7, 34.8 percent of BoNT-A 200 U and 34.3 percent of BoNT-A 320 U patients had clinically significant improvement in pain. Treatment was well-tolerated.ConclusionsBoth doses provided effective relief from chronic MPS; benefits were maintained for at least three months.

Effectiveness and Safety of Botulinum Toxin Type A in Children with Musculoskeletal Conditions: What Is the Current State of Evidence?

Children with musculoskeletal conditions experience muscle weakness, difficulty walking and limitations in physical activities. Standard treatment includes physiotherapy, casting, and surgery. The use of botulinum toxins appears as a promising treatment on its own, but usually as an adjunct to other treatment modalities and as an alternative to surgery. The objectives were to establish the evidence on the effectiveness, safety and functional outcome of BTX-A in children with musculoskeletal conditions. A literature search using five electronic databases identified 24 studies that met our inclusion criteria. Two randomized clinical trials were included; most studies were case studies with small sample sizes and no control group. Improvements in gait pattern, function, range of motion, reduction of co-contractions, and avoidance of surgical procedures were found following BTX-A injections. Adverse events were not reported in 10 studies, minor adverse events were reported in 13 children and there were no severe adverse events. Additional doses appear safe. BTX-A is a promising treatment adjunct in improving functional outcomes in children with musculoskeletal conditions. Future studies including larger samples, longer follow-up periods and a comparison group are required to provide evidence on the effectiveness and safety of this drug in children with musculoskeletal conditions.

Repeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

BackgroundEfficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO). ObjectivesDescribe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO. Design, setting, and participantsProspective data from a single centre were collected from the first 100 patients. InterventionBladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting. MeasurementsOAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate. Results and limitationsTwo hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)–related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients. ConclusionsBoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

Effects of botulinum toxin type a in the bladder wall of children with neurogenic bladder dysfunction: a comparison of histological features before and after injections

Study received institutional review board approval. Supported by the Italian Ministry of Health. * Correspondence: Department of NephroUrology and NeuroUrology Unit, Bambino Gesu Pediatric Hospital, Piazza S Onofrio 4, 00165 Rome, Italy (telephone: 0039.06.68592643; FAX: 0039.06.68592518; e-mail: mosiello@opbg.net). Purpose: Botulinum toxin type A has gained popularity in urology. Most reported studies have been in adults at urology centers and most have addressed long-term safety. Since botulinum toxin type A treatment for neurogenic bladder dysfunction requires repeat injections, verifying that such treatment does not induce fibrosis in children seems essential. Materials and Methods: The study was approved by the institutional review board and patients were enrolled after we obtained written consent. Patients with neurogenic bladder dysfunction not responding to conventional treatment (anticholinergics and clean intermittent catheterization) were treated with 10 IU/kg botulinum toxin type A up to a maximum of 300 IU. Endoscopic cold cup biopsies were obtained from the posterolateral bladder wall 1.5 to 2 cm above the ureteral orifice. Bladder wall findings were categorized into 3 groups, including inflammatory infiltration, edema and fibrosis. Each criterion was then graded as mild or severe and analyzed by Fisher’s exact test (p 0.05). Results: A total of 46 bladder wall biopsies were obtained from 40 patients 2 to 18 years old. Biopsies were evaluated in groups 1 and 2, including group 1—20 from patients with no botulinum toxin type A injection and group 2—20 after botulinum toxin type A injection. Group 2 was subdivided into group 3—10 biopsies after 1 injection and group 4—10 after multiple injections. Six patients underwent biopsy twice, that is before the first and second treatments. Histological changes were present in all biopsies. When comparing groups 1 and 2, there was no statistically significant difference in inflammation and edema. However, there was a significant difference in fibrosis between groups 1 and 4 (p 0.05) with apparently decreased fibrosis after multiple injections. Conclusions: In our experience repeat botulinum toxin type A injections into the detrusor in children do not lead to increased fibrosis in the bladder wall. This study confirms the long-term safety of botulinum toxin type A in the pediatric population.

Effects of Botulinum Toxin Type A in the Bladder Wall of Children With Neurogenic Bladder Dysfunction: A Comparison of Histological Features Before and After Injections

Botulinum toxin type A has gained popularity in urology. Most reported studies have been in adults at urology centers and most have addressed long-term safety. Since botulinum toxin type A treatment for neurogenic bladder dysfunction requires repeat injections, verifying that such treatment does not induce fibrosis in children seems essential. The study was approved by the institutional review board and patients were enrolled after we obtained written consent. Patients with neurogenic bladder dysfunction not responding to conventional treatment (anticholinergics and clean intermittent catheterization) were treated with 10 IU/kg botulinum toxin type A up to a maximum of 300 IU. Endoscopic cold cup biopsies were obtained from the posterolateral bladder wall 1.5 to 2 cm above the ureteral orifice. Bladder wall findings were categorized into 3 groups, including inflammatory infiltration, edema and fibrosis. Each criterion was then graded as mild or severe and analyzed by Fisher's exact test (p <0.05). A total of 46 bladder wall biopsies were obtained from 40 patients 2 to 18 years old. Biopsies were evaluated in groups 1 and 2, including group 1-20 from patients with no botulinum toxin type A injection and group 2-20 after botulinum toxin type A injection. Group 2 was subdivided into group 3-10 biopsies after 1 injection and group 4-10 after multiple injections. Six patients underwent biopsy twice, that is before the first and second treatments. Histological changes were present in all biopsies. When comparing groups 1 and 2, there was no statistically significant difference in inflammation and edema. However, there was a significant difference in fibrosis between groups 1 and 4 (p <0.05) with apparently decreased fibrosis after multiple injections. In our experience repeat botulinum toxin type A injections into the detrusor in children do not lead to increased fibrosis in the bladder wall. This study confirms the long-term safety of botulinum toxin type A in the pediatric population.

Relief of Periorbital Pain After Acute Angle Closure Glaucoma Attack by Botulinum Toxin Type A

To assess the efficacy and safety of botulinum toxin type A (BoNT-A) injection in patients suffering from intractable periorbital pain after acute angle closure glaucoma (AACG). In this prospective randomized intervention study, 19 patients suffering from periorbital pain after an AACG attack were injected with BoNT-A or placebo for pain relief. Patients were assessed on days 1, 2, 7, 14, 30, 60, and 90. The main outcomes were mean change of visual analog rating scale (VARS) and index scores measured through a quality-of-life questionnaire (EQ-5D), and changes in the visual analog scale (VAS), all of which were assessed at each visit. A secondary outcome was the frequency and nature of adverse events and the number of patients who withdrew from the study as a result. In the treatment group (n=10), the mean index score of EQ-5D and VAS changed significantly from the placebo group (by 0.299 and 2.61, respectively) from day 2 (P<0.01). The VARS of EQ-5D also disclosed significant changes from day 2 (17, P<0.01). In addition, efficacy was maintained mainly between days 2 and 60 but declined slightly by day 90. The most frequently reported treatment-related adverse events in the treatment and placebo groups were local tenderness (21%), subcutaneous hemorrhage (10.5%), and conjunctivitis (10.5%). No severe adverse events were reported during the study or follow-up period. BoNT-A is effective and well tolerated for the treatment of periorbital pain after an AACG attack. Its effects may be maintained for 3 months.

Evaluation of efficacy and safety of botulinum toxin type A injection in patients requiring temporary tarsorrhaphy to improve corneal epithelial defects.

To evaluate the efficacy and safety of botulinum toxin type A (Dysport, (Ipsen Biopharm Ltd, Wrexham, UK)) injection in patients requiring temporary tarsorrhaphy to improve corneal epithelial defects. Thirty patients were enrolled into the prospective study between March 2007 and September 2009. Doses of 15 and 30U of Dysport were injected into the levator palpebrae superioris muscle through the eyelid. The patients were followed daily until completion of ptosis and then 1-2 weekly until complete resolution of levator function and improvement of corneal condition. Ptosis took 2.64±1.85 days to be completed (range 1-9 days) and lasted for 12±2.19 weeks. For patients with seventh nerve palsy, 30U Dysport was appropriate to produce sufficient ptosis whereas in other patients 15U of toxin was sufficient. In 83.3% of patients ptosis was sufficient for complete recovery of corneal epithelium and 16.7% required a second procedure (Amniotic membrane transplantation, conjunctival flap). There was a direct correlation between age and duration of ptosis. In patients with seventh nerve palsy, the amount of resultant ptosis was significantly lower than that of other patients. The only adverse effects of injection were superior rectus underaction (33.3%) and diplopia (16.7%) which resolved in all patients without any intervention. Dysport injection is a safe and effective substitute for surgical tasorrhaphy with fewer complications.

Efficacy of Intra-Articular Botulinum Toxin Type A in Painful Knee Osteoarthritis: A Pilot Study

To evaluate the efficacy and safety of botulinum toxin type A (BoNT-A) injected intra-articularly in 60 subjects with moderate pain and functional impairment secondary to knee osteoarthritis. The study investigators hypothesized that intra-articular BoNT-A would result in statistically significant improvements in pain and function at 8 weeks. Double-blind, randomized, single tertiary care academic medical center trial with 6-month follow-up. Sixty patients aged 40 years or older with painful osteoarthritis of the knee who had failed physical therapy, medications, and/or injection therapy presenting to the musculoskeletal or orthopedic outpatient clinics at a large tertiary care medical institution. All 60 patients completed 8-week follow-up, but only 32 patients completed the 26-week follow-up. Subjects were randomized to receive a single injection of corticosteroid, low-dose BoNT-A (100 units), or high-dose BoNT-A (200 units). Outcome measures were compared at baseline, 4, 8, 12, and 26 weeks after injection. The primary outcome measure was pain visual analog scale (VAS) at 8 weeks. Secondary outcome measures included Western Ontario McMaster Arthritis Index, Short Form-36 scores, patient global assessment, 40-meter timed walk, and adverse effects. The primary end point was pain VAS score at 8 weeks, which decreased within each group but only reached statistical significance in the low-dose BoNT-A group. In the intra-articular corticosteroid group, VAS decreased from 6.4 +/- 1.8 to 5.4 +/- 2.3 (P = .15); for low-dose BoNT-A, from 6.6. +/- 1.9 to 4.5 +/- 2.2 (P = .01); and for high-dose BoNT-A, from 6.6 +/- 1.4 to 5.9 +/- 2.4 (P = .15). All groups showed statistically significant improvements in Western Ontario McMaster Arthritis Index scores (pain, stiffness, function) at 8 weeks. No serious adverse events were noted in any group. This pilot study supports a possible role for BoNT-A as a treatment option for symptomatic knee osteoarthritis; however, larger double-blind randomized studies are needed to determine whether BoNT-A is more effective than placebo in this patient population.