BTX-A Group Research Articles

Safety and effectiveness of ethanol neurolysis with and without onabotulinumtoxinA in children with cerebral palsy.

OnabotulinumtoxinA is commonly used to relieve spasticity in children with neurologic disorders. Ethanol neurolysis may be used to target more muscles but is less well studied, especially in pediatrics. To determine the safety and effectiveness of ethanol neurolysis with onabotulinumtoxinA injections compared to only onabotulinumtoxinA injections for the treatment of spasticity in children with cerebral palsy. Prospective cohort study including patients with cerebral palsy receiving onabotulinumtoxinA and/or ethanol neurolysis from June 2020 to June 2021. Outpatient physiatry clinic. A total of 167 children with cerebral palsy not undergoing other treatments during injection period. Injection with either onabotulinumtoxinA only (112 children) or a combination of ethanol and onabotulinumtoxinA injections (55 children) using both ultrasound guidance and electrical stimulation. A post-procedure evaluation at 2 weeks after injection documented any adverse effects experienced by the child and perceived magnitude of improvement using an ordinal scale from 1 to 5. Multiple linear regression was used to identify and control for covariates including Gross Motor Function Classification System, gender, age, weight, ethnicity, race, and dosage. Only weight was identified as a confounding factor. When controlled for weight, combined onabotulinumtoxinA and ethanol injections had a greater magnitude of improvement (3.78/5) compared with onabotulinumtoxinA injections alone (3.44/5), a difference of 0.34 points on the rating scale (95% confidence interval: 0.01-0.69; p = .045). However, the difference was not clinically significant. One patient in the onabotulinumtoxinA-only group and two patients in the combined onabotulinumtoxinA and ethanol group reported mild, self-limiting adverse effects. Ethanol neurolysis under ultrasound and electrical stimulation guidance may be a safe and effective treatment for children with cerebral palsy that allows more spastic muscles to be treated than onabotulinumtoxinA alone.

Hengli® Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: To evaluate the efficacy and safety of Hengli® Chinese botulinum toxin type A (BTX-A; 100 U) in Chinese patients with overactive bladder. Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial in Chinese patients who were inadequately managed with anticholinergic medications. Eligible patients were randomized 2:1 to receive intradetrusor injections of Hengli® BTX-A (n = 144) or placebo (n = 72). The primary endpoint was the change in the number of daily micturition episodes at week 6 from baseline. The secondary efficacy endpoints included the average frequency of urgency and urinary incontinence (UI) episodes per day, urgency score, average micturition volume per day, OABSS, and QoL score. Results: In the Hengli® BTX-A group, there was a significantly greater reduction in the average number of micturition episodes per 24 h compared with the placebo group (3.28 vs. 1.43; p = 0.003). Moreover, there was a significantly greater improvement in the daily number of urgency episodes, micturition volume and OABSS score. An increased post-void residual urine volume, dysuria, and urinary tract infection represented adverse events (AEs) in the Hengli® BTX-A group. Most AEs were mild or moderate in severity. One patient in the BTX-A group initiated clean intermittent catheterization (CIC) during treatment. Conclusion: Hengli® BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, Identifier: CTR20131190.

Botulinum toxin type-A infiltration of the external anal sphincter to treat outlet constipation in motor incomplete spinal cord injury: pilot cohort study

Background Outlet constipation is a major problem in spinal cord injury (SCI) patients. We aimed to study the efficacy of external anal sphincter (EAS) infiltration with type-A botulinum toxin (BTX-A) in motor incomplete SCI patients with outlet constipation. Methods Double blind, randomized, placebo controlled, comparative study in 16 motor incomplete SCI subjects. Patients were randomly assigned toreceive100 UI of BTX-A (n = 9) or physiologic serum infiltration (n = 7) in the EAS under electromyographic guidance. Outcome measures included a questionnaire for clinical bowel function evaluation, colonic transit time and anorectal manometry. All assessments were done at baseline, 1 and 3 months after treatment. Results Fourteen patients completed the study. In the BTX-A group we observed an improvement of subjective perception of bowel function (p = 0.01), constipation (p = 0.02) and neurogenic bowel dysfunction score (p = 0.02). The anorectal manometry revealed are duction of EAS voluntary contraction pressure (p = 0.01). No changes were observed in the placebo group. No significant side effects were observed in none of the groups. Conclusion BTX-A infiltration of the EAS is a safe technique that in motor incomplete SCI, decreases the EAS contraction and the anal canal pressure during straining, and improves outlet constipation symptoms. Future studies in larger populations are needed.

Efficacy of botulinum-A for nocturnal bruxism pain and the occurrence of bruxism events: a meta-analysis and systematic review

The purpose of this study was to explore the treatment efficacy of botulinum-A (BTX-A) in nocturnal bruxism. Five electronic databases (PubMed, Web of Science, Cochrane, Embase and Clinical Trials) were searched to identify related randomised controlled trials up to September 1, 2020. Five evaluation indices were extracted, namely, the pain at rest and at chewing (PR and PC), the number of bruxism events (NBE) and the self-assessment by patients (SA), to assess the treatment efficacy of BTX-A in bruxism. All data analyses were conducted using Review Manager (Version 5.3; The Cochrane Collaboration, London, United Kingdom). Six studies were included in this review. The sample was composed of 148 participants. Compared with the placebo group, the BTX-A group showed the significantly improved the PR index scores (MD, 1.16 cm; 95%CI, 0.65 to 1.67 cm; p < 0.00001), slightly improved the PC index scores (SMD, 0.25; 95%CI -0.14 to 0.64; p = 0.21), and the NBEs were significantly decreased in the before-injection group compared with that in the after-injection group (MD, 1.72; 95%CI, 0.60 to 2.85; p = 0.003). The results of this study suggest that BTX-A possesses significant therapeutic efficiency for the relief of pain and events of bruxism. However, whether the events of bruxism would recur or rebound after botulinum toxin injection needs more follow-up clinical evidence.

Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Management of Post-Stroke Spasticity: A Randomized Controlled Study.

The purpose of the current study was to investigate the antispastic efficacy of dry needling in combination with botulinum toxin-A injections. Thirty stroke patients with elbow flexor spasticity were randomised into two groups; the patients treated with botulinum toxin-A injections and exercise into the BTX-A group, and patients treated with botulinum toxin-A injections, exercise, and dry needling in the BTX-A+Dry needling group. Spasticity was evaluated using the modified Ashworth scale and modified Tardieu scale before treatment, immediately after treatment, the third day after treatment, second week after treatment and at the third month after treatment. The upper extremity motor function was evaluated using the Fugl-Meyer upper extremity motor function scale. A statistically significant difference in all parameters was found after treatment in both groups compared to before treatment (p<0.05). In all evaluation parameters immediately after treatment, on the third day after treatment, the second week after treatment and the third month after treatment, a statistically significant difference in favour of the BTX-A+Dry needling group was achieved compared to before treatment (p<0.05). Dry needling combined with botulinum toxin-A injections performed over a total of four sessions with three-day intervals, contribute to the antispastic effect. Also combined therapy is more effective and provides longer-lasting results.

Safety of combined salivary gland and multilevel intramuscular onabotulinumtoxinA injections with and without ethanol in pediatric patients with cerebral palsy: A retrospective study.

To evaluate the safety of combining salivary gland onabotulinumtoxinA (BTX-A) injections for sialorrhea with intramuscular BTX-A injections for spasticity in the same procedure. A retrospective cohort study in a tertiary hospital center. Patients selected were younger than 20years, diagnosed with cerebral palsy, and received their first salivary gland BTX-A injection between March 2011 and July 2015. Chart review and telephone interviews were performed. The primary outcome measure was the rate of adverse events after combined BTX-A injections into salivary glands and muscles. The secondary outcome measure was the efficacy of injections, as reported by patients. Twenty-five of the 52 selected patients received salivary gland BTX-A injections only, and 27 received concurrent salivary gland and multi-level intramuscular chemodenervation with BTX-A with or without alcohol. The rate of adverse events was < 10% in both groups; 4% in "Salivary Only Group" and 7% in the "Salivary + Multilevel Intramuscular Chemodenervation with BTX-A group (with or without alcohol)". Both approaches were equally effective in meeting their goals of salivary injections (> 50% improvement for at least two months). In the "salivary only" and in the "salivary + multi-level intramuscular" group, 76 and 85% of the patients reached their goals respectively. Combining BTX-A injections for sialorrhea with multilevel intramuscular BTX-A injections (with or without alcohol) appears to be safe and effective and allows treatment of patients for both conditions simultaneously.

Comparative Study between Intracavernosal Injection of Botulinum Toxin type A [50 and 100 unit], Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction

Evidence has been arising suggesting that Botulinum toxin type A [BTX-A] injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction [ED] resistant to oral and intracavernous injection [ICI] therapy, thus it could be an alternative option for failed medical and other injectable therapy.. to compare safety, efficacy and durability of different doses of BTX-A [50 and 100 Unit] in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.. Forty-five patients with Vasculogenic erectile dysfunction who are failed treatment with non-surgical options were included at this study after elimination of all patients who are not matching eligible criteria or not complete the follow up program. The patients were randomized into 3equal groups, each group include 15 patients. Group [I] injected with 100U BTX-A, group [II] injected with 50U BTX-A and Control group injected with normal saline. All groups underwent follow up at 2 weeks, 3 months and 6 months intervals after injection, for assessment of all subjective data as, IIEF-5 Questionnaire [SHIM score], Erection hardness score [EHS], Sexual encounter profile [SEP 2 and 3], Global assessment score[ GAS 2 and 3]. Also assessment of objective data by penile Doppler details.. Although 25 patients [55.6%] respond to BTX-A injection subjectively and objectively {13 patients [28.9%] in group [I] and 12 patients [26.7%] in group [II]}, but this impressive effect was not durable especially in group [II] as 9 patients [20%] show lost effect through complete follow up till 6 month in comparison to 5 patients [11.1%] in group [I] show same lost effect. Besides that, 5 patients [11.1 %] not responding to this treatment option {two patients [4.4%] in group [I] and 3 patients [6.7%] in group [II], also patients in Control group show non-significant subjective improvement. BTX-A could be a potential but not durable therapy for erectile dysfunction, as BTX-A [50 and 100 Unite] show almost same efficacy but, with complete follow up through 6 months, BTX-A 100U is more durable than 50U

Intraoperative Onabotulinumtoxin-A Reduces Postoperative Narcotic and Anticholinergic Requirements After Continent Bladder Reconstruction

To determine if intradetrusor injection of onabotulinumtoxin-A (BTX-A) would reduce postoperative narcotic and anticholinergic requirements in children undergoing open continent bladder reconstruction. After institutional review board approval, we retrospectively reviewed all bladder reconstructions performed. Bladder reconstruction was defined as the following procedures in any combination: bladder neck reconstruction and sling, bladder neck closure, Mitrofanoff, Monti, or bladder augmentation. We identified 15 children who underwent reconstruction with BTX-A injection and compared these with 15 children who did not receive BTX-A. Postoperative narcotic and anticholinergic requirements were recorded as well as length of stay, time to diet, time to return of bowel function, and complications. All medications were converted to morphine mEq/kg per day or mg/kg per day to standardize for patient size and length of stay. Thirty patients who underwent open bladder reconstruction were included. Fifteen received BTX-A injection and 15 did not. The BTX-A group required significantly less narcotic medication postoperatively compared with the no-BTX-A group (0.32 vs 0.85 morphine mEq/kg per day; P = .0002). The BTX-A group also required significantly less anticholinergic medication compared with the no-BTX-A group (0.22 vs 0.88 mg/kg per day; P = .024). There was no significant difference between the groups with respect to length of stay (98.27 vs 9.287 days; P = .34) or return of bowel function (5.53 vs 4.93 days; P = .994). Complication rate between the groups was similar (P >.99). Intraoperative injection of BTX-A significantly reduced postoperative narcotic and anticholinergic requirements in patients who underwent open continent bladder reconstruction. This is an encouraging alternative treatment to manage postoperative pain with no associated risk of significant complications.

Efficacy of botulinum toxin A for the treatment of bladder pain syndrome: A systematic review

ObjectivesTo determine the efficacy and safety of BTX-A, compared with other interventions for the treatment of BPS to improve quality of life. MethodsThis systematic review fulfills all the requirements of the Cochrane manual and PRISMA reporting guidelines. The PROSPERO registration number is: CRD42016039480. Clinical trials without language discrimination were included. BPS patients over 18 y/o that were treated with BTX-A were included. Studies were searched in published databases and no published literature from inception to the present day. Risk of bias analysis was done using the Cochrane risk of bias tool. Results88 articles were found with the designed search strategies. After exclusions, four studies were included in the qualitative analyses. Kasyan et al. (2012) compared BTX-A with hydrodistention. Manning et al. (2014) compared the injection of BTX-A with the injection of normal saline in previously hydrodistended bladders. In both cases, primary end point was measured by the O’Leary-Sant questionnaire score. El-Bahnasy et al. (2009) compared BTX-A with BCG administration, through Global Response Assessment. Kuo et al. (2015) compared hydrodistention plus suburothelial injections of BTX-A with hydrodistension plus normal saline injections. Reduction in pain was estimated by VAS bladder pain score. A similar efficacy to their controls had been found in Kasyan and Manning studies. El-Bahnasy had found improvement in BTX-A in all parameters. Kuo et al. (2015) found a significantly reduction in pain in the BTX-A group. Regarding the risk of bias, three studies did not have adequate descriptions of selection, performance and detection bias. The study of Manning had low risk of selection, attrition and reporting bias. ConclusionThere is not enough evidence to conclude the efficacy of BTX-A for the treatment of interstitial cystitis to improve quality of life.

Macroplastique and Botox are superior to Macroplastique alone in the management of neurogenic vesicoureteric reflux in spinal cord injury population with presumed healthy bladders

Context/ObjectiveVesico-ureteric reflux(VUR) is a known complication of neuropathic bladder in spinal cord injury(SCI) population. Bulking agents such as Macroplastique are new minimally-invasive treatment option for VUR with good results. The aim of this study is to assess the efficacy of Macroplastique alone or in combination with Botox(BTX-A), in managing VUR in SCI population with presumed healthy bladders and correlate the pre-and post-injection urodynamic findings with the outcome.DesignRetrospective comparative study.ParticipantsSCI patients with VUR and presumed health bladders (normo-compliant, low filling pressures), treated with macroplastique alone or in combination with BTX-A, who had pre and post-intervention Video-urodynamics (VUDS) and followed up for at least 12 months.InterventionsMacroplastique and BTX-A injections, VUDS.Outcome measuresThe primary end point was the overall treatment rate of VUR at 3 months and the secondary outcomes were the success rate (treated + improved) and the comparison of urodynamic parameters (pre-and post-injection).ResultsWe studied 34 intervention-naïve SCI patients. 19 had only Macroplastique (Group 1) and 15 had Macroplastique and BTX-A (Group 2). The overall treatment rate was 65.4% for group 1 and 88.9% for group 2 (P = 0.029). The overall success rate (treated + improved) was 80.8% and 94.4% respectively (P = 0.123). The comparison of follow up VUDS parameters showed a statistically significant rise in the detrusor pressure of group 1 (34.04cmH2O vs.19.2cmH2O, P = 0.008) and a drop in compliance (19.8mls/cmH2O vs.26.3mls/cmH2O, P = 0.018) as compared to baseline.ConclusionThe combination of BTX-A and Macroplastique is more effective that Macroplastique alone in the management of secondary VUR in SCI patients with presumed healthy bladders.

Eficacia de la toxina botulínica A para el tratamiento del síndrome de dolor vesical: una revisión sistemática

ObjectivesTo determine the efficacy and safety of BTX-A, compared with other interventions for the treatment of BPS to improve quality of life. MethodsThis systematic review fulfils all the requirements of the Cochrane manual and PRISMA reporting guidelines. The PROSPERO registration number is: CRD42016039480.Clinical trials without language discrimination were included. BPS patients over 18 y/o that were treated with BTX-A were included. Studies were searched in published databases and no published literature from inception to the present day. Risk of bias analysis was done using the Cochrane risk of bias tool. Results88 articles were found with the designed search strategies. After exclusions, four studies were included in the qualitative analyses. Kasyan et al., 2012 compared BTX-A with hydrodistention. Manning et al., 2014 compared the injection of BTX-A with the injection of normal saline in previously hydrodistended bladders. In both cases, primary end point was measured by the O’Leary-Sant questionnaire score. El-Bahnasy et al., 2009 compared BTX-A with BCG administration, through Global Response Assessment. Kuo et al., 2015 compared hydrodistention plus suburothelial injections of BTX-A with hydrodistension plus normal saline injections. Reduction in pain was estimated by VAS bladder pain score. A similar efficacy to their controls had been found in Kasyan and Manning studies. El-Bahnasy had found improvement in BTX-A in all parameters. Kuo el al. 2015, found a significantly reduction in pain in the BTX-A group. Regarding the risk of bias, three studies did not have adequate descriptions of selection, performance and detection bias. The study of Manning had low risk of selection, attrition and reporting bias. ConclusionThere is not enough evidence to conclude the efficacy of BTX-A for the treatment of interstitial cystitis to improve quality of life.

MP67-01 PRELIMINARY EVIDENCE SUGGESTS PERIURETERAL BOTULINUM TOXIN TYPE A INJECTION IMPROVES URETERAL STONE PASSAGE IN THE PORCINE MODEL

INTRODUCTION AND OBJECTIVES: We evaluated the use of periureteral injection of botulinum toxin type A (Botox , BTX-A) to facilitate passage of ureteral stones in a porcine model. We believe that reducing detrusor muscle tone around the intramural ureter may facilitate passage of ureteral stones through the ureterovesical junction. METHODS: With complete Institutional Animal Care and Use Committee approval, artificial stones (BegoStone plus) were placed by retrograde ureteroscopy into the proximal ureter using fluoroscopic guidance using an in vivo porcine model. Six animals underwent periureteral BTX-A injection 30 U / mL to 3 locations around the ureteral orifice and 6 animals were in the control group undergoing periureteral injection of normal saline. RESULTS: There was a significant decrease in time to stone passage in the BTX-A group compared to the control group, 2.6 1.3 vs. 6.8 2.9 days respectively (p1⁄4 0.018). None of the animals had evidence of vesicoureteral reflux post-procedure (N1⁄40/12). CONCLUSIONS: Preliminary results suggest periureteral injection of BTX-A facilitates ureteral stone passage in this model. BTX-A may provide a simple, office-based endoscopic treatment option for ureteral stones. Further studies would be necessary to evaluate its efficacy in humans as compared to traditional medical expulsive therapy.

Preliminary Evidence Suggests Periureteral Botulinum Toxin Type A Injection Improves Ureteral Stone Passage in the Porcine Model.

We evaluated the use of periureteral injection of botulinum toxin type A (Botox(®), BTX-A) to facilitate passage of ureteral stones in a porcine model. We believe that reducing detrusor muscle tone around the intramural ureter may facilitate passage of ureteral stones through the ureterovesical junction. With complete Institutional Animal Care and Use Committee approval, artificial stones (BegoStone plus) were placed by retrograde ureteroscopy into the proximal ureter using fluoroscopic guidance using an in-vivo porcine model. Six animals underwent periureteral BTX-A injection 30 U/mL to three locations around the ureteral orifice, and six animals were in the control group undergoing periureteral injection of physiologic saline. There was a significant decrease in time to stone passage in the BTX-A group compared with the control group, 2.6 ± 1.3 vs 6.8 ± 2.9 days, respectively (p = 0.018). None of the animals had evidence of vesicoureteral reflux postprocedure (N = 0/12). Preliminary results suggest that periureteral injection of BTX-A facilitates ureteral stone passage in this model. BTX-A may provide a simple, office-based endoscopic treatment option for ureteral stones. Further studies would be necessary to evaluate its efficacy in humans compared with traditional medical expulsive therapy.

Polyclonal neural cell adhesion molecule antibody prolongs the effective duration time of botulinum toxin in decreasing muscle strength.

This study aimed to investigate if the effective duration time of botulinum toxin A (Btx-A) could be prolonged by polyclonal neural cell adhesion molecule antibody (P-NCAM-Ab). 175 male SD rats were randomly divided into three major groups: control group (n=25), Btx-A group (n=25), and P-NCAM-Ab groups. P-NCAM-Ab groups were composed of five sub-groups, with 25 rats each in the dose-response study. Muscle strength of rat lower limbs was determined using a survey system. The expressions of muscle-specific receptor tyrosine kinase (MuSK) and neural cell adhesion molecule (NCAM) were determined by real-time polymerase chain reactions (RT-PCR) and western blotting (WB). The muscle strength was significantly decreased by Btx-A in Btx-A/P-NCAM-Ab groups compared with normal control group. Besides, the muscle strength of P-NCAM-Ab group was significantly decreased compared with the Btx-A group. The recovery time of muscle strength in P-NCAM-Ab group was significantly longer compared with Btx-A group. RT-PCR and WB assay showed that PNCAM-Ab delayed the increase of MuSK and NCAM after Btx-A injection. P-NCAM-Ab prolongs the effective duration time of Btx-A in decreasing muscle strength, which could provide a novel enhancement in clinical application.

IGF-1 Antibody Prolongs the Effective Duration Time of Botulinum Toxin in Decreasing Muscle Strength

Botulinum toxin type-A (Btx-A), a powerful therapeutic tool in various medical specialties, requires repeated injections to maintain its effect. Therefore, novel methods to prolong the effective duration time of Btx-A are highly needed. Rats were assigned to three major groups: control group (n = 30), Btx-A group (n = 30), and IGF-1 Ab groups. IGF-1 Ab groups were composed by sub-groups A1–A5 (each has 25 rats) for the subsequent IGF-1Ab dose-effect study. Muscle strength was determined by a survey system for rat lower limbs nerve and muscle function. Muscle-specific receptor tyrosine kinase (MuSK), Insulin-like growth factor binding protein-5 (IGFBP5), and growth-associated protein, 43-kDa (GAP43) were determined by real-time polymerase chain reactions (PCRs) and Western blot. We found that Btx-A decreased the muscle strength, with a paralysis maintained for 70 days. IGF-1Ab prolonged the effective duration time of Btx-A. Real-time PCRs and Western blot showed that IGF-1Ab delayed the increase of MuSK and IGFBP5 after Btx-A injection, without affecting GAP43. These results indicate that IGF-1Ab might prolong the effective duration time of Btx-A on muscle strength through delaying the increase of MuSK. It would be interesting to determine whether IGF-1Ab can be used as an auxiliary measure to the Btx-A treatment in the future.

Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine

Objective To compare the effects of botulinum toxin type A with those of amitriptyline on the treatment of chronic daily migraines. Methods Chronic migraine sufferers were randomized into two groups and treated with 25 or 50 mg/day of amitriptyline or 250 U of botulinum toxin type A. A reduction of at least 50% in the number of pain episodes, in the intensity of pain, and in the number of drug doses for pain and reports of improvement by the patient or by the examiner were the main endpoints. Results Seventy-two subjects were enrolled in the study. A reduction of at least 50% in the number of days of pain was recorded in 67.8% of the patients in the BTX-A group and 72% ( n = 23) of the patients in the AM group ( p = 0.78; RR = 0.94; CI = 0.11–8). The reduction in the intensity of pain, as assessed using the visual analogical scale, was 50% in the BXT-A group and 55.6% in the AM group ( p = 0.79; RR = 1.11; CI = 0.32–3.8). The reduction in the number of pain drug doses was 77% for the toxin group and 71% for the amitriptyline group ( p = 0.76; RR = 0.92; CI = 0.45–1.88). Conclusions Botulinum toxin type A was as effective as amitriptyline for the prophylactic treatment of chronic daily migraines.

Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients

Anismus is a significant cause of chronic constipation. This study came to revive the results of BFB training and BTX-A injection in the treatment of anismus patients. Forty-eight patients with anismus (33 women; mean age 39.6 +/- 15.9) were included in this study. All patients fulfilled Rome II criteria for functional constipation. All patients underwent anorectal manometry, balloon expulsion test, defecography, and electromyography (EMG) activity of the EAS. All patients had non-relaxing puborectalis muscle. The patients were randomized into two groups. Group I patients received biofeedback therapy, two times per week for about 1 month. Group II patients were injected with BTX-A. Follow-up was conducted weekly in the first month then monthly for about 1 year. In the BFB training group, three patients quit before the end of sessions with no improvement; initial improvement was recorded in 12 patients (50%) while long-term success was recorded in six patients (25%). In the BTX-A group, clinical improvement was recorded in 17 patients (70.83%), but the improvement persisted only in eight patients (33.3%). There is a significant difference between BTX-A group and BFB group regarding the initial success, but this significant difference disappeared at the end of follow-up. Manometric relaxation was achieved significantly post-BFB and post-BTX-A injection with no significant difference between the two groups. Biofeedback training has a limited therapeutic effect on patients suffering from anismus. BTX-A injection seems to be successful for temporary treatment of anismus.

Efficacy and impact of botulinum toxin A on quality of life in patients with neurogenic detrusor overactivity

To evaluate the effect of a single injection of 500 U of botulinum toxin A (BTX-A; Dysport) on use of oral rescue medication, bladder compliance, continence and quality of life in a randomized, placebo-controlled, double-blind study in patients with incontinence due to neurogenic detrusor overactivity. As this group of patients often have severe symptoms, oral tolterodine was allowed as rescue medication and the amount of tolterodine consumed was our primary endpoint. A total of 31 patients with urinary leakage due to spinal cord injury, myelomeningocele, trauma at birth, multiple sclerosis and myelitis of another cause were randomized to intravesical injections of either 500 U of BTX-A or placebo. Intake of tolterodine and episodes of urinary leakage were registered. Cystometry was performed after 6, 12 and 26 weeks and quality of life was assessed. Patients in the BTX-A group had a significantly lower intake of tolterodine throughout the study compared to those in the placebo group (p=0.003). Cystometric capacity was significantly higher at 6 (p<0.001) and 12 weeks (p=0.026) and maximum detrusor pressure and frequency of urinary leakage were significantly (p<0.01) lower during follow-up in the BTX-A group compared to the placebo group. In addition, many quality-of-life parameters were significantly improved in the BTX-A group compared to the placebo group. Intravesical injection of 500 U of BTX-A in patients with neurogenic detrusor instability was shown to be an effective treatment which reduced use of oral medication, high detrusor pressure and frequency of urinary leakage during the overall study period of 26 weeks. Quality of life was also significantly improved.

Novel therapeutic agents: BOTOX (Botulinum Toxin Type A) treatment of patients with sub-acute low back pain: A randomized, double blind, placebo-controlled study

BTX-A (Botulinum Toxin Type A, BOTOX®, Allergan) injections have become a common treatment for soft tissue back pain. However, rigorous placebo-controlled studies are uncommon in this indication. To assess BTX-A efficacy for sub-acute low back pain in a randomized, double blind, placebo-controlled, placebo run-in trial. At screening, placebo injections were made in 59 patients with low back pain (31m, 28f; average age:43; average pain VAS score: 7.31). Twenty-eight did not show a placebo response and were randomized into this study. At baseline, (screening +4 weeks), 15 patients received placebo and 13 received BTX-A. Injections were made at 5 bilateral paraspinal sites from lumbar 1 to para-lumbar 5. Per-site doses were 1.6 mL placebo, or 40U BTX-A totaling 400U in the treatment group. Examinations, (including two questionnaires: Oswestry Low Back Pain Disability, and Low Back Pain Impact), were made at screening, baseline, 4, 8, and 12 weeks. Patients kept a diary of concomitant medications and adverse events. At week 4 post-injection, average VAS scores had decreased –2.2 points in the BTX-A group and -0.3 points in the placebo group (p=0.03). By weeks 8 and 12 average scores had decreased -2.7 and -3.2 points with BTX-A, but only -1.0 and -1.1 points with placebo (p=0.036 and 0.01 respectively). Both questionnaires showed that although some patient perception indices improved with BTX-A, distinction between groups was inconclusive overall. BTX-A injections produce a significant and sustained decrease in low back pain VAS scores in patients pre-screened for responsiveness to placebo. While this result clearly demonstrates BTX-A efficacy, larger controlled trials are still needed.

A randomized, double‐blind, placebo‐controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke

To study the efficacy and safety of botulinum toxin type A (BtxA) in the treatment of upper limb muscle spasticity, caused by stroke. This was a randomized, controlled trial. Patients received either placebo injections or a total of 1000 IU of BtxA (Dysport) into five muscles of the affected arm. Muscle tone was assessed using the Modified Ashworth Scale (MAS). Other outcome measures were the change in the joint range of motion (ROM), the Barthel index, pain score, goal attainment and the subjective evaluation of benefit by patients and investigators. The patients were assessed blind to randomization at baseline and 4, 8, 12 and 16 weeks after treatment. Fifty nine patients were recruited and received treatment. One patient was lost to follow-up before the last scheduled visit of the study. The group of patients who received BtxA had a significant reduction in the summed MAS score at week 4 compared with the placebo group (P=0.004). The magnitude of benefit over the 16 week follow-up period was significantly reduced for the BtxA group in the wrist (P=0.004) and the finger joints (P=0.001) when compared with the placebo. There was no statistically significant difference between the groups in the joint ROM, muscle pain, goal-attainment or the Barthel index scores at week 4 of the study. At week 16, the BtxA group showed significantly greater improvement in the passive ROM at the elbow (P=0.036). The patients' global assessment of benefit at the end of the study showed that 16 (50%) patients in the placebo group had 'much improved' or had 'some improvement' compared with 24 (92.3%) patients in the BtxA group (P=0.007). The investigators' rating for the same item was 16 (50%) and 23 (88.4%) patients, respectively (P=0.002). Sixteen and twenty patients in the BtxA and placebo groups, respectively, had an adverse event. The most frequently reported adverse events were accidental injury, respiratory and urinary tract infections and muscle pain. The findings of the present study suggest that treatment with BtxA in a dose of 1000 units reduces muscle tone in patients with post-stroke upper limb spasticity. This effect is sustained for at least 16 weeks. BtxA is safe in the dose used in this study. IMPORTANT NOTE: The authors wish to emphasize that the botulinum toxin preparation used in this study was Dysport (Ipsen Ltd) which has a different therapeutic equivalence from other commercially available product, Botox (Allergan Inc.).