Long-term Efficacy Of Botulinum Toxin Research Articles

Longitudinal Assessment of Botulinum Toxin Treatment for Lateral Trunk Flexion and Pisa Syndrome in Parkinson's Disease: Real-life, Long-Term Study.

Lateral trunk flexion (LTF) and its severe form, called Pisa syndrome (PS), are highly invalidating axial postural abnormalities associated with Parkinson's disease (PD). Management strategies for LTF lack strong scientific evidence. We present a real-life, longitudinal study evaluating long-term efficacy of botulinum toxin (BoNT) injections in axial muscles to reduce LTF and PS in PD. A total of 13 PD patients with LTF > 5° received ultrasound- and electromyography-guided BoNT injections every 4 months. Seven untreated matched PD patients with LTF served as controls and their changes in posture after 18 months were compared with those of seven patients continuing BoNT over 12 months. 53.8% of patients continued the BoNT injections for at least 12 months. Various individual LTF responses were observed. Overall, BoNT-treated patients obtained a not statistically significant improvement of LTF of 17 ± 41% (p = 0.237). In comparison, the seven untreated PD patients suffered a deterioration in LTF over 12 months by 36 ± 45% (p = 0.116), showing a significantly different trajectory of posture change (p = 0.026). In conclusion, repeated BoNT injections in axial muscles showed varying effects in managing PD-associated LTF, suggesting that: (a) a relevant number of patients with LTF can benefit from BoNT; (b) long-term treatment could prevent LTF worsening; (c) an instrumented, personalized approach is important; and (d) there is a need for prospective, long-term studies.

Long-term outcomes of Botulinum toxin in the treatment of chronic anal fissure: 5 years of follow-up.

Chronic anal fissure is a frequent and disabling disease, often affecting young adults. Botulinum toxin and lateral internal sphincterotomy are the main therapeutic options for refractory cases. Botulinum toxin is minimally invasive and safer compared with surgery, which carries a difficult post-operative recovery and fecal incontinence risk. The long-term efficacy of Botulinum toxin is not well known. The aim of this study was to evaluate the long-term efficacy and safety of Botulinum toxin in the treatment of chronic anal fissure. This was a retrospective study at a single center, including patients treated with Botulinum toxin from 2005 to 2010, followed over at least a period of 5 years. All patients were treated with injection of 25U of Botulinum toxin in the intersphincteric groove. The response was registered as complete, partial, refractory and relapse. Botulinum toxin was administered to 126 patients, 69.8% (n = 88) were followed over a period of 5 years. After 3 months, 46.6% (n = 41) had complete response, 23.9% (n = 21) had partial response and 29.5% (n = 26) were refractory. Relapse was observed in 1.2% (n = 1) at 6 months, 11.4% (n = 10) at 1 year, 2.3% (n = 2) at 3 years; no relapse at 5 years. The overall success rate was 64.8% at 5 years of follow-up. Botulinum toxin was well tolerated by all patients and there were no complications. The use of Botulinum toxin to treat patients with chronic anal fissure was safe and effective in long-term follow-up.

The role of Botulinum toxin injection in the management of achalasia

Botulinum toxin injection into the lower esophageal sphincter is an established therapy for the treatment of achalasia. This review will highlight recent studies that shed light on the role of Botulinum toxin injection in the management of achalasia. Recent studies have shown that Botulinum toxin injection is the most common initial endoscopic therapy for achalasia, most likely due to its safety and ease of administration. However, this trend represents a deviation from recent guidelines which consider Botulinum toxin injection less efficacious than alternative treatments like pneumatic dilation and laparoscopic Heller myotomy. Over the past decade, multiple commercial formulations of Botulinum toxin injection have been introduced, but the techniques, indications, and therapeutic efficacy for Botulinum toxin have largely remained unchanged. This review will evaluate recent guidelines, consensus articles, meta-analyses, and landmark studies to expound on the short and long-term efficacy of Botulinum toxin, injection dosages, and technique, as well as its efficacy compared to pneumatic dilation, myotomy, and combination therapy. Despite its relatively poor long-term efficacy, Botulinum toxin injection continues to play an important role in elderly patients with comorbidities and as salvage therapy for achalasia.

The use of botulinum toxin type A in masseteric muscle hypertrophy: Long-term effects and lasting improvement

In this study, we aimed to evaluate the long-term efficacy of botulinum toxin A injection in reducing the masseter muscle thickness. Between 2007 and June 2008, we retrospectively analyzed the data from 28 patients (21 females, 7 males; mean age: 25.5±4.5 years; range 20 to 46 years) with benign masseter hypertrophy treated with botulinum toxin A injections. All patients were diagnosed by the morphometric analysis of the masseter muscle. The injections were repeated intermittently every six months and totally for six times. The patients were recalled and the last measurement was performed at a mean follow-up of 13.2 months. The values obtained following consecutive injections were compared and a statistically significant reduction in thickness of masseter muscle thickness after every single injection was found (p<0.001). The final measurement following treatment discontinuation revealed that this reduction was long-lasting. Botulinum toxin A injection is a safe and long-term effective therapy for the masseter muscle hypertrophy.

Long-term efficacy of botulinum toxin A for treatment of blepharospasm, hemifacial spasm, and spastic entropion: a multicentre study using two drug-dose escalation indexes

To investigate the long-term effectiveness and safety of botulinum neurotoxin A (BoNT-A) treatment in patients with blepharospasm (BEB), hemifacial spasm (HFS), and entropion (EN) and to use for the first time two modified indexes, 'botulin toxin escalation index-U' (BEI-U) and 'botulin toxin escalation index percentage' (BEI-%), in the dose-escalation evaluation. All patients in this multicentre study were followed for at least 10 years and main outcomes were clinical efficacy, duration of relief, BEI-U and BEI-%, and frequency of adverse events. BEB, HFS, and EN patients received a mean BoNT-A dose with a significant inter-group difference (P<0.0005, respectively). The mean (+/-SD) effect duration was statistically different (P=0.009) among three patient groups. Regarding the BoNT-A escalation indexes, the mean (+/-SD) values of BEI-U and BEI-% were statistically different (P=0.035 and 0.047, respectively) among the three groups. In BEB patients, the BEI-% was significantly increased in younger compared with older patients (P=0.008). The most frequent adverse events were upper lid ptosis, diplopia, ecchymosis, and localized bruising. This long-term multicentre study supports a high efficacy and good safety profile of BoNT-A for treatment of BEB, HFS, and EN. The BEI indexes indicate a significantly greater BoNT-A-dose escalation for BEB patients compared with HFS or EN patients and a significantly greater BEI-% in younger vsolder BEB patients. These results confirm a greater efficacy in the elderly and provide a framework for long-term studies with a more flexible and reliable evaluation of drug-dose escalation.

‘Why do children with cerebral palsy discontinue therapy with botulinum toxin A?’

Developmental Medicine & Child NeurologyVolume 48, Issue 4 p. 319-320 Free Access ‘Why do children with cerebral palsy discontinue therapy with botulinum toxin A?’ Michaela Linder-Lucht MD, Corresponding Author Michaela Linder-Lucht MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg University *Correspondence to: [email protected]Search for more papers by this authorJanbernd Kirschner MD, Janbernd Kirschner MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorJochen Herrmann MD, Jochen Herrmann MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorKatrin Geth MD, Katrin Geth MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorRudolf Korinthenberg MD, Rudolf Korinthenberg MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorSteffen Berweck MD, Steffen Berweck MD Department of Pediatric Neurology and Developmental Medicine, Dr von Hauner's Children's Hospital, University of Munich, Germany.Search for more papers by this authorFlorian Heinen MD, Florian Heinen MD Department of Pediatric Neurology and Developmental Medicine, Dr von Hauner's Children's Hospital, University of Munich, Germany.Search for more papers by this authorVolker Mall MD, Volker Mall MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this author Michaela Linder-Lucht MD, Corresponding Author Michaela Linder-Lucht MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg University *Correspondence to: [email protected]Search for more papers by this authorJanbernd Kirschner MD, Janbernd Kirschner MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorJochen Herrmann MD, Jochen Herrmann MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorKatrin Geth MD, Katrin Geth MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorRudolf Korinthenberg MD, Rudolf Korinthenberg MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this authorSteffen Berweck MD, Steffen Berweck MD Department of Pediatric Neurology and Developmental Medicine, Dr von Hauner's Children's Hospital, University of Munich, Germany.Search for more papers by this authorFlorian Heinen MD, Florian Heinen MD Department of Pediatric Neurology and Developmental Medicine, Dr von Hauner's Children's Hospital, University of Munich, Germany.Search for more papers by this authorVolker Mall MD, Volker Mall MD Department of Neuropediatrics and Muscular Disorders, Children's University Hospital, Freiburg UniversitySearch for more papers by this author First published: 02 March 2007 https://doi.org/10.1017/S0012162206000697Citations: 17AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. References 1 Berweck S., Heinen F. (2004) Use of botulinum toxin in pediatric spasticity (cerebral palsy). Mov Disord 19 (Suppl 8): S162– S167. 2 Jefferson RJ. (2004) Botulinum toxin in the management of cerebral palsy. Dev Med Child Neurol 46: 491– 499. 3 Brashear A., Bergan K., Wojcieszek J., Siemers ER., Ambrosius W. (2000) Patients' perception of stopping or continuing treatment of cervical dystonia with botulinum toxin type A. Mov Disord 15: 150– 153. 4 Calace P., Cortese G., Piscopo R., Della Volpe G., Gagliardi V., Magli A., De Berardinis T. (2003) Treatment of blepharospasm with botulinum neurotoxin type A: long-term results. Eur J Ophthalmol 13: 331– 336. 5 Defazio G., Abbruzzese G., Girlanda P., Vacca L., Curra A., De Salvia R., Marchese R., Raineri R., Roselli F., Livrea P., Berardelli A. (2002) Botulinum toxin A treatment for primary hemifacial spasm: a 10-year multicenter study. Arch Neurol 59: 418– 420. 6 Hsiung GY., Das SK., Ranawaya R., Lafontaine AL., Suchowersky O. (2002) Long-term efficacy of botulinum toxin A in treatment of various movement disorders over a 10-year period. Mov Disord 17: 1288– 1293. 7 Palisano RJ. (1993) Validity of goal attainment scaling in infants with motor delays. Phys Ther 73: 651– 658. 8 Herrmann J., Geth K., Mall V., Bigalke H., Schulte-Mönting J., Linder M., Kirschner J., Berweck S., Korinthenberg R., Heinen F., Fietzek UM. (2004) Clinical impact of antibody formation to botulinum toxinAin children. Ann Neurol 55: 732– 735. 9 Jankovic J., Vuong KD., Ahsan J. (2003) Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 60: 1186– 1188. Citing Literature Volume48, Issue4April 2006Pages 319-320 ReferencesRelatedInformation

Long‐term botulinum toxin efficacy, safety, and immunogenicity

To determine the long-term efficacy of botulinum toxin (BTX) treatments, we analyzed longitudinal follow-up data on 45 patients (32 women; mean age, 68.8 years) currently followed in the Baylor College of Medicine Movement Disorders Clinic, who have received BTX treatments continuously for at least 12 years (mean 15.8 +/- 1.5 years). Their mean response rating after the last injection, based one a previously described scale 0-to-4 scale (0 = no effect; 4 = marked improvement) was 3.7 +/- 0.6 and the mean total duration of response was 15.4 +/- 3.4 weeks. Although the latency and total duration of the response to treatment have not changed over time, the peak duration of response (P < 0.005) and dose per visit (P < 0.0001) have increased since the initial visit. Furthermore, global rating (P < 0.02) and peak effect (P < 0.05) have improved. In total, 20 adverse events occurred in 16 of 45 (35.6%) patients after their initial visit and 11 adverse events in 10 of 45 (22.2%) patients at their most recent injection visit. Antibody (Ab) testing was carried out in 22 patients due to nonresponsiveness; blocking Abs were confirmed by the mouse protection assay in 4 of 22 (18%) patients. Of the Ab-negative patients, 16 resumed responsiveness after dose adjustments and 2 persisted as nonrespondents. Except for 1 patient, the 4 Ab-positive and the 2 clinical nonresponders are being treated with BTX-B. This longest reported follow-up of BTX injections confirms the long-term efficacy and safety of this treatment.

Long-term efficacy of botulinum toxin A in treatment of various movement disorders over a 10-year period.

Although botulinum toxin A (BTX) has been licensed in Canada for treatment of various movement disorders since 1990, few clinical studies regarding its long-term efficacy and side effects have been reported. We conducted a retrospective analysis of 235 patients who received BTX from our movement disorders clinic over a 10-year period (January 1990 to December 1999). A total of 2,616 treatment cycles (multiple injections) were administered to 235 patients with cervical dystonia (CD), hemifacial spasm (HS), blepharospasm (BP), and other movement disorders. Substantial benefit at 5 years was seen in most patients (90% in BP, 88% in HS, 63% in CD, 100% in jaw closing and lower limb dystonia, and 56% in writer's cramp). Benefit was maintained for up to 10 years in CD, HS, and BP data, with a 75.8% benefit reported. Twenty-eight percent of patients discontinued treatment during the follow-up period due to a variety of reasons. Of these, 9.1% of patients developed primary resistance, and 7.5% of patients secondary resistance. Adverse effects, mostly minor, developed in 27% of patients at any one time, occurring over 4.5% of treatment cycles. These were most frequently reported in blepharospasm (22 of 36 patients in 40 cycles), followed by hemifacial spasm (21 of 70 patients in 46 cycles), and cervical dystonia (17 of 106 in 28 cycles). Only 1.3% of patients discontinued therapy due intolerable adverse effects. The results show that BTX is a safe and effective treatment of various types of movement disorders, and most side effects are well tolerated. Discontinuation for any reason was also low after 5 years. Efficacy was maintained after long periods of treatment with high degree of patient satisfaction.

Long-term efficacy and quality of life in the treatment of focal hyperhidrosis with botulinum toxin A.

Botulinum toxin A has been used increasingly in the treatment of focal hyperhidrosis. To assess the long-term efficacy of botulinum toxin A in the treatment of hyperhidrosis and the changes in quality of life and patient satisfaction with treatment. A questionnaire was designed to assess the efficacy using visual analog scales and the quality of life both before and after treatment using a modified Dermatology Life Quality Index scale. There was a reduction in the hyperhidrosis and a statistically significant improvement in the quality of life scores for the axillae, palms, and forehead. Botulinum toxin A injections are safe and effective for the treatment of hyperhidrosis of the axillae, palms, and forehead, resulting in an improved quality of life for patients.

Long-Term Efficacy and Quality of Life in the Treatment of Focal Hyperhidrosis with Botulinum Toxin A

BACKGROUND Botulinum toxin A has been used increasingly in the treatment of focal hyperhidrosis. OBJECTIVE To assess the long-term efficacy of botulinum toxin A in the treatment of hyperhidrosis and the changes in quality of life and patient satisfaction with treatment. METHODS A questionnaire was designed to assess the efficacy using visual analog scales and the quality of life both before and after treatment using a modified Dermatology Life Quality Index scale. RESULTS There was a reduction in the hyperhidrosis and a statistically significant improvement in the quality of life scores for the axillae, palms, and forehead. CONCLUSION Botulinum toxin A injections are safe and effective for the treatment of hyperhidrosis of the axillae, palms, and forehead, resulting in an improved quality of life for patients.

Long-Term Efficacy of Botulinum Toxin in Classical Achalasia: A Prospective Study

We sought to examine the long-term efficacy of intrasphincteric Botulinum toxin A injection in a prospective cohort study of 30 patients with achalasia. Thirty patients with classical achalasia were treated with intrasphincteric Botulinum toxin A injection. Follow-up consisted of clinical assessment, symptom scoring, and postinjection manometry. Symptomatic improvement for >3 months was seen in 23 of 30 patients (77%). Of the 23 initial responders, seven (30%) experienced a sustained symptomatic response after a single Botulinum toxin injection (mean follow-up, 21 months). The remaining 16 initial responders (70%) eventually relapsed (mean initial response, 11 months). Nine received a 2nd Botulinum toxin injection, and seven experienced an ongoing response (mean duration, 9 months); two patients eventually required a 3rd injection with good effect (mean duration, 22 months). The remaining seven patients who relapsed after Botulinum toxin opted for pneumatic dilation or surgical myotomy. Five of the seven patients who had no initial response received a 2nd injection but again did not respond. A residual lower esophageal sphincter pressure <18 mm Hg after the first Botulinum toxin injection predicted a good response to Botulinum therapy (single or multiple injections, p < 0.002, positive predictive value = 0.71, negative predictive value = 1.0). Neither initial nor sustained response to Botulinum toxin could be predicted based on gender, age, duration of illness, previous pneumatic dilation, or esophageal motility before treatment. We found that 77% of patients with classical achalasia experienced a good symptomatic response after Botulinum toxin and 30% of initial responders achieve sustained symptomatic relief after a single treatment with Botulinum toxin. The initial responders who relapsed did well with subsequent Botulinum toxin A. Lack of an initial symptomatic response and residual lower esophageal sphincter pressure > or =18 mm Hg after Botulinum toxin are associated with a poor response.

Long-term efficacy of Botulinum toxin in classical achalasia: a prospective study

OBJECTIVE: We sought to examine the long-term efficacy of intrasphincteric Botulinum toxin A injection in a prospective cohort study of 30 patients with achalasia. METHODS: Thirty patients with classical achalasia were treated with intrasphincteric Botulinum toxin A injection. Follow-up consisted of clinical assessment, symptom scoring, and postinjection manometry. RESULTS: Symptomatic improvement for >3 months was seen in 23 of 30 patients (77%). Of the 23 initial responders, seven (30%) experienced a sustained symptomatic response after a single Botulinum toxin injection (mean follow-up, 21 months). The remaining 16 initial responders (70%) eventually relapsed (mean initial response, 11 months). Nine received a 2nd Botulinum toxin injection, and seven experienced an ongoing response (mean duration, 9 months); two patients eventually required a 3rd injection with good effect (mean duration, 22 months). The remaining seven patients who relapsed after Botulinum toxin opted for pneumatic dilation or surgical myotomy. Five of the seven patients who had no initial response received a 2nd injection but again did not respond. A residual lower esophageal sphincter pressure <18 mm Hg after the first Botulinum toxin injection predicted a good response to Botulinum therapy (single or multiple injections, p < 0.002, positive predictive value = 0.71, negative predictive value = 1.0). Neither initial nor sustained response to Botulinum toxin could be predicted based on gender, age, duration of illness, previous pneumatic dilation, or esophageal motility before treatment. CONCLUSIONS: We found that 77% of patients with classical achalasia experienced a good symptomatic response after Botulinum toxin and 30% of initial responders achieve sustained symptomatic relief after a single treatment with Botulinum toxin. The initial responders who relapsed did well with subsequent Botulinum toxin A. Lack of an initial symptomatic response and residual lower esophageal sphincter pressure ≥18 mm Hg after Botulinum toxin are associated with a poor response.