BTA Injection Research Articles

Open label experience of repeated OnabotulinumtoxinA injections towards the sphenopalatine ganglion in patients with chronic cluster headache and chronic migraine.

A novel technique for injection of OnabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) has shown promise in refractory chronic migraine (CM) and chronic cluster headache (CCH). Open label safety and efficacy data are presented here. Patients with refractory CM or CCH who had received at least one injection and completed headache diaries were included. Efficacy was defined as ≥50% reduction in moderate-to-severe headache days for CM, or ≥50% reduction in attack frequency for CCH, at weeks five to eight. Over 261 injections, there were 123 adverse events (AE), of which one was serious. Most (93%) AEs were mild and all were transient. The 50% response to one injection was 81% for CM and 69% for CCH. The response gradually reduced over subsequent months for CM but stayed between 55% and 67% for CCH. Repeated injections were beneficial. Injections resulted in improvement for both groups and was maintained with repeated injections. Repeat injection after three months may be beneficial in CM. Adverse events were not uncommon, but universally transient, presumably as a result of the mechanism of action of BTA. Repeated BTA injection towards the SPG could be an effective treatment for refractory CM and CCH. Larger, randomised, placebo-controlled trials are required.

OnabotulinumtoxinA Injections for the Treatment of Myofascial Pelvic Pain: 12-Year Experience at a Tertiary Care Academic Center

Objective: The aim of this study was to highlight the safety of OnabotulinumtoxinA (BTA) injections, with or without concurrent pudendal nerve block, in treating women with myofascial pelvic pain (MFPP). Design: This was a retrospective cohort study. Setting: The review was conducted in a tertiary care academic center. Participants/Materials: We conducted a chart review of patients who were diagnosed with MFPP and treated with BTA with or without pudendal nerve block between January 2010 and February 2022. Methods: BTA was injected transvaginally into the pelvic floor muscle group. The primary outcomes were adverse events after BTA injections, and the secondary outcome was the effect of concomitant pudendal nerve block at the time of BTA injections. Results: The cohort included 182 patients; 103 (56.6%) received BTA injections with pudendal nerve block, and 79 (43.4%) received BTA alone. There were no significant demographic differences between the two groups. Post-treatment complications of BTA administration included worsening of pelvic pain (11.5%), constipation (6.6%), urinary tract infection (2.7%), urinary retention (3.8%), and fecal incontinence (2.7%). No statistical difference was noted in the number of phone calls, patient-initiated electronic messages, emergency room visits, or clinic visits for both groups within 30 days post-treatment. The mean number of total injections was 1.6 in the BTA-only group and 1.7 in the BTA with pudendal block group (p = 0.421). Median time to re-intervention with a second BTA injection was 6.0 months; 5.6 months in the BTA with pudendal block group; and 6.8 months in the BTA-only group, p = 0.46. There were 63 re-intervention events after BTA injections. Limitations: Limitations of our study include the retrospective design making it vulnerable to missing or incomplete data available for review. Conclusion: OnabotulinumtoxinA is beneficial in treating women with MFPP; with a duration of therapeutic effect of approximately 6 months. The use of a concurrent pudendal nerve block did not impact clinical outcomes.

The Roles of Media, Social Comparison and Self-discrepancy on Overweight/Obese Patients’ Decision to Undergo Intragastric Botulinum Toxin-A Injection

Body image is the sum of individuals’ perceptions of their own bodies. There are various factors that affect body image, one of which is sociocultural factors. Sociocultural factors, including family, peers and the media, are important factors affecting the body image of individuals. The effects of being overweight on one’s body image perception has been one of the most frequently researched topics in recent years. Studies have also shown that comparing one’s body with people in the media, and the dissatisfaction with one’s body resulting from it, motivates people to resort to various methods of losing weight. Doctors recommend various procedures for health reasons. Moreover, overweight women choose some surgical procedures such as intragastric botox injection, due to their concerns about their body image. Intragastric Botulinum Toxin-A injection (stomach botox) is one of them. This study aims to explore how sociocultural factors affect the overweight/ class I obese female patients’ decision to undergo an intragastric botox injection treatment from an interpretative phenomenological approach. The sample of the study consisted of 12 female patients who had an intragastric botox injection in the last six months. Semi-structured interviews were conducted with the patients. The interpretive phenomenological analysis revealed seven themes; self-definition through physical characteristics, motivations towards intragastric botox injection, attitudes towards the body, the perceived effects of being overweight, comparing one’s own body, the role of the media in the decision-making process, and treatment plans for changing one’s appearance in the future. It has been found that the body image perceptions of the patients play an important role in the processing-decision-making processes.. In addition, it has been observed that social media is a channel frequently used by patients for the purpose of obtaining information. The study is important in terms of trying to understand cognitive processes including self-evaluations and body image, their motivations behind intragastric BTA injection, and attitudes toward their bodies. 

OV02 COMPLEX PARASTOMAL HERNIA REPAIR WITH MESH FISTULA AND MESH INFECTION

Abstract Aim Parastomal hernias of any size can be difficult to manage and greatly affect a patient’s quality of life, however, they can be even more problematic when associated with loss of domain and infection. The aim of our video was to demonstrate open repair of a massive parastomal hernia complicated by loss of domain, mesh fistula, and mesh infection. Material and Methods Images and footage from clinic and the operative procedure were included. Results A 51-year-old female with a history of prior APR followed by failed ventral and parastomal hernia repairs presented with a massive parastomal hernia that was significantly impacting her and her family’s quality of life. Due to her hernia, she had become immobile and was bed bound. Furthermore, the hernia had caused significant chronic constipation secondary to colonic dysmotility. The patient also had loss of domain, and her hernia appeared to be complicated by a chronic mesh infection with a draining sinus. She underwent pre-operative bilateral botulinum toxin A injection in the oblique abdominal musculature. She then underwent open preperitoneal parastomal hernia repair with biologic mesh, excision of prior mesh, primary fistula repair, total abdominal colectomy, and end ileostomy. The patient tolerated the procedure well without complications and has continued to do well in follow-up. She has had great improvement in her quality of life. Conclusions In this patient with a massive parastomal hernia complicated by loss of domain, mesh fistula, and mesh infection, we demonstrate a successful open preperitoneal repair following pre-operative BTA injection.

Targeted chemodenervation of the posterior belly of the digastric muscle for the management of jaw discomfort in facial synkinesis

Botulinum toxin (BT-A) chemodenervation has been proved to significantly improve the physical and psychological well-being of patients suffering from facial synkinesis. Despite this, a cohort of patients has persistent tightness and discomfort around the angle of the jaw, which may be caused by synkinesis within the posterior belly of digastric (PBD) muscle. This study was designed to evaluate the benefits of ultrasound-guided BT-A injections into the PBD. Thirty-three patients with recalcitrant tightness and discomfort around the angle of the jaw, despite maximal facial therapy and platysmal chemodenervation were selected for inclusion. Patients underwent ultrasound-guided BT-A injection into the ipsilateral PBD muscle (skin puncture site 1 cm inferior and posterior to the angle of mandible). Outcomes consisted of the Facial Disability Index (FDI), Synkinesis Assessment Questionnaire (SAQ), and a visual analogue scale (VAS) designed to assess tightness and pain around the PBD when moving the jaw, swallowing, and masticating. Questionnaires were completed two weeks before and postinjection. Statistical analysis was performed using a paired t-test. Nineteen patients completed the post-treatment outcome questionnaire. A statistically significant improvement was noted in the physical and social function aspects of the FDI and all aspects of the patient-reported VAS scores apart from tightness and pain on jaw retrusion and swallowing. There was no significant difference in the SAQ. This study has demonstrated the patient-perceived benefit of ultrasound-targeted BT-A chemodenervation of PBD. This represents a low-risk treatment option that can be easily added to the repertoire of treatments offered to patients with post paralysis facial synkinesis.

Chronic Migraine and Medication Overuse Headache Worsening After OnabotulinumtoxinA Withdrawn Due to the Severe Acute Respiratory Syndrome-Coronavirus-2 Pandemic.

Introduction: OnabotulinumtoxinA (BT-A) is a preventive treatment for chronic migraine (CM), which needs to be administered regularly by a trained clinician every 3 months. The spread of the severe acute respiratory syndrome coronavirus-2 pandemic has forced many patients to momentarily stop the scheduled BT-A injections. The goal of this study was to explore whether those patients experienced a worsening of their CM and, if any, the clinical predictors of migraine worsening after BT-A withdrawal.Methods: This was a retrospective, multicenter study. Patients' clinical data were obtained from their clinical documentation stored at each center. In particular, the following variables were collected: the mean number of headache days in the last month (NHD), the average number of painkillers taken in the last month (AC), the average number of days in which patients took, at least, one painkiller in the last month (NDM), the average intensity of migraine using the numeric rating scale (NRS) score in the last month, and the average score obtained at the six-item Headache Impact Test. The variables mentioned earlier were compared before and after BT-A withdrawal.Results: After BT-A suspension, there was a significant increase in the NHD (P = 0.0313, Kruskal–Wallis rank test), AC (P = 0.0421, Kruskal–Wallis rank test), NDM (P = 0.0394, paired t-test), NRS score (P = 0.0069, Kruskal–Wallis rank test), and six-item Headache Impact Test score (P = 0.0372, Kruskal–Wallis rank test). Patients who were not assuming other preventive treatments other than BT-A displayed similar results. Patients who experienced a >30% worsening in NHD after BT-A was withdrawn displayed a longer CM history (P = 0.001, Kruskal–Wallis rank test), a longer MOH duration (P = 0.0017, Kruskal–Wallis rank test), a higher AC value at the baseline (P = 0.0149, Kruskal–Wallis rank test), a higher NDM (P = 0.0024, t-test), and a higher average value of the NRS score (P = 0.0073, Kruskal–Wallis rank test).Conclusion: BT-A withdrawn during severe acute respiratory syndrome coronavirus-2 pandemic was associated with a general worsening in patients suffering from CM, hence the need to continue BT-A injection to avoid patients' worsening.

Combined Interventional Treatment of Refractory Chronic Migraine

Migraine is one of the main causes of disability in modern world. Treatment of chronic refractory migraine (RCM) would be a challenge even for experienced physician. The aim of this study was to analyze the effect of combination therapy for RCM: greater occipital nerve’s (GON) pulsed radiofrequency (PRF) and botulinum toxin injections. We observed 6 female patients, suffering from RCM according to the European Headache Federation criteria. All patients had long history of migraine (5–44 years) with conservative treatment failure (at least three medication groups). Their migraine could be classified as refractory for long period of time (1–10 years). All of our patients passed a combination of PRF and BTA injection as consecutive 1-day treatments. Botulinum toxin type A injections were done in accordance to the PREEMPT protocol, followed by ultrasound-guided PRF of GONs bilateral. The observation period was 6 months after the procedure. We observed a positive response to treatment in all patients with dramatic reduction of pain intensity (from 7 ± 1 to 2 ± 2 on NRS scale) and significant decrease in the number of headache days (from 22 ± 5 to 4 ± 4) during first month after treatment. Two patients (30%) were pain free after the treatment until the end of the observation. No adverse effects were registered. Bilateral GON’s PRF followed by botulinum toxin therapy as 1-day treatment may be a useful option for the treatment of refractory chronic migraine. These interventional procedures are effective, minimally invasive, inexpensive, safe, and well-tolerated and can be performed on an outpatient basis.

Clinical assessment of the effectiveness of botulinum toxin A in the treatment of temporomandibular joint pain dysfunction syndrome

Assessment of the effectiveness of botulinum toxin A in the treatment of temporomandibular joint pain dysfunction syndrome. In accordance with the diagnostic and treatment guidelines for TMJPDS, 20 patients with TMJPDS with pronounced pain on palpation of the chewing muscles, discoordination of the chewing muscles according to the EMG, and degenerative changes in the temporomandibular joint according to the MRI were examined. The patients had no contraindications to the use of botulinum toxin. Exclusion criteria: 1) age under 21 years, 2) somatic pathology, 3) refusal of the steps of the proposed diagnostic and treatment algorithm. Methods used: clinical, psychometric (visual analogue scale (VAS) - for pain assessment), X-ray, electromyographic and statistical methods. An objective reduction in the tone of the chewing muscles was observed after treatment In both groups. However, 30 days after the injection of BtA the IMPACT indicator in the first group was reduced by 403.5 µV or more (38.5%, p<0.05), while in the second group it decreased by 201.5 µV or more (25%, p<0.05). A correlation was identified between the VAS index (mean 7 points, severe pain level) and IMPACT (p<0.05). The onset of a significant pain reduction was observed one week after BtA injection, the most pronounced effect was achieved after 2 weeks and lasted for about 3 months. The use of BtA as part of the temporomandibular joint pain dysfunction syndrome treatment algorithm contributes to the creation of a «therapeutic window» for comprehensive rehabilitation of patients in this group. It increases the efficacy of the conducted treatment and contributes to a significant prolongation of the TMJPDS remission.

Effectiveness of preventive onabotulinumtoxin A injections for migraine headaches is dependent on the circadian time of administration

ABSTRACT We have previously shown that quarterly preventive onabotulinumtoxin A (BTA) injections administered to diurnally active patients for chronic migraines (CM) associate with increased discomfort when performed in the morning. The purpose of this study was to further examine if the effectiveness of preventive BTA injections depends on the procedure’s circadian timing. A total of 90 diurnally active patients with a medical history of CM and undergoing BTA injection therapy were enrolled in the study. One hundred and fifty-five units of BTA were administered according to the standardized PREEMPT protocol, either during the course of morning (AM) or afternoon (PM) clinic hours. Patients were asked to keep headache diaries, which were reviewed at the time of their follow-up BTA injections 3 months later. The number of headache days experienced during the first, second, and third month following BTA injection, and the number of headache days during the last 7 days prior to follow-up was collected, as was the self-rating of the effectiveness of BTA treatment. Fifty-five (61%) patients were injected during the AM clinic and 35 (39%) during the PM clinic. There was no difference in gender, race, and age variables between the AM and PM patients. The average total number of headache days during 3 months following injection was significantly higher for the AM-treated compared to the PM-treated patients (22.37 ± 18.85 vs. 10.54 ± 7.5, p =.0007). AM patients also reported a higher number of headache days during each of the 3 months following BTA injection. In contrast, PM patients reported higher effectiveness of preventive BTA treatment. The average number of headache days during the week prior to the follow up, as well as the presence of headache on the day of the follow-up was not significantly different between the AM and PM groups. Scheduling diurnally active CM patients with stable circadian sleep/wake routine for afternoon BTA injections appear to improve the effectiveness of BTA therapy as well as patients’ satisfaction with the treatment.

Intragastric Botulinum Toxin A Injection Is an Effective Obesity Therapy for Patients with BMI > 40kg/m2: a Systematic Review and Meta-analysis.

We conducted a systematic review and meta-analysis to assess the efficacy of intragastric BTA injection in patients with obesity and morbid obesity. Five RCTs were identified. Intragastric BTA injection was no superior to saline in absolute weight loss or BMI change, but significantly lengthened the gastric emptying time (MD, 15.57; 95% CI, 8.75 to 22.38). In meta-regression analysis, the absolute weight loss was lower in the patients with high baseline BMI. In subgroup analysis, the use of BTA in absolute weight loss was significantly lower among the patients with baseline BMI more than 40kg/m2 (MD, - 5.31; 95% CI, - 6.17 to - 4.45). The benefit of intragastric BTA injection in reduction of absolute weight was observed in patients with baseline BMI more than 40kg/m2.

Type a botulinum toxin in the management of spontaneous salivary otorrhea: a case report

BackgroundSpontaneous salivary otorrhea is a rare presentation only previously documented twice in literature where parotid salivary secretions are found in the external auditory canal. Conventional treatment of spontaneous parotid salivary fistulas includes surgical management with interposed grafts, fistula tract ablation, and possible superficial parotidectomy. Associated risks include facial nerve injury, Frey syndrome and facial scarring. Here we report the first case of spontaneous salivary otorrhea conservatively managed with a type A botulinum toxin (BTA) injection.Case presentationA 17-year-old female presented with a 5-month history of left sided otorrhea and transient left facial swelling associated with gustatory stimulation. The otorrhea fluid tested positive for salivary amylase and negative for beta 2 transferrin. Fifty units of BTA were injected into the left parotid gland under ultrasound guidance. Cessation of symptoms was achieved 3 weeks after intervention. The patient remains symptom-free at the 2 year follow up.ConclusionBTA injection was well tolerated under ultrasound guidance and has led to long-term resolution of the patient’s symptoms. BTA injection appears to be a safe and effective way to conservatively manage this rare presentation of spontaneous salivary otorrhea.

86. Onabotulinumtoxin-A treatment in chronic migraine with medication overuse: A two years Italian experience

Onabotulinumtoxin-A (BT-A) is an authorised prophylactic therapy in chronic migraine (CM). Its efficacy has been proved by both clinical trials and observational studies. Few data are still available on the efficacy of BT-A injection and the most adequate treatment interval after the first year of follow-up. This study aimed to verifyefficacy, safety and the most adequate timing of BT-A injections in CM patients during the second year of treatment. we evaluated 20 CM patients with medication overuse MO (17 females and 3 males) treated with BT-A for 24 months. After the fourth treatment, we decided to retreat responder patients based on their clinical result. Main efficacy variables were registered at each visit, including days of headache/migraine, total cumulative headache hours, MIDAS and HIT-6 scores, together with symptomatic drugs intake. All variables at week 24 maintained the improvement evidenced at week 12. Adverse events were rare and did not require treatment discontinuation. Most of the patients (n = 13) continued to perform trimestral injections, 5 patients every 4 months and 2 patients every 6 months. BT-A in CM patients is effective even after two years of treatment when administered with an individualised interval according to the clinical outcome.

Botulinus toxin in complex treatment of myofacial pain syndrome

The aim of the study was to assess the efficacy of type A Botulinus toxin (BTA) in pain release by TMJ functional pain disorders. The study included 211 patients with TMJ functional pain disorder (20.4% males and 79.6% females; mean age 45.3 years). The patients underwent clinical examination and bioelectric activity assessment of masticatory muscles by electromyography (EMG). EMG specters of 20 healthy volunteers with intact dental arches served as a control. After examination BTA was injected in muscular pain trigger points. All patients had muscular hypertonus, unilateral in 88.6% and bilateral in 11.4%. EMG showed the decrease of masticatory muscle activity on affected side to mean values of 165±20 mkV (30.0%, p<0.05) and on contralateral side to 460±31 mkV (89.6%, p>0.05). BTA injections in tensed muscles released significantly muscle-induced facial pain and improved quality of life. During 6 months follow up myofacial pain disorder relapse was seen in 3 patients. The results allow recommending BTA injection in muscular pain trigger points for treatment of myofacial pain syndrome and prolonged muscle relaxation.

Botulinum toxin injection in laryngeal dyspnea.

Data, regarding the use of botulinum toxin (BT-A) in laryngeal dyspnea, are scarce, coming from some cases reports in the literature, including Vocal fold paralysis, laryngeal dystonia, vocal cord dysfunction also called paradoxical motion of the vocal fold (PMVF), and post-neuroleptic laryngeal dyskinesia. There is no consensus regarding the muscles and the doses to inject. The aim of this study is to present a retrospective review of patients treated in our ENT Department by BT-A injection in this indication. This study is a retrospective study describing patients who underwent an injection of botulinum toxin for laryngeal dyspnea in the ENT Department from 2005 to 2015years. The inclusion criteria were a dyspnea associated with a laryngeal dysfunction, confirmed by flexible fiberoptic nasopharyngolaryngoscopy. Information concerning the causes of the dyspnea, the botulinum toxin BT-A injections procedure, post-injection follow-up, and respiratory outcome were collected for all patients included. In the group of 13 patients included, the main cause identified as principal factor linked with the short breath was: a bilateral VF paralysis (Patel et al., Otolaryngol Head Neck Surg 130:686-689, 7), laryngeal dystonia (Balkissoon and Kenn, Semin Respir Crit Care Med 33:595-605, 2), Anxiety syndrome associated with unilateral vocal fold paralysis or asthma (Marcinow et al., Laryngoscope 124:1425-1430, 3), and an isolated asthma (Zwirner et al., Eur Arch Otorhinolaryngol 254:242-245, 1). Nine out of the thirteen patients were improved by the injections. A BT-A-induced stable benefit for four patients led them to stop the injections in the follow-up. Good outcome was observed in five other patients (main cause: bilateral VP paralysis), allowing a progressive lengthening of the delay between BT-A injections. Four patients did not report a positive risk/benefit ratio after BT-A injections; two of them (with bilateral VF paralysis), because of respiratory side effects and lack of benefit without the side effects for the two others. This failure of effect was not related with BT-A doses injected. This study provides support for using BT-A injections as a symptomatic treatment of periodic laryngeal dyspnea, regardless of the etiologic context. From our data, we suggest that a small starting dose (of around 4 U BT-A Botox®) could be enough for a first injection to obtain a good benefit. The target muscle should be determined by the EMG analysis.

Effect of endoscopic pyloric therapies for patients with nausea and vomiting and functional obstructive gastroparesis.

To determine the effect of botulinum toxin A (btA) injection or balloon dilation (BD) of the pylorus on symptoms and body weight in patients with GP and 3cpm GMA. Patients were identified who had GP, normal 3cpm GMA, and normal endoscopy that excluded mechanical obstruction of the pylorus. Electrogastrograms (EGG) with water load tests (WLT) were recorded to determine GMA. Gastric emptying was measured with 4h scintigraphy. Each patient underwent up to three pyloric treatments with btA or BD. Thirty-three patients (29 women) with an average age of 42years were studied. Seventy-nine percent had idiopathic GP and 21% had diabetic GP. The average percent meal retained at 4h was 42% and each EGG test showed normal 3cpm GMA. Nausea was the major symptom in 76% of patients. Complete or partial symptom response occurred in 75%, 72%, and 88% of patients after the first, second, or third endoscopic pyloric treatment, respectively. Overall, 78% of the 33 patients reported improvement in symptoms and average weight gain was 1.54lb from baseline to final treatment (p<0.04). Pyloric therapies appear to be effective treatments in symptomatic patients with GP and 3cpm GMA and controlled trials are warranted.

Electromyographic control of botulinum toxin a injections in the upper extremities in patients with spasticity of various etiology

The study was aimed at studying the efficacy of botulinum toxin A injections combined with EMG-control of the injections in patients with upper limb spasticity of various etiology for decreasing muscle tone and improving the passive limb function as well as at assessing the possibility of a botulinum toxin dose reduction under combination of these methods. 61 patients with upper limb spasticity of different etiology were evaluated. The main group consisted of 29 patients who were injected with abobotulinum, the botulinum toxin A (500 U per vial), under EMG-control. The control group consisted of 32 patients who received BTA injections without EMG-control. A repeated BTA injection was performed on the 4th month of the study. Patients in both groups received standard rehabilitation therapy. The spasticity pattern was determined using the Arm Spasticity Pattern (ASP) scale. Evaluation of the treatment efficacy was performed using the modified Ashworth scale to determine upper limb spasticity and the modified Barthel Index scale to assess the quality of life as well as the Disability Assessment Scale (DAS) and Clinical Global Impression (CGI) scale. The main spasticity patterns were as follows: the type III was in 13 (44.8%) and 17 (53.1%) patients, the type I was in 9 (31.0%) and 9 (28.1%) patients, and the type VI was in 7 (24.2%) and 6 (18.8%) patients of the main and control groups, respectively. One month after BTA treatment, a significant improvement was observed in both groups, but the improvement in the main group was more pronounced compared to that in the control group (р<0.05). This difference persisted for the whole treatment period (р<0.05). The DAS score demonstrated improvement in both groups, but only patients of the main group had a statistically significant improvement in putting the arm through a sleeve (р<0.05). EMG-control enabled a reduction in the BTA dose by 50-300 U. BTA injections under EMG-control in upper limb spasticity patients may improve the treatment efficacy.

An analysis of treatment of the Russian group of patients in the international observational study «Factors influencing response to botulinum toxin type A in patients with idiopathic cervical dystonia»

The analysis of the results of treatment of the Russian patient population in the frame of international, multicenter, non-interventional study of CD, the primary purpose of which was to determine the response rate to therapy with BTA at the peak of the effect: after one course of injections in settings of routine practice, as well as the results of application of modern definition for "response" to treatment with BTA. In Russia 60 patients with idiopathic CD were included. Patients were classified as «responders» according to the following 4 criteria: effect size (improvement by ≥ 25% assessed by TWSTRS); effect duration: ≥ 12 weeks interval between the BTA injection and the day when the patient reported a decrease of clinical effect, indicating the need for repeated treatment; good tolerability of treatment (no treatment-related serious adverse events (AEs) during the study period); patient-reported Clinical Global Improvement (CGI) score is +2 («significant improvement») or +3 («very significant improvement») at the visits 2 or 3. In the Russian population, patients with a ≥ 25% improvement by TWSTRS scale at visit 2 (peak effect) accounted for 88.3%. Most of patients (81.6%) and physicians (81.7%) evaluated the efficacy of therapy as a «significant improvement» or «very significant improvement» by CGI. The criterion of the effect duration was achieved in 50% of cases. The BTA therapy was well tolerated (no severe AEs related to treatment) in 98.3% of patients. Overall, 40% of all patients met all the criteria for response to BTA treatment. According to the analysis of the general population, a high degree of response was observed for the effect size (73.6%), tolerability (97.5%) and patient-reported global clinical improvement (69.8%). Subjective assessment of the duration of the effect was achieved in 49.3% of patients, with 28.6% of patients considered as responders. Most patients met three of the four criteria. The proposed multifactorial definition of «response» may be of practical use for routine practice.

Botulinum Toxin Treatment in Patients Up to 3 Years of Age Who Have Esotropic Duane Retraction Syndrome

ABSTRACTPurpose: To report the results of botulinum toxin (BOTOX®, Allergan) type A (BTA) bilateral injection in the treatment of Duane retraction syndrome (DRS) type 1 in patients aged up to 3 years.Methods: We studied the results of BTA bilateral injection in eight consecutive patients with DRS type 1 and esotropia in primary gaze. Average follow-up was 74 ± 71 months. The main variables analyzed were horizontal and vertical deviation and face turn. Patients were anesthetized with nitrous oxide (N2O). A mean dosage of 5.6 ± 1.8 IU (range 2.5–7.5 IU) of botulinum toxin diluted in 0.9% saline solution was injected under electromyography control in each medial rectus muscle.Results: Seven patients had one affected eye and one patient had bilateral involvement. The mean preoperative esotropia was 32 ± 10 prism diopters (PD). Three patients (37.5%) had also a vertical deviation. All patients had face turn ranging between 15° and 45° before BTA injection. In the last follow-up, 4 patients were orthotropic (50%), 1 (12.5%) had 3 PD exotropia and 3 (37.5%) had esotropia averaging 25 PD mean. The 3 esotropic patients needed surgical correction. Vertical strabismus improved in 3 patients achieving complete resolution in one of these patients. Two patients, without vertical strabismus before the BTA injection, developed a 5-PD vertical deviation, one of them required surgery. Face turn improved in all patients.Conclusion: Botulinum toxin injection is an alternative treatment for patients with DRS type 1 presents esotropia and face turn in children up to 3 years of age.

Onabotulinumtoxin A for Treating Overactive/Poor Compliant Bladders in Children and Adolescents with Neurogenic Bladder Secondary to Myelomeningocele

This retrospective study was performed to verify the efficacy and safety of Onabotulinumtoxin A (BTX-A) in treating children with neurogenic bladder (NB) secondary to myelomeningocele (MMC) with detrusor overactivity/low compliance. From January 2002 to June 2011, 47 patients out of 68 with neuropathic bladder were selected (22 females, 25 males, age range 5–17 years; mean age 10.7 years at first injection). They presented overactive/poor compliant neurogenic bladders on clean intermittent catheterization, and were resistant or non compliant to pharmacological therapy. Ten patients presented second to fourth grade concomitant monolateral/bilateral vesicoureteral reflux (VUR). All patients were incontinent despite catheterization. In the majority of patients Botulinum-A toxin was administered under general/local anesthesia by the injection of 200 IU of toxin, without exceeding the dosage of 12IU/kg body weight, diluted in 20 cc of saline solution in 20 sites, except in the periureteral areas. Follow-up included clinical and ultrasound examination, urodynamics performed at 6, 12 and 24 weeks, and annually thereafter. Seven patients remained stable, 21 patients required a second injection after 6–9 months and 19 a third injection. VUR was corrected, when necessary, in the same session after the BT-A injection, by 1–3 cc of subureteral Deflux®. Urodynamic parameters considered were leak point pressure (LPP), leak point volume (LPV) and specific volume at 20 cm H2O pressure. The results were analyzed using the Wilcoxon test. All patients experienced a significant 66.45% average increase of LPV (Wilcoxon paired rank test = 7169 × 10 −10) and a significant 118.57% average increase of SC 20 (Wilcoxon paired rank test = 2.466 × 10 −12). The difference between preoperative and postoperative LPP resulted not significant (Wilcoxon paired rank test = 0.8858) No patient presented severe systemic complications; 38/47 patients presented slight hematuria for 2–3 days. Two patients had postoperative urinary tract infection. All patients were hospitalized for 24 h with catheterization. Thirty-eight out of 47 patients achieved dryness between CIC; nine patients improved their incontinence but still need pads. Ten patients have resumed anticholinergic agents. Our results suggest that the use of BTX-A is safe and effective in patients with MMC with a positive effect on their dryness and quality of life.

Therapeutic application of Botulinum Toxin A in patients with local muscle dystonia and oral dyskinesia

Botulinum Toxin Type A has been introduced as new therapeutic regime in neurological, cosmetic, urinary, gastrointestinal and pain-related conditions. The use of Botulinum Toxin A in craniomandibular disorders is discussed controversially. Local muscle dystonia is defined as movement disorder in combination with sustained muscle contractions. Contortion, repetitive movements and atypical posture are frequently seen symptoms in such cases. The movements are involuntary and often painful. A single muscle or a group of muscles, even the whole body may be involved. Oral dyskinesias are involuntary repetitive movements of the mouth and face. Severe bruxism can be included in this form of movement disorder. Within this study, patients diagnosed with severe bruxism or local muscle dystonia including oral dyskinesia were examined with electromyography before and after treatment. Subjects were randomly allocated to either myo-relaxation medication and relaxation splint therapy or to Botulinum Toxin A injection therapy. Surface EMG parameters of chewing and neck muscles were used to judge the treatment effects. A positive impact of BTA on EMG-characteristics, reflecting the functional condition of facial muscles, had been detected. BTA injections seem to have a positive effect in patients with bruxism and local muscle dystonia. An increased quantity of mandibular movements and a better coordination can be observed after BTA injection. In comparison with a standard myo relaxation therapy, the effects of BTA treatment are more distinct and long standing. BTA appears to be a promising therapeutic regime in patients with focal muscle dystonia and oral dyskinesia. A confirmed diagnosis and lege artis application by experienced clinicians constitute as sine qua non. Further studies are required to improve our knowledge in Botulinum Toxin A treatment of muscle dystonia and dyskinesia.