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OBJECTIVE: To evaluate the effectiveness of physical rehabilitation (PR) and injections of botulinum toxin type A (BTA) in the correction of muscles hypertonicity ty of the healthy side of the face or its prevention in patients with facial nerve neuropathy (FNN). MATERIAL AND METHODS: One hundred and forty-six patients with FNN of various etiologies with muscles hypertonicity of the healthy side or the risk of its development were studied. The term of treatment was 33 [10; 99] days. There are 88 women and 58 men aged 42 [34; 56] years. Diagnosis included clinical examination and stimulation electroneuromyography (ENMG, n=113; 77.4%) with assessment of M-wave amplitude asymmetry. All patients were prescribed a standard PR complex, in addition - relaxation of the muscles of the healthy side by injections of BTA (Incobotulinumtoxin A) - BTA group (n=38) or by special PR techniques - physiotherapy group (n=108). RESULTS: In both groups, patients were comparable in age, sex and severity of FNN at clinical assessment. But objectively, in the BTA group there were more symptomatic forms (63.2% vs 43.5%; p=0.038), cases of M-wave amplitude asymmetry over 90% in ≥2 branches (52.6% vs 18.5%; p=0.032). Displacement of the face midline was a factor limiting recovery (68.4% and 62%; χ2=0.495; p=0.482) in two groups. With amplitude asymmetry of more than 90% in ≥2 branches (a predictor of the risk of unfavorable outcome), a favorable outcome occurred more often in the BTA group (80% versus 45%; χ2=5.227; p=0.023). In case of amplitude asymmetry of less than 90% in all branches, a favorable outcome was observed in two groups. CONCLUSION: Indications for botulinum therapy in patients with FNN are deep prosoparesis or prosoplegia, muscles hypertonicity of the healthy side, displacement of the face midline, ENMG predictors of the risk of unfavorable outcome. PR is an effective method of prevention in patients with a favorable prognosis of outcome or treatment of mild forms.

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OBJECTIVE: To compare the effectiveness of physical rehabilitation (PR) and botulinum therapy in the treatment of facial nerve neuropathy (FNN) complications. MATERIAL AND METHODS: Sixty-eight patients with FNN of various etiologies, including 70 women and 6 men aged 38 [31; 46] years, were studied. Time to seek medical help was 717 [256; 1638] days. Diagnosis of the motor pattern included determining the strength of facial muscles, identifying complications - muscle hypertonicity and synkinesis, assessment with the House-Brackmann Grading System, the Facial Nerve Grading System 2.0 and the Sunnybrook facial grading system. All patients were prescribed a standard PR complex, additionally muscle relaxation was performed on both sides by injections of Incobotulinumtoxin A (BTA) - BTA group (n=34; 44.7%) or special PR techniques - physiotherapy group (n=42; 55.3%). RESULTS: The both groups are comparable by age, sex, etiology and duration of treatment, however, patients in the BTA group have more severe stage of FNN (U=534.5; p=0.031). There is a limitation in the volume of active movements in patients with muscles hypertonicity of the affected side, which was associated with insufficient muscle strength. In the BTA group, the severity of complications (muscles hypertonicity and synkinesis) is decreased on the affected side, and in 1/4 of the cases it is accompanied by an increase of muscles strength. In the physiotherapy group, the decrease in the severity of complications is less significant, but is associated with an increase of muscles strength (χ2=45.505; p<0001). CONCLUSIONS: PR and botulinum toxin therapy are effective methods of treating FNN complications. Special PR techniques for relaxing and stretching muscles are applicable for the prevention and treatment of mild disorders. Botulinum therapy allows achieving a significant stable clinical effect in the treatment of moderate and severe complications (muscle hypertonicity and synkinesis).

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Background: Despite the increasing need for the improvement of enlarged facial pores, the treatment remains challenging. A few previous studies have reported the effects of micro-focused ultrasound with visualization (MFU-V) or intradermal incobotulinumtoxin-A (INCO) on enlarged facial pores. Objective: To evaluate the efficacy and safety of combined treatment with superficial MFU-V and intradermal INCO for enlarged facial pores. Methods: This single-center retrospective study included 20 patients treated with MFU-V and intradermal INCO to improve enlarged facial pores. Outcomes were evaluated 1, 4, 12, and 24 weeks after a single session of the combined procedure. Pore count and density were objectively quantitated using a three-dimensional scanner, and improvement was assessed using the physician and patient Global Aesthetic Improvement Scale (GAIS). Results: The mean pore count and density decreased after one week and decreased by up to 62% until 24 weeks. After one week, almost all patients (100% in physician GAIS and 95% in patient GAIS) showed improvement with a grade 3 (much improved) or higher. All adverse events were transient. Conclusion: Combined treatment with MFU-V and intradermal INCO could be effective and safe for reducing enlarged facial pores; the improvements can be sustained for up to 24 weeks.

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OBJECTIVE: To assess the longitudinal attainment of patient-centred and function related goals after integrated spasticity management including repeated cycles of botulinum toxin A type A (BoNT-A) injections in real life settings over a period of 2 years. The article presents analysis of the results within the subpopulation of patients from Russia. MATERIAL AND METHODS: This international, multicentre, observational, prospective, longitudinal cohort study (registered at clinicaltrials.gov as NCT02454803) included patients ≥18 years old with upper-limb spasticity of any aetiology in whom a decision had already been made to inject any BoNT-A formulation commercially available in the Russi. The treatment outcomes were evaluated using the Upper Limb Spasticity Index, which combines the patient-centred Goal Attainment Scaling (GAS) with a set of targeted standardised measures to assess the neurological impairment. The extent of functional impairment was assessed using the DAS. RESULTS: 168 Russian patients from 7 sites with a mean age of 49.8 years participated in the study. The Russian subpopulation had some differences from the overall study population in baseline characteristics of patients and injection practices of BoNT-A treatment. During the study period, the majority of Russian patients received AboBoNT-A (Dysport) injections - 142 (85%) patients at cycle 1, while OnaBoNT-A (Botox) was used in 14 (8%) patients, and IncoBoNT-A (Xeomin) - in 12 (7%) patients. Higher doses of AboBoNT-A were observed compared to the overall population, mean doses of AboBoNT-A between cycles 1 and 4 were 909-934 U in the Russian patients and 814-859 U in the overall population. In general, patients of the Russian subpopulation successfully achieved their treatment goals. The mean cumulated GAS T-score over the study was 51.1±3.0, marginally exceeding the same parameter in the overall population (49.5±5.9). Across the 6 goal domains, cumulated GAS T-scores in Russian subpopulation were highest for the goals related to passive function and pain relief, with mean scores of 51.8±4.2 and 51.6±4.8, respectively. In the overall population cumulated GAS T-scores were highest for involuntary movements (mean 50.5±5.6) and pain relief (mean 50.4±6.2). The lowest GAS T-scores were for the treatment goals related to active function in both Russian subpopulation and overall population, the mean scores were 48.3±5.5 and 46.6±7.4 respectively. The study results also showed significant improvement in in terms of reduction of muscle tone according to MAS (Modified Ashworth Scale) and the extent of functional impairment according to DAS (Disability Assessment Scale). CONCLUSIONS: The results of this subgroup analysis on patients from Russia showed high effectiveness of repeated cycles of BoNT-A injections as part of the integrated upper limb spasticity management conducted in real life settings, both in terms of reduction of muscle tone and correction of functional impairment, which contributes to the successful achievement of the treatment goals. The right choice of individual patient-centred treatment goals and methods for assessing their achievement are important components of the treatment and rehabilitation process for patients with spastic paresis of the upper limb.

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Post-stroke spasticity frequently occurs in patients with stroke, and there is a need for more quality-of-life assessments for different therapies. We evaluated for the first time in Romania the quality of life among patients with post-stroke spasticity, comparing two therapies over a 6-month period: botulinum toxin type A (BOT) with conventional therapy (CON). We also assessed the reduction of spasticity and functionality secondary to the increase in the mobility in upper limbs. This study was based on a prospective, randomized design, including subjects with post-stroke spasticity (N = 34; 34-80 years of age): in the CON arm, patients received therapy against muscle spasticity and physiotherapy, and, in the BOT arm, patients received incobotulinumtoxin-A and additionally conventional treatment, if required. Among 34 treated subjects in the two arms, the quality of life was significantly higher after BOT therapy (p < 0.001), represented by improvement in movement (p < 0.001), usual activities (p = 0.018), and distress (p < 0.001). Improvements in muscle tone (Ashworth Scale) over 6 months of treatment period were greater in the BOT arm (100%) than in the CON arm (11.8%). These preliminary results suggested that incobotulinumtoxin-A increased quality of life by improving movement, daily activities, mental health, and muscle tone more effectively than conventional therapy and could form a basis for future comparator studies.

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Sialorrhea, or excessive saliva beyond the margin of the lip, is a common problem in many neurological diseases. Previously, sialorrhea has been underrecognized in Parkinson's disease (PD) patients. Despite this, many patients rank sialorrhea as one of the most debilitating complaints of Parkinson's disease. Previous treatment for sialorrhea has been suboptimal and has been plagued by significant side effects that are bothersome and can be dangerous in patients with a concurrent neurodegenerative disease. This review sought to review the anatomy, function, and etiology of sialorrhea in PD. It then sought to examine the evidence for the different treatments of sialorrhea in PD, and further examined newer evidence for safety and efficacy in minimally invasive treatment such as botulinum toxin.

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In contrast to the prevailing arguments presented in the current review, the incidence of neutralising antibody (NAb) formation is not a significant issue for any of the present type A therapeutic botulinum neurotoxin (BoNT) products. Furthermore, clinical non-responsiveness is poorly correlated with the presence of NAbs. The overriding evidence supports the view that the rate of NAb formation is low, does not differ significantly between the different type A BoNT products and that it is not the major factor in clinical response. BoNT products are highly effective and important therapies for the treatment of a variety of neurological and non-neurological conditions.

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Objectives: In Romania, the strokes' incidence is of 61,500 per year and improving upper limb function is the essence in rehabilitation after a stroke to maximize the patient quality of life and reduce disability. In this study, it is compared the cost-effectiveness of the treatment of post-stroke upper limb spasticity with incobotulinumtoxin-A (INCO), with or without electromyographic control, against the conventional therapy programme alone (CON). Methods: A Markov state transition model was developed to effectuate a cost-utility analysis (CUA). Measurements of health-related quality of life were derived from relevant clinical trials. Utility values for quality of life by response status were derived from the Short-Form-12 (SF-12) Health Survey data from a published study. The incremental cost-effectiveness ratio (ICER) of INCO (fixed, every 12 weeks) against CON was calculated in Ron per quality-adjusted life-year (QALY) gained for both therapies. Costs and outcomes were discounted using different scenarios at 3% and 5% per year with a time horizon of 3 and 5 years because Romanian legislative norms don't specify the discount rates and time horizon for pharmacoeconomic analysis. Probabilistic sensitivity analyses (PSA) were managed on the base case with distributions attributed to the frequency of repeat dosing and utility valuation of the responder and the non-responder for health utilities derived from both mental and physical health state. Results: Compared with CON, in all 4 scenarios, therapy with INCO had an incremental cost-effectiveness ratio (ICER) of less than 950 Euro per QALY gained (1 Euro = 4.7 Ron). INCO proved to be more favorable treatment option than CON in the treatment of upper limb spasticity in Romania. Despite costs being higher for patients treated with INCO, this treatment has more advantageous Incremental Cost-Effectiveness Ratio. Conclusions: This therapy should be taken into account when considering rehabilitation options because it is highly cost-effective at < EURO 1,000/QALY gained, a very low WTP (Willingness To Pay) threshold. INCO proved to be a disruptive innovation because it is a new and more effective treatment, and, in the end, much higher in quality of life for patients with post-stroke upper limb spasticity.

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BACKGROUND: Restless Legs Syndrome (RLS) is a common movement disorder with an estimated prevalence of up to 12%. Previous small studies with onabotulinumtoxin A (OnaA) for RLS have shown inconsistent results. METHODS: Twenty-four patients with an International RLS score (IRLS) of >11 (moderate-severe) were enrolled in this blinded, placebo-controlled crossover study. Twenty-one patients completed the evaluations at 4, 6, and 8 weeks after each injection. One-hundred units of Incobotulinumtoxin A (IncoA) or normal saline were injected into tibialis anterior, gastrocnemius, and biceps femoris muscles each side. RESULTS: Improvement from a severe (IRLS >21) to a mild/moderate (IRLS ≤20) score was significant at four weeks (p = 0.0036) and six weeks (p = 0.0325) following IncoA administration compared to placebo. Additionally, there was significant improvement in pain score at six weeks as measured by Visual Analogue Scale (p = 0.04) and the Johns Hopkins Quality of Life Questionnaire (p = 0.01) in the IncoA group. Definite or marked improvement on Patient Global Impression of Change was seen in 7 out of 21 patients in the IncoA group vs. 1 out of 21 patients in the placebo group at 4 weeks (p = 0.012). CONCLUSION: IncoA injection lead to a reduction in severity of RLS symptoms, pain score, and quality of life, without any adverse effects.

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Botulinum toxin type A is one of the most useful treatments of sialorrhea in neurological disorders. Evidence for the use of incobotulinumtoxin A (inco-A) in the treatment of sialorrhea is limited. Thirty-six patients with sialorrhea were treated with infiltrations of inco-A into both parotid glands. The severity of sialorrhea was evaluated by the Drooling Severity Scale (DSS), and the Drooling Frequency Scale (DFS). Patients' perceptions of clinical benefit were recorded via the Patient Global Impression of Improvement (PGI-I) scale. Following treatment, there was a significant difference in both the DFS and the DSS (p < 0.001). Clinical benefits on the basis of the PGI-I were present in up to 90% of patients.

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Background: Sialorrhoea and drooling are disabling manifestations of different neurological disorders. The aim of this study was to evaluate the effects of botulinum neurotoxin type A (BoNT/A) injection on hypersalivation in 90 patients with neurological diseases of different aetiologies, and to define the minimum number of injected salivary glands to reduce sialorrhoea. Determining the minimum number of glands that need to be engaged in order to have a significant reduction in drooling may be very useful for establishing the minimum total dosage of BoNT/A that may be considered effective in the treatment of hypersalivation. Methods: Twenty-five mouse units (MU) of BoNT/A (onabotulinumtoxin A, Botox; Allergan, Irvine, CA, USA; 100 MU/2 mL, 0.9% saline; or incobotulinumtoxin A, Xeomin; Merz Pharma, Germany; 100 MU/2 mL, 0.9% saline) were percutaneously injected into the parotid (p) glands and/or submandibular (s) glands under ultrasound control. On this basis, patients were divided into three groups. In group A (30 patients), BoNT/A injections were performed into four glands; in group B (30 patients), into three glands, and in group C (30 patients), into two glands. Patients treated in three glands (group B) were divided into two subgroups based on the treated glands (2 p + 1 s = 15 patients; 2 s + 1 p = 15 patients). Similarly, patients being injected in two glands (group C) were subdivided into three groups (2 p = 10 patients; 1 p + 1 s = 10 patients; 2 s = 10 patients). In patients who were injected in three and two salivary glands, saline solution was injected into the remaining one and two glands, respectively. Assessments were performed at baseline and at 2 weeks after the injections. Results: BoNT/A significantly reduced sialorrhoea in 82 out of 90 patients. The effect was more evident in patients who had four glands injected than when three or two glands were injected. The injections into three glands were more effective than injections into two glands. Conclusions: Our results have shown that BoNT/A injections induced a significant reduction in sialorrhoea in most patients (91%). In addition, we demonstrated that sialorrhoea associated with different neurological diseases was better controlled when the number of treated glands was higher.

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BACKGROUND: Incobotulinumtoxin-A (Xeomin(®), Merz Pharmaceuticals, Sydney, New South Wales) is a formulation of botulinum neurotoxin type A that is free of complexing proteins. OBJECTIVE: To assess the cost-effectiveness of incobotulinumtoxin-A administered with flexible treatment intervals compared to onabotulinumtoxin-A (Botox(®), Sydney, New South Wales) in blepharospasm and cervical dystonia from the perspective of Australian health care providers. METHODS: A Markov state transition model was developed to perform a cost-utility analysis to compare the cost and health benefits of incobotulinumtoxin-A to that of onabotulinumtoxin-A. The cost-utility analysis compared incobotulinumtoxin-A treatment, given at minimum intervals of 6 weeks and maximum intervals of 20 weeks, with onabotulinumtoxin-A treatment, given at minimum intervals of 12 weeks and maximum intervals of 20 weeks. The Markov model consisted of three health states and followed patients in weekly cycles for 5 years. Only direct health care costs associated with the acquisition and administration of type A botulinum neurotoxins were included. Utility values were derived from a prospective, open-labeled cohort study. The primary outcome measure was the incremental cost per quality-adjusted life-year. Univariate and probabilistic sensitivity analyses were conducted. RESULTS: Incobotulinumtoxin-A was cost-effective compared to onabotulinumtoxin-A in both blepharospasm and cervical dystonia, with an incremental cost/quality-adjusted life-year gained of A$ 25,588 and A$ 23,794, respectively. CONCLUSIONS: Incobotulinumtoxin-A administered at flexible treatment intervals determined by the needs of the patient was found to be a cost-effective treatment option when compared to the administration of onabotulinumtoxin-A in the Australian health care system. The option to administer incobotulinumtoxin-A according to the needs of the patient resulted in patients experiencing symptoms for a fewer number of weeks compared to onabotulinumtoxin-A given at minimum 12-week intervals.

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INTRODUCTION: Botulinum toxin (BoNT) is the treatment of choice for many neurologic movement disorders, including blepharospasm, hemifacial spasm, and cervical dystonia. There are two serotypes approved for use by the US Food and Drug Administration: three brands of serotype A and one of serotype B. Many attempts have been made at establishing dose conversion ratios between brands and serotypes. This review focuses on the existing data comparing different formulations of the same BoNT serotypes as well as that comparing different serotypes with one another. We focus on existing data regarding switching from one formulation or serotype to another and will also discuss the issue of immunogenicity of BoNT. With this information as a foundation, recommendations on safety of switching agents are addressed. METHOD: Literature review searching PubMed and Google Scholar using the search terms "switching botox", "dosing equivalency in botox", and "comparing botox". RESULTS/CONCLUSION: Overall, there are many studies that demonstrate the efficacy and safety of each of the brands of BoNTs used in clinical practice. However, determination of dosing equivalencies among these brands and serotypes is complex with inconsistencies among the studies. When switching from one brand to another, the clinician should be aware of these issues, and not make the assumption that such ratios exist. Tailoring the dosage of each brand of BoNT to the clinical situation is the most prudent treatment strategy rather than focusing closely on conversion factors and concerns for immunogenicity.