Employment of higher doses of botulinum toxin type A to reduce spasticity after stroke (original) (raw)
Related papers
Journal of Neurology, 2010
Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients. Botulinum toxin type A (BoNTA) has been shown effective for upper limb spasticity. This study assesses the treatment of lower limb spasticity in a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, we evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke lower limb spasticity. One hundred twenty patients with lower limb spasticity were randomized to a single treatment with BoNTA 300 U or placebo. The tone of the ankle flexor was assessed at baseline and through 12 weeks using the Modified Ashworth Scale (MAS). Gait pattern and speed of gait were also assessed. The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS ankle score. Significant improvement in spasticity with BoNTA 300 U was demonstrated by a mean difference in the AUC of the change from baseline in the MAS ankle score between the BoNTA and placebo groups (-3.428; 95% CIs, -5.841 to -1.016; p = 0.006; t test). A significantly greater decrease from baseline in the MAS ankle score was noted at weeks 4, 6 and 8 in the BoNTA group compared to the placebo group (p \ 0.001). Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.016-0.048, Wilcoxon test), but not by the patient or physical/occupational therapist. Assessments of gait pattern using the Physician's Rating Scale and speed of gait revealed no significant treatment differences but showed a tendency towards improvement with BoNTA. No marked difference was noted in the frequency of treatment-related adverse events between BoNTA and placebo groups. This was the first large-scale trial to indicate that BoNTA significantly reduced spasticity in lower limb muscles.
Journal of Rehabilitation Medicine, 2021
B otulinum toxin A (BoNT-A) has been in clinical use for treating post-stroke spasticity for approximately 30 years and is the accepted standard of care for focal post-stroke spasticity (1). It is currently known that BoNT-A treatment is safe and effective for use in both upper and lower limb spasticity, where it can result in both active and passive functional gains (2). Furthermore, BoNT-A is a first-line pharmacological treatment in the management of post-stoke focal and multi-focal spasticity, which, along with a multidisciplinary team (MDT) approach, should be part of a rehabilitation programme to promote optimal clinical effect (3-5). In addition, the Royal College of Physicians' (RCP) guidelines for management of adult spasticity using BoNT-A JRM JRM
Botulinum Toxin Type A for the Treatment of Lower Limb Spasticity after Stroke
Drugs
Post-stroke lower limb spasticity impairs balance and gait leading to reduced walking speed, often increasing wheelchair use and caregiver burden. Several studies have shown that appropriate treatments for lower limb spasticity after stroke include injections of botulinum toxin type A (BoNT-A), phenol or alcohol, surgical correction and a rehabilitation program. In the present article, we review the safety and effectiveness of BoNT-A for the treatment of lower limb spasticity after stroke, with a focus on higher doses of BoNT-A. The cumulative body of evidence coming from the randomized clinical trials and openlabel studies selected in the article suggest BoNT-A to be safe and efficacious in reducing lower limb spasticity after stroke. Studies of high doses of BoNT-A also showed a greater reduction of severe post-stroke spasticity. In stroke survivors with spasticity of the ankle plantar-flexor muscles, a combined approach between surgery and BoNT-A can be indicated. However, controversy remains about improvement in motor function relative to post-stroke spasticity reduction after BoNT-A treatment.
Neurologia i Neurochirurgia Polska, 2021
Aim of the study. SPACE, a prospective, non-interventional, open-label, multinational study, investigated physicians' and subjects' assessment of safety, efficacy, and health-related quality of life (HRQoL) following botulinum neurotoxin type-A (BoNT-A) treatment to understand real-world clinical usage for the management of focal and multifocal spasticity. Clinical rationale for the study. Treatment guidelines recommend the use of BoNT-A for the management of spasticity in adults. This study assessed how physicians use BoNT-A therapy in real-world clinical practice, and provided evidence on long-term safety and efficacy over a period of up to 2 years. Materials and methods. BoNT treatment-naïve adults with spasticity of any aetiology received any BoNT-A formulation at their physician' s discretion, and were observed for ≤ 8 treatment cycles (≤ 2 years). Daily practice information, physician' s global assessments of tolerability and efficacy, and HRQoL were documented. Incidences of adverse drug reactions or all adverse events were documented for non-Mexican subjects and for Mexican subjects, respectively, due to protocol differences based on local regulatory requirements. Results. A total of 701 subjects were enrolled (safety population; nine countries). Physicians rated the tolerability of BoNT-A as 'very good' or 'good' for 88.2-97.4% of subjects throughout the study (subject numbers declined throughout this non-interventional study). Adverse drug reactions were reported for 16/600 (2.7%) of the non-Mexican subjects, with two considered to be 'definitely related' to treatment (injection-site haematoma, n = 1; botulism, n = 1). For 687 subjects, efficacy was rated 'very good' or 'good' by most physicians and subjects. Improvements in HRQoL were observed. Conclusions and clinical implications. Throughout this 2-year study, BoNT-A treatment was generally well-tolerated, effective, and associated with an improved HRQoL. This study makes a valuable contribution to the broader understanding of how physicians use BoNT-A therapy to manage spasticity in real-world clinical practice.
Brain injury, 2015
To determine the independent effectiveness of adjunctive therapies when provided in conjunction with botulinum neurotoxin (BoNT-A) injection for focal spasticity in adults with neurological conditions. Nine electronic databases. A systematic search was performed to identify randomized, controlled trials (RCTs) evaluating the benefit of adjunctive therapies following BoNT-A injection. Two authors extracted the data independently. Each trial was assessed for internal validity and rated for quality using the PEDro scale. Articles were further appraised using the American Academy of Neurology (AAN) evidence classification to construct concise clinical recommendations. The search identified 12 studies that reported on the effects of eight different adjunctive therapies following BoNT-A injection in adults with focal spasticity. No high level evidence was identified. The mean PEDro score for the 12 studies was 5.6 (SD = 1.6) and the clinical recommendations provided were Grade U, indicati...