Dataset Information

Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.

ABSTRACT:

Background

Inconsistent data have been reported for the effectiveness of intramuscular botulinum toxin type A (BTXA) in patients with limb spasticity after stroke. This meta-analysis of available randomized controlled trials (RCTs) aimed to determine the efficacy and safety of BTXA in adult patients with upper and lower limb spasticity after stroke.

Methods

An electronic search was performed to select eligible RCTs in PubMed, Embase, and the Cochrane library through December 2018. Summary standard mean differences (SMDs) and relative risk (RR) values with corresponding 95% confidence intervals (CIs) were employed to assess effectiveness and safety outcomes, respectively.

Results

Twenty-seven RCTs involving a total of 2,793 patients met the inclusion criteria, including 16 and 9 trials assessing upper and lower limb spasticity cases, respectively. For upper limb spasticity, BTXA therapy significantly improved the levels of muscle tone (SMD=-0.76; 95% CI -0.97 to -0.55; P<0.001), physician global assessment (SMD=0.51; 95% CI 0.35-0.67; P<0.001), and disability assessment scale (SMD=-0.30; 95% CI -0.40 to -0.20; P<0.001), with no significant effects on active upper limb function (SMD=0.49; 95% CI -0.08 to 1.07; P=0.093) and adverse events (RR=1.18; 95% CI 0.72-1.93; P=0.509). For lower limb spasticity, BTXA therapy was associated with higher Fugl-Meyer score (SMD=5.09; 95%CI 2.16-8.01; P=0.001), but had no significant effects on muscle tone (SMD=-0.12; 95% CI -0.83 to 0.59; P=0.736), gait speed (SMD=0.06; 95% CI -0.02 to 0.15; P=0.116), and adverse events (RR=1.01; 95% CI 0.71-1.45; P=0.949).

Conclusions

BTXA improves muscle tone, physician global assessment, and disability assessment scale in upper limb spasticity and increases the Fugl-Meyer score in lower limb spasticity.

SUBMITTER: Sun LC

PROVIDER: S-EPMC6475544 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.

Sun Li-Chun LC Chen Rong R Fu Chuan C Chen Ying Y Wu Qianli Q Chen RuiPeng R Lin XueJuan X Luo Sha S

BioMed research international 20190407

<h4>Background</h4>Inconsistent data have been reported for the effectiveness of intramuscular botulinum toxin type A (BTXA) in patients with limb spasticity after stroke. This meta-analysis of available randomized controlled trials (RCTs) aimed to determine the efficacy and safety of BTXA in adult patients with upper and lower limb spasticity after stroke.<h4>Methods</h4>An electronic search was performed to select eligible RCTs in PubMed, Embase, and the Cochrane library through December 2018. ...[more]

PMID: 31080830

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Project description:Background: The combined use of Robot-assisted UL training and Botulinum toxin (BoNT) appear to be a promising therapeutic synergism to improve UL function in chronic stroke patients. Objective: To evaluate the effects of Robot-assisted UL training on UL spasticity, function, muscle strength and the electromyographic UL muscles activity in chronic stroke patients treated with Botulinum toxin. Methods: This single-blind, randomized, controlled trial involved 32 chronic stroke outpatients with UL spastic hemiparesis. The experimental group (n = 16) received robot-assisted UL training and BoNT treatment. The control group (n = 16) received conventional treatment combined with BoNT treatment. Training protocols lasted for 5 weeks (45 min/session, two sessions/week). Before and after rehabilitation, a blinded rater evaluated patients. The primary outcome was the Modified Ashworth Scale (MAS). Secondary outcomes were the Fugl-Meyer Assessment Scale (FMA) and the Medical Research Council Scale (MRC). The electromyographic activity of 5 UL muscles during the "hand-to-mouth" task was explored only in the experimental group and 14 healthy age-matched controls using a surface Electromyography (EMGs). Results: No significant between-group differences on the MAS and FMA were measured. The experimental group reported significantly greater improvements on UL muscle strength (p = 0.004; Cohen's d = 0.49), shoulder abduction (p = 0.039; Cohen's d = 0.42), external rotation (p = 0.019; Cohen's d = 0.72), and elbow flexion (p = 0.043; Cohen's d = 1.15) than the control group. Preliminary observation of muscular activity showed a different enhancement of the biceps brachii activation after the robot-assisted training. Conclusions: Robot-assisted training is as effective as conventional training on muscle tone reduction when combined with Botulinum toxin in chronic stroke patients with UL spasticity. However, only the robot-assisted UL training contributed to improving muscle strength. The single-group analysis and the qualitative inspection of sEMG data performed in the experimental group showed improvement in the agonist muscles activity during the hand-to-mouth task. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03590314.

Project description:BackgroundNon-invasive neuromodulation is a promising approach for improving spasticity and motor function after stroke. However, it is still unclear which type of non-invasive neuromodulation is effective and evidence of important differences between them and botulinum toxin (BoNT) injection is limited. We aimed to assess the comparative efficacy and acceptability of non-invasive neuromodulation technologies and BoNT for post-stroke spasticity and motor function.MethodsIn this network meta-analysis, Cochrane Library, EMBASE, MEDLINE, Web of Science, Scopus, CNKI, and Wan Fang Data were searched from the earliest records to 8 October 2024. Randomised controlled trials that compared any type of non-invasive neuromodulation therapies, BoNT, and control treatments (including sham or no stimulation/injection) for post-stroke spasticity measured by modified Ashworth scale (MAS) were included. MAS, motor function, and acceptability were pooled using random-effects model with summary weighted mean difference (WMD) or risk ratios (RR) alongside 95% confidence interval (CI). Ranking probabilities of the treatments were estimated. Clinical importance was categorized as definite, probable, possible, or definitely not, considering the relationship between effect measures (95% CI) and minimal clinically important difference (1, 6, and 1.5 points for MAS, motor function, and acceptability, respectively). The quality of evidence was assessed using CINeMA online web. PROSPERO registration CRD42024543494.Findings6260 studies were identified and 185 trials (11,185 participants; 12 interventions) were included. Compared with control treatments, BoNT, high- and low-frequency repetitive transcranial magnetic stimulation (HFrTMS and LFrTMS), and anodal, cathodal, and dual transcranial direct current stimulation (atDCS, ctDCS, and dtDCS) significantly improved spasticity at short-term follow-up (WMD range -0.81 to -0.31), but did not achieve clinical importance. At mid-term, ctDCS (WMD = -2.00; 95% CI: -3.03, -0.97) and dtDCS (WMD = -1.62; 95% CI: -3.22, -0.02) were more efficacious than control treatments in reducing post-stroke spasticity with probable clinical importance. For motor function, atDCS, ctDCS, and dtDCS were more efficacious than control treatments (WMD range 6.29-13.00), with probable clinical importance, while BoNT, HFrTMS, and LFrTMS with possible clinical importance (WMD range 3.42-5.28). Various modalities have comparable acceptability to control treatments (RR range 0.48-1.46). Confidence in accordance with CINeMA ranged from high to low. Sensitivity and meta-regression analyses on limb measured, cointervention, and stroke stage confirmed the main findings of this study.InterpretationTaken together with clinical importance, evidence available supports three forms of tDCS as effective treatments for post-stroke spasticity and/or motor impairments, whereas BoNT, HFrTMS, and LFrTMS for motor impairments. These modalities could be considered alongside rehabilitation interventions as core treatments for post-stroke spasticity and motor impairments.FundingChina Postdoctoral Science Foundation (2024M752230).

Project description:BackgroundTo explore the efficacy and safety of botulinum toxin in patients who received distraction osteogenesis of the lower extremities.MethodsWe searched the PubMed, Medline, Cochrane Library, and Web of Science databases for randomized controlled trials that administered botulinum toxin to individuals who underwent distraction osteogenesis of the lower limbs. The final search was conducted on July 6, 2021. Quality assessments were conducted using the Cochrane risk of bias tool and the Jadad scale. We performed random-effects meta-analysis to calculate the standardized mean differences (SMDs) and confidence intervals (CIs) of the pooled effect sizes, and subgroup analysis and meta-regression were performed for potential moderators.ResultsOur analysis of four randomized controlled trials, which enrolled a total of 257 participants, revealed that the difference in pain during the distraction phase was not statistically significant between groups (SMD, - 0.165; 95% CI, - 0.379 to 0.050, p = 0.133, I2 = 0.0%). The meta-regression analyses did not find any influence on the effect size, considering age (β = - 0.0092; p = 0.61) and the amount of lengthening (β = 0.0023; p = 0.99). Subgroup analysis did not reveal difference between different doses of botulinum toxin and single or multi-site study design. An analysis of two randomized controlled trials enrolling a total of 177 individuals demonstrated a limited effect of botulinum toxin in reducing postoperative pain (SMD, - 0.239; 95% CI, - 0.641 to 0.162, p = 0.24, I2 = 37.6%), total adverse events (SMD, - 0.207; 95% CI, - 0.505 to 0.090, p = 0.17, I2 = 0.0%), and infection of pin site (SMD, - 0.131; 95% CI, - 0.428 to 0.165, p = 0.39, I2 = 0.0%). No botulinum toxin-related adverse events were reported.ConclusionsThe current evidence does not support the administration of botulinum toxin in patients who receive distraction osteogenesis of the lower limbs. However, we were unable to draw decisive conclusions because of the limitations of our meta-analysis. Future well-designed, large-scale randomized controlled trials are necessary to confirm our conclusions.

Project description:BackgroundThis study aimed to evaluate the combined effects of robotic training (RT) and botulinum toxin (BTX) injections on motor function and spasticity in individuals with post-stroke upper limb spasticity (ULS). We also sought to investigate the optimal timing of RT and BTX administration.MethodsForty-two participants with chronic stroke-induced ULS were initially enrolled and randomized into four groups: Group B4R4 (RT + BTX at 4 weeks [W4]), Group B0R0 (RT + BTX at baseline [W0]), Group B0R4 (BTX at W0, RT at W4), and Group B4R0 (RT at W0, BTX at W4). Clinical assessments and robotic kinematic evaluations were performed at W0, W4, and 8 weeks (W8). The primary outcome was the Fugl-Meyer assessment (FMA) score, and secondary outcomes included the modified Ashworth scale (MAS) of the elbow and kinematic parameters, such as spectral arc length, mean speed, hand path ratio, and movement deviation in various tasks. Changes in outcome measures over time were analyzed using a linear mixed-effects regression model or ordinal logistic regression.ResultsOf the 42 participants, 40 completed the study. From W0 to W4, Group B0R0 exhibited the most favorable outcomes in terms of spasticity (MAS-elbow flexor and extensor) and kinematic variables, suggesting that the combined application of BTX and RT is superior to sole interventions in improving motor function and spasticity. From W0 to W8, Group B0R4 demonstrated the most substantial improvements in FMA scores and kinematic parameters, indicating that the combined use of BTX and RT, particularly when RT is initiated 1 month after BTX injection, results in superior functional outcomes compared to other intervention timings.ConclusionsThe combination of RT and BTX is more effective in enhancing motor function and reducing spasticity in individuals with ULS than either intervention alone or no intervention. Furthermore, the timing of RT relative to BTX injection plays a critical role in maximizing therapeutic benefits in individuals with stroke and ULS, given the distinct modes of action of each intervention.Trial registrationclinicaltrials.gov NCT02228863. The study was retrospectively registered on August 23, 2014.

Project description:ObjectivesThe therapeutic effects of botulinum neurotoxin (BoNT) are well documented in upper limb spasticity. However, several factors may influence treatment efficacy, including targeting of neuromuscular junctions (NMJs). We examined whether NMJ-targeted BoNT injections were non-inferior, in terms of efficacy, to current injection practices.DesignOpen-label prospective evaluator-blinded study.SettingConducted across 20 medical centres in Denmark, Finland, Norway and Sweden (24 September 2012 to 11 March 2015).ParticipantsAged ˃18 years with upper limb spasticity (Modified Ashworth Scale [MAS] score of 2 or 3) following stroke or traumatic brain injury, had received ≥2 consecutive BoNT-A treatment cycles (the latest of which was abobotulinumtoxinA [aboBoNT-A]) and needed BoNT-A retreatment (same modality as previous cycle). Patients requiring aboBoNT-A doses >800units were excluded. In total, 88 patients were randomised (intention-to-treat [ITT] population), most were male (n=58/88, 65.9%) and 54/88 (61.4%) completed the study (per protocol [PP] population).InterventionsRandomisation (1:1) to receive a single dose of aboBoNT-A (≤800 U) according to either current clinical practice (300 U/mL) or as an NMJ-targeted injection (100 U/mL).Primary outcome measureProportion of patients with a ≥1 level reduction from baseline in MAS score at week 4 post-injection (responders).ResultsIn the ITT population, the proportion of responders at elbow flexors was 72.7% in the current practice group and 56.8% in the NMJ-targeted group (adjusted difference -0.1673 [95% CIs: -0.3630 to 0.0284]; p=0.0986). Similar results were observed in the PP population (69.0% vs 68.0%, respectively, adjusted difference 0.0707 [-0.1948 to 0.3362]; p=0.6052).ConclusionsOwing to the limited number of participants, non-inferiority of NMJ-targeted injections could not be determined. However, there was no statistical difference between groups. Larger studies are needed confirm whether the two techniques offer comparable efficacy.Trial registration numberNCT01682148.

Dataset Information

Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.

Background

Methods

Results

Conclusions

Publications

Efficacy and Safety of Botulinum Toxin Type A for Limb Spasticity after Stroke: A Meta-Analysis of Randomized Controlled Trials.

Similar Datasets

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