Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis

ObjectiveTo provide a comprehensive overview of reported effects and scientific robustness of botulinum toxin (BoNT) treatment regarding the main clinical goals related to poststroke upper limb spasticity, using the International Classification of Functioning, Disability and Health.Data SourcesEmbase, PubMed, Wiley/Cochrane Library, and Ebsco/CINAHL were searched from inception up to May 16, 2018.Study SelectionWe included randomized controlled trials comparing upper limb BoNT injections with a control intervention in patients with a history of stroke. A total of 1212 unique records were screened by 2 independent reviewers. Forty trials were identified, including 2718 patients with history of stroke.Data ExtractionOutcome data were pooled according to assessment timing (ie, 4-8wk and 12wk after injection), and categorized into 6 main clinical goals (ie, spasticity-related pain, involuntary movements, passive joint motion, care ability, arm and hand use, and standing and walking performance). Sensitivity analyses were performed for the influence of study and intervention characteristics, involvement of pharmaceutical industry, and publication bias.Data SynthesisRobust evidence is shown for the effectiveness of BoNT in reducing resistance to passive movement, as measured with the (Modified) Ashworth Score, and improving self-care ability for the affected hand and arm after intervention (P<.005) and at follow-up (P<.005). In addition, robust evidence is shown for the absence of effect on arm-hand capacity at follow-up. BoNT was found to significantly reduce involuntary movements, spasticity-related pain, and caregiver burden, and improve passive range of motion, while no evidence was found for arm and hand use after intervention.ConclusionsIn view of the robustness of current evidence, no further trials are needed to investigate BoNT for its favorable effects on resistance to passive movement of the spastic wrist and fingers, and on self-care. No trials are needed to further confirm the lack of effects of BoNT on arm-hand capacity, whereas additional trials are needed to establish the suggested favorable effects of BoNT on other body functions, which may result in clinically meaningful outcomes at activity and participation levels.     

A型肉毒毒素治疗紧张性头痛的临床研究

目的观察A型肉毒毒素治疗紧张性头痛的临床疗效和不良反应。方法选取31例紧张性头痛患者,应用A型肉毒毒素进行颅周肌肉注射治疗。问卷调查并记录每例紧张性头痛患者治疗前、后3个月紧张性头痛发作情况,比较紧张性头痛发作频率、持续时间、严重程度及使用止痛药物情况,观察不良反应。结果A型肉毒毒素治疗后第1个月,紧张性头痛发作频率、发作持续时间、发作严重程度均较治疗前明显下降(P<0.01),使用止痛药物较治疗前显著减少(P<0.01),疗效至少可维持3个月,且不良反应轻微、短暂。结论A型肉毒毒素颅周肌肉注射治疗紧张性头痛有一定疗效,不良反应轻微、短暂,值得进一步验证。     

肉毒毒素注射后功能性电刺激与运动平板同步治疗脑卒中后足下垂及足内翻的疗效观察

目的观察A型肉毒毒素(BTX-A)注射后功能性电刺激同步减重平板治疗对脑卒中患者足下垂及足内翻的影响。 方法采用随机数字表法将67例脑卒中后出现足下垂及内翻的患者分为联合治疗组（22例）、电刺激组（23例）及常规治疗组（22例）。3组患者均在B超及电刺激引导下进行BTX-A注射治疗,24h后常规治疗组患者给予常规干预（包括使用脑保护剂及进行肢体功能锻炼、步态训练、平衡训练、日常生活活动能力训练等）,联合治疗组在常规治疗基础上辅以功能性电刺激与减重平板同步治疗,电刺激组则在常规治疗基础上辅以功能性电刺激。于治疗前、治疗6周后对各组患者进行疗效评定,具体疗效评定指标包括胫骨前肌与腓肠肌外侧头积分肌电值（iEMG）、踝背伸协同收缩率(CR)、改良Ashworth量表(MAS)评分、Berg平衡量表(BBS)评分、功能性步行分级(FAC)、踝背伸与外翻活动度(ROM)等。 结果治疗后3组患者胫骨前肌iEMG、腓肠肌外侧头iEMG、踝背伸CR、MAS评分、BBS评分、FAC评分、踝背伸与外翻ROM均较治疗前明显改善（P<0.05）;通过组间比较发现,治疗后3组患者腓肠肌外侧头iEMG组间差异无统计学意义(P>0.05);联合治疗组胫骨前肌iEMG［(1.54±0.23)mV］、踝背伸CR［(13.32±8.47)%］、MAS评分［(0.29±0.35)分］、BBS评分［(42.37±4.28)分］、FAC评分［(4.26±1.14)分］、踝背伸ROM［(15.58±1.32)°］与外翻ROM［(14.33±1.41)°］均显著优于电刺激组及常规治疗组水平(P<0.05)。 结论于BTX-A注射后同步进行功能性电刺激及减重平板训练,能进一步改善脑卒中患者足下垂及足内翻畸形,促其步行功能改善,该联合疗法值得临床推广、应用。     

超声引导下肉毒毒素环咽肌注射治疗延髓背外侧综合征所致吞咽障碍1例报道

目的 采用超声引导下肉毒毒素环咽肌注射治疗延髓背外侧综合征所致吞咽障碍。方法 回顾本院1例临床资料。结果 患者延髓背外侧梗死后,导致环咽肌失弛缓,经常规吞咽治疗和球囊扩张术后未见明显好转,予超声引导下肉毒毒素环咽肌注射,经藤岛一郎摄食-吞咽功能等级量表、Rosenbek渗漏-误吸量表评定和透视荧光吞咽检查分析,吞咽功能改善,治疗后1个月和3个月随访,吞咽功能正常。结论 超声引导下肉毒毒素注射治疗延髓背外侧综合征所致环咽肌失弛缓有一定的近期和远期效果。     

A Platform Stratifying a Sequestering Agent and a Pharmacological Antagonist as a Means to Negate Botulinum Neurotoxicity

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Botulinum toxin injections in the management of non-neurogenic overactive bladders in children

Introduction

Non-neurogenic detrusor overactivity in children leads to varying degrees of functional impairments (urinary urgency, pollakiuria, urge incontinence, nocturia). Botulinum toxin has shown its effectiveness in the management of detrusor overactivity in neurological patients.

Objectives

To evaluate the relevance of intravesical Botulinum toxin injections for the treatment of non-neurogenic overactive bladders in children. These pediatric patients were resistant to all the usual therapeutics (e.g. bladder/bowel rehabilitation, anticholinergic drugs, management of diet/hygiene habits and constipation, percutaneous posterior tibial nerve stimulation).

Materials and methods

8 children (mean age: 12.5 years), 5 girls, 3 boys with daytime and/or nighttime incontinence and non-neurogenic detrusor overactivity validated by urodynamic testing. Urodynamic testing was conducted before the injections as well as 6 weeks and 1 year post injections. We used Dysport® 8 Speywood Units/kg injected via cystoscopy into 25 different sites.

Results

We noted improvements without any complaints during bladder voiding for all patients, in 6 patients the overactivity disappeared after 1 injection. Compliance was improved early-on in half the cases and at 1 year for all cases (from 12% to 61%, p = 0.01). Noninhibited contractions decreased constantly in both frequency and intensity. Clinical symptoms improved: mean of 7.75 daytime urinary incontinence episodes (IE) per week before the injection vs. 3 after the procedure (p = 0.04). For nighttime IE the improvement was even more noticeable with 7.38 nighttime IE episodes per week before the injection vs. 2.06 after the procedure (p = 0,02).

Conclusion

Intradetrusor Botulinum toxin injections are a potential therapeutic option for the management of non-neurogenic detrusor overactivity in children resistant to the usual treatments.     

An Updated Systematic Review and Statistical Comparison of Standardised Mean Outcomes for the Use of Botulinum Toxin in the Management of Lower Urinary Tract Disorders

Context

Botulinum toxin A (BoNTA) has received regulatory approval for use in neurogenic detrusor overactivity (NDO) and overactive bladder (OAB), but it remains unlicensed in other lower urinary tract symptoms (LUTS) indications such as nonneurogenic LUTS in men with benign prostatic enlargement (LUTS/BPE), bladder pain syndrome (BPS), and detrusor sphincter dyssynergia (DSD).

Objective

To compare statistically the outcomes of high level of evidence (LE) studies with placebo using BoNTA for LUTS indications; NDO, OAB, LUTS/BPE, BPS and DSD.

Evidence acquisition

We conducted a systematic review of the published literature on PubMed, Scopus, and Embase reporting on BoNTA use in LUTS dysfunction. Statistical comparison was made between high LE studies with placebo and low LE studies.

Evidence synthesis

In adult NDO, there are significantly greater improvements with BoNTA in daily incontinence and catheterisation episodes (−63% and −18%, respectively; p < 0.01), and the urodynamic parameters of maximum cystometric capacity (MCC), reflex volume, and maximum detrusor pressure (MDP) (68%, 61%, and −42%, respectively; all p < 0.01). In OAB, BoNTA leads to significant improvements in bladder diary parameters such as daily frequency (−29%), daily urgency (−38%), and daily incontinence (−59%) (all p < 0.02). The urodynamic parameters of MCC and MDP improved by 58% (p = 0.04) and −29% (p = 0.002), respectively. The risk of urinary tract infection was significantly increased from placebo at 21% versus 7% (p < 0.001), respectively; the risk of intermittent self-catherisation increased from 0% to 12% (p < 0.001). Men with LUTS/BPE showed no significant improvements in International Prostate Symptom Score, maximum flow rate, or prostate volume. There were insufficient data for statistical analysis in DSD, BPS, and paediatric studies. Low LE studies were found to overestimate the effects of BoNTA in all indications, but differences from high LE studies were significant in only a few parameters.

Conclusions

BoNTA significantly improves all symptoms and urodynamic parameters in NDO and OAB. The effect of BoNTA in treating LUTS dysfunction appears to be overestimated in lower as opposed to higher LE studies.     

Beyond a motor disorder: A prospective evaluation of sleep quality in cervical dystonia

BackgroundLittle is known about sleep disturbances in cervical dystonia (CD), particularly the relationship to motoric symptoms. It is critical to clarify these points given the impact on quality of life.MethodsPrimary CD patients receiving botulinum toxin (BoNT) injections and age- and gender- matched healthy controls were included. In both groups, sleep quality and daytime sleepiness were assessed. In CD, these assessments were repeated following BoNT injections. CD severity, mood symptoms, and health impact of CD were also assessed.Results54 CD patients and 55 controls were included. Impaired sleep quality was more frequent in CD compared to controls (t = 4.82, p < 0.0005), even when controlling for the effects of depression, anxiety, and benzodiazepineuse (F = 5.62, p = 0.020). Excessive daytime sleepiness was not significantly different between groups (t = 1.67, p = 0.1). 48 patients received BoNT and returned for follow-up. There was no improvement in sleep quality (t = 0.834, p = 0.41) or daytime somnolence (t = 1.77, p = 0.083) despite improvement in CD severity (t = 4.77, p < 0.0005) with BoNT. There was a small improvement in health impact (t = 2.10, p = 0.04).ConclusionSleep quality was more impaired in CD patients, compared to healthy subjects, and did not improve following BoNT treatment, despite a robust improvement in CD severity. This dichotomy suggests that sleep aberrations in CD require separate focus for effective treatment and cannot be viewed as secondary complications of the motor elements of this condition.     

Current uses of botulinum toxin A as an adjunct to hand therapy interventions of hand conditions

Study designLiterature review.DiscussionBotulinum toxin A, a neurotoxin causing temporary muscle paralysis at the neuromuscular junction, has been used to treat multiple acquired conditions of the hand and upper extremity. Initially approved for use in treating blepharospasm and strabismus in the 1980s, indications have expanded to include spasticity associated with cerebrovascular accidents, vasospastic disorders, focal dystonias, and pain conditions. This article reviews the current literature discussing the efficacy of botulinum toxin A in management of disorders of the hand and upper extremity relevant to hand therapists.Level of evidenceNA.     

The Treatment of Chronic Anal Fissure with Botulinum Toxin

Background /Aims: The aim of this study was to evaluate the effectiveness of botulinum toxin for the treatment of uncomplicated dorsal chronic idiopathic anal fissure.

Material and Methods: Forty-five patients who reported post defecatory anal pain since two months or more were given a total of 20U botulinum toxin in the anal sphincter apparatus on both sides as well as below the anal fissure. Results: Thirty-seven patients received a second session of 25U botulinum toxin injection. Thirty-five patients (78%) presented completely healed anal fissure, while ten needed lateral internal sphincterotomy. All patients were followed up for 8-36 months. Two patients relapsed.

Conclusion: Local injection of botulinum toxin is a new and safe treatment; however, two sessions of injections are necessary to be effective and long-term follow-up to assess the recurrence rate of fissure is needed to evaluate further this method of treatment. Partial internal lateral sphincterotomy is no more the treatment of choice for chronic anal fissure.