Botulinum toxin versus submandibular duct relocation for severe drooling

Aim Botulinum neurotoxin type A (BoNT‐A) has been described as an effective intervention for drooling and is being increasingly adopted. However, its effectiveness compared with established treatments is still unknown. We undertook a within‐participants observational study to examine this. Method An historic cohort was formed of 19 children and young adults (10 males, nine females) with severe drooling who underwent BoNT‐A injections followed by surgical re‐routing of the submandibular duct at least 6 months later. Mean age at time of admission was 11 years 5 months (range 5–17y) and mean age at the time of surgery was 14 years (range 6–23y). Fifteen children were diagnosed with bilateral cerebral palsy (CP), three with unilateral CP, and one with non‐progressive developmental delay. Gross Motor Function Classification System levels were the following: level I, n=1; level II, n=2; level III, n=7; level IV, n=6; and level V, n=3). The primary outcome was the drooling quotient, which was assessed before each intervention and 8 and 32 weeks thereafter. A multivariate analysis of variance of repeated measures was performed, with the measurement points as the within‐participant variables. Results The drooling quotient was reduced to a greater extent after surgery than after BoNT‐A administration (p=0.001). Compared with a baseline value of 28, the mean drooling quotient 8 weeks after surgery was 10, and 32 weeks after surgery was 4 (p<0.001). Among the group treated with BoNT‐A, the drooling quotient showed a significant reduction from a baseline value of 30 to 18 after 8 weeks (p=0.02), and a continued but diminished effect after 32 weeks (drooling quotient 22; p=0.05). Interpretation Both interventions are effective, but surgery provides a larger and longer‐lasting effect.     

Botulinum toxin A versus B in sialorrhea: A prospective,randomized, double‐blind,crossover pilot study in patients with amyotrophic lateral sclerosis or Parkinson's disease

Background: Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Methods: Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT‐A) or B (BoNT‐B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re‐treated with the other serotype. Ultrasound‐guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT‐A (Dysport) and 2500 U BoNT‐B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Results: Twenty‐seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT‐A and BoNT‐B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT‐B treatments (3.2 ± 3.7 days) compared to BoNT‐A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT‐A and BoNT‐B, respectively (P = NS). The only toxin‐related side effect was a change to saliva thickness. Conclusions: Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT‐B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT‐B treatment. © 2011 Movement Disorder Society     

Botulinum toxin type B for sialorrhoea in children with cerebral palsy: a randomized trial comparing three doses

Aim The aim of the present study was to evaluate the efficacy and safety of three doses of botulinum toxin type B (BoNT‐B) in reducing persistent sialorrhoea in children with cerebral palsy (CP). Method Children with CP and refractory sialorrhoea were randomized to one of four groups: a control group and three experimental groups receiving a low (1500 mouse units [MU]), medium (3000MU), or high (5000MU) dose of BoNT‐B respectively, into bilateral salivary glands. Drooling was measured using the Thomas‐Stonell rating scale, and the weight and the number of bibs used per day were counted in all children at baseline, 4, and 12 weeks after BoNT‐B injection. Results Twenty‐seven children (15 males, 12 females; mean age 7y 10mo, SD 1y 6mo; range 5–15y) were randomized into a control (seven children: four males, three females) and experimental groups receiving low (six children: four males, two females), medium (seven children: four males, three females), and high (seven children: three males, four females) doses of BoNT‐B respectively. All children had mixed neurological disorders consisting of spastic paraparesis, tetraparesis, dystonic movements, and ataxia. Gross Motor Function Classification System levels ranged from III to V, and all children had moderate or severe intellectual disability. Estimated means with their standard errors (SEM) of drooling were at baseline, 4, and 12 weeks respectively, as follows: control group, 12.1 (2.1), 11.9 (2.1), 11.8 (2.2), p for trend 0.992; low dose group, 13.8 (2.3), 11.4 (2.3), 13.9 (2.3), p for trend 0.952; medium dose group, 13.9 (2.1), 6.7 (2.1), 7.1 (2.1) p for trend 0.008; and for the high dose group 14.4 (2.1), 5.0 (2.1), 5.6 (2.1), p for trend 0.002. Side effects included dense saliva, xerostomia, and difficulty in swallowing, and were more frequent in the high‐dose group. Interpretation A 3000MU injection of BoNT‐B into the salivary glands significantly improved the frequency and severity of sialorrhoea in children with CP. The lower dose was ineffective, and the higher dose produced no greater benefit and more side effects.     

Parotid and submandibular botulinum toxin A injections for sialorrhoea in children with cerebral palsy

The aim of this study was to determine whether botulinum toxin A (BTX-A) injected into the parotid and submandibular salivary glands of children aged 6 to 16 years with cerebral palsy (CP) and relative sialorrhoea significantly decreases their drooling and improves their quality of life. Twenty children (10 males, 10 females; mean age 10y 1mo [SD 3y 8mo]; range 6y 1mo-16y 7mo) with CP, identified as having significant daily drooling (scoring at least 6 on drooling frequency/severity scales) were recruited. BTX-A (2U/kg; maximum 70U) was injected under sedation, using ultrasound guidance (1.4U/kg and 0.6U/kg divided between parotid and submandibular glands respectively). Nineteen children completed the study: 15 with spastic quadriplegia (Gross Motor Function Classification System [GMFCS] Level V); one with dystonia (GMFCS Level V); one with hemiplegia (GMFCS Level II); and two with a mixed pattern of CP (GMFCS Levels III and V). Drooling was assessed by five methods at baseline, and 4 and 12 weeks after injection. Qualitative assessment of drooling frequency and severity scores showed statistically significant reductions at 4 weeks (p<0.001) and 12 weeks (p=0.006). Qualitative assessment of quality of life scores (rated by parents and teachers separately) also significantly improved (p<0.001 and p=0.023 respectively). Quantitative assessments showed that the number of bibs/scarves changed per day was significantly reduced at 4 weeks (p<0.001). There was no side effect from the injections themselves; 89% of parents and children wished for further intrasalivary BTX-A injections in the future. We conclude that percutaneous intrasalivary BTX-A injections into the parotid and submandibular salivary glands can reduce drooling in children with CP and relative sialorrhoea, leading to an improvement in their quality of life.     

Drooling in cerebral palsy: hypersalivation or dysfunctional oral motor control?

Aim  To investigate whether drooling in children with cerebral palsy (CP) in general and in CP subtypes is due to hypersalivation.
Method  Saliva was collected from 61 healthy children (30 males, mean age 9y 5mo [SD 11mo]; 31 females, mean age 9y 6mo [1y 2mo]) and 100 children with CP who drooled (57 males, mean age 9y 5mo [3y 11mo], range 3–19y; 43 females, mean age 10y 1mo [4y 9mo], range 4–19y), of whom 53 had spastic, 42 had dyskinetic, and five had ataxic CP. Almost all children were affected bilaterally, and 90 of them were at Gross Motor Function Classification System levels III or higher. The saliva was collected by the swab saliva collection method. The intensity of drooling was evaluated using the drooling quotient.
Results  No difference was found in the flow rates, age, or sex between healthy children and children with CP who drooled. On additional subgroup analysis, the flow rates of children with dyskinetic CP differed statistically from those of healthy children (submandibular p =0.047, parotid p =0.040).
Interpretation  This study supports the finding in previous studies that no hypersalivation exists in children with CP who drool. Dysfunctional oral motor control seems to be responsible for saliva overflow from the mouth, whereas increased unstimulated salivary flow may occur in children with dyskinetic CP as a result of hyperkinetic oral movements.     

Randomized trial of botulinum toxin injections into the salivary glands to reduce drooling in children with neurological disorders

The primary aim of this randomized, controlled trial was to assess the effectiveness of botulinum toxin A (BoNT-A) injections into the submandibular and parotid glands on drooling in children with cerebral palsy (CP) and other neurological disorders. Secondary aims were to ascertain the duration of any such effect and the timing of maximal response. Of the 48 participants (27 males, 21 females; mean age 11y 4mo [SD 3y 3mo], range 6-18y), 31 had a diagnosis of CP and 15 had a primary intellectual disability; 27 children were non-ambulant. Twenty-four children randomized to the treatment group received 25 units of BoNT-A into each parotid and submandibular gland. Those randomized to the control group received no treatment. The degree and impact of drooling was assessed by carers using the Drooling Impact Scale questionnaire at baseline and at monthly intervals up to 6 months postinjection/baseline, and again at 1 year. Maximal response was at 1 month at which time there was a highly significant difference in the mean scores between the groups. This difference remained statistically significant at 6 months. Four children failed to respond to the injections, four had mediocre results, and 16 had good results. While the use of BoNT-A can help to manage drooling in many children with neurological disorders, further research is needed to fully understand the range of responses.     

Botulinum toxin injections for children with excessive drooling

The objective of this study was to evaluate the feasibility of ultrasonography-guided injections of botulinum toxin A into the parotid glands of children with severe drooling (sialorrhea). Excessive drooling is common in children with chronic neurologic disorders. Preliminary observations in adults suggest that injections of botulinum toxin A into the parotid glands can decrease drooling, but the optimal dose, sites of injection, and concomitant use of imaging during injections and its use for children have not been established. Ultrasonography was used to guide the injection of botulinum toxin (10-25 IU) into both parotid glands of nine children with excessive drooling. Subjective and objective measures of the severity of drooling were collected before and after botulinum toxin A injections. A booster injection was provided if the initial response was inadequate. Injections were well tolerated, and no adverse reactions were observed. Ultrasonography revealed that the parotid gland showed a variable depth, extent, and vascularization. Eight of nine patients needed a booster injection after 1 month. Objective measures of drooling severity were improved in seven of nine patients. However, subjective improvement was reported in only three of nine patients, and this improvement was functionally significant in only one patient. Although intraparotid injection of botulinum toxin A is safe and causes a reduction in saliva production in children, the doses used in this study did not result in functionally significant improvement. Higher doses of botulinum toxin A in the parotid glands or concomitant injections into the submandibular glands can increase the efficacy of these injections. Variability in size, depth, and vascular supply of the parotid gland suggests the importance of ultrasonography guidance for optimizing injections. These results underscore the need for further studies to establish the efficacy of this treatment in children.     

Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonism.

Drooling is a frequent symptom in Parkinson's disease (PD), occurring in almost 75% of all patients. Although it is now well known that drooling in PD is the result of swallowing difficulties rather than excessive saliva production, few treatments have been developed to reduce it. Clinical studies suggest that botulinum toxin A (BTX) injections into salivary glands are effective in decreasing drooling in PD patients. In this double-blind, placebo-controlled study, 20 patients with parkinsonism (idiopathic PD or multiple system atrophy), were randomly assigned to receive 450 U of BTX (Dysport; Ipsen, Berkshire, UK) or 2 ml of placebo, injected into the parotids and submandibular glands under ultrasonographic guidance. Treatment efficacy and safety were assessed at baseline, 1 week and 3 months after BTX injections using clinical scales (Drooling Severity and Drooling Frequency scales) and side effects surveillance. After treatment, the average secretion of saliva in the BTX group was significantly lower than in the placebo group, as appraised by clinical measurements. No side effects were observed in either group. BTX injection into parotids and submandibular glands, under ultrasonographic guidance, is an effective and safe treatment for drooling in parkinsonism.     

Quantitative reduction of saliva production with botulinum toxin type B injection into the salivary glands

Drooling is common in patients with neurological disorders. Recently, botulinum toxin type B has been shown to be effective in the treatment of drooling. The authors present a unique case of a 57-year-old man with a history of a brainstem stroke and severe drooling. The patient's parotid and submandibular glands were injected under ultra-sound guidance with botulinum toxin type B. Saliva was collected and quantified before and after the injections by 2 different collection methods: suctioning and dental rolls. Total saliva production decreased by 23.8% after injection of the parotid glands and by 85.8% after submandibular injection compared to the preinjection level. The 2 methods demonstrated similar results. In addition, the patient experienced less drooling and increased participation in therapies without any side effects. This case demonstrates that saliva secretion and drooling can effectively be treated by injections of botulinum toxin type B into the salivary glands.     

The impact of botulinum toxin A and abduction bracing on long-term hip development in children with cerebral palsy

Aim To study the long‐term impact of 3 years of botulinum toxin A (BoNT‐A) injections and abduction bracing on hip development in children with bilateral spastic cerebral palsy (CP). We wanted to know if early treatment improved hip development and reduced the need for surgery. Method A long‐term review of hip morphology and surgery requirements in children who participated in a multicentre, randomized controlled trial. The trial investigated short‐term effects of BoNT‐A injections combined with an abduction brace, compared with usual care, on hip displacement in children with bilateral spastic CP. Results Forty‐six children with bilateral spastic CP (31 males, 15 females; 10 with diplegia, 36 with quadriplegia; mean age at enrolment of 3y 2mo, mean age at most recent clinical review 13y 11mo [range 10y 6mo–16y 8mo]; three children in Gross Motor Function Classification System level II, 11 in level III, 20 in level IV, 12 in level V) were followed for a mean of 10 years 10 months from recruitment to the trial. Mean migration percentage was 15.9% in the BoNT‐A group and 15.2% in the comparison group (t=0.26, p=0.79). Eighty‐nine percent of hips in the treatment group and 91% hips in the comparison group had satisfactory development, using a valid scale (Mann–Whitney U test=867.50, z=?1.59, p=0.11). Forty children had preventive surgery (21 treatment group, 19 comparison group) and 18 children had reconstructive surgery (10 treatment, 8 comparison). Interpretation In children with bilateral spastic CP, early treatment with BoNT‐A and hip abduction bracing does not reduce the need for surgery or improve hip development at skeletal maturity.     

Salivary gland botulinum toxin injections for drooling in children with cerebral palsy and neurodevelopmental disability: a systematic review

Aim The aim of this paper was to systematically review the efficacy and safety of botulinum toxin (BoNT) injections to the salivary glands to treat drooling in children with cerebral palsy and neurodevelopmental disability. Method A systematic search of The Cochrane Central Register of Controlled Trials, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, and the Physiotherapy Evidence Database (PEDro) was conducted (up to 1 October 2011). Data sources included published randomized controlled trials (RCTs) and prospective studies. Results Sixteen studies met inclusion criteria. Three outcome measures support the effectiveness of BoNT for drooling. One RCT found an almost 30% reduction in the impact of drooling on patients’ lives, as measured by the Drooling Impact Scale (mean difference ?27.45; 95% confidence interval [CI] ?35.28 to ?19.62). There were sufficient data to pool results on one outcome measure, the Drooling Frequency and Severity Scale, which supports this result (mean difference ?2.71; 95% CI ?4.82 to ?0.60; p<0.001). There was a significant reduction in the observed number of bibs required per day. The incidence of adverse events ranged from 2 to 41%, but was inconsistently reported. One trial was terminated early because of adverse events. Interpretation BoNT is an effective, temporary treatment for sialorrhoea in children with cerebral palsy. Benefits need to be weighed against the potential for serious adverse events. More studies are needed to address the safety of BoNT and to compare BoNT with other treatment options for drooling.     

Does Motor Performance Matter in Botulinum Toxin Efficacy for Drooling?

The aim of this study was to define factors that influence therapy outcome of submandibular botulinum toxin injections for drooling in children with cerebral palsy or mental disability. We postulated that differences in response may be explained by the variation of dysfunctions in the various cerebral palsy subtypes. Prospectively collected data were evaluated of 80 spastic and 48 dyskinetic children, of whom 70% had an IQ of <70. In addition, the data of 23 fully ambulant children with mental disability only were examined. Flow and Drooling Quotient were assessed at baseline and at 8 weeks after injection. After treatment, both the Drooling Quotient and submandibular flow decreased in all children. Morbidity associated with the procedure was limited. Ninety-three children responded to botulinum. Decrease of submandibular flow in these children was associated with reduction of parotid flow. In those who did not respond to therapy, spread across all 3 diagnostic classifications, parotid flow increased after injection. Response failure is characterized by increased parotid flow after injection; however, the precise role of parotid flow in therapy failure remains unclear. We cannot predict who will respond to botulinum toxin to treat drooling.     

Effectiveness of sedation using nitrous oxide compared with enteral midazolam for botulinum toxin A injections in children

This randomized, double‐blind, placebo‐controlled study compared the efficacy of inhaled nitrous oxide (N₂O) with enteral midazolam for sedation of children with cerebral palsy (CP) undergoing botulinum toxin A (BoNT‐A) injections. Fifty children (29 males, 21 females; mean age 8y 2mo [SD 4y 5mo]; range 1–16y) were randomized to sedation with N₂O (n=25) or midazolam (n=25). Groups were similar in type of CP (diplegia, 11; triplegia, three; quadriplegia, 16; hemiplegia, 16; other, three) and Gross Motor Function Classification System level (Level I, 4; II, 24; III, 4; IV, 13; V, 5). Both groups were equally sedated at time of injection (p=0.661), but those in the midazolam group were more sedated at time of discharge (p<0.001). N₂O was more effective in reducing pain compared with midazolam as measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (p=0.010), parental estimate of pain (p=0.009), and nursing estimate of pain (p=0.007). Parents in the N₂O group rated it better than prior sedation with midazolam for BoNT‐A injections (p=0.031). Physicians and nurses reported no difference in ease of procedure between the groups. One child in the midazolam group and eight in the N₂O group had adverse effects, all of which resolved promptly. N₂O appears to be an effective means of sedation for children undergoing outpatient BoNT‐A injections.     

超声定位肌电图引导下A型肉毒毒素治疗重度流涎的临床观察

目的：评价A型肉毒毒素（BTX-A）治疗流涎的疗效。方法：选择流涎患者5例,其中帕金森病（PD）3例,脑梗死2例。采用教师流涎分级法（TDS）及流涎频率评分后于超声定位后肌电图引导下对患者腮腺和颌下腺进行BTX-A多点注射,于治疗前及治疗后2周、1个月和3个月时进行流涎测评。结果：TDS和流涎频率评分：BTX-A治疗前为（4.6±0.5）分和（3.0±0.0）分;BTX-A注射后2周降至（2.6±0.9）分和（1.6±0.5）分;1个月时为（2.8±1.1）分和（1.8±0.8）分,与治疗前比,差异有统计学意义（P〈0.05）;3个月时为（3.2±1.3）分和（2.0±1.0）分,与治疗前比,差异仍有统计学意义（P〈0.05）。5例患者均无明显并发症出现。结论：BTX-A局部注射治疗流涎是一种安全、有效的新方法。     

Botulinum toxin A for drooling in Parkinson's disease: a pilot study to compare submandibular to parotid gland injections

Drooling is a common and incapacitating problem in Parkinson's disease (PD). Treatment with botulinum neurotoxin (BoNT) into the parotid glands seems beneficial. Injection of the submandibular glands may also be effective since these produce 70% of the daily unstimulated saliva. We randomly allocated patients to BoNT injections into the submandibular glands or the parotid glands. Within-group improvements were significant for the submandibular group, but not for the parotid group. Between-group differences showed a trend towards superiority for the submandibular group. Injecting the submandibular glands instead of the parotid glands seems a promising approach, and larger studies are justified.     

Determinants of responsiveness to botulinum toxin,casting, and bracing in the treatment of spastic equinus in children with cerebral palsy

Aim The objective was to determine whether specific intrinsic (age, pattern of cerebral palsy [CP], child’s motivation) and extrinsic (number of treatments, parenting stress) characteristics were associated with responsiveness to botulinum toxin A (BoNT‐A) injections in children with CP 3 months after injection into the gastrocnemius muscle. Method Children with hemiplegia or diplegia recruited from a BoNT‐A programme were evaluated before and 3 months following injection of BoNT‐A into the gastrocnemius. Outcome measures included muscle tone, range of motion, gait pattern, level of ambulation, gross motor function, and functional independence. Determinants of responsiveness to BoNT‐A considered were age, number of treatments, distribution of CP, parenting stress, and motivation. Results Thirty‐one children were recruited (17 males, 14 females) – 22 with hemiplegia and nine with diplegia. Twenty‐eight were classified at Gross Motor Function Classification System (GMFCS) level I and three at level III. The mean age was 6 years 4 months (SD 2y 11mo). Younger age (p=0.015) and fewer number (p=0.024) of BoNT‐A treatments were associated with greater change in gross motor function. Child’s motivation and parenting stress were significantly associated with improvements in muscle tone (p=0.006–0.017), passive range of motion (p=0.008–0.033), gait pattern (p=0.005–0.042), level of ambulation (p=0.001–0.043), and functional independence (p=0.004–0.027). Interpretation The results indicate that child, family, and treatment characteristics influence the degree of responsiveness to BoNT‐A treatment. The contribution of contextual factors (personal and environmental) on responsiveness may be underappreciated in children with CP.     

Botulinum toxin type-B improves sialorrhea and quality of life in bulbaronset amyotrophic lateral sclerosis

Background Sialorrhea is a disabling problem in bulbaronset amyotrophic lateral sclerosis (ALS). Botulinum toxin (BTX) type A and B have been proposed as alternatives to traditional treatments. Objectives To evaluate the efficacy and safety of BTX type B in the treatment of sialorrhea in patients with bulbar-onset ALS. Methods Open-label prospective study of BTX type B injections in parotids (1000 U) and submandibular (250 U) glands using anatomic landmarks. Primary outcome was rate of responders (improvement > 50% on visual analogue scales (VAS) of severity and disability of sialorrhea) 1 month post-treatment. Other outcomes included subjective (drooling and quality of daily living questionnaires) and objective (cotton roll weights and number of paper handkerchiefs used) evaluations. Safety evaluations included questionnaires regarding brain stem symptoms. Results Sixteen ALS patients were included. At 1 month the rate of responders was 75% with a mean reduction of 70% in severity and disabling VASs. Fifteen patients (94 %) reported some benefit with drooling reduction. In objective measurements there was a reduction over 60 % in saliva production and in the number of handkerchiefs used. Onset of effect occurred within 3 days. Most patients reported better quality of living. The most frequent side-effects were viscous saliva, local pain, chewing weakness and respiratory infection. There were no changes in blood pressure or cardiac rate. At 3 months, there was still a positive effect in all outcomes. All patients except one manifested their willingness to repeat treatment. Conclusions Anatomic guided BTX type B injections seem effective and safe to treat sialorrhea in bulbar-onset ALS.     

Repeat botulinum toxin-A injections in the upper limb of children with hemiplegia: a randomized controlled trial

Aim  To test the effectiveness of repeat botulinum toxin A (BoNT‐A) injections in the affected arm of 22 children with hemiplegic cerebral palsy (19 males, three females), aged 1 year 10 months to 4 years 10 months (mean 3y 8mo, SD 9mo) in a randomized controlled trial. Method  Children received either three series of BoNT‐A injections plus twice‐weekly occupational therapy (OT) or OT alone in 16‐week cycles. Muscles targeted at each injection cycle in the 11 children receiving BoNT‐A+OT were the adductor pollicis (n=9), flexor pollicis longus (n=5), flexor digitorum superficialis (n=8), flexor digitorum profundus (n=8), flexor carpi radialis (n=2), flexor carpi ulnaris (n=6), pronator teres (n=10), and biceps brachii (n=11). Parental perception of treatment efficacy was assessed using the Canadian Occupational Performance Measure (COPM) and the Goal Attainment Scale (GAS), quality of movement using the Quality of Upper Extremity Skills Test (QUEST), fine motor skills using the Peabody Developmental Motor Scale – Fine Motor (PDMS‐FM), and spasticity using the Modified Tardieu Scale (MTS). Between‐group differences at 12 months were analysed using independent‐sample t‐tests. Results  All children were at Gross Motor Function Classification System levels I (BoNT‐A+OT n=6; OT n=8) or II (n=5 and n=3 respectively) and were too young to be classified using the Manual Ability Classification System. The BoNT‐A+OT group had higher COPM performance scores (mean difference ?0.8, 95% confidence interval [CI] ?1.5–0.0) and higher GAS T scores (mean difference ?6.9, 95% CI ?13.8 to ?0.1]). No significant difference was found for the COPM satisfaction, PDMS‐FM, or QUEST scores. The BoNT‐A+OT group showed progressive reduction in spasticity compared with the OT group. At study completion MTS mean difference was 50.0° (95% CI 22.4–77.6) for pronators and 20.9° (95% CI 2.4–39.4) for wrist flexors. Interpretation  Repeat BoNT‐A injections in the upper limb combined with OT resulted in progressively reduced spasticity and improved parental perception of performance.     

No change in calf muscle passive stiffness after botulinum toxin injection in children with cerebral palsy

Aim Stiffness and shortening of the calf muscle due to neural or mechanical factors can profoundly affect motor function. The aim of this study was to investigate non‐neurally mediated calf‐muscle tightness in children with cerebral palsy (CP) before and after botulinum toxin type A (BoNT‐A) injection. Method Sixteen children with spastic CP (seven females, nine males; eight at Gross Motor Function Classification System level I, eight at level II; age range 4–10y) and calf muscle spasticity were tested before and during the pharmaceutically active phase after injection of BoNT‐A. Measures of passive muscle compliance and viscoelastic responses, hysteresis, and the gradient of the torque–angle curve were computed and compared before and after injection. Results Although there was a slight, but significant increase in ankle range of motion after BoNT‐A injection and a small, significant decrease in the torque required to achieve plantigrade and 5° of dorsiflexion, no significant difference in myotendinous stiffness or hysteresis were detected after BoNT‐A injection. Interpretation Despite any effect on neurally mediated responses, the compliance of the calf muscle was not changed and the muscle continued to offer significant resistance to passive motion of the ankle. These findings suggest that additional treatment approaches are required to supplement the effects of BoNT‐A injections when managing children with calf muscle spasticity.     

Botulinum toxin B increases mouth opening in patients with spastic trismus

Background: Severe generalized spastic movement disorders of various aetiologies often involve the jaw muscles and lead to a spastic trismus with masseter muscle hypertonia. We report a placebo‐controlled randomized study on patients with spastic trismus. Methods: Eleven patients with masseter hypertonia because of stroke, hypoxic encephalopathy or traumatic brain injury were allocated to either botulinum toxin serotype B (BoNT/B) injections into the masseter muscles or placebo treatment. The dental gap, the amount of saliva, salivation scales, and a clinical goal attainment were evaluated. Results: Three weeks after injection the BoNT/B group showed a significantly increased mouth opening compared with placebo treatment (P < 0.05). In addition to the muscle paralysing effect, a goal attainment scale demonstrated a clinical benefit for the BoNT/B group (P < 0.01). Conclusions: Botulinum toxin serotype B injections into the masseter muscles effectively reduce hypertonia and provide for better mouth opening, thereby contributing to a positive and desired clinical goal.