Early retreatment of infantile esotropia: comparison of reoperation and botulinum toxin. Results of a prospective randomized trial of botulinum toxin therapy in acute unilateral sixth nerve palsy. Retreatment of children after surgery for acquired esotropia: reoperation versus botulinum injection. Botulinum vs adjustable suture surgery in the treatment of horizontal misalignment in adult patients lacking fusion. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Early physiotherapy after injection of botulinum toxin increases the beneficial effects on spasticity in patients with multiple sclerosis. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Botulinum toxin A in the hemiplegic upper limb: a double-blind trial. Failure of fixed-dose, fixed muscle injection of botulinum toxin in torticollis.
To compare the efficacy of reoperation and botulinum toxin injection in treating infantile esotropes early after unsatisfactory surgical alignment.
                55 strabismic children who had been unsuccessfully operated for infantile esotropia were randomised to reoperation (28 patients) or botulinum toxin injection (27 patients). The motor outcomes (percentage of successful motor outcome and percentage change in deviation) were compared at 6 months, 1 year, and 3 years after retreatment, and the sensory outcomes (percentage with fusion ability and stereo perception) at the 3 year follow up visit.
                The motor and sensory outcomes and the stability of motor results were similar in patients reoperated and treated with botulinum injection. At the 3 year visit 67.8% and 59.2% of children were, respectively, within 8 prism dioptres of orthotropia (p=0.72). The frequency of fusion ability was, respectively, 60.7% and 51.8% (p=0.71), and the frequency of stereo perception (</=400 seconds of arc, Randot circles), 57.1% and 48.1% (p=0.70). The botulinum injection was more likely to be effective when carried out in the 6 months following initial surgery.
                Botulinum injection is a rapid and less invasive alternative to reoperation in children who have been unsuccessfully treated with surgery to correct infantile esotropia. Forty-seven patients entered a prospective randomized trial to assess the effect of early botulinum neurotoxin A treatment to the ipsilateral antagonist medial rectus on the ultimate recovery rate of acute unilateral sixth nerve palsy. Twenty-two patients received injections and 25 acted as controls. The overall etiologies were microvascular (72.3%), unknown (17%), multiple sclerosis (6%), and one case each of central nervous system (CNS) sarcoidosis and basilar artery ectasia. Eighty-three percent of the patients entered the trial within 2 weeks of the onset of symptoms and 95.7% within 3 weeks. The controls had a final recovery rate of 20/25 (80%), and the injected group had a final recovery rate of 19/22 (86%). No serious side effects were encountered. We conclude that there is no evidence for a prophylactic effect of botulinum toxin in the group that we have studied. Two viable options were compared, reoperation and botulinum toxin injection, in the management of children who need retreatment after surgery for acquired esotropia.
                47 strabismic children previously operated to correct an acquired esotropia were randomised to reoperation or botulinum toxin injection. Reoperation was undertaken in 24 of these patients and botulinum toxin injection in 23 of them. The percentage net change in distance deviation, the percentage of patients with successful motor outcome, detectable fusion, and stereopsis were compared 1 year after retreatment and at last visit (average follow up: 2.9 years in reoperation group, and 2.7 years in botulinum group). The motor success rate relative to time elapsed from initial surgery was evaluated.
                There was no significant difference in the motor and sensory outcomes between patients reoperated and treated with botulinum injection. The frequency of correction to within 8 prism dioptres of orthotropia was, respectively: 75% versus 69.56% at 1 year; 70.83% versus 60.86% at last visit. Botulinum injection could be more effective when performed within 3 months of initial surgery.
                Botulinum injection is a rapid and safe procedure that may be as effective as reoperation in the management of children who need a secondary procedure after surgery for acquired esotropia. Thirty patients were treated with either botulinum toxin or adjustable suture surgery in a prospective, randomized clinical trial. All patients had horizontal deviations greater than 10 prism diopters and absent fusion. Seventeen patients were assigned to toxin treatment, and 13 were assigned to surgical treatment. Follow-up at 6 months after either procedure indicated that surgery was superior, with patient alignment showing a 92.7% average net change, compared with a 50.50% net change in the botulinum-treated group. There was no difference in response between those patients with a starting deviation of 20 PD or less and greater than 20 PD in the surgery group. However, in the botulinum-treated group, those patients with a starting deviation of 20 PD or less seemed to show better responses than those patients with greater than 20 PD. Patients with esotropia showed an 88.89% change with surgery and a 51.55% change with toxin treatment. Patients with exotropia had a 95.83% change with surgery but a 50.3% change with toxin treatment. Since we had 20 patients with exotropia and 10 patients with esotropia, a more formal comparison would require larger numbers. To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with type A-resistant cervical dystonia (CD).
                Local intramuscular injections of BoNT are an effective therapy for CD. After repeated use, some patients become resistant to therapy. BoNT/B, effective in type A toxin-responsive patients, is proposed as an alternative therapy for type A-resistant patients.
                The authors performed a 16-week, double-blind, placebo-controlled trial of BoNT/B in type A-resistant patients with CD. After resistance to therapy was confirmed with the frontalis-type A test, placebo or 10,000 U BoNT/B was administered in a single session into two to four clinically involved muscles. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was the primary efficacy measurement. TWSTRS-Total, three visual analog scales (Patient Global Assessment of Change, Principal Investigator Global Assessment of Change, Patient Analog Pain Assessment), and adverse events were assessed at baseline and weeks 2, 4, 8, 12, and 16.
                A total of 77 patients participated (38 placebo, 39 active). Improvements in severity, disability, and pain were documented in the BoNT/B-treated group. TWSTRS-Total scores were improved in the BoNT/B-treated group at weeks 4 (p = 0.0001), 8 (p = 0.0002), and 12 (p = 0.0129). All three visual analog scales demonstrated improvements at week 4 (p < 0.0001, 0.0001, and 0.001). A Kaplan-Meier analysis supported a duration of effect of 12 to 16 weeks in the active group. Dry mouth and dysphagia were self-limited adverse effects, reported more commonly in the BoNT/B group.
                Botulinum toxin type B (BoNT/B) (NeuroBloc) is safe and efficacious for the management of patients with type A-resistant cervical dystonia with an estimated duration of treatment effect of 12 to 16 weeks. To determine whether additional physiotherapy increases botulinum toxin type A effects in reducing spasticity in patients with multiple sclerosis.
                A single-blind, randomized, controlled pilot trial with a 12-week study period.
                Thirty-eight patients with progressive multiple sclerosis affected by focal spasticity and who were observed at the Multiple Sclerosis Centre operating in the S. Andrea Hospital in Rome.
                For intervention all patients received botulinum toxin type A; the treatment group also received additional physiotherapy to optimize management through passive or active exercise and stretching regimens.
                To measure objective and subjective level of spasticity, patients were assessed at baseline, 2, 4 and 12 weeks post treatment by Modified Ashworth Scale and visual analogue scale.
                When compared with the control group, we found a significant decrease of spasticity by Modified Ashworth Scale (P < 0.01 by t-test) in the treatment group at week 2 (2.73 versus 3.22), week 4 (2.64 versus 3.33) and week 12 (2.68 versus 3.33). The mean (%) difference in Modified Ashworth Scale score between baseline and the end of follow-up was -0.95 (26.1) in the treatment group and -0.28 (7.7) in the control group (P < 0.01). The combined treatment proved also to be more effective by visual analogue scale (P < 0.01) at week 4 (6.95 versus 5.50) and at week 12 (7.86 versus 6.56) but not at week 2 (5.18 versus 5.50; P = 0.41).
                Our data suggest that physiotherapy in combination with botulinum toxin type A injection can improve overall response to botulinum toxin. To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with cervical dystonia (CD).
                BoNT/B is a form of chemodenervation therapy for the treatment of patients with CD.
                The authors performed a 16-week, randomized, multicenter, double-blind, placebo-controlled trial of BoNT/B in patients with CD who continue to respond to botulinum toxin type A. Placebo, or 5,000 U or 10,000 U of BoNT/B was administered in two to four muscles involved clinically in CD. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at week 4 was the primary efficacy measure. Clinical assessments and adverse events were recorded for treatment day 1 and at weeks 2, 4, 8, 12, and 16.
                A total of 109 patients were enrolled randomly across all three treatment groups. The mean improvement in the TWSTRS-Total scores in each group at week 4 was 4.3 (placebo), 9.3 (5,000 U), and 11.7 (10,000 U). For the prospectively defined primary contrast (10,000 U versus placebo), highly significant differences were noted for the primary (TWSTRS-Total, baseline to week 4, p = 0.0004) and supportive secondary (Patient Global Assessment, baseline to week 4, p = 0.0001) outcome measures. Improvement in pain, disability, and severity of CD occurred for patients who were treated with BoNT/B when compared with placebo-treated patients. Overall, improvements associated with BoNT/B treatment were greatest for patients who received the 10,000-U dose. The duration of treatment effect for BoNT/B was 12 to 16 weeks for both doses.
                Botulinum toxin type B (NeuroBloc) is safe and efficacious at 5,000 U and 10,000 U for the management of patients with cervical dystonia. In a randomised, double-blind study, the effects of intramuscular injection of botulinum toxin type A (BtA) into the upper limb were compared with those of normal saline solution in 14 patients with cerebral palsy; their mean age was 9 years. Range of movement and function were assessed before injection and at 2 and 12 weeks after injection. BtA injection significantly increased maximum active elbow and thumb extension and significantly reduced tone at wrist and elbow. The hand grasp-and-release score improved, representing a modest functional change, but fine motor function, assessed by the ability to pick up coins, did not improve and in some cases deteriorated temporarily. The most notable subjective change was the cosmetic benefit of reduced involuntary elbow flexion. The tone-reducing effect of BtA was clinically detectable in comparison with the placebo and patients and parents perceived the change as beneficial. The median of changes in the treatment group was small but the range was large, suggesting that BtA can be useful in selected patients. We studied the effect of botulinum toxin injection in 30 patients with torticollis in a double-blind, placebo-controlled, crossover study. A fixed dose of toxin was injected into the contralateral sternocleidomastoid and both trapezius muscles. Clinical improvement was assessed by a rating scale and by patient self-evaluation. Subjective rating noted improvement in some patients, but there was no change in objective measures. The use of larger doses and injection of additional muscles may be necessary to achieve increased efficacy of botulinum toxin in the treatment of torticollis.
The majority of published literature on the use of botulinum toxin in the treatment of strabismus consists of retrospective studies, cohort studies or case reviews. Although these provide useful descriptive information, clarification is required as to the effective use of botulinum toxin as an independent treatment modality. Four RCTs on the therapeutic use of botulinum toxin in strabismus have shown varying responses ranging from a lack of evidence for prophylactic effect of botulinum toxin in acute sixth nerve palsy, to poor response in patients with horizontal strabismus without binocular vision, to no difference in response in patients that required retreatment for acquired esotropia or infantile esotropia. It was not possible to establish dose effect information. Complication rates for use of Botox™ or Dysport™ ranged from 24% to 55.54%.