Treatment of idiopathic spasmodic torticollis with botulinum toxin A: a double-blind study on twenty-three patients. Efficacy and safety of a standardised 500 unit dose of Dysport (clostridium botulinum toxin type A haemaglutinin complex) in a heterogeneous cervical dystonia population: results of a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel group study. Failure of fixed-dose, fixed muscle injection of botulinum toxin in torticollis. Quantitative EMG in botulinum toxin treatment of cervical dystonia. A double-blind, placebo-controlled study. A double blind trial of botulinum toxin "A" in torticollis, with one year follow up. Botulinum toxin treatment in spasmodic torticollis. Double-blind, placebo-controlled trial of botulinum toxin injections for the treatment of spasmodic torticollis. Double-blind, placebo-controlled study of botulinum toxin injections in the treatment of cervical dystonia.
In a double-blind, placebo-controlled study, 23 patients suffering from intractable spasmodic torticollis (ST) were given successively either botulinum toxin A (BTA) or normal saline by intramuscular injections in the affected muscles. Evaluation was carried out by three blinded observers, using a clinical and video assessment of the severity of torticollis, employing a scoring system described by Tsui (1). Patients were also asked to subjectively comment on changes in the amount of pain and on changes in the activities of daily living (ADL). BTA was proven to be superior on all forms of assessment to placebo, and these results were statistically significant. Side effects mainly consisted of pain at the injection site. Tiredness occurred at equal frequency with BTA and placebo. No serious or systemic side effects were noted. Botulinum toxin is a safe, effective and relatively simple treatment for spasmodic torticollis. Results from a dose-ranging study in a selected group of de novo patients with rotational cervical dystonia (CD) suggest that 500 units of Dysport (Clostridium botulinum toxin type A haemaglutinin complex) is the optimal starting dose. The present study aimed to confirm the efficacy and safety profile of this dose in a population of CD patients more representative of those seen in a typical dystonia clinic. A total of 68 patients with moderate to severe CD (Tsui score > or = 9) were randomly assigned to receive placebo or Dysport 500 units. Treatment was administered according to the clinical pattern of head deviation, using a standardised injection protocol. A total of 21 patients (11 Dysport, 10 placebo) had not previously received botulinum toxin type A (BtxA) injections, and 47 patients (24 Dysport, 23 placebo) had received BtxA more than 12 weeks previously. Assessments were performed at baseline and weeks 4, 8 and 16. Patients defined as non-responders at week 4 were re-treated in an open phase with 500 units of Dysport at week 6, and were followed up at week 10. Significant between-group differences in Tsui scores were present at weeks 4 (p=0.001) and 8 (p=0.002). Similarly, there were significant between-group differences (p < 0.001) in patient and investigator assessments of response in favour of Dysport at weeks 4 and 8. Also, more Dysport (49%) than placebo (33%) patients were pain-free at week 4 (p=0.02). Overall, 30/35 (86 %) Dysport patients and 14/33 (42%) placebo patients were classified as responders at week 4. Adverse events were reported by 15/35 Dysport patients and 9/33 placebo patients. Open phase treatment produced improvements in Tsui (p < 0.001) and pain scores (p=0.011), and 23/24 patients were classified as responders. Although individual dose titration and muscle selection is desirable, this study demonstrated that a dose of 500 units of Dysport injected into clinically identified neck muscles without electromyographic guidance is safe and effective in the treatment of patients with the major clinical types of cervical dystonia. 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. We used turns-amplitude analysis of the EMG as a guidance for botulinum toxin (BT) treatment in 19 patients with cervical dystonia. At the first examination, muscles showing abnormal activity (> 100 turns/sec at rest) were given BT 75 units (10 patients) or placebo (9 patients). At subsequent examinations, about 6, 12 and 18 weeks after the start, BT 75 units were given to all hyperactive muscles. Six weeks after the first BT treatment the sternocleidomastoid muscle contralateral to the involuntary head rotation and the ipsilateral and contralateral posterior neck muscles (PNM) showed a reduction of involuntary activity, as indicated by reduced turns/sec and mean amplitude at rest. Similar changes were seen when comparing BT treatment with placebo. The reduction was greater in the contralateral sternocleidomastoid muscle than in PNM, suggesting that PNM need higher doses of BT. At maximal voluntary contraction, BT treated muscles showed unchanged turns/sec (5/6 tests), decreased mean amplitude and increased ratio (turns/amplitude). This may reflect a functional random loss of muscle fibres, combined with inability to activate all motor units. A high (89%) clinical success rate with BT therapy was obtained, and it is concluded that quantitative EMG is a useful tool for the precise identification of hyperactive muscles, for optimal placing of the injection cannula and for unbiased monitoring of the treatment effect. A double blind placebo controlled crossover trial was performed of botulinum toxin "A" in 20 patients with spasmodic torticollis. There was a statistically significant benefit for those treated with toxin; 12 on toxin improved objectively, compared with four on placebo (p less than 0.04). After a follow up period of one year, 16 still seemed to benefit from repeated toxin injections. The main side effect was dysphagia, which appeared to be dose related in individual patients. Botulinum toxin A was administered to 19 patients in a double-blind placebo controlled trial. Toxin was more effective than placebo for improving both head position and pain which was measured by an objective rating scale and videofilm assessments. Following the controlled trial, treatment with botulinum toxin was continued in an open fashion. A total of 60 patients with torticollis received toxin in a total of 117 treatment periods. The mean follow up period was 8.4 months. In 39 patients with pain there was benefit in 77% of treatment periods. Some improvement in neck posture occurred in 83% of the treatment periods with a mean duration of 12 weeks. Side effects were frequent with dysphagia being the most common (28% of treatment periods). Botulinum toxin is an effective treatment for toticollis but treatment should be initiated with doses at the lower end of the range used in this study (400-600 mouse units). We enrolled 55 patients in a double-blind, placebo-controlled, parallel design study of the effectiveness of botulinum toxin (Botox) injections for the treatment of spasmodic torticollis. Patients received a standard series of injections, either placebo or Botox. We determined the sites of injection and dose per muscle by the nature of head deviation. Compared with placebo, Botox produced statistically significant improvement in the severity of torticollis, disability, pain, and degree of head turning. There were no serious side effects. During the double-blind phase, 61% of patients injected with Botox improved; 74% of patients subsequently improved during a later open phase at a higher dose of Botox. Direction of head turning, severity of torticollis, and presence or absence of jerky movements did not significantly influence the response rate. We conclude that Botox is a valuable treatment for spasmodic torticollis. Botulinum toxin injections were given to 23 patients with cervical dystonia in a double-blind, placebo-controlled, crossover study. Each patient was randomly given 100 units of botulinum A toxin and placebo in two respective sets of injections into the two most active contracting neck muscles at least 3 months apart. Before and 3 weeks after each set of injections, the cervical dystonia was "blindly" scored by the investigator. Each patient was also asked to independently score the improvement of the dystonia and neck pain. Four patients dropped out and one patient showed spontaneous remission. The remaining 18 patients completed the study and showed a significant improvement after the injections of botulinum toxin in comparison with that of the placebo. The effect started about 1 week after injection and the maximal effect lasted about 11 weeks in patients with a satisfactory response. The neck pain was satisfactorily relieved in 9 of 10 patients affected. There were no significant side effects. Thus, botulinum toxin injection is effective in treating cervical dystonias; injection of a higher dose of botulinum toxin in a greater number of neck muscles is required for those patients with complex cervical dystonia.