Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial. Effect of anticholinergic agents upon acquired nystagmus: a double-blind study of trihexyphenidyl and tridihexethyl chloride. Quantitative EMG in botulinum toxin treatment of cervical dystonia. A double-blind, placebo-controlled study. Botulinum toxin A in the hemiplegic upper limb: a double-blind trial. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Double-blind, placebo-controlled study of botulinum toxin injections in the treatment of cervical dystonia. Improvement in quality of life after botulinum toxin-A injections for idiopathic detrusor overactivity: results from a randomized double-blind placebo-controlled trial. A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients. Randomized controlled trial of intrasphincteric botulinum toxin A injection versus balloon dilatation in treatment of achalasia cardia.
Botulinum toxin type A (BTA) is replacing trihexyphenidyl as the treatment of choice for idiopathic cervical dystonia (ICD), but there has never been a direct comparative study.
                This trial compares the effectiveness of BTA with that of trihexyphenidyl in a prospective, randomized, double-blind design. Sixty-six consecutive patients with ICD were randomized to treatment with trihexyphenidyl tablets plus placebo injection or placebo tablets plus BTA injections. Tablets were administered daily according to a fixed schedule. Dysport or saline was injected under EMG guidance at study entry and again after 8 weeks. Patients were assessed for efficacy at baseline and after 12 weeks by different clinical rating scales.
                Sixty-four patients completed the study, 32 in each group. Mean dose of BTA was 292 mouse units (first session) and 262 mouse units (second session). Mean dose of trihexyphenidyl was 16.25 mg. The changes on the Disability section of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-Disability) (primary outcome), Tsui Scale, and the General Health Perception Subscale were significantly in favor of BTA. More patients treated with BTA had an improvement of at least three points on the TWSTRS-Disability (14 versus 6) and on the Tsui Scale (23 versus 12). Adverse effects were significantly less frequent in the BTA group.
                BTA is significantly more effective in the treatment of ICD, with less adverse effects. We conducted a randomized, double-blind, crossover trial of two anticholinergic agents--trihexyphenidyl and tridihexethyl chloride (a quaternary anticholinergic that does not cross the blood-brain barrier)--in patients with acquired nystagmus and measured visual acuity and nystagmus before and at the end of 1 month on each medication. Of the 10 patients admitted to the study, only five completed trials of both drugs due to intolerance of medication or intercurrent illness. Of six patients who completed the trial of trihexyphenidyl, only one showed improvement. Of six patients who completed a trial of tridihexethyl chloride, four showed improvement. We conclude that (1) trihexyphenidyl is not a reliable treatment for acquired nystagmus, although occasional patients may benefit; (2) anticholinergic agents may suppress nystagmus by peripheral rather than central mechanisms; and (3) the side effects of anticholinergic agents limit their effectiveness in the treatment of nystagmus. 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. 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. Myofascial pain syndrome (MPS) is one of the most common causes of chronic musculoskeletal pain. Several methods have been recommended for the inactivation of trigger points (TrP).
                This prospective, single-blind study was proposed to compare TrP injection with botulinum toxin type A (BTX-A) to dry needling and lidocaine injection in MPS.
                Eighty-seven trigger points (cervical and/or periscapular regions) in 23 female and six male patients with MPS were treated and randomly assigned to three groups: lidocaine injection (n=10, 32 TrP), dry needling (n=10, 33 TrP), and BTX-A injection (n=9, 22 TrP).
                Clinical assessment including cervical range of motion, TrP pain pressure threshold (PPT), pain scores (PS), and visual analog scales for pain, fatigue, and work disability were evaluated at entry and the end of the 4th week. Additionally, depression and anxiety were evaluated with the Hamilton depression and anxiety rating scales, and quality of life was assessed using the Nottingham health profile (NHP). The subjects were also asked to describe side effects. INJECTION PROCEDURE: One milliliter of 0.5% lidocaine was administered to each TrP in the lidocaine injection group, 10-20 IU of BTX-A to each TrP in the BTX-A group, and dry needling to each TrP in the last group, followed by stretching of the muscle groups involved. The patients were instructed to continue their home exercise programs.
                Pain pressure thresholds and PS significantly improved in all three groups. In the lidocaine group, PPT values were significantly higher than in the dry needle group, and PS were significantly lower than in both the BTX-A and dry needle groups. In all, visual analog scores significantly decreased in the lidocaine injection and BTX-A groups and did not significantly change in the dry needle group. Disturbance during the injection procedure was lowest in the lidocaine injection group. Quality of life scores assessed by NHP significantly improved in the lidocaine and BTX-A groups but not in the dry needle group. Depression and anxiety scores significantly improved only in the BTX-A-injected group.
                Injection is more practical and rapid, since it causes less disturbance than dry needling and is more cost effective than BTX-A injection, and seems the treatment of choice in MPS. On the other hand, BTX-A could be selectively used in MPS patients resistant to conventional treatments. 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. OBJECTIVE To determine whether botulinum toxin-A (BTX-A) treatment has an effect on the quality of life (QoL) of patients with overactive bladder (OAB) refractory to anticholinergics. PATIENTS AND METHODS This was a single centre, randomized, double-blind, placebo-controlled trial. Participants were men and women with idiopathic detrusor overactivity (IDO). Participants were randomised to receive either 200 U of BTX-A (Botox(R), Allergan Inc., Irvine, CA, USA; n = 16) or placebo (n = 18) via a trigone-sparing flexible cystoscopic technique. QoL was assessed using the King's Health Questionnaire (KHQ) at baseline and at 4 and 12 weeks, after injection. At 12 weeks patients were 'unblinded' and a further open-label follow-up in the BTX-A group occurred at 24 weeks. The changes in the subdomains of the KHQ were assessed over the study period. RESULTS Overall QoL was significantly improved in the BTX-A treated patients compared with placebo in the blinded part of the study. When analysing the KHQ subdomains, 'Incontinence Impact', 'Emotions', 'Physical Limitations', 'Social Limitations' and 'Severity Measures' were significantly improved in those that received BTX-A compared with placebo. The 'Symptom Severity' domain was also significantly improved at 4 weeks but not at 12 weeks. At 12 weeks 'Role Limitations' also became statistically significant in favour of BTX-A. The open-label extension study suggested these benefits last for at least 24 weeks. CONCLUSIONS BTX-A bladder injections at 200 U appear to improve QoL in patients with OAB symptoms and IDO refractory to anticholinergics for at least 24 weeks. As well as the improvement seen in clinical parameters with this form of therapy, perhaps of more importance to the patient, is the improvement in QoL. In twenty-five SCI subjects, antispasticity effects of three putative antispasticity agents [clonidine (an alpha-2 noradrenergic agonist), cyproheptadine (a 5-HT2 antagonist) and baclofen (a GABA-B agonist)] were tested in terms of changes in leg tone as graded by the Ashworth scale (AS), in terms of the vibratory inhibition of the H-reflex (VII) and in terms of the ability of the knee to swing passively in the pendulum test as quantified by video motion analysis. When compared to the no drug period, all three drug treatments showed an antispasticity effect on the AS, the VII and the amplitude of the first swing and the relaxation index of the pendulum test, p. < 0001. Surprisingly, cyproheptadine and baclofen produced a greater reduction in the VII than clonidine, p. < 01. The amplitude of the first swing in the pendulum test correlated well with the AS, r = .88, and the antispasticity effects of the drugs produced improvements in both measures, a reduced AS and increased amplitude of knee swing in the pendulum test. Therefore, video motion analysis of the pendulum test is as valid a measure of spasticity as the Ashworth scale and is not limited by subjectivity of the examiner. As the few randomized controlled trials available in the literature comparing botulinum toxin (BT) injection with established endoscopic treatment of achalasia cardia, i.e. pneumatic dilatation, showed conflicting results, we conducted a prospective randomized trial. Seventeen consecutive patients with achalasia cardia diagnosed during a period between December 1997 and February 2000 were randomized into two treatment groups [pneumatic dilatation by Rigiflex dilator (n=10), BT injection by sclerotherapy needle into four quadrants of lower esophageal sphincter (LES) (n=7) 80 units in five cases, 60 units in two cases] after dysphagia grading, endoscopy, barium esophagogram, and manometry, all of which were repeated 1 week after treatment. Patients were followed up clinically for 35.2+/-14 weeks. Chi-squares, Wilcoxon rank-sum test, Kaplan-Meier method and log-rank tests were used for statistical analysis. After 1 week, 6/7 (86%) BT-treated vs. 8/10 (80%) dilatation-treated patients improved (P=NS). There was no difference in LES pressure and maximum esophageal diameter in the barium esophagogram in the two groups before therapy. Both therapies resulted in significant reduction in LES pressure. The cumulative dysphagia-free state using the Kaplan-Meier method decreased progressively in BT-treated compared with dilatation-treated patients (P=0.027). Two patients with tortuous megaesophagus, one of whom had failed dilatation complicated by perforation previously, improved after BT. One other patient in whom pneumatic dilatation had previously failed improved in a similar manner. BT is as good as pneumatic dilatation in achieving an initial improvement in dysphagia of achalasia cardia. It is also effective in patients with tortuous megaesophagus and previous failed pneumatic dilatation. However, dysphagia often recurs during 1-year follow up.
The available evidence suggests that BtA injections provide more objective and subjective benefit than trihexyphenidyl to patients with cervical dystonia. We could not draw any conclusions about other anticholinergic drugs. Future trials should explore the role of anticholinergic drugs in patients that do not get benefit with BtA.