Current medical research and opinion
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Randomized Controlled Trial Comparative Study Clinical Trial Controlled Clinical Trial
A double-blind, long-term study of tizanidine ('Sirdalud') in spasticity due to cerebrovascular lesions.
A double-blind study was carried out in 30 patients suffering from spasticity due to cerebrovascular lesions to compare the long-term efficacy and tolerability of tizanidine hydrochloride with that of baclofen. A 2-week titration phase identified the optimum dose of tizanidine (max. 20 mg/day) or baclofen (max. 50 mg/day) in each patient. Patients were then treated with this dose for a 50-week maintenance phase. ⋯ Side-effects in the tizanidine group were mild and transient and no patients discontinued the study; in the baclofen group, 3 patients discontinued the study due to severe side-effects. However, both drugs were assessed as effective and fairly well tolerated in the long-term. Although there were no statistically significant differences between the two drugs, the global assessment of antispastic efficacy revealed a nearly significant difference (p = 0.057) in favour of tizanidine and the global assessment of tolerability was also in favour of tizanidine.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparative analgesic efficacy and tolerability of ketorolac tromethamine and glafenine in patients with post-operative pain.
In a randomized, single-dose, double-blind, parallel comparative trial of analgesic efficacy, 96 adult patients received either 10 mg ketorolac tromethamine or 400 mg glafenine orally the morning after surgery if they requested pain relief medication. Each patient provided a baseline pain assessment and then received the assigned medication. Patients assessed pain intensity and pain relief and reported any adverse events in interviews held 30 minutes after drug administration and then hourly for 6 hours. ⋯ The differences in overall response were statistically significant (p = 0.017). Fourteen (30%) patients who received ketorolac tromethamine and 17 (35%) who received glafenine reported adverse experiences that began or seemed to worsen after administration of the study drugs. The most prominent were drowsiness and sleeping, both of which are common in post-surgical patients.
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Randomized Controlled Trial Comparative Study Clinical Trial Controlled Clinical Trial
A multi-centre, double-blind trial of tizanidine, a new antispastic agent, in spasticity associated with hemiplegia.
A double-blind study was carried out in 105 patients with chronic spasticity associated with hemiplegia in order to compare the efficacy and tolerability of tizanidine with that of diazepam. Dosage was increased progressively, if tolerated, to a maximum of 24 mg tizanidine or 30 mg diazepam per day at the end of 2 weeks. The optimum dosage was then maintained for 6 weeks. ⋯ Evaluation of the effect of therapy revealed an improvement with each drug in approximately 83% of patients, with the overall evaluation being slightly (but non-significantly) in favour of tizanidine. There were fewer discontinuations of treatment in the tizanidine group as a result of side-effects. It would appear, therefore, that tizanidine is an effective and well-tolerated drug in the treatment of cerebral spasticity.
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Randomized Controlled Trial Comparative Study Clinical Trial
Multi-centre, double-blind trial of a novel antispastic agent, tizanidine, in spasticity associated with multiple sclerosis.
A multi-centre, double-blind study was carried out in 100 patients suffering from chronic spasticity due to multiple sclerosis to compare the effectiveness of tizanidine hydrochloride with that of baclofen. Patients were allocated at random to receive treatment initially with daily doses of either 6 mg tizanidine or 15 mg baclofen and the dose was increased during the first 2 weeks up to a maximum of 24 mg tizanidine or 60 mg baclofen per day. Patients were then treated with the optimum dose for 6 weeks. ⋯ The antispastic efficacy of tizanidine was greater after 8 weeks than after 2 weeks, whereas the efficacy of baclofen decreased slightly with time. Both drugs showed good overall tolerability in more than 60% of patients. Thus, tizanidine is a well tolerated and effective muscle relaxant, the antispastic efficacy of which is well maintained over time, and it promises to be particularly useful in the treatment of spasticity due to multiple sclerosis.
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One hundred and eight patients who had been taking phenytoin for a year or more, either alone or in combination with other drugs, were examined for gum hypertrophy by three observers independently. Approximately 90% of the patients showed either mild or no gum hypertrophy and severe swelling occurred in only 1%. ⋯ A tendency for higher serum phenytoin levels to be associated with greater gum hypertrophy was observed. Because the condition was causing no problems in over 90% of patients, it is considered that gum hypertrophy per se should not deter a physician from using phenytoin in the treatment of epilepsy.