engleski

. Comparison of the safety and efficacy of Botulinum toxin type-A and tizanidine in the treatment of cervical dystonia

Objective: To compare the safety and efficacy of botulinum toxin type-A vs tizanidine in the treatment of cervical dystonia. Patients and Methods:This was a single-blind, randomised, comparative, parallel and two-way crossover study to compare the safety and efficacy of BOTOX&#174; versus tizanidine in the treatment of 42 na&#239; ve idiopathic cervical dystonia patients using the Toronto Western Spasmodic Rating Scale (TWSTRS). Secondary efficacy comprised pain frequency and severity, physician and patient global assessment, and quality of life (QoL). In phase I, Group A received botulinum toxin type-A as BOTOX&#174; (dose range from 100 to 200 U) and Group B received tizanidine as Sirdalud&#174; (dose range from 4 mg to 16 mg) for 6 weeks. In phase II Group A was not treated again but Group B swiched to BOTOX&#174; . Results and Discussion: BOTOX&#174; group showed a greater decrease in TWSTRS score (p<0.0001 at Week 6). Greater decreases in pain frequency and severity were also noted in Group A at Week 6 (decreased frequency, p=0.003 ; decreased severity, p=0.008). Similar reductions were seen in Phase II when tizanidine patients were swiched to BOTOX&#174; . Physician global assessment, patient global assessment and QoL all improved more following BOTOX&#174; treatment compared to tizandine treatment, with statistically significant differences being seen for all analyses at Weeks 2 and 6. Patients also experienced more adverse events following tizanidine treatment (76%) compared to BOTOX&#174; treatment (phase I: 43%, phase II: 40%). Conclusion: BOTOX&#174; treatment provided a significant benefit compared to tizanidine oral medication.

BOTOX&#174;; cervical dystonia; tizanidine

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