AIM: To confirm and compare the therapeutic efficacies and adverse effects of Chinese botulinum toxin type A (CBTX-A, Lanzhou Biological Products Institute, China) and current Botox (Allergan Inc., CA, USA) in the treatment of blepharospasm (BS) and hemifacial spasm (HFS). MATERIAL AND METHODS: We performed an open, prospective, comparative trial comparing CBTX-A and Botox for the treatment of BS and HFS in 273 patients since 2006. 107 patients were treated withcurrent Botox and 166 with CBTX-A, with the age, disease durations and severity of spasm matched. The patients enrolled were followed up for 6 months. RESULTS: There were no significant differences in the clinical effects of the two preparations, including the onset of response, peaked effect time and duration of effects (p > 0.05). The Cohen scores showed a significant reduction after BTX-A injections. Considerable improvement of symptoms for the BS and HFS patients was observed 7 days, 4 weeks, 12 weeks, and 24 weeks after the injection with either current Botox or CBTX-A (p < 0.05). There was no significant difference in the effectiveness rate for both HFS patients and BS patients between CBTX-A group and Botox group (p > 0.05). No statistical differences were noted in adverse reactions between them (p > 0.05). CONCLUSION: The two preparations were both simple and effective for the patients with blepharospasm and hemifacial spasm.
RCT Entities:
AIM: To confirm and compare the therapeutic efficacies and adverse effects of Chinese botulinum toxin type A (CBTX-A, Lanzhou Biological Products Institute, China) and current Botox (Allergan Inc., CA, USA) in the treatment of blepharospasm (BS) and hemifacial spasm (HFS). MATERIAL AND METHODS: We performed an open, prospective, comparative trial comparing CBTX-A and Botox for the treatment of BS and HFS in 273 patients since 2006. 107 patients were treated with current Botox and 166 with CBTX-A, with the age, disease durations and severity of spasm matched. The patients enrolled were followed up for 6 months. RESULTS: There were no significant differences in the clinical effects of the two preparations, including the onset of response, peaked effect time and duration of effects (p > 0.05). The Cohen scores showed a significant reduction after BTX-A injections. Considerable improvement of symptoms for the BS and HFSpatients was observed 7 days, 4 weeks, 12 weeks, and 24 weeks after the injection with either current Botox or CBTX-A (p < 0.05). There was no significant difference in the effectiveness rate for both HFSpatients and BSpatients between CBTX-A group and Botox group (p > 0.05). No statistical differences were noted in adverse reactions between them (p > 0.05). CONCLUSION: The two preparations were both simple and effective for the patients with blepharospasm and hemifacial spasm.