Botulinum toxin A (BTA) is considered an effective treatment of
blepharospasm and
hemifacial spasm, but there are few studies to permit a comparison of its different formulations. This prospective, randomized, double-blind study compared
Prosigne, a BTA of Chinese origin, with
Botox to establish safety, efficacy, and equivalence of doses between those 2 formulations in
blepharospasm and
hemifacial spasm treatment. Fifty-seven patients participated in this study: 21
blepharospasm (from whom 11 were treated with
Botox; and 10, with
Prosigne) and 36
hemifacial spasm patients (17 were treated with
Botox; and 19, with
Prosigne). All patients were similar in age, disease time span, number of previous shots, and time elapsed since the last BTA application.
Pain and burning during the injection and the result of the treatment were similar in both groups. There were no systemic adverse events, and the local ones were observed with similar intensity and frequency for both groups. The mean effect time length was similar for both
blepharospasm (11.3 weeks for both toxins) and
hemifacial spasm patients (12.8 weeks for
Botox and 12.9 weeks for
Prosigne). In both
blepharospasm groups, only the 36-Item Short-Form Health Survey emotional aspects domain showed improvement from baseline after 16 weeks. There were no differences between the 36-Item Short-Form Health Survey scores before and after the treatment of all
hemifacial spasm patients. Therefore, it has been concluded that
Botox and
Prosigne have similar efficacy, safety, and tolerability profiles, so that a dose equivalence of 1:1 may be considered for
blepharospasm and
hemifacial spasm treatments.