A Prospective, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Type A Botulinum Toxins Botox and Prosigne in the Treatment of Cervical Dystonia

Abstract

Botulinum toxin A (BTA) is considered an effective treatment of cervical dystonia. The aim of this prospective, randomized, double-blind study was to compare Botox and Prosigne, a BTA of Chinese origin, with a view to establish the safety, the efficacy, and the equivalence of doses of the 2 formulations in the treatment of cervical dystonia. Twenty-four patients were randomized to receive 300 U of Botox or Prosigne (12 patients in each group). The patients were assessed before the injection and after 4 and 16 weeks by the Toronto Western Spasmodic Torticollis Rating Scale and the Short-Form 36 for quality of life before and 16 weeks after the injection. All patients were comparable in age, time since onset, number of previous injections, and time since last BTA application. According to the Toronto Western Spasmodic Torticollis Rating Scale scores, the patients improved after injection and the scores increased after 16 weeks, without returning to baseline values. Both pain and burning during the injection and the treatment outcomes were similar in both groups. No systemic adverse events occurred, and the severity and frequency of local events were comparable in both groups. Average duration of effect was similar in both groups (11 weeks). The quality-of-life evaluations before and after the injections were comparable in both groups. Social aspects, pain, and vitality improved after 16 weeks in both groups. In conclusion, Botox and Prosigne were determined to have equivalent efficacy, safety, and tolerability profiles and dose equivalence for cervical dystonia treatment is 1:1.