Background: Benign essential blepharospasm (BEB) is characterized by progressive involuntary contractions of the protractor muscles, sometimes leading to a debilitating closure of the lids. It is currently treated with the injection of botulinum neurotoxin A (BoNT/A). The purpose of this study was to compare 2 BoNT/A preparations (i.e., Xeomin and Botox) in the treatment of BEB.
Methods: This was a prospective, randomized, double-blinded split-face technique in 48 patients already treated by Botox for BEB. Patients received the same medication to either side of the face for 4 injections, and were then evaluated using subjective and objective measures. Blepharospasm Disability Index (BSDI) and Jankovic Rating Scale (JRS) were assessed using a repeated-measures analysis of variance (ANOVA) and paired t test. Patient preference and objective comparison of residual orbicularis strength and spasm were compared using a multinomial logistic regression model, a repeated-measures ANOVA, and a paired t test.
Results: A paired t test showed no preference between Xeomin and Botox (P = 0.7205) and demonstrated a tendency toward not having a preference for either medication (P = 0.0301 vs Botox and P = 0.0039 vs Xeomin). The regression model showed no effect of time on patient preference (P = 0.4217). The ANOVA for BSDI scores did not reveal any difference between the 2 medications as compared with baseline (P = 0.8161), nor did it demonstrate an effect of time on BSDI scores (P = 0.6108). A paired t test found no difference between the 2 scores (P = 0.1909) at baseline. There was no difference in JRS scores for either medication when compared with baseline (P = 0.2314), nor was there an effect of time on such scores (P = 0.4951). There was also no difference between the 2 medications according to paired t test (P = 0.3224) at baseline. Baseline residual orbicularis strength was similar between the 2 medications (paired t test; P = 0.3228). ANOVA shows an effect of time on orbicularis strength (P = 0.0055), but no difference was seen at any of the 5 visits (P > 0.05). Baseline spasm scores were similar between Botox and Xeomin (paired Student t test; P = 0.3228). The ANOVA shows no difference between both medications at any point in time (P = 0.4408), and that time had no effect on the efficacy of either treatment (P = 0.3268).
Conclusion: No difference between Xeomin and Botox was detected in either subjective or objective measures for the treatment of BEB.