Korean J Ophthalmol.  2019 Oct;33(5):430-435. 10.3341/kjo.2016.0123.

Comparison of Safety and Efficacy of Botox and Neuronox in the Management of Benign Essential Blepharospasm: A Split-face Study

• Sane S
• Ali MJ
• Naik MN

• KMID: 2459524
• DOI: http://doi.org/10.3341/kjo.2016.0123

Abstract

PURPOSE
To compare the efficacy and safety of Botox and Neuronox in the management of benign essential blepharospasm (BEB).
METHODS
We performed a triple-masked, randomized control study to compare Botox and Neuronox in 48 eyes of 24 patients with BEB. All 24 patients randomly received Botox or Neuronox in the periorbital region in a masked, randomized split-face manner, keeping the injection sites and doses uniform. The toxin preparation, injection, and clinical evaluations were done by three independent observers. Objective outcome measures included improvement in the severity of spasm, grading of the functional visual status, changes in palpebral fissure height, lagophthalmos, superficial punctate keratitis and Schirmer's test at 2 weeks, 6 weeks, and upon conclusion of the effect of the toxin. Subjective outcome measures included duration of the effect and a forced choice stating which half of the face was better. Evaluations were performed through clinical measurements, external digital photography, and high-definition videography.
RESULTS
The mean duration of relief from spasms was 3.78 months (standard deviation, 1.58 months; range, 1 to 6 months). The improvement in the objective parameters like severity of spasm and functional visual status was statistically significant at the 2-week and 6-week follow-up visits (p < 0.001). The changes in palpebral fissure height, lagophthalmos, and superficial punctate keratitis were equally observed in both groups. At 2 and 6 weeks, three of 24 (12.5%) and one of 24 (4%) patients, respectively, reported an unequal effect between the two sides of the face, but this difference was not statistically significant. At final follow-up (conclusion of the toxin effect), patients reported equal effect with no preference for either hemiface. No statistically significant differences were found in the comparative analysis between the Neuronox and Botox groups.
CONCLUSIONS
Neuronox and Botox are comparable in terms of their safety and efficacy in the management of BEB.

Keyword

Blepharospasm; Botulinum toxins; Botulinum toxin type A

MeSH Terms

Blepharospasm*
Botulinum Toxins
Botulinum Toxins, Type A*
Clothing
Follow-Up Studies
Humans
Keratitis
Masks
Outcome Assessment (Health Care)
Photography
Spasm
Botulinum Toxins
Botulinum Toxins, Type A

Figure

• 

  Fig. 1 The seven sites of Botulinum toxin injection used in this study. Site 1, 4 mm above the upper punctum; site 2, 4 mm above the lateral canthus; site 3, 4 mm below the lower punctum; site 4, 4 mm below the lateral canthus; site 5, 1 cm lateral to the lateral canthus; site 6, 8 mm above the brow hair at the junction of the medial and middle third of the brow; site 7, 8 mm above the brow hair at the junction of the lateral and middle third of the brow. Written informed consent for publication was obtained from the participant.

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