Botulinum Toxins Injections for Hypertonic Limbs—Is It So Effective?

A special issue of Toxins (ISSN 2072-6651). This special issue belongs to the section "Bacterial Toxins".

Deadline for manuscript submissions: 31 May 2024 | Viewed by 1591

Special Issue Editor


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Guest Editor
1. Department of Neurology, Shaare Zedek Medical Center, Jerusalem 9103102, Israel
2. The Movement Disorders Clinic, Shaare Zedek Medical Center, Jerusalem 9103102, Israel
3. The School of Medicine, The Hebrew University, Jerusalem 91905, Israel
Interests: botulinum toxins

Special Issue Information

Dear Colleagues,

Botulinum toxin (BT) is a widely recognized safe and effective treatment, routinely used for various medical conditions, including cervical dystonia (CD), hemifacial spasm (HFS) and blepharospasm. It is now also used to alleviate the upper and lower spasticity of the limbs. The evidence of its efficacy in the treatment of limb dystonia is even more scarce, primarily because it is not covered by insurance in most, if not all, countries. Furthermore, the treatment's effectiveness results have varied among studies. It is uncertain whether one hyperactive disorder of a limb is more responsive to BT than another. In contrast to BT treatment for CD, HFS, post-facial paralysis synkinesis or blepharospams, which was widely proved to be effective and safe, BT treatment for hyperactive limbs lack evidence relating its efficacy. In addition, the dropout rates are high for BT injections of hyperactive limbs, while compliance of BT for facial and cervical muscles is high.

This issue of Toxins is focused on BT treatment of spastic and dystonic limbs. The aim of this issue is to increase our knowledge on the efficacy of BT injections for hyperactive limbs, in order to optimize its efficacy.

Dr. Gilad Yahalom
Guest Editor

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Keywords

  • botulinum
  • spastic limb
  • spasticity
  • dystonic limb
  • efficacy

Published Papers (1 paper)

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Research

16 pages, 767 KiB  
Article
A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox® versus Botox® in Post-Stroke Upper Limb Spasticity
by Dong Hyun Ye, Min Ho Chun, Yoon Ghil Park, Nam-Jong Paik, Shi-Uk Lee, Seung Don Yoo and Deog Young Kim
Toxins 2023, 15(12), 697; https://doi.org/10.3390/toxins15120697 - 12 Dec 2023
Viewed by 1433
Abstract
Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in [...] Read more.
Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in comparison to onabotulinum toxin A (Botox®) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject’s Global Assessment (SGA), the Investigator’s Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by −1.14 ± 0.59 in the Liztox® group and −1.22 ± 0.59 in the Botox® group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [−∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox® injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients. Full article
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