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Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study

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Division of Neurology, Rajavithi Hospital, Department of Medical Services, Ministry of Public Health, Bangkok 10400, Thailand
2
Division of Neurology, Department of Medicine, College of Medicine, Rangsit University, Bangkok 10400, Thailand
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Division of Neurology, Department of Medicine, Sunpasitthiprasong Hospital, Ubon Ratchathani 34000, Thailand
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Division of Neurology, Department of Medicine Lampang Hospital, Lampang 52000, Thailand
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Division of Neurology, Department of Medicine Suratthani Hospital, Suratthani 84000, Thailand
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Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand
*
Author to whom correspondence should be addressed.
Toxins 2021, 13(10), 694; https://doi.org/10.3390/toxins13100694
Received: 7 July 2021 / Revised: 31 August 2021 / Accepted: 31 August 2021 / Published: 1 October 2021
(This article belongs to the Special Issue Neurophysiology of Botulinum Toxins in Clinical Practice)
Various types of botulinum toxin (BoNT) have been studied to treat cervical dystonia (CD). Although high-dose BoNT has proven efficacy, it increases the risk of adverse events. For this reason, this study was planned to identify the non-inferiority efficacy, tolerability, and safety of low-dose neubotulinum toxin A (Neu-BoNT-A) versus low-dose abobotulinum toxin A (Abo-BoNT-A) in CD treatment. The 48-week, prospective, randomized, controlled crossover design study of CD treatment, with 50-unit Neu-BoNT-A and 250-unit Abo-BoNT-A injections at 12-week intervals, was conducted over a 24-week treatment period. This study used the following standardized rating scales to assess the efficacy of BoNT: the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); health-related quality of life (HRQoL); the Cervical Dystonia Impact Profile (CDIP-58); the Short Form 36 health survey questionnaire (SF-36); and, for the depressive symptoms of CD patients, the Center for Epidemiological Studies-Depression Scale (CES-D) and the Patient Health Questionnaire-9 (PHQ-9). Fifty-two CD patients were enrolled from October 2019 to January 2021. The mean scores of the TWSTRS total at the post-treatments in both Neu-BoNT-A and Abo-BoNT-A had a significant reduction from baseline (p = 0.008 and 0.002, respectively). However, the mean changes of the TWSTRS total at the 12- and 24-week treatments between the two treatment groups were not significantly different (p = 0.284 and 0.129, respectively). The mean scores of the HRQoL questionnaires (the CIDP-58 and the SF-36) and the depressive symptoms (the CES-D and the PHQ-9) in both treated groups at the post-treatments did not significantly decrease from baseline and were comparable. Two patients treated with Abo-BoNT-A (250 units) reported cervical tension and benign paroxysmal positional vertigo (BPPV). There were no serious adverse events reported. Though both low-dose BoNT-As were effective at improving clinical symptoms without significant side effects, both treatments did not predict change in quality of life and depression. With the non-inferiority criteria, low-dose Neu-BoNT-A has a similar efficacy, safety, and tolerability to Abo-BoNT-A. View Full-Text
Keywords: abobotulinum toxin A; neubotulinum toxin A; the Toronto Western Spasmodic Torticollis Rating Scale; the Cervical Dystonia Impact Profile; the Short Form 36 health survey questionnaire; the Center for Epidemiological Studies-Depression Scale; the Patient Health Questionnaire-9 abobotulinum toxin A; neubotulinum toxin A; the Toronto Western Spasmodic Torticollis Rating Scale; the Cervical Dystonia Impact Profile; the Short Form 36 health survey questionnaire; the Center for Epidemiological Studies-Depression Scale; the Patient Health Questionnaire-9
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MDPI and ACS Style

Kongsaengdao, S.; Arayawithchanont, A.; Samintharapanya, K.; Rojanapitayakorn, P.; Maneeton, B.; Maneeton, N. Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study. Toxins 2021, 13, 694. https://doi.org/10.3390/toxins13100694

AMA Style

Kongsaengdao S, Arayawithchanont A, Samintharapanya K, Rojanapitayakorn P, Maneeton B, Maneeton N. Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study. Toxins. 2021; 13(10):694. https://doi.org/10.3390/toxins13100694

Chicago/Turabian Style

Kongsaengdao, Subsai, Arkhom Arayawithchanont, Kanoksri Samintharapanya, Pichai Rojanapitayakorn, Benchalak Maneeton, and Narong Maneeton. 2021. "Low-Dose Neubotulinum Toxin A versus Low-Dose Abobotulinum Toxin A Injection for the Treatment of Cervical Dystonia: A Multicenter, 48-Week, Prospective, Double-Blinded, Randomized Crossover Design Study" Toxins 13, no. 10: 694. https://doi.org/10.3390/toxins13100694

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