Evidence map›Paper›PMID 36070998›Full record

ArticleAnnals of rehabilitation medicine2022

Efficacy and Safety of Botulinum Toxin Type A (NABOTA) for Post-stroke Upper Extremity Spasticity: A Multicenter Phase IV Trial.

Wonjae Hwang, Seong Min Kang, Sang Yoon Lee, Han Gil Seo, Yoon Ghil Park, Bum Sun Kwon, Kwang Jae Lee, Deog Young Kim, Hyoung Seop Kim, Shi-Uk Lee

Abstract read
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Article in Annals of rehabilitation medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Wonjae HwangDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Seong Min KangDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Sang Yoon LeeDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.
Han Gil SeoDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Yoon Ghil ParkDepartment of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.
Bum Sun KwonDepartment of Rehabilitation Medicine, Dongguk University College of Medicine, Goyang, Korea.
Kwang Jae LeeDepartment of Physical Medicine and Rehabilitation, Presbyterian Medical Center (Jesus Hospital), Jeonju, Korea.
Deog Young KimDepartment and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea.
Hyoung Seop KimDepartment of Physical Medicine and Rehabilitation, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Shi-Uk LeeDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.

Funding

Daewoong Pharmaceutical Co. Ltd.
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.

methodsThis prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.

resultsThere was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.

conclusionNABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.

Indexed as

Botulinum toxin type AClinical trialMuscle spasticityPhase 4SafetyStrokeTreatment efficacy

Identifiers

PMID36070998
PMCPMC9452292

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.