Evidence map›Paper›PMID 33291807›Full record

Observational studyToxins2020

The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

Patricia Khan, Marcelo Riberto, João Amaury Frances, Regina Chueire, Ana Cristina Ferreira Garcia Amorim, Denise Xerez, Tae Mo Chung, Lucia Helena Costa Mercuri, Alexandre Luiz Longo, Sérgio Lianza and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Toxins, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02390206 (An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 31% of its field
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.

NCT02390206 completednot on this map

An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients

TypeobservationalSponsorIpsenRan2015 to 2017Enrolled239ConditionsSpasticity
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
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

12 authors at 10 institutions in 2 countries.

Patricia KhanCentro Catarinense de Reabilitação, Florianópolis, Santa Catarina 88025-301, Brazil.
Marcelo RibertoFaculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, São Paulo 14049-900, Brazil.ORCID 0000-0001-9549-8830
João Amaury FrancesHospital Bettina Ferro de Souza, Campus IV da Universidade Federal do Pará, Belém, Pará 66075-110, Brazil.
Regina ChueireFaculdade de Medicina de São José do Rio Preto, Autarquia Estadual, São José do Rio Preto 15090-000, Brazil.
Ana Cristina Ferreira Garcia AmorimCentro de Reabilitação e Readaptação Dr. Henrique Santillo (CRER), Goiânia, Goiás 74653-230, Brazil.
Denise XerezServiço de Medicina Física e Reabilitação, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21941-590, Brazil.
Tae Mo ChungInstituto de Medicina Física e Reabilitação, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo 04116-030, Brazil.
Lucia Helena Costa MercuriHospital São Paulo-UNIFESP, São Paulo 04024-002, Brazil.
Alexandre Luiz LongoClinica Neurológica e Neurocirúrgica de Joinville, Joinville, Santa Catarina 89202-165, Brazil.
Sérgio LianzaHospital Alemão Oswaldo Cruz, São Paulo 01323-020, Brazil.
Pascal MaisonobeIpsen, 92100 Boulogne Billancourt, France.
Viviane C Ruiz-SchutzIpsen, São Paulo 04571-010, Brazil.
Faculdade de Medicina de São José do Rio Preto · BRFundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina · BRHospital Alemão Oswaldo Cruz · BRHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital Municipal São José · BRHospital São Paulo · BRIpsen (France) · FRUniversidade de Ribeirão Preto · BRUniversidade Federal do Pará · BRUniversidade Federal do Rio de Janeiro · BR

Funding

Ipsen NA
6 · The paper itself

Abstract

Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI: 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI: 49.9, 65.3] vs. 64.1% [95% CI: 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.

Indexed as

AdolescentAdultAgedBotulinum Toxins, Type ABrazilChronic DiseaseFemaleHumansMaleMiddle AgedMuscle SpasticityNeuromuscular AgentsQuality of LifeStrokeTreatment OutcomeYoung AdultBotulinum Toxins, Type ANeuromuscular Agentspainquality of lifespasticitystroke

Identifiers

PMID33291807
PMCPMC7762077
OpenAlexW3111933128

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.