PMID- 36462105
OWN - NLM
STAT- MEDLINE
DCOM- 20230113
LR  - 20230113
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 43
IP  - 1
DP  - 2023 Jan
TI  - Safety and Efficacy of Edaravone in Patients with Amyotrophic Lateral Sclerosis: 
      A Systematic Review and Meta-analysis.
PG  - 1-11
LID - 10.1007/s40261-022-01229-4 [doi]
AB  - BACKGROUND AND OBJECTIVE: The efficacy and safety of edaravone for the treatment 
      of amyotrophic lateral sclerosis (ALS) remain unclear. The aim of this 
      meta-analysis was to provide evidence-based medical guidance and advice for the 
      clinical application of edaravone in the treatment of ALS. METHODS: PubMed, 
      Embase, Chinese Biomedical Literature Database (CBM), Cochrane Library and Web of 
      Science were searched through 09 March 2022 for randomized controlled trials 
      (RCTs) on the safety and efficacy of edaravone versus placebo during follow-up of 
      patients with ALS. A summary of the outcome measures with GRADE was performed. 
      This study was registered on PROSPERO (ID: CRD 42022319997). RESULTS: Five RCTs 
      with a total of 566 participants were included, and there was a significant 
      difference (mean difference [MD] 1.33, 95% confidence interval [CI] 0.33-2.34; 
      p = 0.009) in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale 
      (ALSFRS-R) score between the treatment and placebo groups. The edaravone group 
      had an increased grip strength (MD 0.26, 95% CI 0.03-0.49; p = 0.03) and modified 
      Norris Scale score (MD 2.81, 95% CI 1.18-4.43; p = 0.0007). However, there were 
      no significant differences between groups for the change in forced vital capacity 
      (FVC)% (MD 0.55, 95% CI - 3.15 to 4.24; p = 0.77), pinch strength (MD 0.05, 95% 
      CI - 0.05 to 0.16; p = 0.33) or Amyotrophic Lateral Sclerosis Assessment 
      Questionnaire (ALSAQ-40) score (MD - 4.76, 95% CI - 9.56 to 0.03; p = 0.05). The 
      incidence of adverse events (AEs) (risk ratio [RR] 0.09, 95% CI 0.93-1.05; 
      p = 0.65), serious adverse events (SAEs) (RR 0.72, 95% CI 0.52-1.00; p = 0.05) 
      and the number of deaths (risk difference [RD] 0.00, 95% CI - 0.02 to 0.03; 
      p = 0.83) were not statistically different from the placebo group. The quality of 
      evidence was low only for SAEs, and the remaining outcome measures were of 
      moderate quality. CONCLUSIONS: Compared with placebo, edaravone may provide 
      potential clinical benefits in the treatment of ALS and may not increase the 
      number of AEs and deaths. However, due to the low-quality evidence of the 
      included studies and the small sample size, more high-quality and high-standard 
      research evidence is needed to confirm these results. PROTOCOL REGISTRATION: This 
      study was registered on PROSPERO (ID: CRD 42022319997).
CI  - (c) 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Gao, Mengxia
AU  - Gao M
AUID- ORCID: 0000-0002-9321-8986
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China.
FAU - Zhu, Lingqun
AU  - Zhu L
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China.
AD  - Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese 
      Medicine, Beijing, 100700, China.
FAU - Chang, Jingling
AU  - Chang J
AD  - Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese 
      Medicine, Beijing, 100700, China.
FAU - Cao, Tianyu
AU  - Cao T
AUID- ORCID: 0000-0002-5299-847X
AD  - Department of Neurology, Dongzhimen Hospital, Beijing University of Chinese 
      Medicine, Beijing, 100700, China.
FAU - Song, Lianying
AU  - Song L
AUID- ORCID: 0000-0001-5012-9716
AD  - Department of Radiology, Dongzhimen Hospital, Beijing University of Traditional 
      Chinese Medicine, Beijing, 100700, China.
FAU - Wen, Chunli
AU  - Wen C
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China.
FAU - Chen, Yi
AU  - Chen Y
AUID- ORCID: 0000-0003-4192-7139
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China.
FAU - Zhuo, Yudi
AU  - Zhuo Y
AUID- ORCID: 0000-0003-3529-817X
AD  - Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, 
      Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China.
FAU - Chen, Fei
AU  - Chen F
AUID- ORCID: 0000-0001-6104-1541
AD  - Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, 
      China. dzmyyhouqin@163.com.
LA  - eng
GR  - No. 2019-JYB-TD-003/Special Funds for Basic Scientific Research in Central 
      Universities of China/
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20221203
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - S798V6YJRP (Edaravone)
SB  - IM
MH  - Humans
MH  - Edaravone/adverse effects
MH  - *Amyotrophic Lateral Sclerosis/drug therapy
MH  - Surveys and Questionnaires
EDAT- 2022/12/04 06:00
MHDA- 2023/01/14 06:00
CRDT- 2022/12/03 11:15
PHST- 2022/11/16 00:00 [accepted]
PHST- 2022/12/04 06:00 [pubmed]
PHST- 2023/01/14 06:00 [medline]
PHST- 2022/12/03 11:15 [entrez]
AID - 10.1007/s40261-022-01229-4 [pii]
AID - 10.1007/s40261-022-01229-4 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2023 Jan;43(1):1-11. doi: 10.1007/s40261-022-01229-4. Epub 
      2022 Dec 3.