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Article: CHInese medicine NeuroAiD efficacy on stroke recovery - Extension study (CHIMES-E): A multicenter study of long-term efficacy

TitleCHInese medicine NeuroAiD efficacy on stroke recovery - Extension study (CHIMES-E): A multicenter study of long-term efficacy
Authors
KeywordsTraditional Chinese medicine
Stroke recovery
NeuroAiD
MLC601
Long-term outcome
Clinical trial
Acute stroke
Issue Date2015
Citation
Cerebrovascular Diseases, 2015, v. 39, n. 5-6, p. 309-318 How to Cite?
Abstract© 2015 S. Karger AG, Basel. Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.
Persistent Identifierhttp://hdl.handle.net/10722/220869
ISSN
2015 Impact Factor: 3.359
2015 SCImago Journal Rankings: 1.744

 

DC FieldValueLanguage
dc.contributor.authorVenketasubramanian, Narayanaswamy-
dc.contributor.authorYoung, Sherry H.-
dc.contributor.authorTay, San San-
dc.contributor.authorUmapathi, Thirugnanam-
dc.contributor.authorLao, Annabelle Y.-
dc.contributor.authorGan, Herminigildo H.-
dc.contributor.authorBaroque, Alejandro C.-
dc.contributor.authorNavarro, Jose C.-
dc.contributor.authorChang, Hui Meng-
dc.contributor.authorAdvincula, Joel M.-
dc.contributor.authorMuengtaweepongsa, Sombat-
dc.contributor.authorChan, Bernard P L-
dc.contributor.authorChua, Carlos L.-
dc.contributor.authorWijekoon, Nirmala-
dc.contributor.authorDe Silva, H. Asita-
dc.contributor.authorHiyadan, John Harold B-
dc.contributor.authorSuwanwela, Nijasri C.-
dc.contributor.authorWong, K. S Lawrence-
dc.contributor.authorPoungvarin, Niphon-
dc.contributor.authorEow, Gaik Bee-
dc.contributor.authorLee, Chun Fan-
dc.contributor.authorChen, Christopher L H-
dc.date.accessioned2015-10-22T09:04:40Z-
dc.date.available2015-10-22T09:04:40Z-
dc.date.issued2015-
dc.identifier.citationCerebrovascular Diseases, 2015, v. 39, n. 5-6, p. 309-318-
dc.identifier.issn1015-9770-
dc.identifier.urihttp://hdl.handle.net/10722/220869-
dc.description.abstract© 2015 S. Karger AG, Basel. Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.-
dc.languageeng-
dc.relation.ispartofCerebrovascular Diseases-
dc.subjectTraditional Chinese medicine-
dc.subjectStroke recovery-
dc.subjectNeuroAiD-
dc.subjectMLC601-
dc.subjectLong-term outcome-
dc.subjectClinical trial-
dc.subjectAcute stroke-
dc.titleCHInese medicine NeuroAiD efficacy on stroke recovery - Extension study (CHIMES-E): A multicenter study of long-term efficacy-
dc.typeArticle-
dc.description.natureLink_to_subscribed_fulltext-
dc.identifier.doi10.1159/000382082-
dc.identifier.scopuseid_2-s2.0-84928713140-
dc.identifier.volume39-
dc.identifier.issue5-6-
dc.identifier.spage309-
dc.identifier.epage318-
dc.identifier.eissn1421-9786-

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