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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. II
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.accessioned2024-07-18T06:45:27Z
dc.date.available2024-07-18T06:45:27Z
dc.date.issued2022
dc.identifier.urihttps://hdl.handle.net/20.500.14353/539
dc.description.abstractBackground: 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.en
dc.description.sponsorshipThe CHIMES-E study was supported by the CHIMES Society, a nonprofit organization, and grants were received by CLHC from the National Medical Research Council of Singapore (NMRC/1288/2011 and NMRC/1096/2006).en
dc.language.isoenen
dc.publisherS. Karger AG, Baselen
dc.subjectAcute strokeen
dc.subjectTraditional Chinese medicineen
dc.subjectStroke recoveryen
dc.subjectMLC601en
dc.subjectNeuroAiDen
dc.subjectClinical trialen
dc.subjectLong-term outcomeen
dc.subjectCHIMESen
dc.subjectHerbal remediesen
dc.subjectStroke treatmenten
dc.subjectmRSen
dc.subject.lcshCerebrovascular diseaseen
dc.subject.lcshMedicine, Chineseen
dc.subject.lcshClinical trialsen
dc.subject.lcshNeurosciencesen
dc.subject.lcshTherapeuticsen
dc.subject.lcshNeuroprotective agentsen
dc.titleCHinese medicine NeuroAiD efficacy on stroke recovery – extension study (CHIMES-E): A multicenter study of long-term effficacyen
dc.typeArticleen
dcterms.accessRightsOpen accessen
dcterms.licenseCreative Commons Attribution-NonCommercial 3.0 Unported license
dc.citation.journaltitleCerebrovascular Diseasesen
dc.citation.volume39en
dc.citation.issue1en
dc.citation.firstpage309en
dc.citation.lastpage318en
dc.identifier.doi10.1159/000382082
local.isIndexedByScopusen


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