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CHinese medicine NeuroAiD efficacy on stroke recovery – extension study (CHIMES-E): A multicenter study of long-term effficacy

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Date
2022
Author
Venketasubramanian, Narayanaswamy ORCID
Young, Sherry H.
Tay, San San ORCID
Umapathi, Thirugnanam ORCID
Lao, Annabelle Y.
Gan, Herminigildo H. ORCID
Baroque, Alejandro C. II
Navarro, Jose C.
Chang, Hui Meng
Advincula, Joel M.
Muengtaweepongsa, Sombat ORCID
Chan, Bernard P.L ORCID
Chua, Carlos L.
Wijekoon, Nirmala ORCID
de Silva, H. Asita
Hiyadan, John Harold B. ORCID
Suwanwela, Nijasri C. ORCID
Wong, K.S Lawrence ORCID
Poungvarin, Niphon
Eow, Gaik Bee ORCID
Lee, Chun Fan ORCID
Chen, Christopher L.H.
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Abstract
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.
URI
https://hdl.handle.net/20.500.14353/539
Recommended Citation
Venketasubramanian, N., Young, S. H., Tay, S. S., Umapathi, T., Lao, A. Y., Gan, H. H., ... & Chen, C. L. (2022). CHinese medicine NeuroAiD efficacy on stroke recovery – extension study (CHIMES-E): A multicenter study of long-term effficacy. Cerebrovascular Diseases, 39(1), 309-318.
DOI
10.1159/000382082
Type
Article
Keywords
Acute stroke Traditional Chinese medicine Stroke recovery MLC601 NeuroAiD Clinical trial Long-term outcome CHIMES Herbal remedies Stroke treatment mRS
Subject
Cerebrovascular disease OCLC - FAST (Faceted Application of Subject Terminology) Medicine, Chinese OCLC - FAST (Faceted Application of Subject Terminology) Clinical trials OCLC - FAST (Faceted Application of Subject Terminology) Neurosciences OCLC - FAST (Faceted Application of Subject Terminology) Therapeutics OCLC - FAST (Faceted Application of Subject Terminology) Neuroprotective agents OCLC - FAST (Faceted Application of Subject Terminology)
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