CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

Because this was done in the first three months there is absolutely no way to ascribe  which intervention actually worked due to spontaneous recovery during that time.  There is nothing proven in this research about NeuroAID except they don't know how to properly design a research study to prove the theory they are espousing. But they tried very hard to confuse the issue by putting in lots of tables.
ChInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

Venketasubramanian N.^a · Young S.H.^b · Tay S.S.^b · Umapathi T.^c · Lao A.Y.^d · Gan H.H.^e · Baroque II A.C.^f · Navarro J.C.^f · Chang H.M.^g · Advincula J.M.^h · Muengtaweepongsa S.ⁱ · Chan B.P.L.^j · Chua C.L.^k · Wijekoon N.^l · de Silva H.A.^l · Hiyadan J.H.B.^m · Suwanwela N.C.ⁿ · Wong K.S.L.^o · Poungvarin N.^p · Eow G.B.^q · Lee C.F.^r · Chen C.L.H.^s · for the CHIMES-E Study Investigators
^aRaffles Neuroscience Centre, Raffles Hospital, Singapore, ^bChangi General Hospital, Singapore, and ^cNational Neuroscience Institute - Tan Tock Seng Campus, Singapore, Singapore; ^dDavao Medical School Foundation Hospital, Room 415, Medical Arts Building, San Pedro Hospital, Davao City, ^eJose Reyes Memorial Medical Center, San Lazaro Compound, Sta. Cruz, Manila, and ^fUniversity of Santo Tomas Hospital, Manila, Philippines; ^gNational Neuroscience Institute - Singapore General Hospital Campus, Singapore, Singapore; ^hWest Visayas State University Medical Center, Lapaz, Iloilo City, Philippines; ⁱThammasat University, Pathum Thani, Thailand; ^jNational University Hospital, National University Health System, Singapore, Singapore; ^kPhilippine General Hospital, University of the Philippines Manila, Manila, Philippines; ^lUniversity of Kelaniya, Ragama, Sri Lanka; ^mBaguio General Hospital and Medical Center, Baguio City, Philippines; ⁿChulalongkorn University, Pathunwan, Bangkok, Thailand; ^oChinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong; ^pSiriraj Hospital, Bangkoknoi, Bangkok, Thailand; ^qPenang Hospital, Jalan Residensi, 10990, Georgetown, Penang, Malaysia; ^rSingapore Clinical Research Institute, Singapore, and ^sNational University of Singapore, Clinical Research Centre, Singapore, Singapore Corresponding Author

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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.