Efficacy and Safety of MLC601 (NeuroAiD®), a Traditional Chinese Medicine, in Poststroke Recovery: A Systematic Review

Siddiqui, Fahad Javaid; Venketasubramanian, Narayanaswamy; Chan, Edwin; Chen, Christopher

doi:10.1159/000346231

Cited by 34 publications

(36 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…27 We updated the meta-analysis to include all CHIMES patients, and this showed an OR for good functional outcome at the end of study period of 1.25 (95% CI, 1.00-1.56; P=0.05) in favor of MLC601 (Figure 4). Because all the studies in the systematic review had nonacute strokes with onset-to-treatment windows of ≤1 week to 6 months, we explored the effect of time window by including only CHIMES patients who started treatment >48 hours from stroke onset.…”

Section: Discussionmentioning

confidence: 99%

Chinese Medicine Neuroaid Efficacy on Stroke Recovery

Chen

Young²,

Gan³

et al. 2013

Stroke

Self Cite

View full text Add to dashboard Cite

Background and Purpose— Previous clinical studies suggested benefit for poststroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset. The Chinese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study tested the hypothesis that MLC601 is superior to placebo in acute, moderately severe ischemic stroke within a 72-hour time window. Methods— This multicenter, double-blind, placebo-controlled trial randomized 1100 patients with a National Institutes of Health Stroke Scale score 6 to 14, within 72 hours of onset, to trial medications for 3 months. The primary outcome was a shift in the modified Rankin Scale. Secondary outcomes were modified Rankin Scale dichotomy, National Institutes of Health Stroke Scale improvement, difference in National Institutes of Health Stroke Scale total and motor scores, Barthel index, and mini-mental state examination. Planned subgroup analyses were performed according to age, sex, time to first dose, baseline National Institutes of Health Stroke Scale, presence of cortical signs, and antiplatelet use. Results— The modified Rankin Scale shift analysis–adjusted odds ratio was 1.09 (95% confidence interval, 0.86–1.32). Statistical difference was not detected between the treatment groups for any of the secondary outcomes. Subgroup analyses showed no statistical heterogeneity for the primary outcome; however, a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted. Serious and nonserious adverse events rates were similar between the 2 groups. Conclusions— MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00554723.

show abstract

Section: Discussionmentioning

confidence: 99%

Chinese Medicine Neuroaid Efficacy on Stroke Recovery

Chen

Young²,

Gan³

et al. 2013

Stroke

Self Cite

View full text Add to dashboard Cite

show abstract

“…Clinical studies, which assessed the benefit and safety of MLC601 in non-acute stroke patients using different clinical outcomes [7,8,9,10,11,12,13,14,15,16,]have been published.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2015

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…Clinical studies on patients with nonacute stroke showed that MLC601 (NeuroAiD TM ) improved recovery with a good safety profile. 6 Because MLC601 has been reported to improve cerebral blood flow velocity in patients with subacute stroke 7 and potentially induce ischemic preconditioning by activating ATP-dependent potassium channels, 8 we hypothesized that MLC601 may have an effect on preventing occurrence of early vascular events within 3 months of stroke onset.…”

mentioning

confidence: 99%

Effects of MLC601 on Early Vascular Events in Patients After Stroke

Chen

Venketasubramanian

Lee

et al. 2013

Stroke

Self Cite

View full text Add to dashboard Cite

Background and Purpose-Early vascular events are an important cause of morbidity and mortality in the first 3 months after a stroke. We aimed to investigate the effects of MLC601 on the occurrence of early vascular events within 3 months of stroke onset. Methods-Post hoc analysis was performed on data from subjects included in the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study, a randomized, placebo-controlled, double-blinded trial that compared MLC601 with placebo in 1099 subjects with ischemic stroke of intermediate severity in the preceding 72 hours. Early vascular events were defined as a composite of recurrent stroke, acute coronary syndrome, and vascular death occurring within 3 months of stroke onset. Results-The frequency of early vascular events during the 3-month follow-up was significantly less in the MLC601 group than in the placebo group (16 [

show abstract

Efficacy and Safety of MLC601 (NeuroAiD®), a Traditional Chinese Medicine, in Poststroke Recovery: A Systematic Review

Cited by 34 publications

References 23 publications

Chinese Medicine Neuroaid Efficacy on Stroke Recovery

Chinese Medicine Neuroaid Efficacy on Stroke Recovery

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

Effects of MLC601 on Early Vascular Events in Patients After Stroke

Contact Info

Product

Resources

About