Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

Harandi, Asghar Amini; Abolfazli, Roya; Hatemian, A.; Ghragozlee, K.; Ghaffarpour, Majid; Karimi, Maryam; Shahbegi, S.; Pakdaman, Hossein; Tabasi, M.; Tabatabae, A. L.; Nourian, Alireza

doi:10.4061/2011/721613

Cited by 35 publications

(35 citation statements)

References 10 publications

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“…This is consistent with previously published studies on MLC601, which detected improved functional outcomes and motor recovery among mainly nonacute ischemic stroke patients. 11,12,14 These findings support the possible neurorestorative effects of MLC601 and would be topics of interest for further nonclinical and clinical investigations.…”

Section: Discussionsupporting

confidence: 66%

“…Because previous studies on MLC601 suggested a benefit in nonacute ischemic stroke patients, [11][12][13][14][15][16][17] the time window of 72 hours was chosen for this study in an attempt to test both the neuroprotective and neurorestorative properties of MLC601.…”

Section: Discussionmentioning

confidence: 99%

“…11 More studies have since been published assessing the benefit and safety of MLC601 in nonacute stroke patients using different clinical outcomes. [12][13][14][15][16][17][18][19] Although most patients experience some spontaneous recovery in the months after a stroke, the degree and timing of recovery are variable. Improving functional outcomes through specific interventions is a relatively unexplored area of great public health potential.…”

Section: August 2013mentioning

confidence: 99%

“…[11][12][13][14][15][16][17][18] MLC601 and matching placebo were provided by Moleac (Singapore). Each 400 mg MLC601 capsule contains 9 herbal components (extracts derived from raw herbs consisting of Radix astragali, Radix salviae miltorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Prunus persica, Radix polygalae, and Rhizoma acori tatarinowii) and 5 animal components (Hirudo, Eupolyphaga seu steleophaga, Calculus bovis artifactus, Buthus martensii, and Cornu saigae tataricae).…”

Section: Study Treatmentmentioning

confidence: 99%

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Chinese Medicine Neuroaid Efficacy on Stroke Recovery

Chen

Young²,

Gan³

et al. 2013

Stroke

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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.

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Section: Discussionsupporting

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Section: August 2013mentioning

confidence: 99%

Section: Study Treatmentmentioning

confidence: 99%

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Chinese Medicine Neuroaid Efficacy on Stroke Recovery

Chen

Young²,

Gan³

et al. 2013

Stroke

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“…Another study was identified through personal contact of the author (C.C.). In total, 5 studies were short-listed for full text evaluation [7,14,15,16,17]. Of these, 1 was the previous systematic review of 2 unpublished Chinese trials.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2013

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Background: Subsequent to a pooled analysis of 2 trials, several more studies have been published assessing the benefit of MLC601 in stroke patients. Hence, it is timely to conduct an updated meta-analysis to frame the interpretation of the results of an ongoing large multicenter, randomized, double-blind, placebo-controlled study. Therefore, we conducted a systematic review of the efficacy of MLC601 in improving the recovery of stroke patients. Methods: PubMed® and the Cochrane Library® databases were searched for trials evaluating MLC601 in stroke patients. Primary outcome was functional independence, assessed by the Barthel Index or the Diagnostic Therapeutic Effects of Apoplexy scoring system, item 8. Secondary outcomes were improvement in functional independence scores, motor recovery, reduction in visual field defect and increase in cerebral blood flow. Two authors performed the article selection, appraisal and data extraction while resolving differences through discussion or consulting a third author. Data were analyzed in RevMan5®. Meta-analysis was conducted using a random effects model. Results: This review included 6 studies with overall low risk of bias but some clinical heterogeneity. MLC601 increased the chances of achieving functional independence after stroke compared to control treatments (risk ratio, 2.35; 95% CI, 1.31-4.23). No deaths and 4 serious adverse events were reported in the MLC601 group, although detail was sparse with inconsistent reporting. Conclusions: There is evidence that MLC601 as an add-on to standard treatment could be effective in improving functional independence and motor recovery and is safe for patients with primarily nonacute stable stroke.

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