A double-blind, placebo-controlled, randomized phase II pilot study to investigate the potential efficacy of the traditional chinese medicine Neuroaid (MLC 601) in enhancing recovery after stroke (TIERS).
OBJECTIVE
Previous clinical studies have shown that Neuroaid (MLC 601) may be beneficial in post-stroke rehabilitation. Our aim was to investigate the efficacy of Neuroaid on motor recovery in ischemic stroke patients using rehabilitation endpoints in accordance with the International Conference on Harmonization/Good Clinical Practice guidelines, in order to provide predictive information for further larger trials.


METHODS
This is a phase II double-blind, placebo-controlled pilot study of 40 subjects admitted with a recent (less than 1 month) ischemic stroke. All subjects were given either Neuroaid or placebo, 4 capsules 3 times a day for 4 weeks. Fugl-Meyer Assessment (FMA), National Institutes of Health Stroke Scale and Functional Independence Measure scores were measured at initiation of the treatment, and at 4 and 8 weeks.


RESULTS
None of the outcomes was statistically significant between the two groups. However, FMA scores showed a positive trend for improvement with Neuroaid treatment over time. Subgroup analysis of subjects with posterior circulation infarction and severe stroke both showed a tendency for better recovery.


CONCLUSIONS
Some positive trends were observed in the Neuroaid group. A larger multicenter trial focusing on severe stroke patients is needed to better evaluate the role of Neuroaid in aiding stroke recovery in rehabilitation.
Kong
Keng He
KH
Tan Tock Seng Hospital Rehabilitation Centre, Ang Mo Kio Hospital, National University Hospital of Singapore, Singapore. keng_he_Kong @ ttsh.com.sg
Wee
Seng Kwee
SK
Ng
Chwee Yin
CY
Chua
Karen
K
Chan
Kay Fei
KF
Venketasubramanian
N
N
Chen
Christopher
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018697:Nootropic Agents / Q000627:therapeutic use*; D010865:Pilot Projects; D028321:Plant Preparations / Q000627:therapeutic use*; D020127:Recovery of Function; D012307:Risk Factors; D018401:Sample Size; D020521:Stroke / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D004365:Drugs, Chinese Herbal; C546417:Neuroaid; D018697:Nootropic Agents; D028321:Plant Preparations