Efficacy of MLC601 on functional recovery after stroke: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND PURPOSE: Traditional Chinese medicine (TCM) MLC601 has shown promising results on functional recovery of patients after stroke. This study aimed to evaluate the pooled effect of its efficacy. METHODS: Systematic review and meta-analysis of randomized controlled trials (RCTs) assessing efficacy of MLC601 vs other TCM compounds or placebo. The pooled effect was the relative risk (RR) combined by random effects model. A prediction effect interval was estimated for new studies and a cumulative meta-analysis was performed. RESULTS: Four studies comprising five RCTs were included. The pooled RR was 1.64 (95% CI = 1.05-2.57; p-value = 0.031) favouring MLC601, but heterogeneity was large (I(2) = 80%; Q-test p-value = 0.0005). Therefore, the prediction interval was wide and consistent with a null effect (RR range = 0.36-7.45). The cumulative meta-analysis showed a decreasing pattern of effect size through time, with higher effects for trials comparing MLC601 vs other TCM and a systematic decrease of the pooled effect when including later trials comparing MLC601 vs placebo. CONCLUSIONS: Evidence on the efficacy of MLC601 has decreased over time and when the comparison arm is placebo instead of other TCM compound. Current evidence suggests MLC601 does not outperform placebo on functional recovery after stroke.