MLC901 in hypoxic-ischemic brain injury patients: A double-blind, randomized placebo-controlled pilot study

Hypoxic-ischemic brain injury (HIBI) is a disabling consequence of cardiopulmonary resuscitation, which has no direct treatment except supportive care. Many studies have used pharmacological agents to reduce or stop this disability. MLC901 is a traditional Chinese medicine showing neuroprotective and regenerative effects on focal and global ischemia in previous animal and human studies. We designed an experimental, randomized, double-blind, placebo-controlled study to analyze MLC901 efficacy in HIBI patients. METHODS: In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules 3 times per day over 6 months. We assessed the 2 groups by modified Rankin Scale and Glasgow Outcome Scale at baseline, and follow-up visits in 3rd month, and 6th-month after injury. RESULTS: Thirty-one patients completed this study. There was no significant difference in baseline characteristics between the 2 groups as regards age, gender, time of resuscitation, the interval between injury and start of the intervention, and the length of intensive care unit stay. Both the placebo and intervention groups improved during the investigation. However, the Glasgow Outcome Scale and modified Rankin Scale scales were significantly improved in the MLC901 group compared to the placebo after 6 months (P < .05) with close to no adverse effects. No major side effect was reported. CONCLUSION: MLC901 has shown, compared to placebo, a statistically better improvement at 6 months in neurological functions of patients with HIBI.