Clinical Outcomes of MLC601 (NeuroAiDTM) in Traumatic Brain Injury: A Pilot Study
by
Asra Al Fauzi 1,*, Krisna Tsaniadi Prihastomo 2, I. G. M. Aswin R. Ranuh 1, Tedy Apriawan 1, Joni Wahyuhadi 1, M. Arifin Parenrengi 1, Agus Turchan 1, Abdul Hafid Bajamal 1 and Hari Basuki Notobroto 3
Asra Al Fauzi 1,*, Krisna Tsaniadi Prihastomo 2, I. G. M. Aswin R. Ranuh 1, Tedy Apriawan 1, Joni Wahyuhadi 1, M. Arifin Parenrengi 1, Agus Turchan 1, Abdul Hafid Bajamal 1 and Hari Basuki Notobroto 3
1
Department of Neurosurgery, Faculty of Medicine, Universitas Airlangga—Dr. Soetomo General Academic Hospital, Surabaya Neuroscience Institute, Surabaya 60286, Indonesia
2
Department of Neurosurgery, Dr. Kariadi Hospital Medical Center, Faculty of Medicine, Diponegoro University, Semarang 50111, Indonesia
3
Department of Biostatistics and Population Studies, Faculty of Public Health, Universitas Airlangga, Surabaya 60111, Indonesia
*
Author to whom correspondence should be addressed.
Brain Sci. 2020, 10(2), 60; https://doi.org/10.3390/brainsci10020060
Received: 19 December 2019 / Revised: 31 December 2019 / Accepted: 16 January 2020 / Published: 21 January 2020
(This article belongs to the Section Clinical Neuroscience)
Background: MLC601 is a natural product formulation from Chinese medicine that is extensively studied in ischemic stroke. Traumatic brain injury (TBI) shares pathophysiological mechanisms with ischemic stroke, yet there are few studies on the use of MLC601 in treating TBI. This Indonesian pilot study aimed to investigate clinical outcomes of MLC601 for TBI. Methods: This randomized controlled trial included subjects with nonsurgical moderate TBI allocated into two groups: with and without MLC601 over three months in addition to standard TBI treatment. Clinical outcomes were measured by the Glasgow Outcome Scale (GOS) and Barthel Index (BI) observed upon discharge and at months (M) 3 and 6. Results: Thirty-two subjects were included. The MLC601 group (n = 16) had higher GOS than the control group (n = 16) at all observation timepoints, though these differences were not statistically significant (p = 0.151). The BI values indicated a significant improvement for the MLC601 group compared to the control group at M3 (47.5 vs. 35.0; p = 0.014) and at M6 (67.5 vs. 57.5; p = 0.055). No adverse effects were associated with MLC601 treatment. Conclusion: In this cohort of nonsurgical moderate TBI subjects, MLC601 showed potential for a positive effect on clinical outcome with no adverse effects.
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Keywords:
MLC601; traumatic brain injury; nonsurgical lesion; clinical outcome
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MDPI and ACS Style
Al Fauzi, A.; Prihastomo, K.T.; Ranuh, I.G.M.A.R.; Apriawan, T.; Wahyuhadi, J.; Parenrengi, M.A.; Turchan, A.; Bajamal, A.H.; Notobroto, H.B. Clinical Outcomes of MLC601 (NeuroAiDTM) in Traumatic Brain Injury: A Pilot Study. Brain Sci. 2020, 10, 60.
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