NeuroAiD

NeuroAiD is an oral treatment proposed to support functional recovery after strokes.[1] It has also shown effectiveness as a complementary treatment for other brain injuries and Alzheimer's disease.[2] There were two formulations of NeuroAiD: MLC601 (NeuroAiDTM) was first developed.[1] Since 2018 MLC601 formulation is no longer on the market, and has been replaced by MLC901 (NeuroAiDTMII), a simplified formulation containing only 9 botanical ingredients.[3] It can be administered orally or through a feeding tube.[2]

Common side effects include abdominal discomfort, headaches, dry mouth, nausea, vomiting, and diarrhea.[1] Though very rare, some patients have reported serious adverse events in clinical trials (jaundice, hypokalemia, seizures, and recurring strokes), none being related to treatment according to investigators' opinion.[4]

NeuroAiD was first registered and marketed in China in 2001.[1][5] It was patented in the United States in 2013,[6] but has not yet been approved by the FDA. NeuroAiD is distributed by Moleac,[7] and is derived from traditional Chinese medicine.[5][4][8] According to the CEO of Moleac, NeuroAiD is sold in at least 25 countries, and 20,000 people have taken it.[9]

Composition

NeuroAiD I, or MLC601, is composed of nine herbal components (astragalus root, Salvia miltiorrhiza root, chishao, rhizome lovage, Angelica sinensis root, safflower, peach, thinleaf milkwort root, and grassleaf sweet flag rhizome) and five components derived from animals (Hirudo medicinalis, Eupolyphaga seu steleophaga, Calculus bovis artifactus, Buthus martensii, and Cornu saigae tataricae).[10] NeuroAiDTMII, or MLC901, is a simpler form of the medication that only contains the nine herbal components without the animal components.[3] Since 2018, MLC601 formulation is no longer marketed.

Pharmacology

Pharmacological studies suggest that NeuroAiD can aid with stroke recovery by improving neuroprotection, neurogenesis, and neuroplasticity by amplifying endogenous processes of self-protection and self-repair of the brain.[11][12][13] MLC901 can activate KATP channels, which has a neuroprotective effect against brain ischemia.[14]

Clinical studies

In 2013, the largest randomized placebo-controlled clinical trial of NeuroAiD, also known as the CHIMES study, was published.[15] Though the primary endpoint was not met [16][14] the extension CHIMES-E study found that treatment with NeuroAiD for 6 to 18 months significantly increased stroke patients’ odds of functional independence compared to the placebo group.[17] However a systematic review of four clinical studies concluded that MLC601 is not significantly better than placebo on improving functional recovery after stroke.[18]

Both MLC601 and MLC901 have also shown the potential to improve cognition in patients of Alzheimer’s disease because MLC 601 can modulate amyloid precursor protein processing, and MLC901 can have positive effects on tau phosphorylation.[19] NeuroAiD has also been tested as a recovery aid for spinal cord injury patients.[20] The standard dosage over a recommended treatment period of three months is four capsules three times a day for MLC601 and two capsules three times a day for MLC901.[21][22]

Safety

Studies have considered NeuroAiD safe to take on top of standard ischemic stroke medications.[23][22] There have been minimal side effects, with the most common adverse effects being digestive issues such as nausea, vomiting, discomfort, diarrhea, and dry mouth, along with headaches.[23]<[22][24] Though very rare, some patients have reported serious adverse events in clinical trials (jaundice, hypokalemia, seizures, and recurring strokes), none being related to treatment according to investigators’ opinion.[24]

In 2013, an analysis from the CHIMES study indicated a significant reduction in the occurrence of early vascular events (i.e., recurrent stroke, acute coronary syndrome, vascular death) for the NeuroAiD group compared to the placebo group.[25]

NeuroAiD did not modify hematological, hemostatic, and biochemical parameters in the bodies of ordinary subjects and stroke patients.[26] Several other studies have considered NeuroAiD a safe treatment for acute ischemic stroke patients,[27] traumatic brain injury patients,[28] and hemorrhagic stroke patients.[29]

The medication is contraindicated in pregnant and breastfeeding women.[30]

Approvals and patents

NeuroAiD was approved by the Sino Food and Drug Administration in August 2001, under the name Danqi Piantan Jiaonang.[10][31] NeuroAiD has also been approved for use in other Asian countries such as Singapore.[32] In 2006, NeuroAiD was also chosen for the Chinese Ministry of Science and Technology's Key Technologies Research & Development program.[33]

In 2013, Moleac filed a patent for NeuroAiD with the European Patent Office, which was eventually approved in 2019.[34] In the same year, Moleac also filed a patent application with the U.S. Patent Office.[6]

References

  1. 1 2 3 4 Venketasubramanian N, Kumar R, Soertidewi L, Abu Bakar A, Laik C, Gan R (November 2015). "The NeuroAiD Safe Treatment (NeST) Registry: a protocol". BMJ Open. 5 (11): e009866. doi:10.1136/bmjopen-2015-009866. PMC 4654343. PMID 26567259.
  2. 1 2 Chen CL, Sharma PR, Tan BY, Low C, Venketasubramanian N (2019). "The Alzheimer's disease THErapy with NEuroaid (ATHENE) study protocol: Assessing the safety and efficacy of Neuroaid II (MLC901) in patients with mild-to-moderate Alzheimer's disease stable on cholinesterase inhibitors or memantine-A randomized, double-blind, placebo-controlled trial". Alzheimer's & Dementia. 5: 38–45. doi:10.1016/j.trci.2018.12.001. PMC 6352850. PMID 30723778.
  3. 1 2 Heurteaux C, Gandin C, Borsotto M, Widmann C, Brau F, Lhuillier M, et al. (June 2010). "Neuroprotective and neuroproliferative activities of NeuroAid (MLC601, MLC901), a Chinese medicine, in vitro and in vivo". Neuropharmacology. 58 (7): 987–1001. doi:10.1016/j.neuropharm.2010.01.001. PMID 20064536. S2CID 22044836.
  4. 1 2 Siddiqui FJ, Venketasubramanian N, Chan ES, Chen C (2013). "Efficacy and safety of MLC601 (NeuroAiD®), a traditional Chinese medicine, in poststroke recovery: a systematic review". Cerebrovascular Diseases. 35 Suppl 1: 8–17. doi:10.1159/000346231. PMID 23548914.
  5. 1 2 Tan CN, Choy D, Venketasubramanian N (2020). "NeuroAid II (MLC901) in Haemorrhagic Stroke". Case Reports in Neurology. 12 (Suppl 1): 212–217. doi:10.1159/000508588. PMC 7802497. PMID 33505298.
  6. 1 2 US 20130287870, Moha Ou Maati H, Lazdunski M, Heurteaux C, Picard D, "Novel uses for traditional Chinese medicines", published 31 October 2013, assigned to Moleac Pte Ltd.
  7. ↑ Heurteaux C, Widmann C, Moha ou Maati H, Quintard H, Gandin C, Borsotto M, et al. (2013). "NeuroAiD: properties for neuroprotection and neurorepair". Cerebrovascular Diseases. 35 Suppl 1: 1–7. doi:10.1159/000346228. PMID 23548913.
  8. ↑ Widmann C, Gandin C, Petit-Paitel A, Lazdunski M, Heurteaux C (December 2018). "The Traditional Chinese Medicine MLC901 inhibits inflammation processes after focal cerebral ischemia". Scientific Reports. 8 (1): 18062. Bibcode:2018NatSR...818062W. doi:10.1038/s41598-018-36138-0. PMC 6305383. PMID 30584250.
  9. ↑ Grens K (2013-07-05). "Herbal stroke remedy no better than dummy pill". Reuters.
  10. 1 2 Kim I, Pollitt E, Leibel RL, Viteri FE, Alvarez E (September 1984). "Application of receiver-operator analysis to diagnostic tests of iron deficiency in man". Pediatric Research. 18 (9): 916–920. doi:10.1203/00006450-198409000-00025. PMID 6483514.
  11. ↑ Heurteaux C, Gandin C, Borsotto M, Widmann C, Brau F, Lhuillier M, et al. (June 2010). "Neuroprotective and neuroproliferative activities of NeuroAid (MLC601, MLC901), a Chinese medicine, in vitro and in vivo". Neuropharmacology. 58 (7): 987–1001. doi:10.1016/j.neuropharm.2010.01.001. PMID 20064536. S2CID 22044836.
  12. ↑ Quintard H, Borsotto M, Veyssiere J, Gandin C, Labbal F, Widmann C, et al. (September 2011). "MLC901, a traditional Chinese medicine protects the brain against global ischemia". Neuropharmacology. 61 (4): 622–631. doi:10.1016/j.neuropharm.2011.05.003. PMID 21605573. S2CID 6194484.
  13. ↑ Heurteaux C, Widmann C, Moha ou Maati H, Quintard H, Gandin C, Borsotto M, et al. (2013). "NeuroAiD: properties for neuroprotection and neurorepair". Cerebrovascular Diseases. 35 Suppl 1 (Suppl. 1): 1–7. doi:10.1159/000346228. PMID 23548913. S2CID 16589542.
  14. 1 2 Chen CL, Young SH, Gan HH, Singh R, Lao AY, Baroque AC, et al. (August 2013). "Chinese medicine neuroaid efficacy on stroke recovery: a double-blind, placebo-controlled, randomized study". Stroke. 44 (8): 2093–2100. doi:10.1161/STROKEAHA.113.002055. PMID 23780952. S2CID 11203386.
  15. ↑ "Chinese Medicine Neuroaid Efficacy on Stroke Recovery: A Double-Blind, Placebo-Controlled, Randomized Study". ResearchGate. 2013-07-01. Retrieved 2022-02-09.
  16. ↑ Kong KH, Wee SK, Ng CY, Chua K, Chan KF, Venketasubramanian N, Chen C (2009). "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)". Cerebrovascular Diseases. 28 (5): 514–521. doi:10.1159/000247001. PMID 19816018. S2CID 24186802.
  17. ↑ Venketasubramanian N, Young SH, Tay SS, Umapathi T, Lao AY, Gan HH, et al. (2015). "CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy". Cerebrovascular Diseases. 39 (5–6): 309–318. doi:10.1159/000382082. PMID 25925713. S2CID 15564537.
  18. ↑ González-Fraile E, Martín-Carrasco M, Ballesteros J (2016). "Efficacy of MLC601 on functional recovery after stroke: A systematic review and meta-analysis of randomized controlled trials". Brain Injury. 30 (3): 267–70. doi:10.3109/02699052.2015.1118764. PMID 26890534.
  19. ↑ Chen CL, Sharma PR, Tan BY, Low C, Venketasubramanian N (2019-01-23). "The Alzheimer's disease THErapy with NEuroaid (ATHENE) study protocol: Assessing the safety and efficacy of Neuroaid II (MLC901) in patients with mild-to-moderate Alzheimer's disease stable on cholinesterase inhibitors or memantine-A randomized, double-blind, placebo-controlled trial". Alzheimer's & Dementia. 5: 38–45. doi:10.1016/j.trci.2018.12.001. PMC 6352850. PMID 30723778.
  20. ↑ Kumar R, Htwe O, Baharudin A, Ariffin MH, Abdul Rhani S, Ibrahim K, et al. (December 2016). "Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN Study): Protocol of An Exploratory Study In Assessing the Safety and Efficacy of NeuroAiD Amongst People Who Sustain Severe Spinal Cord Injury". JMIR Research Protocols. 5 (4): e230. doi:10.2196/resprot.6275. PMC 5168536. PMID 27919862.
  21. ↑ Venketasubramanian N, Kumar R, Soertidewi L, Abu Bakar A, Laik C, Gan R (November 2015). "The NeuroAiD Safe Treatment (NeST) Registry: a protocol". BMJ Open. 5 (11): e009866. doi:10.1136/bmjopen-2015-009866. PMC 4654343. PMID 26567259.
  22. 1 2 3 Reimer H (30 January 2022). "What Is Neuroaid? (with pictures)". www.wise-geek.com. Retrieved 2022-02-16.
  23. 1 2 Harandi AA, Abolfazli R, Hatemian A, Ghragozlee K, Ghaffar-Pour M, Karimi M, et al. (2011). "Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial". Stroke Research and Treatment. 2011: 721613. doi:10.4061/2011/721613. PMC 3138057. PMID 21776364.
  24. 1 2 Siddiqui FJ, Venketasubramanian N, Chan ES, Chen C (2013). "Efficacy and safety of MLC601 (NeuroAiD®), a traditional Chinese medicine, in poststroke recovery: a systematic review". Cerebrovascular Diseases. 35 Suppl 1 (Suppl. 1): 8–17. doi:10.1159/000346231. PMID 23548914. S2CID 7259932.
  25. ↑ Chen CL, Venketasubramanian N, Lee CF, Wong KS, Bousser MG (December 2013). "Effects of MLC601 on early vascular events in patients after stroke: the CHIMES study". Stroke. 44 (12): 3580–3583. doi:10.1161/STROKEAHA.113.003226. PMID 24135924. S2CID 17134169.
  26. ↑ Gan R, Lambert C, Lianting J, Chan ES, Venketasubramanian N, Chen C, et al. (2008). "Danqi Piantan Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients". Cerebrovascular Diseases. 25 (5): 450–456. doi:10.1159/000126919. PMID 18417963. S2CID 25577836.
  27. ↑ Young SH, Zhao Y, Koh A, Singh R, Chan BP, Chang HM, et al. (2010). "Safety profile of MLC601 (Neuroaid) in acute ischemic stroke patients: A Singaporean substudy of the Chinese medicine neuroaid efficacy on stroke recovery study". Cerebrovascular Diseases. 30 (1): 1–6. doi:10.1159/000313398. PMID 20395679. S2CID 207601152.
  28. ↑ Theadom A, Barker-Collo S, Jones KM, Parmar P, Bhattacharjee R, Feigin VL (August 2018). "MLC901 (NeuroAiD II™) for cognition after traumatic brain injury: a pilot randomized clinical trial". European Journal of Neurology. 25 (8): 1055–1e82. doi:10.1111/ene.13653. PMC 6055867. PMID 29611892.
  29. ↑ Kumar R, Abu Bakar A, Thanabalan J, Paramasvaran S, Toh CJ, Jaffar A, et al. (July 2020). "Safety and Use of MLC601/MLC901 (NeuroAiDTM) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry". Brain Sciences. 10 (8): E499. doi:10.3390/brainsci10080499. PMC 7465020. PMID 32751570.
  30. ↑ "Neuroaid Full Prescribing Information, Dosage & Side Effects". MIMS Malaysia. Retrieved 2022-02-18.
  31. ↑ Gan R, Lambert C, Lianting J, Chan ES, Venketasubramanian N, Chen C, et al. (2008). "Danqi Piantan Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients". Cerebrovascular Diseases. 25 (5): 450–456. doi:10.1159/000126919. PMID 18417963. S2CID 25577836.
  32. ↑ Siow CH (2008). "Neuroaid in stroke recovery". European Neurology. 60 (5): 264–266. doi:10.1159/000155220. PMID 18781074.
  33. ↑ Chen C, Venketasubramanian N, Gan RN, Lambert C, Picard D, Chan BP, et al. (March 2009). "Danqi Piantang Jiaonang (DJ), a traditional Chinese medicine, in poststroke recovery". Stroke. 40 (3): 859–863. doi:10.1161/STROKEAHA.108.531616. PMID 19164787.
  34. ↑ EP 2838545A1, Moha Ou Maati H, Lazdunski M, Heurteaux C, Picard D, "Composition comprising herbs", published 31 October 2013, assigned to Moleac Pte Ltd.
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