Neuroaid

NeuroAiD (MLC 601) is a natural treatment for stroke. The treatment was historically developed in China as a Traditional Chinese Medicine (TCM) to help stroke patients achieve rehabilitation at late stage. Each year 150,000 patients are treated in China. NeuroAiD was introduced on the international markets in 2006 by Moleac Pte Ltd, a biopharmaceutical company in Singapore. Moleac developed NeuroAiD by making the link between the traditional Chinese medicine and biotechnologies.^[1][2]

General information

NeuroAiD I and NeuroAiD II

There are two versions of NeuroAiD: NeuroAiD (MLC601) and NeuroAiD II (MLC901). MLC 601 and 901 refer to the blend of natural ingredients.^[3]

NeuroAiD is a natural add-on to stroke treatment. In many countries it is prescribed by neurologists or available Over the Counter from pharmacies. These distributors are mainly in Asia, for example It is possible to buy NeuroAiD in pharmacies in Singapore as it has officially been registered as a Chinese Proprietary Medicine in Singapore (July 2006).^[4]

Composition

NeuroAiD is made of 14 ingredients from the Chinese pharmacopoeia which main ingredients are : Radix Astragali, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Radix Polygalae, and Radix Angelicae Sinensis.^[5]

Quality standards

Neuroaid is manufactured according to prevailing Good Manufacturing Practices (GMP). In 2002, TCM were recognized as medicines by the World Health Organisation.^[6]

Dosage

The normal treatment is four capsules are to be taken three times a day during three months for the normal treatment. The ”starter” treatment is four capsules three times a day during one month.

Mechanisms of action

The latest study has established the neuroproliferative and neuroprotective effect of NeuroAiD601 hence its potential role in neuroplasticity after stroke.^[7] NeuroAiD has been proved to stimulates the secretion of BDNF. The in vitro and in vivo results show that NeuroAiD makes cell more resistant against glutamate aggression, increases neurite outgrowth and connectivity as well as reduces the infarct volume, therefore results in better neurological functions.^[3]

Safety and Efficacy

NeuroAiD has not completed the four necessary clinical trial phases to be recorded as a prescribed drug in Europe or the USA. Yet This treatment is already registered in many Asian countries such as Singapore, China, the Philippines, Iran where it is sold as a legal natural add-on to stroke therapy.

Interactions and side effect

Research on drug interactions with aspirin as an antiplatelet agent were conducted and revealed no severe side effect. Yet today, no other interaction researches have been recorded so far. According to Neuroaid website Moleac's pharmaco vigilance database some side effects: cases of mild headaches, cases of nausea or vomiting cases of dry throat/increased thirst after several months of NeuroAiD stroke treatment, and therefore a need to drink more water. These interactions are said to be rare (0,5% of patients).^[8]

Biochemical tests

Biochemical tests were conducted in 2008 to show NeuroAiD do not modify hemostasis hematology and biochemistry in normal subjects and stroke patients.^[9] This clinical trial revealed no interaction were recorded with aspirin. More, the treatment does not increase the risk of bleeding, thrombosis and has no effect on blood pressure, liver, or kidneys functions.^[9].This data supported the idea of prescribing Neuroaid as an add-on to existing treatment received by post stroke treatment, as it is now performed in the CHIMES study.

Efficacy

Laboratory studies

Heurteaux C., Lazdunski M. and a few other scientists demonstrated in a cell and rodent models of focal ischemia that NeuroAiDII (MLC 901) had neuroprotective, neuroplasticity and neuroproliferative (neurogenesis) effects.^[3] To cut a long story short this means the treatment has three effects: first to strengthen the neurons (neuroprotection), second to enable neurons to create connections which were initially done by the tissues damaged by the stroke, and third trigger the growth of new neurons in the brain, which may take over some of the processing previously done by the necrosed tissues.^[3][10]

Clinical Trials

Large scale trial at the chronic stage of Stroke

In January 2009, Stoke published a paper summarizing clinical trial comparing NeuroAiD to another Traditional Chinese Medicine on 605 patients in post stroke recovery. Patients started Neuroaid at least two weeks and less than 6 month after their stroke. The research revealed using NeuroAiD gave 2,4 more chances to achieve independence, and on average reduces 25% of motor deficits. This study did not record any serious side effects.^[11]

Large scale trial at the acute stage of Stroke

A large scale clinical trial is being conducted in Asia on 1100 patients, initiated on Neuroaid within 72 hours of the stroke onset. The study is conducted according to latest methodology on stroke trials and in compliance with ICH and GCP standards. A patient takes four capsules three times a day for three months as an add on to medication. The study protocol has been published in the international journal of stroke and updates are available on clinicaltrials.gov.^[11][12]

Other pilot studies

Tiers

The double blind placebo-controlled randomized Phase II Pilot study called TIERS was conducted on 40 patients receiving four capsules of NeuroAiD (MLC601) 3 times a day for four weeks. The treatment was initiated less than one month after the stroke. The results published in 2009 showed that NeuroAiD was 58% more efficient than the placebo panel and that the five best NeuroAiD responders recovered 39% more than the five best placebo responders.^[13]

European Neurology

European Neurology, initiated in 2008, is a case reports made on 10 patients who received two to three months of treatment. NeuroAiD was initiated between one week to six months after stroke. Improvements were seen on both motor balance, visual and speech functions. Results showed six full recoveries, two good recoveries one moderate recovery and one poor recovery.^[14]

References

1. ^ Ravindran, N. (December 2006–January 2007). "Uncovering New Drugs from Traditional Cures". Singapore Institute of Management. http://www.sim.edu.sg/mbs/pub/mag/mbs_pub_mag_list.cfm?ID=2163&mnuid=92. ^{[unreliable medical source?]}
2. ^ Aisha, Noor (October 15, 2006). "New TCM drug offers hope for stroke patients". The Business Times. http://www.neuroaid.com/articles/New-TCM-drug-offers-hope-for-stroke-patients.pdf. ^{[unreliable source?]}
3. ^ ^{a b c d} Heurteaux C, Gandin C, Borsotto 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. 
4. ^ "Chinese medicine to help stroke victims". AsiaOne. April 30, 2007. Archived from the original on April 30, 2007. http://www.neuroaid.com/articles/Chinese-medicine-to-help-stroke-victims.pdf. ^{[unreliable source?]}
5. ^ ezyhealth&beauty Magazine,05/2007Renewing hopep28-29^{[verification needed]}
6. ^ Pricard, David; Moleac (May 17, 2007). "Going West With Eastern Medicine - Traditional Chinese Medicine Is Entering The Mainstream In Terms Western Practitioners Understand". Medical News Today. http://www.medicalnewstoday.com/articles/71151.php. ^{[unreliable source?]}
7. ^ Chen C, Venketasubramanian N, Gan RN, et al. (March 2009). "Danqi Piantang Jiaonang (DJ), a traditional Chinese medicine, in poststroke recovery". Stroke; a Journal of Cerebral Circulation 40 (3): 859–63. doi:10.1161/STROKEAHA.108.531616. PMID 19164787. 
8. ^ http://www.neuroaid.com/en/about_neuroaid/safety_data
9. ^ ^{a b} Gan R, Lambert C, Lianting J, et al. (2008). "Danqi Piantan Jiaonang does not modify hemostasis, hematology, and biochemistry in normal subjects and stroke patients". Cerebrovascular Diseases 25 (5): 450–6. doi:10.1159/000126919. PMID 18417963. 
10. ^ "Moleac Announces Breakthrough Results on Neuroprotective and Neurogenerative Properties of NeuroAiD" (Press release). Moleac. February 11, 2010. http://www.bizjournals.com/prnewswire/press_releases/Singapore/2010/02/11/HKTH002. Retrieved 2010-04-01. 
11. ^ ^{a b} Chen C, Venketasubramanian N, Gan RN, et al. (March 2009). "Danqi Piantang Jiaonang (DJ), a traditional Chinese medicine, in poststroke recovery". Stroke 40 (3): 859–63. doi:10.1161/STROKEAHA.108.531616. PMID 19164787. 
12. ^ http://clinicaltrials.gov/ct2/results?term=neuroaid
13. ^ Kong KH, Wee SK, Ng CY, et al. (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): 514–21. doi:10.1159/000247001. PMID 19816018. 
14. ^ Siow CH (2008). "Neuroaid in stroke recovery". European Neurology 60 (5): 264–6. doi:10.1159/000155220. PMID 18781074.