In recent years, interest in complementary medicine has re-ignited in a big way as consumers turn to nature in the search of alternative remedies. In particular increasing numbers of people are beginning to seek answers to needs unaddressed by Western science by looking to the ancient knowledge of Traditional Chinese Medicines.

This accounts for the high penetration of complementary medicines in developed economies. According to World Health Organisation estimates, more than half the populations of developed countries have tried alternative medication at least once. However, most western trained practitioners have had little exposure to or training in traditional medicine and find it difficult to guide their patients in their choices.

The challenge of traditional medicine for Western practitioners

The trend of using traditional remedies as a substitute for chemically formulated drugs is set to continue with an industry growth rate of between 5 - 15 per cent a year, and much of it is no doubt due to the common layman belief that the more 'natural' a product, the fewer the side effects.

Western practitioners, however, have long been uncomfortable with this assumption and this has resulted in many alternative treatments being sidelined as 'quack medicine' lacking scientific basis. This stance is exacerbated by the dearth of research on most traditional remedies. Active ingredients and their mechanisms of action and interaction with concomitant treatments are unknown or not described in clinically accepted ways, while existing evidence based data often does not meet stringent Western criteria.

As a result the common reaction of skeptical Western medical practitioners is to follow a precautionary principle when advising patients and avoid recommending alternatives altogether. This helps to discourage uncritical enthusiasm for complementary medication among most patients and prevents the misuse of unproven or low-quality treatments. However this also denies many patients access to promising products, leaving certain medical needs unmet.

Bringing traditional medicine to the mainstream

It is possible, however, to incorporate alternative treatments into a Western medical framework - giving doctors a firm basis upon which to evaluate these treatments.

One such example is Neuroaid, a Traditional Chinese Medicine aimed at supporting stroke recovery, marketed by Moleac. Western medicine today offers a plethora of products and surgical treatments that deal with preventing the causes of stroke. However, its only offering for stroke patients after the hyper-acute stage comprises physiotherapy, which leaves recent stroke patients with only a 33% chance of full recovery. No Western drug offerings address the patient rehabilitation process.

When Moleac identified Neuroaid, clinical data had already been generated on the medication - a sizeable double-blind randomized clinical trial on over 600 patients had been conducted in China. The trial produced a 2.11 odd ratio in complete responders on a functional scale and very favorable outcomes on individual neurological deficit scores. The fact that the research had been conducted on patients several months after their stroke onset suggested Neuroaid helps stroke rehabilitation by improving the brain's neuroplasticity. No such drug exists in Western Pharmacopoeia.

This made the potential contribution Neuroaid could bring to stroke survivors an exciting prospect. However it was possible that the product's entirely herbal and natural formulation - engineered along the principles of Qi - would excite a lot of disbelief in the Western medical fields.

For this reason a Western approach to the development of Neuroaid as a mainstream product was adopted. Since it was already being successfully marketed for consumption in China as a proprietary medicine, the decision was made to focus on clinical development, instead of going back to animal models to evidence the precise mechanism of action.

The first step for this was to ensure the quality and stability of the product for safe consumption in a Western context. While the existing base of usage in China over several hundred thousands patients indicated the safety of NeuroAid, it was important to also ensure safety of consumption for patients receiving Western medical care.

As for stroke, the main concern is the risk of bleeding. Several studies were implemented which showed Neuroaid did not create such risks, even in combination with aspirin as an antiplatelet agent, or when taken over several weeks. Tests were also initiated and are now implemented on the product to ensure quality, including microbial analysis and heavy metal search. Good Manufacturing Practice quality standards are also enforced.

In addition, a review of existing efficacy data from China with Western criteria was conducted, focusing on improvement measured against familiar endpoints, keeping in mind that these trials were conducted using different methodology standards than those used in the West.

With solid safety and quality data in one hand and rigorously tested efficacy data, practitioners are now able to make an informed decision to advise patients on how to integrate NeuroAid into their recovery programs.

The next step is to implement more clinical trials in compliance with Western standards, to establish the exact efficacy of Neuroaid. Plans are in the pipeline for one such study, conducted by international neurologists, to be launched soon this year. Moleac is also exploring imagery markers to establish the actual effect of the drug in improving brain neuroplasticity.

TCM perception in the future

Remedies such as NeuroAid serve the important purpose of filling a need that accepted Western medical practice does not attend to. A balance, therefore, needs to be struck between ascertaining a product's safety and efficacy, and the leap of faith in trying it to "see if it works". Recognising this need, the World Health Organisation's 2002 traditional medicine strategy outlines key goals in promoting and regulating safe and effective traditional medicine; these include safety, quality and efficacy, government policy, access, and rational usage.

The team at Moleac, or companies like Himalaya, an Ayurvedic herbal healthcare company, are part of a small group of biopharmaceutical firms who have responded to this call by pioneering attempts to consolidate existing safety evidence and further prove the efficacy of alternative treatments in the context of Western medicine.

This approach to developing drugs requires an in-depth understanding of both TCM and Western medicine. On top of the usual challenges of product development, identifying a gap in Western medicine and finding a suitably promising candidate, TCM can be a long and difficult process. Coordinating the work of TCM doctors and Western clinicians - who must overcome their differing viewpoints and cultural perspectives in order to collaborate closely - is also a challenge.

However, with the dwindling pipelines and immense financial risks currently hindering many of the larger Western pharmaceutical companies, focusing on this lower-risk, clinical-based model for developing TCM may be the solution for companies seeking to bring new drugs to market faster.

And as in the case of Moleac, emphasis on consumer safety and rigorous pharmaceutical research helps medical practitioners make informed decisions on using the product, removing a key barrier to its widespread usage and ensuring it manages to reach the patients it can benefit.

Written by David Pricard, Co-Founder of Moleac, a biopharma company based at Biopolis in Singapore.

www.moleac.net