Chinese scientists have borrowed three ingredients from the country's traditional medicine practice - a 3,000-year-old approach that aims to regulate the flow of energy in the body - and used modern pharmaceutical technology to devise a formula to tackle dementia, which has no cure.
The resulting blend of ginkgo biloba, ginseng and saffron extracts, called Sailuotong or SLT, is due to enter a late-stage study in Melbourne this month, and a larger clinical trial to validate its impact is slated to begin in China later this year.
The herbal mix offers an untrodden avenue into a research field riddled with failures. Success for SLT could bring the first approved medicine to treat the vascular causes of dementia, a form of age-related deterioration that resembles Alzheimer's disease.
But its backers' hopes extend beyond dementia: they seek to validate a new approach to pharmaceutical innovation combining the ancient wisdom of traditional medicines with the scientific rigour of modern drug development.
"If we're successful in treating vascular dementia, it will be a good example of how other traditional Chinese medicines could potentially be developed," said Beijing-based director of clinical research Zhang Huajian at China Shineway Pharmaceutical Group.
Dementia, afflicting about 50 million people worldwide, is a compelling target.
Despite hundreds of clinical trials investigating potential treatments in recent decades, no new drug has been approved since 2003. The five medications sold for Alzheimer's, the most common cause of dementia, provide only modest relief of symptoms. None can slow the disease's progression.
There are no specific drugs for vascular dementia, which SLT targets.
Chinese herbal ingredients are already used in some important medicines, including the main treatment for malaria, thanks to a tradition preserved in texts such as Huangdi Neijing, the most important book of ancient Chinese medicine.
The group that invented SLT is also working along a similar route to develop treatments for diabetes and related ailments.
While modern pharmaceuticals tend to work on single targets, herbal extracts used in traditional Chinese medicine can interact with the body along multiple pathways, according to China Shineway Pharmaceutical Group's Zhang.
For SLT, researchers isolated the chemical components from each ingredient, identified and characterised their biological activity, and then studied multiple combinations to determine the optimal formulation.
Each capsule contains 10 active components, according to the drug's inventor, Mr Liu Jianxun, director of the research centre at the China Academy of Chinese Medical Sciences' Xiyuan Hospital in Beijing. Mr Liu and his colleagues documented how and where each component is taken up in the body, as well as the effects and mechanisms of action.
It is a level of analysis that has tended to elude traditional Chinese medicines, but which is needed for quality control and standardisation, said Mr Liu, who began working on the project in 1999, a decade before SLT was licensed to Shineway.
"Traditional Chinese medicine has advantages in treating geriatric and chronic diseases," Mr Liu said over the phone from Beijing, where he is also director of the standardised Chinese medicine pharmacology laboratory with China's Ministry of Science and Technology.
"We want to develop better medicines for dementia, regardless of the cause."
Each of SLT's ingredients has been used individually in traditional medicine, said Mr Dennis Chang, a clinical pharmacologist at the University of Western Sydney's NICM Health Research Institute. Mr Chang is chief investigator of the final phase study in Australia.
Ginkgo biloba is taken to improve neurocognition and Panax ginseng is used as a "wonder herb" whose benefits include boosting memory and response. Saffron, a spice derived from the flower of Crocus sativus and used to flavour chicken soup in China, has a reputation for aiding blood circulation and offering antidepressant effects, he said.
In SLT, the combination is designed to work to improve blood circulation and perfusion in the brain, reduce inflammation and enhance communication between brain cells, according to Mr Chang...
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