Opportunities for traditional Chinese medicine to address unmet challenges in modern healthcare.

Evolving the scope of medicine to reflect today's changing environment

Owing to advances in medical science and the increased effectiveness of public health education, life spans are increasing and leading to a new set of major public health challenges around age-associated diseases, including cancer, cardiovascular disease, bone function degeneration, neuronal degeneration, immune dysfunction, and metabolic disease.

The needs of an aging and growing global population require an evolution in drug development—one more focused on prevention than medical approaches of the past. Governments are refocusing healthcare policies from disease treatment to disease prevention, and, in turn, the pharmaceutical industry is shifting more resources from the development of medicines for treatment toward discovering new methods of prevention. Although their development may be slow, vaccines are an example of effective preventative medicine—widely used and demonstrating long-term healthcare cost savings.

Improving the efficacy of medicine is also an important issue. Adjuvant medicine is recognized for its ability to improve the efficacy of other medicines, by working synergistically to decrease side effects and enhance bioavailability. Borneo and Panax pseudo-ginseng is an example of a formulation whose design is important to its effectiveness and bioavailability. In view of these trends and challenges, the scope of medicine needs to adapt, and this should require a more holistic approach.

Challenges facing current mainstream approaches to drug discovery

A reductive approach focusing on treatment is not sufficient to meet the challenges facing modern medicine. Because diseases can be caused by a variety of factors, it is difficult to isolate single chemical compounds with defined targets for the treatment and prevention of diseases. Additionally, when a treatment results in multiple side effects, it is also challenging to find a single drug that can comprehensively address a variety of side effects. Because of the heterogeneous manifestation of disease, a host of factors need to be taken into consideration in developing treatments. Different patients with the same disease can have different responses to a given treatment. Owing to the variety of possible genetic mutations and epigenetic alterations of tumor cells, cancer treatment with target-oriented drugs alone has both value and limitations. Because many drugs for cancer and chronic disease treatment and prevention require long-term use, toxicity may aggregate over time. Development of drug resistance and compensatory mechanisms is often an issue upon treatment. To overcome these different challenges, a polychemical approach can be explored.

A new paradigm for future medicine

Polychemical medicine utilizes a systems biological approach to target multiple mechanisms of disease treatment and prevention, rather than focusing on treatment with single chemical medicines. There are two major approaches to polychemical medicine: (1) a “step-by-step” approach that evaluates the efficacy of combination treatment through trial and error; and (2) a “learning from history” approach that reexamines historical medical practices as the basis for reinventing modern medicine.

Traditional Chinese medicine (TCM) has been an effective polychemical medical approach for centuries. TCM includes multiple approaches for the treatment of complex disease and methods for disease prevention, as well as improving quality of life. TCM could be considered a model for other future polychemical medical approaches.

The chemical and botanical compounds used in TCM have the flexibility to function in a variety of ways in order to address problems at a systems biological level—singly or synergistically—to treat specific diseases or symptoms, as well as a complex network of related issues. TCM is prescribed as “individualized medicine” to optimize its usage. These aspects make TCM a suitable approach to meet the complex challenges facing modern medicine.

Basic regulatory requirements for modern drugs should focus on: (1) consistency of preparation; (2) evidence-based clinical efficacy; (3) safety; and (4) certain knowledge of its action. To make preparations of herbal medicine with consistency, authentication of sources for herbal and botanical compounds is a critical issue, and accurate identification is essential in order to prevent misuse. In order to ensure a high degree of consistency, High Quality Herb Agricultural Practices (HQHAP) is currently considered a good agricultural practice. HQHAP is an advanced approach to standardizing herbal and botanical agricultural practices. Beyond morphological, microscopic, and gene sequence analysis, HQHAP emphasizes the chemical analysis of herbs in vitro (solution state) and in situ (solid state), including matrix-assisted laser desorption/ionization mass spectrometry to determine a chemical image of herbal tissue.

A two-tiered approach to botanical quality control

The challenges of complex diseases should be addressed holistically through a systems biological approach, which includes science-based quality control regulations for the complex botanical compounds. Comprehensive regulatory oversight and quality control measures are required. A two-tiered approach is useful for ensuring botanical quality control. Tier one includes an analysis of the chemical and bioresponse fingerprints, and informatics/data mining technologies. Tier one's aim focuses on a global and relative quantitation. Tier two includes a simplified chemical and biological analysis of pharmacological activity, including the impact on targeted enzymes/receptors and genomic pathways. Tier two focuses on specific and absolute quantitation. An example of this two-tiered approach is PhytomicsQC—a platform used to confirm the consistency of PHY906, an herbal medicine used in cancer therapy in phase III clinical trials (Fig. 1). This comprehensive platform meets the regulatory and scientific challenges of botanical quality control.

Fig. 1

PhytomicsQC integrates technologies for chemical marker compound analysis and chemical fingerprints, comprehensive bioresponse fingerprints, and in vivo animal pharmacology validation.

Opportunities and challenges for herbal medicine as cancer treatment

Cancer's high incidence and mortality makes it a critical public health challenge. To overcome the unmet challenges, two major healthcare strategies should be considered for the development of cancer treatment and prevention practices: (1) developing more selective anticancer drugs with less toxicity; and (2) decreasing the toxicity of current cancer treatment modalities, without compromising their anticancer activity. In most cases, reductive, single-chemical approaches can make incremental improvements. However, holistic polychemical approaches should be considered as mechanisms to synergistically treat and prevent cancer and chronic diseases. Clinical trials of herbal and botanical medicines face several challenges, including proper dosage determination, feasibility of placebo randomized trials, design of add-on studies, and consideration and evaluation of individualized responses. To overcome these challenges, multiple disciplines of science and technology need to work together to advance herbal medicine, including agricultural science, microbiology and soil science, processing and manufacturing technologies, analytical technology, biological and medical science, and bioinformatics technology, including database and data mining. In order to effectively meet the challenges of modern medicine and to advance Chinese and herbal medicine, there needs to be a close collaboration between academia, industry, and government. Because of human, technological, and financial resource limitations, international collaboration is critical for the advancement of holistic approaches to treat and prevent cancer and chronic diseases.

Conflicts of interest

I certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.