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Why TCM needs TQM

Traditional Chinese medicinal botanicals
While TCM has a strong basis in the use of botanicals, a road map is needed to extend acceptance of formulas across the scientific community.

While botanicals and herbal medicines have been used for thousands of years, a path forward is needed to understand and gain acceptance of Traditional Chinese Medicine (TCM) preparations and formulas in the international market. Dr Ray Cooper, professor and university lecturer at the Hong Kong Polytechnic University, discusses some of the key considerations around this opportunity.

Botanicals and herbal medicines have been used for thousands of years, are being used in primary health care of developing countries, and, more recently, the use of botanicals and natural products as therapeutic agents has gained popularity and has expanded globally. They are gaining an ever-wider acceptance in developed countries as many health issues associated with the modern living style cannot be treated effectively with conventional medicine. Examples include preparations and formulae of Traditional Chinese Medicine (TCM), Ayurveda, Kampo, African traditional medicinal plants and Native American traditional medicine.

In the case of TCM, China is spending billions of dollars to turn its traditional remedies into drugs, mining its traditional history in a move to dominate the global pharmaceutical market. There are over 10,000 herbs in the TCM canon, and over 300 herbs are actively prescribed for various diseases. At this point, the Chinese are passing these botanical extracts through extensive biological testing in the hope of finding the next breakthrough drug. They had fantastic success with the anti-malarial drug, artemisinin, now the frontline treatment throughout the world. The discovery came from screening a TCM formula from the artemisia tree.

However, developing safe and effective botanical TCM mixtures is another matter entirely. Even though there is a long history of use and good documentation preserved in ancient texts, the scientific evidence based on today’s standards of inquiry leave much to be desired. Although the Chinese are proud of TCM, they know the outside world is skeptical.

First, TCM is a mixture of several plants and/or herbs. What is the appropriate ratio of the variously chosen plants, what is the scientific rationale for such a preparation, what are the purported bio-actives, and at what dose can the preparation be administered and considered safe? These questions need TCM to pass through a total quality management (TQM) process whereby the following six S’s are practiced:

  • Selection (of right plant and plant part)
  • Sourcing (of right species wild or cultivated)
  • Structures (of chemicals)
  • Standardisation (of actives, and consistent preparations)
  • Safety
  • Substantiation (clinical evidence of use in humans)

A road map forward is needed to better understand and gain acceptance of these preparations and formulae within the scientific and international community. Some specific areas include a) harmonizing standards and international collaborations, b) further improving the research methodologies required to understand the actions of the botanicals and natural products for development better remedies, and c) developing the research strategies to provide scientific data that could substantiate the health claims and provide progress toward total quality management. With a TQM system in TCM, it is possible to examine, explore and design acceptable means of scientific studies of botanicals and natural products, which include TCM. This means specifically linking a suitable chemical marker to a biological signal that can be connected to its therapeutic use: an approach not uniformly used by the industry currently.

In this regard, significant research efforts in different parts of the world have been applied to examine the efficacy and chemical compositions of botanicals and herbs. Reflecting on this body of work, Taylor & Francis (CRC Press) is publishing a new book series, Natural Products Chemistry of Global Plants, addressing natural products and plants used as botanical medicines. The series intends to trace a route through history from ancient civilizations to the modern day showing the importance to man of natural products in medicines, in foods and a variety of other ways. It focuses on the pharmacognosy, covering recognised areas rich in folklore as well as botanical medicinal uses as a platform to present the natural products and organic chemistry. Where possible, the authors will link these molecules to pharmacological modes of action.

There are many current examples that illustrate the opportunity, and the global community will benefit from advancements in this area.

 

Editor’s Note: Dr Ray Cooper completed a doctorate in organic chemistry and after 15 years in R&D in the pharmaceutical industry, he moved to the dietary supplements industry, developed new Chinese botanicals as supplements. He has continued developing innovative products, designing clinical studies, and R&D. Currently he is Professor and university lecturer at the Hong Kong Polytechnic University, Hong Kong, and the editor for the “Natural Products Chemistry of Global Plants” book series. Dr Cooper will be speaking on the topic of “TCM Needs TQM” on Thursday 10 September as part of Vitafoods Virtual Week. Click here to learn more and get registered.

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