The globalization of traditional Chinese medicine (TCM) has focused attention on both the health promoting benefits of these medicinals as well as the potential challenges in their use. Historically, TCM has been used by experienced practitioners safely with few adverse events for thousands of years. As the use of TCM continues to gain in popularity, a new paradigm shift in the use of herbal medicine becomes more apparent. Herbal medicine must be proven safe and efficacious in order to challenge their synthetic pharmaceutical rivals in the treatment of modern disease. Despite their long history of safety, herbal medicine is now being scrutinized by evidence based research. Patients in search of alternatives to pharmaceuticals have turned to herbal medicine. Their quest has been aided by the use of internet technology that has placed herbs traditionally prescribed by trained herbalists in the hands of patients and biomedical practitioners without appropriate knowledge or training in their use. Ensuring that the manufacturing of herbal medicinals is done under quality controlled conditions is paramount to protect the public from inferior products, dangerous substitutions, adulterations and unknown herb toxicity. To ensure a continual future supply of quality controlled herbal medicinals, efforts should be made now to support commercial cultivation of herbs and restrict the use of those that are endangered or prohibited from use. The TCM practitioner can advocate the safe and efficacious use of herbal medicine through education, the promotion of herbal research, demanding only quality controlled herbal products, supporting the efforts of herbal conservation, and becoming an active part of an integrated medical paradigm.
Safety and Efficacy through Education
Educating patients and biomedical practitioners on the use of herbal medicine can empower them to become allies in herbal medicine use. Patients that are well informed regarding medicines are more likely to be compliant in their use, increasing herbal efficacy and ultimately achieving positive therapeutic outcomes. By educating biomedical health practitioners, they will be more likely to utilize herbal medicine appropriately or refer to a Chinese herbalist that has shown competence and expertise in their field. Education in herbal medicine also reduces fear and skepticism by the public. Issues regarding the use of herbs containing aristolochic acid have prompted governmental regulatory authorities to mistakenly assume that most TCM herbs are toxic or harmful due to lack of data (FDA, 2001). Without education on quality controlled processing methods and traditional uses by herbalists, an inherent risk exists of having TCM herbs pulled by authorities from use in the marketplace based on inaccurate information. To ensure the safety and quality of herbal plant use, the herbalist must educate these authorities. A skilled Chinese herbalist can be the link in a modern American integrated medical model by explaining good manufacturing processes (GMP), herbal indications, therapeutic uses, dosing, contraindications and warnings to a Western biomedical practitioner. The continued popularity of herbal remedies worldwide increases the likelihood that herbs and Western drugs will be used together (Chan E, 2010). Part of herbal medicine’s acceptance by biomedical practitioners beyond education will come from validated research. The amount of data being compiled of herbs, formulas, and individual herbal constituents is ever increasing. Herbalists are needed to evaluate this data and collaborate with biomedical Western practitioners and scientists in evidence based research, educating and assisting in the development of rational approaches for safe herbal use (Chan E, 2010).
Safety and Efficacy through Research
Unlike traditional use of TCM based on centuries of clinical case studies and anecdotal evidence, modern medicine in the United States is driven by randomized controlled trials. A Chinese herbalist must be familiar with all forms of research methods, become comfortable in reviewing research literature, take an active part in research and incorporate the best of that knowledge into patient care. The evidence based medicine model proposed by Sackett, 1996 is quite applicable to herbal medicine practice. This patient-centered approach to the use of herbals is based on the practitioner using research and the best of their clinical experience to improve patient outcomes. Given the rich clinical history and individualized patient approach of traditional Chinese medicine, incorporating modern research will only increase the credibility and reliability of herbal medicine. In order to accomplish this task, herbalists are faced with the challenge of designing herbal formulation studies that have all the complexities currently encountered with Western drugs, devices and surgeries (Lao L, 2011). Western medicine and TCM have inherent differences. The Western designed research methods were not designed for TCM and have some challenging aspects. Li, 2009, suggested ten such issues involved in designing clinical research of Chinese herbal medicine. He proposed that there were difficulties in creating adequate placebos, using TCM pattern differentiation in a methodological system that attempts to limit diversity, the absence of quality control and classification of herbs, having limited studies on the efficacy of herbal medicine in randomized double blinded controlled clinical trials (RCTs), and applying Western medicine- based diagnostics including pathology, imaging data and test results into TCM pattern differentiation. Even if these impediments in designing herbal clinical trials are cleared, Chinese medicine is currently sold as a dietary supplement under the Dietary supplement Health and Education Act (DSHEA) (Chang, 1999). The absence of “disease” claims instead of the limited definition “structure and function” claims allowed under DSHEA further complicate the process of designing clinical studies. Ensuring quality control of Chinese herbal medicine in RCT’s is a critical issue that affects the safety and efficacy of Chinese herbal products (Leung KS, 2006). In a search of the Cochrane Library to identify RCTs of Chinese herbs by Leung, 2006, only one trial out of 11 using Chinese herbal medicine discussed quality control interventions used. Resolving these issues, the Chinese herbalist can accelerate the acceptance of TCM by the public and Western scientists. Wang, 2010 suggested that one of the promising methods for reducing toxicity and increasing the safety and quality of Chinese herbal medicine is to design research from a symbiotic perspective using a systems approach, since Chinese herbs are never used as single entities but rather as multi-herb formulations. Traditionally, potential toxic Chinese herbs have always been processed with other herbs specifically matched to counter that toxicity. To validate the effectiveness of herbal medicine in research, a quality controlled product must be used.
Safety and Efficacy through Quality Controlled Formulations
With the rising costs of TCM herbs, the lure by unethical manufacturing entrepreneurs to adulterate expensive herbs with cheaper products is a threat to the safety and efficacy of Chinese herbs. Aflatoxins, heavy metals, herbal constituent variability (marker compounds) and substitution of herbal species are common among poor quality manufacturing companies (Dhar, 2011). Countries outside of China are concerned about the safety and efficacy of traditional Chinese medicines based on observations of herbal products having high risks due to identity, purity and substitutions (Bauer R, 2010). It is hardly reliable now for the traditional herbalists to base quality on smell, taste or physical appearance to authenticate herbs or potentially toxic species. There is a need to improve methods used to evaluate the quality of Chinese medicine (Li SP, 2011). Modern analytical and chemical techniques are necessary to ensure the safety and efficacy of herbs (Lee, 2000). Herbalists must be educated on using or evaluating technology such as infrared spectroscopy or chromatography (Yap KY, 2007). Another method an herbalist can use to control quality is by learning to evaluate and create herbal monographs that incorporate differences between Chinese and other countries standards (Bauer R, 2010). By nature, Chinese herbal medicine is complex, consisting of formulas with several herbs and multiple constituents making processing inherently variable. Chinese herbalists depend on herbal manufacturers and suppliers to produce and supply quality herbal products that are properly processed. Improper processing of Chinese herbal formulas or inappropriate mixture combinations can cause toxicity and side effects (Zhao Z, 2010). Reduction in the level of toxic components of Chinese herbal medicine is evidenced by proper processing of the herbs in all phases of preparation including production, harvesting, processing and the final formulation (Wang J, 2009). Herbalists should ensure that all products are ordered from manufacturers that use ingredient qualification identified in GMP quality standards. TCM herbs are only as efficacious as the quality of the herbal product and the correct TCM diagnosis. Despite the most skilled and adept Chinese herbalist’s diagnosis, if quality herbal specimens are not harvested, stored and processed correctly, efficacy is lost (Zhao Z, 2010). Even when quality controlled herbals are being produced properly, there is increasing pressure on Chinese herbal availability.
Safety and Efficacy through Conservation
The demand for Chinese herbal products has significantly increased in recent years. Thirty years ago, 85% of Chinese medicinal herbs were wild crafted. Today, less than 50% are obtained from wild sources with the remainder being cultivated (Korpik, 2011). The use of cultivated herbs can extend the finite supply of wild sourced herbs and has found favor in countries outside of China. Chinese herbalists should be alert to the potential for sub-quality products that are being picked irresponsibly or changes in herbal quality from over-farming or environmental factors. Herb prices have skyrocketed the last few years being driven by market demand, environmental factors, and foreign influences that have reduced supplies (Fei, 2010). China’s burgeoning economy with many greedy “get rich quick” entrepreneurs sell endangered animal medicinals or sacrifice herbal quality for profits, producing counterfeit herbs that jeopardize the safety of the patient. Chinese herbalists should avoid the use of endangered animal medicinals harvested from animals such as the tiger and Asiatic bear. Herbal alternatives to using threatened animal species will ensure a more humane way to practicing medicine while observing animal rights and welfare. They need to proactively stay informed of legal and market changes that affect herbal medicine by pursuing continuous education and advanced studies to ensure the safe and efficacious use of Chinese herbal medicine as herbalists integrate into a new healthcare paradigm.
Safety and Efficacy through Integrative Medicine
Integration of Chinese and Western medicine appeared approximately four hundred years ago at the beginning of the 17th century. Since that time, history has shown that the cooperation of TCM and Western medicine together is more efficient for the cure and prevention of disease than when used separately (Shin, 1999). Medicinal herbs are becoming increasing popular and important in the Western world by the public and the scientific community (Lee, 2000). Since Chinese herbs are listed as dietary supplements under the DSHEA act, they are not as closely regulated as in China or other countries (Chang, 1999). Pharmaceutical sales worldwide are forecast to grow from 600 billion U.S. dollars in 2010 to over 950 billion U.S. dollars by 2013 (Pan, et al., 2010). Chinese medicine may have fewer side effects and less severe adverse reactions than concentrated single-entity drugs making them more appealing to the consumer (Lee, 2000). Instead of the complex task of developing and isolating a single chemical constituent from an herb, it may be advantageous to develop a standardized herbal extract that yields consistent pharmacological activity (Chang, 2000). An herbal extract may have several active ingredients that add to its pharmacological action. Evidence exists that the pharmacological actions of isolated herbal constituents from herbal extracts can differ significantly from the activity of the whole herb (Chang, 2000). Continued investigation of creating drugs from herbs using modern research is critical to the development of new healing modalities in the 21st century.
The current 2011 strategic plan for the National Institutes of Health National Center for Complementary and Alternative Medicine (NCCAM) lists as one of its objectives, to advance the research on CAM natural products. Herbal products, botanical medicines or traditional medicine formulations are a part of CAM natural products (NCCAM, 2011). Chinese herbalists are in a unique position to assist in the national agenda of making herbal supplements safe and effective for the public through education, participation in clinical research, using quality controlled herbal formulations, practicing herbal conservation and integrating their traditional knowledge with modern pharmacology in creating novel herbal medicines for the future that are safe and efficacious.
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