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1 Herbal Medicine An Introduction to Its History, Usage, Regulation, Current Trends, and Research Needs Sissi Wachtel-Galor and Iris F. F. Benzie CONTENTS 1.1 Herbal Medicine: A Growing Field with a Long Tradition 1 1.2 Herbal Medicine and the Aging Population 4 1.3 Herbal Medicines: Challenges and Regulations 4 1.3.1 International Diversity and National Policies 5 1.3.2 Quality, Safety, and Scientific Evidence 6 1.4 Research Needs 7 1.5 Conclusions 8 Acknowledgments 9 References 9 1.1 HERBAL MEDICINE: A GROWING FIELD WITH A LONG TRADITION Traditional medicine is “the knowledge, skills and practices based on the theories, beliefs and expe- riences indigenous to different cultures, used in the maintenance of health and in the prevention, diagnosis, improvement or treatment of physical and mental illness” (World Health Organization, Traditional Chinese medicine (TCM) is an important example of how ancient and accumulated knowledge is applied in a holistic approach in present day health care. TCM has a history of more than 3000 years (Xutian, Zhang, and Louise 2009). The book The Devine Farmer’s Classic of Herbalism was compiled about 2000 years ago in China and is the oldest known herbal text in the world, though the accumulated and methodically collected information on herbs has been devel- oped into various herbal pharmacopoeias and many monographs on individual herbs exist. Diagnosis and treatment are based on a holistic view of the patient and the patient’s symptoms, expressed in terms of the balance of yin and yang. Yin represents the earth, cold, and femininity, whereas yang represents the sky, heat, and masculinity. The actions of yin and yang influence the interactions of the five elements composing the universe: metal, wood, water, fire, and earth. 1 2 Herbal Medicine: Biomolecular and Clinical Aspects TCM practitioners seek to control the yin and yang levels through 12 meridians, which bring and channel energy (Qi) through the body. TCM is a growing practice around the world and is used for promoting health as well as for preventing and curing diseases. TCM encompasses a range of practices, but herbal medicine is a core part (Engebretson 2002; Nestler 2002; Schmidt et al. 2008; Xutian, Zhang, and Louise 2009). Three of the top-selling botanical products, namely Ginkgo biloba, Allium sativum (garlic), and Panax ginseng, can be traced back to origins in TCM and are today used to treat various diseases (Li, Jiang, and Chen 2008; Xutian, Zhang, and Louise 2009). Over the past 100 years, the development and mass production of chemically synthesized drugs have revolutionized health care in most parts of the word. However, large sections of the population in developing countries still rely on traditional practitioners and herbal medicines for their primary care. In Africa up to 90% and in India 70% of the population depend on traditional medicine to help meet their health care needs. In China, traditional medicine accounts for around 40% of all health care delivered and more than 90% of general hospitals in China have units for traditional medicine (WHO 2005). However, use of traditional medicine is not limited to developing countries, and during the past two decades public interest in natural therapies has increased greatly in indus- trialized countries, with expanding use of ethnobotanicals. In the United States, in 2007, about 38% of adults and 12% of children were using some form of traditional medicine (Ernst, Schmidt, and Wider 2005; Barnes, Bloom, and Nahin 2008). According to a survey by the National Center for Complementary and Alternative Medicine (Barnes, Bloom, and Nahin 2008), herbal therapy or the usage of natural products other than vitamins and minerals was the most commonly used alternative medicine (18.9%) when all use of prayer was excluded. A survey conducted in Hong Kong in 2003 reported that 40% of the subjects surveyed showed marked faith in TCM compared with Western medicine (Chan et al. 2003). In a survey of 21,923 adults in the United States, 12.8% took at least one herbal supplement (Harrison et al. 2004) and in another survey (Qato et al. 2008), 42% of respondents used dietary or nutritional supplements, with multivitamins and minerals most commonly used, followed by saw palmetto, flax, garlic, and Ginkgo, at the time of the interview. The most common reasons for using traditional medicine are that it is more affordable, more closely corresponds to the patient’s ideology, allays concerns about the adverse effects of chemi- cal (synthetic) medicines, satisfies a desire for more personalized health care, and allows greater public access to health information. The major use of herbal medicines is for health promotion and therapy for chronic, as opposed to life-threatening, conditions. However, usage of traditional remedies increases when conventional medicine is ineffective in the treatment of disease, such as in advanced cancer and in the face of new infectious diseases. Furthermore, traditional medicines are widely perceived as natural and safe, that is, not toxic. This is not necessarily true, especially when herbs are taken with prescription drugs, over-the-counter medications, or other herbs, as is very common (Canter and Ernst 2004; Qato et al. 2008; Loya, Gonzalez-Stuart, and Rivera 2009; Cohen and Ernst 2010). Regardless of why an individual uses it, traditional medicine provides an important health care service whether people have physical or financial access to allopathic medicine, and it is a flourish- ing global commercial enterprise (Engebretson 2002; Conboy et al. 2007; Evans et al. 2007). In 1990, expenditure associated with “alternative” therapy in the United States was estimated to be US$13.7 billion. This had doubled by the year 1997, with herbal medicines growing faster than any other alternative therapy (Eisenberg et al. 1998). In Australia, Canada, and the United Kingdom, annual expenditure on traditional medicine is estimated to be US$80 million, US$1 billion, and US$2.3 billion, respectively. These figures reflect the incorporation of herbal and other forms of traditional medicine into many health care systems and its inclusion in the medical training of doc- tors in many parts of the developed world. The total commercial value of the ethnobotanicals market cannot be ignored. For example, in 1995, the total turnover of nonprescription-bound herbal medicines in pharmacies was equal to almost 30% of the total turnover of nonprescription-bound medicines in Germany, and in the United States, the annual retail sales of herbal products was estimated to be US$5.1 billion. In India,

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