Introduction

This chapter focuses on one very popular and widely used segment of Chinese herbal medicine (CHM): the Chinese prepared medicines (CPMs). These preparations were referred to as patent medicines for hundreds of years, then more properly as prepared medicines, and as the regulatory oversight of such products evolved (at least in the United States and Europe), as herbal supplements. The landscape of these “over-the-counter” (OTC) medicines (or supplements) is changing due to regulation, economics (large global profits), adulterants, endangered and extinct species, as well as basic supply and demand. Chinese “patent” medicines were exported from China to the tune of $160 million U.S. dollars in 2009, a growing number partly due to the increased effort by the Chinese government to promote traditional Chinese medicine (TCM) globally.¹ There is a sense in China (among some in the government) that the Chinese have lost ground over the years in the trading of herbal medicines, as well as in the marketing of their traditional medicine. As the global herb market rapidly develops, China still finds itself accounting for only “three to five percent of the market.”²

East Asian medicine (EAM) is defined as a “medical system that arose in East Asia deriving from the traditional concepts of Qi and Yin-Yang Theory. EAM has developed various interventions such as acupuncture and moxibustion, massage and physical manipulation, diet therapy, herbal medicine, meditation and exercise.”^3,4 Although acupuncture is the global face of Chinese or EAM, CHM is the therapeutic core. The “new face” of EAM is the hope, among Asian governments, “that high-volume screening and rigorous clinical trials will unlock the secrets of ancient herbal remedies and that the results will pass muster with Western scientists.”⁵

The CHM (Zhong-Yao in Chinese pin-yin) pharmacy has evolved over many hundreds of years, and is massive in scope and application, as the following “snapshot” of usage in China indicates:

CHM is widely practiced across the world. In the United States, CHM is widely taught in most acupuncture school curriculums. However, for the most part, many students among the 60 accredited schools in the country concentrate on acupuncture with CHM as a secondary study,⁷ but not all by any means. In California specifically, CHM is a major part of the study, licensure, and practice of acupuncturists.⁸

CPM is the OTC medicine of the traditional Chinese pharmacy, which includes thousands of various preparations of classic and conventional Chinese herbal formulas. Much of this medicine has been in constant use for hundreds, even thousands, of years, often maintaining original formulations.

One example is a frequently sold CPM called Jie Geng Wan (Platycodon Root Pills).⁹ The source of this respiratory system medicine is the Jing Kui Yao Lue Fang Lun (“synopsis of the Golden Chamber”), written by Zhang Zhong Jing in 219 A.D.¹⁰ Zhu, writing in his highly useful and informative Clinical Handbook of Chinese Prepared Medicines, explained the following:

Secret family (or company) recipes called patent medicines were first produced in the Song Dynasty (960 to 1234 AD) and were dispensed by government agencies, such as the Imperial Benevolent Prescriptions of the Taiping Period.¹¹ Few true patent medicines exist anymore in the Chinese pharmacy. Many of these medicines have become part of the public domain, making it more appropriate to refer to them collectively as CPMs.

Unfortunately, there are too many dubious CPMs in the worldwide market that have been adulterated in various ways, some containing Western prescriptive medicines, toxic elements, and endangered species often hidden from the unsuspecting consumer.¹³ Consumers may find in their quest for safe, natural, and effective medicine serious, unexpected medical consequences. This is an issue that deserves scrutiny by consumers, practitioners, and regulators alike.

Typical images of the U.S. “Wild West” include cowboys, American Indians, farms, and the frontier life. However, there was another, lesser known presence in the West: the lives of Chinese immigrants. Many came to America seeking life on the “Gold Mountain,” the view of America that had been created in China during the 1800s. According to Paul Buell, writing in his Chinese Medicine on the Golden Mountain book:

The immigrants, mostly men, left their families to mine for gold. Many ended up working as miners or other laborers. They brought with them their traditional form of Chinese medicine and their traditional herbal medicine, which included various forms of CPM. CHM medicine is a highly evolved system of traditional medicine that draws from a materia medica composed of thousands of individual herbs (herbs in TCM include plant, mineral, and animal).^10,15 CPMs would generally be considered an adjunct to CHM in most practices, because they are convenient and good alternatives to the strong, bitter-tasting decoctions often used in practice. Many practitioners, particularly in the West, prefer to use granulated Chinese herbs or powdered herbs.

Global Market

The market for CPMs is huge. More than 5000 “licensed patent medicines” are estimated to exist in China.¹⁶ According to China Today, exports of CHMs worldwide reached 20 billion dollars in 2002. About 5% of this amount was China’s share, and prepared medicines comprised less than one third of this. In China, the famous Tong Ren Tang factory, which exports the most CPMs in China, earned 14.5 million dollars.¹⁷

Outside of the enormous “inside China market,” the growing interest and use of natural medicine worldwide are driving the consumption of prepared medicines rapidly upward. As mentioned previously, this growth has sparked abuse and problems with product labeling and safety that the entire profession is working to counteract.

Although Chinese medicine and pharmacy began to spread outside of China’s borders nearly 2000 years ago, it is only in the past 30 years that interest has grown in North America. Much of this is due to former President Richard Nixon’s trip to the People’s Republic of China in the early 1970s and subsequent reporters’ visits and articles, especially those of James Reston of the New York Times. The growth of acupuncture and oriental medical practices, such as herbal medicine, in the United States has been steady since that time.

The traditional loose herb recipes used in CHM are cooked and made into medicinal soups, which are often bitter and difficult for the American palate. The Chinese solution to this dilemma was to increase the use of raw licorice in the formula and to offer sugar wafers to the patient to help offset the bitter taste, although most Chinese welcome a bitter taste as a normal part of Asian cuisine. The prepared medicines offer an alternative to traditional preparations. A number of companies, particularly in Taiwan and California, have begun to popularize the manufacture and sale of powder and tincture formulas in the single herb form to help “bridge” the traditional form and the prepared, more palatable, forms of medicine. This allows the practitioner to still use the traditional approach, that of mixing and adjusting the formulas tailored to the patient’s individual diagnosis. Prepared formulas are fixed, of course, and do not allow any adjustments in the ingredients.

Before the mid-1970s, the U.S. Food and Drug Administration (FDA) restricted the import and sale of traditional medicines by ethnic groups. New legislation and court rulings since then have lifted these restrictions, which, coupled with the explosion of acupuncture on the American health scene, has opened the door to the spread of prepared medicines.¹⁶

Now, due to this rapid growth in the sale and use of prepared medicines, problems with adulterants and false labeling are increasing, especially in California, where a multiagency herbal medicine task force involving numerous California and federal government agencies was formed in response. The California Department of Health Services documents state that “most imported Asian patent medicines do not fully comply with California laws.”¹⁸ Although some of these violations are potentially dangerous and may involve toxic ingredients and the inclusion of endangered species, many involve labeling issues, which can often be sorted out by revising the labeling at the company of origin.