DRUGS IN IMPORTED CHINESE HERB PRODUCTS
The presence of drugs in Chinese herb products (“patent medicines”) was first revealed in two items among the many U.S. imports of the 1980’s. One is an anti-arthritis product, originally sold under the name Chui Fong Tou Koo Wan, which was labeled to contain 22 herb ingredients but was revealed to contain various combinations of several drugs (see below) during an FDA investigation of adverse reactions—and deaths—among American users of this product. Despite this, the product has been hugely popular among most of those who have tried it.
The other is one of the products named Yin Chiao Chieh Tu Pien; this particular item contains paracetamol (to reduce fever and relieve aching), chlorpheniramine (an antihistamine), and caffeine (a vasodilator). This product clearly mentions the drugs on the label, but it is manufactured by the same factory as a non-drug version with packaging that is quite similar. Thus, some practitioners—or their patients who go to Chinese herb shops—received a drug-containing product when they asked for what they believed was an herbal product. This situation is particularly distressing because Yin Qiao Jie Du Pian (as it is spelled with official pinyin transliteration) is listed in the Pharmacopeia of China with an explicit formulation and method of preparation, without any drugs.
The mixing of drugs and herbs makes good sense to many Chinese medical doctors working in China, and even more so to the manufacturers of patent medicines who gain business by offering more powerful and faster-acting products. As explained to me at one factory that followed this practice: “The drugs make the herbs work faster and better, the herbs take away the side effects of the drugs and broaden the action.”
The extent to which drugs and herbs are being combined was revealed in studies by the Taiwanese FDA (Annual Report of National Laboratories of Foods and Drugs, 1990 and 1991) of products sold in herbal pharmacies, traditional Chinese medical clinics, and in martial arts stores in Taiwan. The investigators found that 30% of the antirheumatic and analgesic products that were sampled contained drugs. The drugs found by thin layer chromatography and spectrophotometric analysis include: acetaminophen, aminopyrine, caffeine, chlormezanone, chlorzoxazone, diazepam, diclofenac, ethoxybenzamide, hydrochlorothiazide, ibuprofen, indomethacin, ketoprofen, mefenamic acid, papaverine, phenylbutazone, piroxicam, prednisolone, and salicylamide. One in four of the sampled anti-asthmatic Chinese herb products contained drugs, mainly theophylline. By contrast, among herb products for treating dysmenorrhea, only 1 of 53 products (2%) contained drugs (it had aminopyrine and caffeine). Some of the drugs found in the Chinese products are not currently licensed for sale (through prescription or over-the-counter) in the U.S.
The situation with imported patent remedies may not be much better in the U.S. than in Taiwan. Recently Mayway Trading Company (San Francisco and Oakland), one of America’s largest distributors of Chinese patent medicines, provided information about test results (the sponsorship of the tests was not clear; it may have originated with the California Food and Drug Administration) of several patents that had been screened for drugs. The results are unpublished, but Mayway did share them with a number of organizations. A substantial number of the products—including several that were frequently prescribed by non-Chinese practitioners of Chinese medicine in the U.S.—contained one or more drugs.
As in the case of the herb-drug mixture for influenza (“Yin Chiao”), the common cold remedies, Gan Mao Ling and Zhong Gan Ling, and the sinus congestion products, Bi Min Gan Wan and Bi Yan Pian, contain drugs. In the most widely used brand of Bi Min Gan Wan there is no ingredient labeling, though a list of seven ingredients—without percentages and without mention of drugs—is offered in one packaging of the tablets. At the October 1996 Chinese Herb Coalition Conference in Berkeley, Richard Ko, of the California Food and Drug Bureau, had this to report: “As an example of what can go wrong, about three weeks ago in Marin county, a cleaning woman in an acupuncturist’s office complained of having a flu. The acupuncturist gave a patent medicine [Zhong Gan Ling]. After 10 days of taking this patent and feeling no improvement, the patient had a blood draw and was diagnosed (wrongly) as having leukemia. She was hospitalized and the herbal formula was analyzed. The formula contained an ingredient, aminopyrine, that causes agranulocytosis [reduction of the white blood cells called neutrophils].” Zhong Gan Ling also contains chlorpheniramine. The California Food and Drug Bureau sent representatives to many Chinese herb shops in November to ask them to discontinue sales of this product.
A cold-flu remedy that is useful for the accompanying sinus congestion is Gan Mao Qing (not to be confused with Gan Mao Ling); this product, labeled only in Chinese at this time, contains isatis, ilex, andrographis, and narcissus blossoms, combined with moroxydine, paracetamol, chlorpheniramine, and other ingredients. A person who purchased this product had no idea that it contained drugs because she didn’t read Chinese; her practitioner turned it over to ITM to find out more about it. Insomnia aids and pain relievers may also be made with drugs.
In many of the cases, the drug-containing products are not labeled as such. Although there is a tendency for the products to implicate themselves as drug-bearers because they have incomplete ingredient labeling (sometimes no ingredient labeling) and sugar-coatings with typical pharmaceutical colorings, this is not always the case.
For example, the so-called “black pills for arthritis” look like traditional remedies made entirely of herbs. The literature accompanying these pills state that they are free of drugs, but cautions that it should not be used by those with diabetes, hypertension, or “any sign of heart disease.” None of the listed herb ingredients are considered—by professional herbalists—to be harmful to persons with such conditions: to the contrary, they are quite suitable for heart disease. The caution arises because of the unlabeled drugs. This product is simply repackaged Zhui Feng Tou Gu Wan (as it is spelled in pinyin transliteration), also called Black Pearls, San Kee, and other names. According to the California Department of Health Services, these products contain varying amounts of one or more of the following drugs, depending on the manufacturer and batch: phenylbutazone, aminopyrine, indomethacin, hydrochlorothiazide, chlordiazepoxide, methyltestosterone, prednisone, chlorzoxazone, acetaminophen, mefenamic acid, dexamethasone, and diazepam. Except for acetaminophen, these are prescription drugs or discontinued drugs. Diazepam (aka Valium) is reportedly present in most of the samples. The list includes steroids (prednisone and methyltestosterone) and non-steroidal anti-inflammatory drugs.
Phenylbutazone has potentially fatal side effects; recently, a case of kidney damage was reported (in Malaysia) due to regular ingestion of two tablets per day of this type of herb product containing 120 mg of phenylbutazone per tablet (but with a product insert stating only herbs were present). Details of this case, in Nephron (1991), were accompanied by reference to the fact that 25 of 30 anti-arthritis preparations seized from Chinese medicine shops in Malaysia contained phenylbutazone in amounts ranging from 0.6–198 mg per pill or capsule. When used as a single drug, the standard dose is 200–300 mg/day. Other drug-laced arthritis products available in the U.S. are Vine Essence Pills and Ox Head Brand Tong Shui Wan; a recent analysis of the latter shows that it contains diazepam (0.8 mg/pill), mefenamic acid (an aspirin-like anti-inflammatory), and diclofenac (Voltaren). Several cardiac medicines, such as Seven Flower Pills, contain potent drugs, and some of them contain toad venom, a highly effective, but potentially dangerous natural compound.
Sometimes the presence of drugs is suggested by the fact that a very small dosage (one or two small pills, capsules, or tablets) is an adequate amount to get very dramatic and prompt effects. Drugs take up less space then crude herbs or crude herb extracts and are usually selected because of their quick action.
Polydrug therapy is often practiced in making herb-drug mixtures. Many people who use the herb-drug mixtures for arthritis report that these pills work where no medically-prescribed treatment has previously succeeded. The pills rarely deliver enough herbs to account for this improvement—in fact, the herbs in some products serve as an essentially inert base for the drugs (which is why the attempts to imitate the product by using the herbs alone are not successful). What makes the products so effective is the mixture of drugs. One of the advantages of herbs compared to drugs that is commonly cited is the fact that they contain numerous active ingredients instead of one isolated ingredient. The components of herbs (both within one herb and within a formula) are said to act synergistically to enhance the desired actions and ameliorate side effects. Similarly, a properly designed drug cocktail, in which each component is present in modest amounts, may have desirable properties.
In the U.S., approved drug products rarely have more than three ingredients; they are usually single drugs. The Food and Drug Administration, concerned about unpredictable drug interactions, will rarely approve polydrug products. Doctors tend to prescribe one product at a time, sometimes building their patients up to a polydrug treatment over several months. But each drug is often given in full recommended dosage, thus limiting the possible combinations because of side effects at these high levels. As a result, one or two days of treatment with the Chinese polydrug products can seem miraculous compared to the standard drug therapies tried before.
Nonetheless, the drugs in the herb products can each be hazardous to susceptible individuals, and the problem of herb-drug mixtures in which the drugs are not labeled is compounded when persons are already taking drug therapies and add the Chinese product. The result can be an adverse drug interaction or an overdose of a drug that is both prescribed and also in the “herb” product. In the absence of controls, herb-drug combinations can be quite variable in their content of drugs and the quantity of the drugs; a product used safely one time may turn out to be unsafe another time. Chinese products can also be blamed for an adverse reaction because they are unapproved and mislabeled, even if they did not actually make a contribution to the problem.
Aside from pills and tablets, topical creams sold in Chinese stores are another area of potential drug application. Many of the products are not labeled in English, but in Chinese they frequently clearly specify the presence of drugs (others are not labeled with the ingredients). Products labeled in English may state the content of drugs, but the inexperienced purchaser may be unaware of this: cortisone cream is called unguentum fluorocortisoni acetatis, or some even less revealing name. Quite a few skin creams for eczema and other disorders sold in Chinese shops contain corticosteroids; several acne creams contain antibiotics (as do some of the pills for acne).
To avoid drug-containing products, one should be especially careful about items that are intended for over-the-counter purchase to relieve specific symptoms or diseases—as opposed to those for treating traditional Chinese syndromes (e.g., Liu Wei Di Huang Wan, for the treatment of kidney yin deficiency syndrome). The manufacturers of most traditional herb formulas in Japan, Taiwan, and mainland China must meet strict standards by their regulatory agencies; they sell drug-free products that usually require a knowledge of traditional Chinese medicine for their selection and proper use. American-made products, in which the extraction, tableting, encapsulating, or other final processing is done here are unlikely to contain drugs, both because of the regulatory situation and the underlying philosophical desire of herb manufacturers to provide non-drug products. Thus, drug-free Chinese herb products are available; one just needs to exercise extra caution to ensure getting them when there are so many products with drugs coming into the country.