Introduction
Centuries-old traditional Chinese medicine plays an important role in health care in its country of origin China, as well as other countries in East and Southeast Asia. Its use is now spreading to other parts of the world including the US, but lack of information and misinformation make the use of TCM products quite difficult.
The Question of Clinical Trials
The oft-asked question is whether TCM products undergo clinical trials. The fact is that these formulas have been safely and effectively used for a long time, some even for a few thousand years. In China and neighboring countries, officially-recognized TCM hospitals are serving the health care needs of millions of people every day. Of course they have clinical trials behind them!
Here in the US, things are different. Though the FDA has officially recognized traditional Chinese herbal remedies in its Q&A, Actions on Dietary Supplements Containing Ephedrine Alkaloids (February 6, 2004), TCM products are only allowed as dietary supplements and must be used as such. Clinical use of TCM remedies in other countries is not recognized here, disregarding the fact that these formulas have been used on humans for centuries. Some people even say that it is necessary for us to test these products on mice first As a matter of fact, during the last few decades, Chinese and other Asian TCM research institutions have done an awful lot using modern technology to verify the empirical effects shown in TCM, including lab trials with mice as well as clinical trials with humans.
Toxicity
Established efficacy with less side effects and low toxicity level make TCM one of the best alternative health care systems of the world. It is indeed true that all ingredients of TCM are from nature and they have less side effects and lower toxicity in comparison with conventional drugs and other medications, but no one who is familiar with TCM has said the TCM is free of side effects. As a matter of fact, Chinese TCM doctors have always been careful with possible side effects and toxicity level of TCM formulas as well as individual herbs. The saying is “all medicine may have certain toxicity in it.” In Chinese pharmacopoeia, herbs are divided into high toxicity, medium toxicity, low toxicity, and non-toxic categories, and all are used differently.
It is natural that Chinese people try to use non-toxic herbs and avoid the toxic ones if possible. In times of need, however, a qualified TCM doctor never shies away from the toxic ones. Since they have such rich experience with the properties of herbs, they know how to manipulate the herbs and formulas to achieve desired results. Most TCM formulas are compound remedies comprising of many herbs. To be able use certain herbs to detoxify or neutralize the toxins contained in another is necessary training in becoming a TCM doctor. One commonly used approach in TCM is to use one poison to eliminate another. The best-known example is the Bovine Bezoar Resurrection Pill. It contains arsenic and mercury, often considered deadly poisons. As the name indicates, it is used in life or death situations such as high fever fright reversal, cerebral ischemic accidents, including stroke. For us here in the US, we do not need to worry because these types of formulas are not allowed to be imported into the country. Responsible importers of TCM products take much care to help customers properly use TCM products to avoid possible toxicity. Some companies use color schemes on their product labels to indicate the safety levels. For instance, green labels can indicate non-toxicity and the products can be used long term, and orange-red indicates caution and the products are used only when needed, or intermittently.
Chemical Residues and Heavy Metals
Another issue that has caused considerable concern in the health products industry is the high chemical residues and heavy metals found in some TCM products. But for us who live outside of China, here are some positive notes: There have always been two quality standards in manufacturing: standards for internal use, and standards for exports. In this case both manufacturers and importers opt for export quality and make sure that prohibited ingredients or contaminated products will not come our way.
Users must exercise care not to buy products of dubious quality, even in the US market. Some TCM products found in the US are not formally imported, but smuggled into the country. So you must not buy things you do not really know. Carefully examine the labels. If they are not properly labeled according to FDA regulations they are probably not up to safety standards. Look for credible and well-established distributors.
There are two ways to ensure high quality in manufacturing. One is to use wild herbs when necessary and the other is to use extracts. Wild herbs are difficult to get, and they are more expensive than cultivated varieties. Extractions remove toxins and impurities from herbs.