by Ted Kaptchuk
The combination of two very publicized simultaneous events has recently encouraged many new patients to seek care from practitioners of East Asian medicine. One incident was a series of newspaper reports concerning the manufacturers of arthritis painkillers such as Vioxx, Celebrex and Bextra, who deliberately hid incriminating information of potential adverse drug effects. (1, 2) The second was the publication in a prominent medical journal (with subsequent media attention) of one of the largest randomized controlled trials of acupuncture ever undertaken which demonstrated acupuncture's superiority over placebo for osteoarthritis of the knees. (3) People saw the utility in trying Chinese medicine as the news bulletins' messages resonated with the public image we try to promote: nature is safer and Chinese medicine works according to the criteria of modern biomedicine. Before we get complacent, I thought it would be worthwhile to share some of my personal observations concerning "natural" and "see, it works according to the criteria of biomedicine." My fundamental concern is that these two messages can, if they have not already, become booby traps that could backfire on the profession of Oriental medicine.
The word 'nature' had no equivalent term in the Chinese language before the late nineteenth century. (4) After this time, the early term zi-ran ("what is so of itself") which carried the implications of "spontaneous process" was adopted to mean "nature" for use in translating Western scientific writings. The Chinese had no radical dichotomy between human culture and nature: both operated according to the same laws and were fundamentally linked. The idea that Chinese medicine is "natural" (as opposed to man-made or synthetic) and, therefore, somehow safe, is not an argument found anywhere in the Chinese classics. The current Chinese medicine argument that 'nature equals safe' was only adopted in the early twentieth century as a defensive tool by the Chinese medical profession to resist the complete seizure of medical power and legitimacy by elite Western medicine physicians. (5) For Chinese medicine, the 'nature equals safe' was a political maneuver to survive in competition with Western medicine. (6) This merger of a belief in "benevolent nature" with a less powerful medical system is equivalent to what happened in the west, at the same time when unorthodox medicines [such as homeopathy, chiropractic and health food] also adopted a natural is better and safer rhetoric. (7,8)
In fact, until the end of the nineteenth century, Chinese practitioners saw their medicine, especially the herbal medicine, as being potentially dangerous and toxic. For example, a central theme of the Materia Medica Classic of the Divine Husbandman (Shen-nong Ben-cao Jing, c. 150 CE) is herbal toxicity. Two thirds of the 365 herbs listed are "poisonous" (you du). Only 120 herbs were "without poison" and are described as not harmful if taken for a long period of time. The Chinese understood that any pharmacodynamic substance generally implies possible toxicity. Medicine in one dosage becomes poison in another dosage.
While our profession sometimes presumes that "nature is safe", Western physicians are constantly bombarded with medical journals reporting that Chinese herbs are toxic, have potential drug-herb interactions, are adulterated by synthetic drugs, are contaminated by heavy metals and otherwise precarious. Unfortunately, these reports are often true. In fact, aconite (fu zi) is toxic and even bitter almond (xing ren) in especially high dosages is dangerous. A sample of 2069 patent formulas manufactured in Taiwan found 24% contaminated by at least one camouflaged drug, (9) while a survey of 260 Asia-manufactured patent medicines collected from California retail stores found 7% containing pharmaceuticals. (10) Chinese herbs do interact with western drugs as the well documented example of warfarin and salvia (dan shen) demonstrate (11); and many herbal preparations have unacceptable levels of heavy metals. (12) The blitz of negative information, while alarmist, is not usually inaccurate. But in the face of such information, we still talk "natural is safe." This bury-our-head-in-the-sand attitude reinforces the perception that practitioners of Chinese medicine, who also believe in qi or yin/yang are na•ve and gullible.
In the face of such a negative report I would obviously not argue for abandoning herbal medicine. The benefits outweigh the risks. Instead, I would argue that our profession should gradually wean itself of the twentieth century "nature-trusting belief" and adopt the more traditional Chinese understanding that all medicines need to be properly used by trained practitioners otherwise they are potentially unsafe. Our treatments work because we have the knowledge to make them safe, not because the herbs are inherently benign. And in terms of patent medicine products, we need to remember that just because a manufacturer says "natural product" does not mean that the products are pure, reliable and prepared under quality controlled conditions. Discernment, caution and care are necessary in all medical systems. I believe that unless we re-organize our rhetoric to match an earlier layer of Chinese thought, the "nature" argument will eventually ensnare us in our own misrepresentations much like the manufacturers of Vioxx and Celebrex were caught in their dishonesty.
The second trap I see in recent events is "see, it works according to the criteria of biomedicine and randomized controlled trials (RCT)." The danger here is that given the history of contradictory RCT evidence in acupuncture research it is likely that new positive trials will be followed by negative trials in the bipolar cycle of positive and negative evidence we have already witnessed. (13) Just witness the even more recent negative RCT of acupuncture for migraine. (14) Interpreting this contradictory evidence is complex and requires a specialized education in epidemiology. (13) Nonetheless, it should be pointed out that a cycle of contradictory evidence is not unique to acupuncture and, in fact, happens even with many FDA approved drugs.
The difference between the drug evidence and acupuncture evidence is that the pharmaceutical companies can often withhold their negative RCT data from surfacing in the public. Depression is a good example. In the US, when a company seeks FDA approval for labeling a drug with a specific indication, two pivotal trials that show superiority over placebo are usually required. Negative RCTs need to be reported to the FDA, but the company can request that this information remain proprietary, confidential and not shared with the public. Therefore, according to information released by the Freedom of Information Act, we have the situation that for paroxetine, an important anti-depressant, only two of the nine RCT were positive and the data from the seven negative trials was not made public. (15) Also, for fluoxetine, the archetypical serotonin reuptake inhibitor (SSRI), the data submitted to the FDA demonstrated only five out of 13 RCTs to be positive.
The same story can be told for many other classes of drugs including: analgesics, anxiolytics, antihypertensives, hypnotics, antianginal agents, antihistamines, nonsteroidal asthma prophylaxis and motility-modifying drugs. (16) For many complaints, especially those concerned with subjective complaints, RCTs may not have what is called "assay sensitivity." (16) For whatever reason, the RCT apparatus for detecting a difference between a genuine treatment and a placebo control sometimes is unreliable and contradictory.
This does not mean scientific research concerning Asian medicine is not important, valuable or even essential. It just suggests that the profession of East Asian medicine needs to be critical and cautious before it invests itself in biomedical criteria of efficacy. Instead, we have to realize that RCT's can be serious and genuine efforts (certainly when performed outside of drug company influences) potentially could give our profession valuable feedback and insights. We need to learn how to interpret and incorporate this type of evidence into the Asian tradition of depending on knowledge transmitted from teachers, classical texts and most critically obtained from our patients' feedback. Such an effort of cross-fertilization will take serious learning and contemplation. But we certainly cannot use the criteria that is common within the profession today: if a RCT supports Oriental medicine it is good research and if it does not find positive evidence for Oriental medicine it is bad research. We cannot afford to have a simplistic and selective double standard of "we like this RCT, but not this RCT." This approach reeks of the hypocrisy that pharmaceutical companies present to the public on a daily basis. (e.g.,1,2) Selectively trumpeting a particular RCT could cause us to lose our professional integrity and moral standards.
References
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