Highlights of the International Conference and Exhibition of the Modernization of Traditional Chinese Medicine and Health Products

August 11-13, 2005; Wanchai, Hong Kong

Robert I. Fox, MD, PhD; Chak S. Lau, MBChB, MD, FRCP

Disclosures

September 16, 2005

In This Article

Differences Between Western Medicine and TCM in the Diagnosis and Treatment of RA

Although RA is a chronic condition, we consider it to be a relatively static condition in western medicine, and use medications to obtain a more optimal long-term outcome. Western medicine recognizes that there are a variety of "subtypes" of RA that we term prognostic factors. Nevertheless, we group a variety of patients with different therapeutic responses as RA, much as one might group all different types of wine together. The latter amalgamation of all wines might horrify the connoisseur of this beverage, but no more so than the lumping of patients with arthritis by a TCM. This fundamental difference in western medicine and TCM is hard to bridge. TCM frequently evaluates the patient and modifies the particular mixture of herbs. In western medicine, we choose a course and follow medications for toxicity and escalate medications if efficacy is not achieved. Comparing western and TCM diagnosis is like trying to stuff the proverbial square peg into a round hole. Thus, the best approach for western medicine will be the identification of which herbs can be used at a constant dose with added efficacy and minimal toxicity.

Prof. Feng Shan Zhang, Department of Rheumatology of Harbin Medical University in Mainland China, reviewed the "modern" western Chinese approach to RA where clinical training and access to laboratory analysis (including blood and radiographic studies) have led to a similar criteria of diagnosis for RA and response to therapy as defined by ACR criteria.[40,41,42] However, to compare the western diagnosis to TCM from a philosophical perspective, laboratory examination penetrates beyond the visible "life world" of the patient, revealing an underlying pathophysiologic disruption independent from human subjectivity. Thus, western physicians have difficulty in understanding TCM and in designing double-blind randomized clinical trials to measure the efficacy of TCM. Indeed, the emphasis will be the use of specific herbal agents versus a western medication (methotrexate) as described in the subsequent studies.

When comparing TCM and western diagnoses, certain chronic medical conditions that are diagnosed in western medicine such as RA do not fit easily into TCM classification. This difficulty in obtaining uniformity in diagnosis of RA was highlighted in a recent study by Zhang and colleagues,[43] who performed a prospective trial at the University of Maryland to determine the pattern of diagnosis and treatment by TCM practitioners. Forty patients with RA who fulfilled ACR criteria in the rheumatology clinic participated in the study.

Each RA patient was examined by 3 different licensed acupuncturists with at least 5 years experience and education in Chinese herbs. Each practitioner then provided both a TCM diagnosis and an herbal prescription. These diagnoses/prescriptions were examined with respect to the rate of agreement among the 3 practitioners. Remarkably:

  • The average agreement with respect to the TCM diagnoses among the 3 TCM practitioners was 31.7% (range, 27.5% to 35%);

  • The degree to which the herbal prescriptions agreed with textbook recommended practice for each TCM diagnosis was 91.7% (range, 85% to 100%);

  • No association was found between the diagnostic methods used and the consistency of diagnosis.

This study is important to US rheumatologists because it points out the significant diagnostic "chasm" between western medicine and TCM. The low level of agreement among TCM for diagnosis and therapy results from the significant differences in the way that disease is diagnosed.[44]

An analogy is the weather report. Large scientific computers have difficulty predicting weather patterns with certainty more than a few days in advance, but on a particular day, it is clear that it is raining. Thus, western medicine is the long-range diagnosis and TCM is the daily weather report. Some conditions such as RA have a daily status detected by TCM but the different goal of western medicine is long-term forecasting. The example of RA indicates the difficulty that western medicine will have in evaluating results of TCM studies and developing a uniform policy for credentialing TCM practitioners or therapy.[45] Thus, the immediate goal is to use traditional medications in a western style randomized trial.

Under the direction of Prof. He Yi-ting in Guandong a multicenter trial involving 9 different institutions included 498 patients with similar clinical characteristics at the time of study initiation. All RA patients fulfilled ACR criteria for RA; ACR 20 and ACR 50 response were determined at 24 weeks.

The western medication "arm" included 247 patients (with 29 dropouts) on a combination of methotrexate, sulfasalazine, and a nonsteroid drug. The traditional medicine "arm" consisted of 249 patients on a regimen of 3 TCMs, which included a set of 2 TCMs to treat by specificity of the disease, while the third TCM was according to the TCM differentiation of syndromes. The patients were evaluated at 2-week intervals with decreased dose if any adverse events were noted. Although the data presented were part of an interim analysis, the results suggest a significant response at both the ACR 20 and ACR 50 level for the traditional medication. In the preliminary analysis, it appeared that the traditional medication was similar in efficacy to the Western drug regimen. However, the study did not have a placebo control and it was not clear whether the observers were blinded to the study. In the short-term analysis at 24 weeks, the safety in terms of liver and blood system laboratory test results or gastrointestinal symptoms favored the herbal medication. However, it is known that one of the particular TCM medication contains Tripterygium wilfordii (8 mg 3 times daily),[46,47]which has known toxicity in women of child-bearing age,[48] and thus may prohibit its long-term use in this patient population. Nevertheless, these efforts to set up a randomized trial with a standardized agent represent a bona fide start to bridging traditional and western medicine.

Prof. Ian Tsang of University of British Columbia reviewed the methodologic issues required for randomized controlled trials (RCTs) designed to test the efficacy of acupuncture or herbal medications. He noted how reports seem to produce contradictory outcomes that resemble random events. However, several other treatments that do not involve drugs (especially those for pain, for example, transcutaneous electrical nerve stimulation, therapeutic ultrasonography, and epidural corticosteroids for sciatica) have similarly confusing results. Most systematic reviews of acupuncture and herbs have called for higher quality trials to resolve inconclusive results. Nonetheless, some of the problems encountered with RCTs on acupuncture and herbs are also shared by RCTs in other clinical domains: insufficient sample size, testing in poorly defined illnesses with imprecise outcomes, vague enrollment criteria leading to heterogeneous study groups, high dropout rates, and inadequate follow-up.

Numerous surveys show that, of all the complementary medical systems, acupuncture enjoys the most credibility in the medical community.[36,37,38] Evidence from RCT research is probably not the main basis for this positive opinion. A more likely reason is the existence of a substantial body of data showing that acupuncture in the laboratory has measurable and replicable physiologic effects that can offer plausible mechanisms for the presumed actions. Extensive research has shown that acupuncture analgesia may be initiated by stimulation in the muscles of high-threshold, small-diameter nerves. These nerves are able to send messages to the spinal cord and then activate the spinal cord, brainstem (periaqueductal gray area), and hypothalamic (arcuate) neurons, that, in turn, trigger endogenous opioid mechanisms.

These responses include changes in plasma or corticospinal fluid levels of endogenous opioids (for example, endorphins and enkephalins) or stress-related hormones (for example, adrenocorticotropic hormone).[36,37,38] In one study, the effects of acupuncture in one rabbit could be transferred to another rabbit by cerebrospinal fluid transfusion. Although questions remain, other studies have shown that acupuncture analgesia could be reversed with naloxone (an endorphin antagonist) in a dose-dependent manner. Acupuncture may inhibit early phase vascular permeability, impair leukocyte adherence to vascular endothelium, and suppress exudative reaction to a degree equivalent to that of orally administered aspirin and indomethacin. Evidence also supports the possibility that one mechanism of acupuncture may be a form of stimulation for the gene expression of neuropeptides. The latter may uncover the basis of the substantial response to pain that we often dismiss as "placebo."

Functional magnetic resonance imaging is also beginning to demonstrate that acupuncture has regionally specific, quantifiable effects on relevant structures of the human brain.[36,37,38] One study found that a specific acupuncture point, traditionally related to vision, activated an occipital lobe region that was the same area activated by stimulation of the eye using direct light. The point was located on the lateral aspect of the foot; stimulation of nearby sham points did not result in similar activation. Other studies show that specific acupuncture points, but not controls, activate structures of descending antinociceptive pathways and deactivate multiple limbic areas that participate in pain processing.

These functional magnetic resonance imaging studies follow earlier efforts showing that electro-acupuncture results in significantly increased concentrations of neuropeptide Y, neurokinin A, and substance P in the rat brain (specifically, the occipital cortex and hippocampus).

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