Establishing The Efficacy Of Traditional Chinese Medicine

Ian KY Tsang

Disclosures

Nat Clin Pract Rheumatol. 2007;3(2):60-61. 

An increasing number of patients are using complementary and alternative medicine (CAM), which led the WHO to publish its Traditional Medicine Strategy 2002-2005[1] and the White House Commission to publish its Complementary and Alternative Medicine Policy.[2] Both these documents address policies towards and the efficacy, quality, and rational use of CAM. In addition, the NIH has established a National Center for Complementary and Alternative Medicine to study CAM.[3]

Traditional Chinese medicine (TCM) is the most commonly used of all the CAM disciplines, and, according to Rao et al.,[4] of the 60-90% of patients with arthritis who have used CAM, most used TCM. Although the use of and interest in TCM is not an indication that TCM is effective, it does show that patients with rheumatic diseases, and perhaps the physicians who treat them, are looking for alternative therapeutic options. Western medicine has not provided satisfactory treatment for all rheumatic diseases, and it is essential that rheumatologists know about TCM in order to better serve their patients.

To understand the issues surrounding the use of TCM, it is essential to realize that it is a comprehensive conceptual system that is very different from the Western reductionist and mechanistic approach to diseases. TCM works around five solid organs−heart, liver, spleen, lung, and kidney­and six hollow viscera−large and small intestine, urinary bladder, stomach, gall bladder, and 'triple burners'. These 'structures' are connected by conduits and vessels with 'qi' (energy) and blood circulating through them. This system is a concept of how the body functions, and the 'structures' are not actual anatomical structures as in Western medicine. The 'qi' and blood are vital substances of life; the function of the solid organs is to store these substances, and the hollow viscera act as reservoirs to regulate the circulation of these substances. TCM is a holistic approach, and emphasizes the importance of keeping all the structures functioning harmoniously. A person is considered to be in good health if every 'structure' is functioning in harmony with the other 'structures' in the body and with the surrounding environment.

To diagnose a condition or disease using Western medicine, the patient's history, physical findings, and test results are used, and treatment is devised according to the patient's symptoms or the root cause of the problem. TCM establishes a diagnosis of the individual rather than the disease, and uses a process called 'syndrome identification', whereby the practitioner makes a dynamic conceptualization of the individual's situation and comes up with a 'pathophysiologic status' (the type of disharmony) for the individual; this status is called 'zheng' or 'syndrome'. The therapeutics used to restore the harmony within the host and between the host and their environment are determined by the identified 'syndrome'. The theory of TCM diagnosis and management has not been elucidated in Western scientific terms, but the TCM 'syndrome identification' process seems to work. Although it is important to understand the theory of TCM, as I think there is a scientific explanation behind it, we should firstly establish whether or not TCM has an impact on patients.

Ideally, all medicine should be rigorously tested,[5] and both the WHO Traditional Medicine Strategy and the White House Commission on Complementary and Alternative Medicine Policy suggest that clinical trials should be carried out to establish the efficacy of CAM. Physicians will, therefore, have to take on the responsibility of conducting these clinical trials. In Western medicine, randomized, controlled trials are the gold standard of rigor in clinical research, and they are designed to determine the efficacy of treatments, where end points can be reduced to one or a few objectives. The randomized, controlled trial design, however, has distinct limitations when applied to TCM, because TCM is holistic and conceptual, and it identifies and treats 'syndromes' rather than diseases. The assessment of the efficacy of TCM tends to use multiple, interactive measures, and its outcomes tend to depend on whether harmony is restored or not, which makes measurement difficult. These differences between Western medicine and TCM indicate that alternative strategies must be developed for the evaluation of TCM.

Over the past 15 years, an increasing number of studies evaluating TCM have been published in Western scientific journals; however, most of the research has not involved collaboration between Western and TCM scientists, and thus has failed to address the fundamental concepts of TCM. English taxonomies of diseases do not correspond with TCM classifications, and the measures of efficacy derived from Western views of disease do not assess the goals of TCM. It is important to incorporate the concepts of both Western medicine and TCM into research protocols. Establishing collaboration between Western medicine and TCM is a major challenge, because communication between the TCM and Western medicine practitioners rarely occurs.

These limitations of research could be overcome by creating a new strategy to evaluate the effect of TCM on rheumatic and musculoskeletal disorders. A collaboration between clinical scientists trained in TCM and those trained in Western medicine should be organized; patients attending a TCM clinic of their own free will should be evaluated, diagnosed, and managed by TCM practitioners according to the TCM principles. Every patient should also be seen by a rheumatologist to establish the Western medical diagnosis. The rheumatologist should not be involved in the treatment or management of the patients. Detailed clinical records according to TCM concepts and standards should be kept. Since each patient will have a Western medical diagnosis, their progress and outcome can be monitored using established Western medicine methods by independent assessors. This model is a form of open, long-term, observational clinical study assessing the effect of TCM on patients with rheumatic disorders; however, it will not assess the TCM diagnoses. This model will generate high-quality, patient-oriented, level 3 evidence according to Ebell and colleagues[6] of the efficacy of TCM. This strategy would also foster communication between TCM and Western medicine practitioners, and could lead to improved TCM services.


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