Discussion on Methodology of Integrated Traditional Chinese and Western Medicine Research, September 31, 1987

Discussion on Methodology of Integrated Traditional Chinese and Western Medicine Research, September 31, 1987

I. Clinical Study Design

1. Topic Selection The key lies in efficacy. Only traditional Chinese medicine theories and formulas with high efficacy (higher than both Western and Chinese medicine) are worth studying for their mechanisms.

2. Case Selection Cases should generally have a clear Western medical diagnosis, with national or global unified standards and quantitative indicators. Traditional Chinese medicine diagnostic criteria should standardize syndromes.

3. Establishment of Control Group Comparison is essential for differentiation; without comparison, there can be no differentiation. Except for studying universally recognized incurable conditions, establishing a control group is very necessary. Traditional Chinese medicine can use recognized Western medicines as controls. The number of cases in the control group and treatment group should be similar; if the number is too small, there will be no statistical significance.

4. Efficacy Criteria Improvement in syndrome and disease often coincide. Western medicine has many objective indicators for judging efficacy, so integrated traditional Chinese and Western medicine clinical studies often use Western standards to determine efficacy. Ideally, there should be a national unified efficacy standard. Besides disease criteria, syndrome criteria are also necessary, because patients’ subjective feelings are an important aspect of determining efficacy. Therefore, combining disease and syndrome is the way to judge efficacy.

II. Indicator Selection

Indicators are crucial for explaining principles and theories. It is best to have few but precise indicators, though during the preliminary testing phase, a wide-net approach can be used to screen indicators. For example, in the study of kidney diseases using integrated traditional Chinese and Western medicine, there were initially many materials. First, over ten indicators were tested on healthy individuals, patients with kidney yang deficiency, and patients with kidney yin deficiency. After repeated trials, it was finally decided that three indicators were necessary.

III. Studying Hepatitis Syndromes Requires Combining Endocrinology

Because hepatitis itself is very complex, extrahepatic syndromes of viral hepatitis are numerous. Some can be studied from an immunological perspective, such as research on antigen-antibody complexes, which can reveal that hepatitis is often accompanied by arthritis, glomerulonephritis, allergic dermatitis, and other problems. Clinical syndromes of liver disease are related to endocrinology, such as low-grade fever, testicular atrophy, male breast development, spider angiomas, palmar erythema, thyroid cysts, cystic breast disease, multiple ailments, functional uterine bleeding, uterine fibroids, delayed menstruation, scanty periods, light menstruation, amenorrhea, infertility, adrenal insufficiency, pigmentation, etc. All of these require endocrine indicators. Low-grade fever in hepatitis is widely recognized, but few people connect low-grade fever with endocrinology. In the 1960s, someone proved that intermediate products of endocrine metabolism, such as pre-cortisol and progesterone, are febrile substances. Normally, these substances are converted into non-febrile forms in the liver through lipid metabolism, but in diseased livers, lipid metabolism is impaired, and the febrile effect of ketones becomes apparent. Fever in liver disease is usually classified as yin-deficiency dampness fever or qi-deficiency fever in traditional Chinese medicine. The former uses Wuling Powder, the latter uses Bu Zhong Yi Qi Tang.

IV. Methods and Discussions

1. Rigorous design to verify efficacy, reasonable control, precise statistics, and repeatability.

2. Acute hepatitis can self-heal in 90% of cases with rest; the focus of treatment is chronic hepatitis.

3. Treatment for abnormal liver function: transaminases, plasma proteins, and bilirubin.

4. Treatment for liver damage or halting fibrosis: for chronic hepatitis, restoring normal liver function does not mean the disease is cured. Because traditional Chinese medicine has limited data on the recovery of hepatitis lesions due to fewer liver biopsies conducted before and after treatment, the completeness of the data is poor. For treating the cause (HBV), eliminating the cause is an important part of treating hepatitis. Currently, there is no definitively effective formula, and quantitative indicators such as HBsAg, HBeAg, and DNA-P are necessary. The mechanism of chronic hepatitis is complex and difficult; any breakthrough in any aspect is very meaningful.

5. Key Breakthrough

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The treatment of chronic active hepatitis is extremely complex; even the most experienced experts and the best-equipped institutions find it difficult to handle all aspects comprehensively. Only by focusing on key breakthroughs while addressing other issues can progress be made. Clinical research differs from clinical treatment in that it cannot tackle everything at once; it must have specific research topics, with a clear focus and not be overly broad. At present, it remains challenging to establish comprehensive indicators for immune modulation, so definitive conclusions cannot yet be drawn. Liver biopsy has long been avoided due to patients' reluctance to undergo the procedure, making it an unattainable goal. In addition, extensive domestic and international literature related to this topic should be reviewed to fully grasp the latest research advances and relevant traditional Chinese medicine theories. First, perseverance is essential; the likelihood of achieving success on the first attempt is very low, so one must continuously refine and supplement their research plan through repeated practice. Once relatively satisfactory therapeutic effects are obtained, a series of procedures such as dosage form reform, drug analysis, and mechanism exploration can be formulated. Second, after determining the main research direction, one should not easily change course or abandon the project midway, but rather continually develop new ideas based on the latest findings in this area. Both short-term efficacy and long-term follow-up outcomes must be observed, with strict criteria for evaluating treatment effectiveness. In addition to clinical manifestations and changes in liver function tests, serum levels of the five hepatitis B markers, DNA polymerase activity, HBV-DNA inhibitory T-cell function, liver tissue pathology, and hemorheological parameters should also be measured. Pre- and post-treatment results must be statistically analyzed and thoroughly compared to provide a reliable basis for screening truly effective drugs. Although treating hepatitis B is a very challenging problem, if we can leverage our strengths, avoid weaknesses, make all-out efforts, and collaborate to overcome obstacles, breakthroughs may be achieved in the near future. The quality of diagnostic indicators must not fall below Western medical standards. Test reagents should be of reliable brands, and efficacy should be evaluated according to unified regulations. To highlight the characteristics of traditional Chinese medicine, syndrome differentiation and individualized treatment are required, using a single formula and a single drug. If the herbal composition remains unchanged, the therapeutic effect may be poor; therefore, while focusing on the primary syndrome, secondary syndromes must also be considered to achieve better treatment outcomes.