I. Clinical Study Design

I. Clinical Study Design

1. Topic Selection: The key lies in efficacy—only Chinese medical theories and formulas that demonstrate high efficacy (higher than both Western and Traditional Chinese Medicine) are worthy of mechanistic research.
2. Case Selection: Cases should generally be clearly diagnosed by Western medicine, and must meet national or global standards with quantifiable indicators. The diagnostic criteria for Traditional Chinese Medicine should be standardized.
3. Establishment of a Control Group: Only through comparison can distinctions be made; without comparison, distinctions cannot be established. Aside from researching widely recognized incurable diseases, establishing a control group is essential. Traditional Chinese Medicine and Western medicine can be compared using well-established Western medications. The number of cases in the control and treatment groups should be comparable; if the sample size is too small, statistical significance will be lacking.
4. Efficacy Criteria: Improvement in both symptoms and disease is often consistent. Western medicine employs numerous objective indicators to assess efficacy, while clinical studies integrating Chinese and Western medicine often rely on Western medical standards to determine efficacy. Ideally, there should be nationally unified efficacy criteria; in addition to disease criteria, symptom criteria are also necessary, as patient perception is a critical factor in determining efficacy. Therefore, combining disease and symptom assessment is a key method for evaluating efficacy.