| ObjectiveThis research is one part of the study of using the clearing liver and releasing stagnancy formula in treating liver depression of the heat syndrome (migraine, non-organic insomnia and generalized anxiety disorder), a randomized controlled clinical trial. It is designed to observe the clinical efficacy and safety of using the clearing liver and releasing stagnancy formula in treating liver depression of the heat syndrome, analyse the relationship between changes of syndromes and diseases, verify the theory of "same treatment for different diseases" in Chinese Medicine in order to provide clinical evaluation evidence for the new drug development and evaluation of the clinical efficacy.MethodAll Cases in the research came from the Dongzhimen Hospital Affiliated To Beijing University Of Chinese Medicine. The collection period was from November 2013 to February 2014. By February 2014, we collected a total of 21 cases of GAD patients with liver depression of the heat syndrome,10 were in the test group and 11 were in the controlled group. A strict inclusion and exclusion criteria was obeyed to enroll patients, and the randomized controlled method was used in the grouping. Patients in the test group was treated with the granules of clearing liver and releasing stagnancy formula while the the Wuling capsule was given to the patients in the control group. All of the patients were treated for 4 weeks and observed per week. We included the patients who met criteria of DSM-IV and Liver Depression Of The Heat Syndrome Diagnosis Scale by the same time. We use Hamilton Anxiety Scale (HAMA) as anxiety condition evaluation criteria and Liver Depression Of The Heat Syndrome Evaluation Scale as evaluation criteria of TCM syndromes. We analysed the collected data by statistical analysis, compared the efficacy between the two groups and different viewpoints, as well as analyse the change of the before and after treatment relationship between the syndrome and disease.ResultClearing liver and releasing stagnancy formula contributed to the significant improvement of the syndrome, while Wuling capsules could not improve the syndrome obviously. Both of the two kinds of drugs could cause the same significant reduce on HAMA scores. For the secondary efficacy measures, patients in the test group had got a significant change of SF-36 scale, while the control group changed a little. Both the two groups of patients improved significantly in MYMOP scores. The test group had significant differences in MYMOP scores after the first, second and forth weeks of the treatment, while patients in the control group had a significant efficacy in MYMOP scores only for the first week of the treatment. When we judge from the total trend charts, we found that the test group got more improvement than the control group in all of the syndrome scale, HAMA, SF-36 and MYMOP scores. At last, we did some analyze on the correlation between the syndrome and HAMA. There was a moderate intensity correlation between the syndrome and HAMA scores changing ratio in the test group, while the correlation was weak in the control group. Both the test group and control group had a positive correlation between the syndrome and HAMA scores before the treatment. After the treatment, there was still a strong positive correlation between the syndrome and HAMA in the test group. While the control group resulted in a negative correlation between the syndrome and HAMA.Conclusion1. Clearing liver and releasing stagnancy formula has advantages over Wuling capsules on improving all of the three aspects of syndrome, diseases and quality of life.2. Preliminary confirmed the relevance between syndrome and disease. But because of sample size limitations, the proof of this conclusion will require further study to confirm.3. Preliminary confirmed the syndrome-centered therapy has more advantages than the treatment only for the disease, which provided a preliminary theory support for syndrome-centered development of proprietary Chinese medicine.
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