| Research object:Due to the variation of life style, the incidence rate of gastral cavity pain showing an increasing trend year by year in Taiwan. Traditional Chinese Medicine has exact curative effect on this illness, but its theoretical basis still need to be explored. This research got through theoretical traceability of Chaihuguizhi Decoction which is a classic prescription treated with gastral cavity pain in "Treatise on Cold Diseases". To clear the theoretical basis, we used this prescription on gastral cavity pain patients in Taiwan, in further to explore its curative effect and safety, finding a better way to relieve the illness of patients.Research methods:This research divided into theoretical and clinical observation two parts. At the theoretical research side, mainly got through combing ancient and modern literature from the Chaihuguizhi Decoction's derivation, keywords interpretation in article, origin of the disease name, pathogenesis interpretation, medicine composition analysis and ancient scholars'clinical application to arrange ancient documents. At the same time, got through modern documents arrangement from analogous prescription application, clinical application, mechanism analysis, in order to provide theoretical basic to clinical application of Chaihuguizhi Decoction. At the clinical observation side, according to inclusion criteria selected 80 cases with gastral cavity pain as research objects who were treated from July 2013 to December 2015 in Taiwan. We selected Sichuan Chinaberry Powder as control medicine. To observe the curative effect of two groups by some indexs before and after treatment, such as symptom score scale to see symptom changes, VAS score to investigate pain improvement, HAMD scale to watch depression improvement. Via telephone or outpatient service follow up 3 months to compare safety.Research result:1. Theoretical research result(1) Ancient documents research.We got through the explore of this prescription derivation, keywords interpretation in the Shanghan article and the disease name found that the application of Chaihuguizhi Decoction started from "Treatise on Cold Diseases", initially applied in treatment of gastral cavity pain. Gastral cavity pain in ancient documents were different from nowadays, name of this disorder were gradually determined until the late Qing dynasty, similar with nowadays diseases of the spleen and stomach system. Physicians from ancient times, the clinical application of this prescription started from gastral cavity pain, gradually expand to Shanghan Syndrome, helopyra, wind-warm syndrome and so on.(2) Modern literature researchGot through the investigation we found that although we made some progress at this prescription's clinical application and mechanism explores, the researchs were relatively dispersive. Most discussions of the physicians were accorded to their adept disorders without the systematic study. At the same time, we found that most of studies were individual cases, rarely large samples. The healing effect was still had to be proofed. Most of the studies were explorations of a disorder without syndrome differentiation subdivisions. Most of mechanism investigations were focused on a certain disorder about cell factors and neurotransmitters, instead of pathogenesis or the network. Most of the research model aimed at the ill, never seen the TCM syndrome model research combined with disorder and syndrome.2. Clinical observation result(1) Demographic data analysisMale in all patients 104 cases (65%), and the youngest was 18 years old, mostly among 21 to 50 ages (63.75%), culture degree in university and above were 145 cases (90.625%).(2) Comparison of syndrome types distributionMost of syndrome types in observation group in turn were:stomach heat, liver and stomach qi stagnation, stasis in stomach collaterals, food stagnation in gastrointestinal tract, stomach yin deficiency, deficiency and cold in spleen and stomach, cold pathogen attack stomach. The order was approximately in common with control group, except stasis in stomach collaterals more than liver and stomach qi stagnation.(3) Curative effect comparisonEffective ratio in observation group was 92.50%, in control group was 90.00%. Compared the curative effect of two group patients without obviously differences (P>0.05). Furthermore, got through the curative effect comparison of each syndrome type, we found that the lowest curative rate was syndrome of cold pathogen attacking stomach within observation group, the second was insufficiency cold of spleen and stomach, within control group the lowest curative rate was deficient cold of spleen and stomach, the second was stomach heat syndrome. Compared the same syndrome type between two groups, curative ratio of the syndrome of cold pathogen attacking stomach in observation group obviously decreased, but stomach heat and deficiency and cold in spleen and stomach syndromes obviously increased, the differences with statistical significances (P<0.05, P<0.01)(4) Symptom scores comparisonAs a whole, before and after treatment the symptom scores of observation and control group without obviously statistical significances (P>0.05). Compared within group, the symptom scores of patients all obviously decreased than before treatment, the differences with statistical significances (P<0.01). Furthermore got through the comparison of each symptom type, the differences between two group patients before treatment without statistical significances (P>0.05). After treatment, compared between two groups, the scores of cold pathogen attacking stomach and deficiency and cold in spleen and stomach symptom obviously increased, but the symptom of stomach heat obviously decreased in observation group with statistical significances (P<0.05). Compared within group, the symptom scores of patients in observation and control group obviously decreased, the differences with statistical significances (P<0.01).(5) Pain scores comparisonVAS scores of control and observation group before and after treatment without obviously statistical significances (P>0.05). Compared within group, VAS scores of two group patients both obviously decreased after treatment, the differences with statistical significances (P<0.01). Furthermore compared each symptom type, we found that VAS score of patients before treatment in two groups, the differences without statistical significances (P>0.05). After treatment, compared between two groups, VAS scores of deficiency and cold in spleen and stomach syndromes in observation group obviously increased. VAS scores of stomach heat syndrome obviously decreased than control group, the differences had statistical significances (P<0.05). Compared within group, VAS scores of two groups all obviously decreased than before treatment, the differences had statistical significances (P<0.01).(6) Depression score comparisonAs a whole, before and after treatment, HAMD scores in control and observation groups without obviously differences (P>0.05). Compared within group, HAMD scores of two groups all obviously decreased than before treatment, the differences with statistical significances (P<0.01). Furthermore got through the comparison of each symptom type we found that HAMD scores before treatment without statistical significances (P>0.05). After treatment, compared between two groups, HAMD scores of cold pathogen attack stomach and deficiency and cold in spleen and stomach syndromes in observation group obviously increased and stomach heat syndrome obviously decreased than control group. The difference is statistically significant (P<0.05). Compared within group, HAMD scores of two groups obviously decreased than before treatment. The difference is statistically significant (P<0.01).(7) Safety comparisonThere were no serious adverse reactions or side effects except occasional nausea during the treatment period. All recovered after treatment, the differences without statistical significances (P>0.05). Followed the patients mainly by telephone or outpatient service in 6 months after treatment, there were 4 cases of recurrence about 5.00% in observation group, and 5 cases of recurrence about 6.25% in control group. Compared the recurrence rates of two groups, the differences without statistical significances (P>0.05).Research conclusion:1. Theoretical research conclusionChaihuguizhi Decoction which is a classic prescription treated with gastral cavity pain in "Treatise on Cold Diseases". We should strengthen the arrangement of this prescription in ancient medical volumes. Drawing on Data Mining Technology to get through prescription research on its rule of diagnosis and treatment. To do the documents arrangement nowadays, studies should focus on illness and symptom combined large sample with multicenter clinical trial research in future. As to mechanism analysis, we should be aimed at superior diseases to develop TCM Syndrome Model discussion. On this basic to do the research on systematic intervention mechanism and improve laboratory-clinic-laboratory evidence chain further.2. Clinical observation conclusion(1) Patients with gastral cavity pain were more common in young and middle-aged men, most of them were intellectual workers with college degree or above in Taiwan. The crowd can be sifted for further screening and education to reduce the incidence of disease(2) Most symptoms of patients with gastral cavity pain in Taiwan were stomach heat, liver and stomach qi stagnation, stasis in stomach collaterals, and food stagnation in gastrointestinal tract syndrome.(3) Chaihuguizhi decoction and Sichuan Chinaberry Powder both with well curative effect on gastral cavity pain, and relatively higher safety.(4) Chaihuguizhi decoction was more suitable for the "he"method and Sichuan Chinaberry Powder was more suitable for moving qi and removing food stagnation to relieve pain. Both were not suitable for the deficiency and cold or cold pathogen. |
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