| Objective:This clinical trial was conducted to observe the clinical efficacy of Wenzhongzhitong Decoction in the treatment of stomach pain(cold qi stagnation and blood stasis syndrome).The purpose of this study was to evaluate the effectiveness of the prescription in treating various stomach digestive diseases caused by cold qi stagnation and blood stasis syndrome.And safety,providing data support for the Chinese medicine preparations that are made in Shanxi Province Traditional Chinese Medicine Hospital.Methods:120 patients with gastric pain(cold qi stagnation and blood stasis syndrome)were collected according to the inclusion criteria by randomized,positive drug and parallel controlled trial design.The patients were divided into experimental group(Wenzhong analgesic prescription)and control group by completely randomized grouping method.(Wenweishu Capsule)60 cases were treated for 2 weeks.The total scores of TCM syndromes and the main symptom scores(spleen and stomach disease ClinRO stomach pain quantitative score,spleen and stomach disease ClinRO stomach pain quantitative score,stomach pain VAS score)were recorded.The scores of each symptom were recorded;the time of analgesia was recorded(days);the safety indexes of the two groups before treatment and 2 weeks after treatment,and the recurrence after 4 weeks of follow-up,objective analysis and evaluation of safety and effectiveness.Results:(1)This study included 120 patients,6 patients lost from the experimental group,4patients lost from the control group,and 110 clinical observations.(2)Efficacy evaluation of TCM syndromes: After 2 weeks of treatment,there was a statistically significant difference between the evaluation groups of TCM syndromes(P<0.05).The rate of TCM group was 72.22% and the effective rate was 94.44%.Wenweishu capsule group The test group was 42.86% and 85.71%,respectively,and the test group was superior to the control group.(3)After 2 weeks of treatment,the difference between the total scores of TCM syndromes was statistically significant(P<0.05),and the experimental group decreased by2.47 points compared with the control group.(4)After 2 weeks of treatment,the spleen and stomach disease ClinRO gastric pain quantitative score,spleen and stomach disease ClinRO bloating quantitative score,stomach pain VAS score,analgesic time group were statistically significant(P<0.05).The experimental group compared with the control group,the average score of gastric pain wasreduced.At 5.30 points,the average score of bloating was reduced by 5.04 points,the VAS score of stomach pain was reduced by 1.25 points,and the analgesic time was reduced by0.61 days.The test group was superior to the control group.(5)The difference between TCM syndrome total score and stomach pain VAS score was statistically significant(P<0.01),which was better than that before treatment.(6)After 2 weeks of treatment,the single symptoms of chest pain were full of nausea,suffocation,acid reflux,and pain.There was a statistically significant difference between the groups(P<0.05);the total effective rate of the chest-swelling symptoms group was92.37%;The total effective rate was 86.54%;the total effective rate of the hernia symptom test group was 94.00%;the control group was 72.00%;the total effective rate of the acid-resistance test group was 93.62%,the control group was 70.21%,and the total effective rate of the pain-tested symptom test group was 92.37%.The control group was86.54%.Wenzhongzhitongfang group was superior to Wenweishu capsule group.There was no significant difference between the patients with poor appetite and cold limbs(P>0.05).(7)The recurrence rate was 4 weeks after stopping the drug: the recurrence rate of the experimental group and the control group were 13.20% and 32.00%,respectively,and the difference was statistically significant(P<0.05).The recurrence of the experimental group was lower than that of the control group.(8)Safety evaluation:No abnormal changes in safety indicators and side effects were observed during the two groups.Conclusion:Both Wenzhongzhitong and Wenweishu Capsule can improve the symptoms of cold-stagnation qi stagnation and blood stasis syndrome in patients with stomach pain.The overall efficacy of Wenzhongzhitong Recipe group is better than Wenweishu capsule group,which can significantly relieve stomach pain,bloating and chest fullness.Mouth,belching,acid reflux,pain and other symptoms,shorten the pain relief time,and no obvious adverse reactions and side effects,high safety level and long-term efficacy,it is worth further promotion and exploration. |
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