| Objective:This study was conducted to further monitor the efficacy and safety of Xiao Chai Hu decoction in combination with Zuo Jin Pill in the treatment of GERD with hepatic and gastric congestion and fever by comparing TCM symptoms and the GERDQ scale before and after GERD treatment with congestion and heat of the liver and stomach.Methods:This experiment is a randomized controlled study,and the subjects participating in this experiment were patients with gastroesophageal reflux disease(hepatogastric stagnant heat type)who attended the Chinese medicine outpatient clinic of the Hospital of Dalian Medical University from January 2022 to January 2023,and a total of 61 cases were eligible for the study and agreed to participate in this trial,among which 5cases were detached due to poor compliance.The ethics committee of Dalian Medical University Hospital considered and approved this topic for review(project number:YJKY-2021-262).Patients with gastroesophageal reflux disease(hepatogastric hyperthermia type)who met the inclusion criteria were divided into two groups and randomly grouped according to the order of consultation,and finally 31 cases were obtained in the observation group and 30 cases in the control group.In this trial,the observation group used Xiao Chai Hu Decoction combined with Zuo Jin Pill,and the control group used Lansoprazole Enteric Capsules.4 weeks was the treatment cycle.Clinical symptoms of the subjects before and after treatment.The clinical symptoms of the subjects before and after treatment were evaluated by using the Chinese Medicine Evidence Rating Scale and the GERDQ scale.The scales used in this study can objectively reflect the severity of clinical symptoms before and after treatment.The statistical analysis of the data in this study were analyzed using SPSS 26.0 statistical software.Results:1.comparison of clinical data: The study was a randomized controlled study in which 66 patients were enrolled,and those who finally met the requirements of the inclusion criteria were divided into two groups according to the order of enrollment using the random number table method,and 61 cases were finally included(n=31 in the observation group and n=30 in the control group).There were no statistically significant differences in age-sex distribution and pre-treatment TCM evidence score and GERDQ scale between the two groups(P>0.05).2.After treatment,the symptoms of TCM acid reflux and heartburn improved significantly in both groups(P< 0.05),and the reduction of heartburn symptoms was more significant in the observation group(P< 0.01).The number of patients whose primary symptoms disappeared after treatment in both groups: 16(51.61%)in the observation group for acid reflux and 8(26.67%)in the control group;21(67.74%)in the observation group for heartburn and 11(36.67%)in the control group.The number of patients whose secondary symptoms disappeared after treatment in both groups was the improvement of the secondary symptom “irritability” in the combined Xiao Qi Hu decoction and Zhu Jin Pill group was significantly better than the control group,which was statistically different(P<0.05),while the other items were not statistically different(P>0.05).3.The total number of TCM symptoms in both groups decreased after treatment.In the observation group,5 cases(16.12%)were cured,13 cases(41.94%)were apparently effective,10 cases(32.26%)were effective,and 3 cases(9.67%)were ineffective,with an effectiveness of clinical treatment of 90.32%;in the control group,1 case(3.33%)was cured,8 cases(26.67%)were apparently effective,15 cases(50.00%)were effective,and 6 cases(20.00%)were ineffective,the efficacy of clinical treatment was 80.00%.The difference between the efficacy of the two groups was statistically significant(P<0.05),indicating that the efficacy of the observation group was better than that of the control group.4.The GERDQ scale of both groups improved significantly after treatment.In the observation group,5 cases(16.12%)were cured,11 cases(35.48%)were effective,13cases(41.94%)were effective,and 2 cases(6.45%)were invalid,with a clinical treatment efficiency of 93.55%;in the control group,2 cases(6.67%)were cured,6cases(20.00%)were effective,18 cases(60.00%)were effective,and 4 cases(13.33%)were invalid,the efficacy of clinical treatment was 86.67%.The difference was statistically significant(P<0.05),and the results showed that symptoms improved better in the observation group than in the control group.Conclusion:Both Xiao Chai Hu Decoction combined with Zuo Jin Pill and Lansoprazole Enteric Capsules could improve patients’ symptoms,and the clinical effect of using Chinese medicine treatment was more obvious in the observation group.The reduction of GERDQ scale and TCM evidence points reflected that Xiao Chai Hu Tang combined with Zuo Jin Wan could significantly improve patients’ main symptoms(acid reflux and heartburn),and the effect was presented at 2 weeks of treatment,which could effectively improve and relieve patients’ clinical symptoms such as acid reflux and heartburn.It is worthy of clinical promotion and application. |
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