| BackgroundNon-erosive Reflux Disease(NERD)is a subtype of Gastroesophageal Reflux Disease(GERD).GERD is defined as a group of symptoms and/or complications caused by the reflux of gastric contents into the esophagus,oral cavity,throat and lungs.NERD is characterized by the presence of reflux symptoms with the absence of Barrett’s Esophagus(BE)and visible injury to the mucus layer of the esophagus.As the leading subtype of GERD,NERD is prevalently affecting individuals globally.While the pathomechanism and pathophysiology of NERD is widely studied in modern medicine,because of its unique pathomechanism,the use of proton pump inhibitors for NERD treatment yields limited effects.Traditional Chinese Medicine(TCM)and its unique treatment ideologies has an advantage in improving the symptoms and enhancing quality of life in GERD patients.While much TCM studies has been done in the area of GERD,studies regarding NERD is relatively scarce.Hence,to spearhead a clinical study to explore the treatment ideologies and syndromes in the treatment of NERD will provide a crucial reference to future evidence-based studies.ObjectivesThrough studying the efficacy and safety of Jian Pi Qing Hua granules along with small dose of omeprazole in the treatment of Spleen deficiency and dampness heat type of NERD patients,we aim to discover the advantage of TCM treatment ideology in the treatment of NERD.This will in turn provide an evidence-based practice to the treatment of NERD in TCM,and provide a foundation to future laboratory studies and drug discovery.MethodsA total of 68 NERD patients with Spleen deficiency and dampness heat subtype are included in the study and randomized into study group and control group.The study group were given Jian Pi Qing Hua granules with omeprazole 1Omg po qd,while the control group were given omeprazole 20mg po qd.Both groups were given omeprazole and Jian Pi Qing Hua granules placebo to achieve double-blind,double simulation,random control study method.After 4 weeks of treatment,statistical analysis was conducted on GERD Q score,TCM syndrome questionnaire score,SF-36 score,PRO index and HAD index of study group and control group.The safety of the granules was studied through comparison of the routine blood test,urine test,fecal test and ALT,AST,BUN,Cr,and ECG before and after treatment.ResultsThis study included a total of 62 effective cases,with 31 cases in study group and control group respectively.The study group comprises of a total of 10 males,21 females,while the control group comprises of 6 males and 25 females.26%of the participants were male and 74%were female,with an average age of 40.50±15.26.There was no statistically significant differences between the gender,age,BMI and drug compliance of the two groups,hence the results are comparable.Efficacy comparison:1.Primary outcome:In terms of improving the main symptoms of NERD based on GERD Q analysis,both study group and control group significantly improved heartburn,reflux and sleep disorders,and there was no significant difference in the improvement between the two groups.There was no significant difference between the two groups for the total effective rate and recurrence based on GERD Q.In the improvement of TCM syndromes of Spleen deficiency and dampness heat subtype,the study group displayed a possible advantage of being able to provide long term improvement of the symptom of belching and acid reflux.There was no significant difference in the total effective rate between the two groups based on the TCM syndrome score scale.2.Secondary outcome:In terms of the quality of life,both groups significantly improved body pain(BP),general health(GH)and health transformation(HT)of the participants.The study group yielded statistically significant improvement as compare to control group in terms of GH.In terms of improving the clinical symptoms and psychological state,both groups provided significant improvements in the six dimensions of the PRO index,and there was no significant difference between groups in the degree of improvement.In terms of psychological well-being,both groups yielded significant improvement in alleviating anxiety and depression,with no significant difference between both groups.Safety:The study group reported 2 adverse event cases with an elevation in ALT and AST.Both were considered mild adverse effects without ruling out its possibility to be associated with the study drug.The control group reported no adverse event.Conclusions1.The use of Jian Pi Qing Hua Granules with low dose omeprazole in the treatment of NERD patients with spleen deficiency and dampness-heat syndrome can effectively improve the main symptoms of NERD such as heartburn and reflux,and the curative effect was not statistically different from the simple application of omeprazole.2.Compared with the simple application of omeprazole,Jian Pi Qing Hua Granules with low dose omeprazole has a better long-term effect on improving the belching and acid reflux symptoms,and shows certain advantage in reducing the burden of medication.Both of the differences are statistically significant.3.Jian Pi Qing Hua Granules can effectively improve the quality of life,clinical symptoms,psychological state(especially the symptoms of anxiety)of patients.But it does not show its advantage compared with the simple application of omeprazole.4.The advantages and safety of Jian Pi Qing Hua Granules in improving the total efficiency of TCM syndromes require further verifications,and its safety needs to be further clarified. |
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