Effect of Shugan Hewei Formula on Intestinal Flora in Treatment of Refractory Gastroesophageal Reflux Disease with Gan-Wei Disharmony:A Randomized Controlled Trial
Objective To evaluate the clinical efficacy and effect on intestinal flora of Shugan Hewei Formula(SGHWF)in the treatment of refractory gastroesophageal reflux disease(rGERD)with Gan-Wei disharmony syndrome.Methods Totally 80 rGERD patients with Gan-Wei disharmony were assigned to the treatment group and the control group by random number table,40 cases in each group.The treatment group was given SGHWF,and the control group was given Esomeprazole magnesium enteric-coated tablets combined with Mosapride citrate dispersible tablets for 8 consecutive weeks of treatment.The changes of Chinese medicine(CM)syndrome,Gastroesophageal Reflux Disease Questionnaire(GERD-Q)scores were observed in the two groups before treatment,and at 4 weeks and 8 weeks of treatment.The changes of intestinal bacterial flora OUT number,diversity,and its abundance were detected after 8 weeks of treatment by applying high throughput sequencing of 16S rDNA.Results Totally 80 cases were finally included in the statistical analysis,40 cases completed the trial in the treatment group and 40 cases in the control group.Compared with baseline,the CM syndrome,GERD-Q scale score were reduced in both groups after 4 weeks and 8 weeks of treatment(P＜0.05).Compared with the same period of the control group,the CM syndrome score of the treatment group decreased after 4 weeks of treatment(P＜0.05);the CM syndrome,GERD-Q scale score decreased after 8 weeks of treatment(P＜0.05),and the effective rate of the treatment group was higher than that of the control group(P＜0.05).After Alpha diversity analysis,Chao1,Ace and sobs indices were increased in the test group after 8 weeks of treatment(P＜0.05).Upon analysis of species composition and abundance of the flora,there was no significant difference between the two groups in intra-and inter-group comparisons at the phylum level(P＞0.05).At the genus level,the relative abundance of Subdoligranulum,norank_f__Oscillospiraceae,and Monoglobus increased after 8 weeks of treatment in the test group(P＜0.05),and the relative abundance of Ruminococcus_gnavus_group decreased(P＜0.05).Conclusion Compared with the optimized PPI combined with Mosapride regimen,SGHWF was more effective in relieving clinical symptomsof rGERD with Gan-Wei disharmony,and its mechanism might be related to the regulation of the diversity of the intestinal flora and the abundance of bacterial genera.
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