Background:Diarrhea-predominant irritable bowel syndrome(IBS-D)is a common functional gastrointestinal disease,that significantly impacts the quality of life and social interactions of patients,and also consumes a sig...Background:Diarrhea-predominant irritable bowel syndrome(IBS-D)is a common functional gastrointestinal disease,that significantly impacts the quality of life and social interactions of patients,and also consumes a significant amount of medical resources.Xi-Feng-Hua-Shi(XFHS)granule is an empirical formula developed by Professor Yao-Zhou Tian,a famous TCM doctor in Jiangsu Province.Clinical experience has shown that XFHS granules are effective at relieving the symptoms of IBS-D patients.Therefore,this study used 16S rDNA sequencing to determine the species and richness of microflora in order to explore the overall efficacy and changes in the intestinal microflora of IBS-D patients after treatment with XFHS granules,and to further understand the mechanism of drug action as a potential new therapeutic method for the clinical treatment of IBS-D.Methods:A total of 66 IBS-D patients who were treated at Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine from June 2021 to January 2022 were recruited and randomly divided into a reatment group and a control group.The treatment group was given XFHS granules and the control group was given placebo granules for 4 weeks.Traditional Chinese medicine(TCM)syndrome scores of patients before and after treatment were recorded,and fresh fecal samples of some patients before and after treatment were collected to analyze the changes of intestinal flora by 16S rDNA sequencing method.Results:The effective rate in the treatment group was 92.86%,which was significantly higher than the control group(P<0.05).The bacterial diversity of IBS-D patients did not change significantly after treatment with XFHS granules,but the species composition analysis showed that the abundance of Firmicutes,Proteobacteria and Cyanobacteria decreased,while the abundance of Bacteroidetes,Actinobacteria and Bifidobacteria increased.Conclusion:XFHS granules can effectively improve the clinical symptoms of IBS-D patients,and its therapeutic effect may be related to regulating the structure and abundance of intestinal flora.展开更多
Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages o...Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.展开更多
基金This work was supported by Social Development Project of Jiangsu Province(No.BE2022817).
文摘Background:Diarrhea-predominant irritable bowel syndrome(IBS-D)is a common functional gastrointestinal disease,that significantly impacts the quality of life and social interactions of patients,and also consumes a significant amount of medical resources.Xi-Feng-Hua-Shi(XFHS)granule is an empirical formula developed by Professor Yao-Zhou Tian,a famous TCM doctor in Jiangsu Province.Clinical experience has shown that XFHS granules are effective at relieving the symptoms of IBS-D patients.Therefore,this study used 16S rDNA sequencing to determine the species and richness of microflora in order to explore the overall efficacy and changes in the intestinal microflora of IBS-D patients after treatment with XFHS granules,and to further understand the mechanism of drug action as a potential new therapeutic method for the clinical treatment of IBS-D.Methods:A total of 66 IBS-D patients who were treated at Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine from June 2021 to January 2022 were recruited and randomly divided into a reatment group and a control group.The treatment group was given XFHS granules and the control group was given placebo granules for 4 weeks.Traditional Chinese medicine(TCM)syndrome scores of patients before and after treatment were recorded,and fresh fecal samples of some patients before and after treatment were collected to analyze the changes of intestinal flora by 16S rDNA sequencing method.Results:The effective rate in the treatment group was 92.86%,which was significantly higher than the control group(P<0.05).The bacterial diversity of IBS-D patients did not change significantly after treatment with XFHS granules,but the species composition analysis showed that the abundance of Firmicutes,Proteobacteria and Cyanobacteria decreased,while the abundance of Bacteroidetes,Actinobacteria and Bifidobacteria increased.Conclusion:XFHS granules can effectively improve the clinical symptoms of IBS-D patients,and its therapeutic effect may be related to regulating the structure and abundance of intestinal flora.
基金supported by National Administration of Traditional Chinese Medicine:2019 Project of building evidence based practice capacity for TCM(No.ZZ13-042-2,No.2019XZZX-XH007)the Jiangsu Administration of traditional Chinese Medicine(No.JD2019SZXZD04).
文摘Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.
