BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastroint...BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.展开更多
Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupun...Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupuncture group(32 cases).In the acupuncture group,Tiānshū(天枢ST25),Zhōngwǎn(中脘CV12),Zúsānlǐ(足三里ST36),Shàngjùxū(上巨虚ST37),Gōngsūn(公孙SP4),Fēnglóng(丰隆ST40),Zhāngmén(章门LR13)and Yīnlíngquán(阴陵泉SP9)were selected and stimulated with routine acupuncture technique,once every two days,3 times weekly,for 8 weeks consecutively,24 times in total.In the shamacupuncture group,the sham-acupoints were selected,0.5 cun or 1 cun superior,inferior,lateral or medial to the corresponding points separately.The blunt-tip needles were used to stimulate only the skin surface of each point.The treatment frequency and courses were the same as the acupuncture group.Before treatment,in 4 weeks of treatment,after treatment and in follow-up,the changes in the score of IBS symptom severity scale(IBS-SSS),Bristol stool form scale and defecation satisfaction were observed in the patients of two groups.After treatment,the effectiveness was assessed in the two groups.Results:In 4 weeks of treatment,after treatment and in follow-up,IBS-SSS score,Bristol stool form scale and defecation satisfaction were all lower than those before treatment in either group(all P<0.01).Bristol stool form scale in the acupuncture group was lower than that in the sham-acupuncture group in4 weeks of treatment,after treatment and in follow-up,while,IBS-SSS score and defecation satisfaction were lower than the sham-acupuncture group in follow-up(all P<0.05).Conclusion:Acupuncture can effectively relieve diarrhea and improves defecation satisfaction in the patients with IBS-D.展开更多
文摘BACKGROUND Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects;particularly,diarrhea-predominant symptoms.Irritable bowel syndrome(IBS)is a gastrointestinal disorder that affects up to 9% of people globally,with diarrhea predominant IBS(IBS-D)being the most prevalent subtype.Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D.AIM To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D.METHODS This is a pragmatic,real world,open label,single arm study comparing a 2-week baseline assessment to a 2-week intervention period.One hundred adults,aged 18 to 65 years,with IBS-D,according to Rome IV criteria,were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care.The primary outcome was an assessment of tolerability after 2-weeks of consumption,while secondary outcomes included changes in stool consistency(Bristol Stool Form Scale),severity of abdominal pain&discomfort,symptoms of urgency,Global Improvement Survey(GIS),and the IBS severity scoring system(IBS-SSS).RESULTS The test product was well-tolerated as each participant successfully completed the full 14-day trial,and there were no instances of dropouts or discontinuation of the study product reported.Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements(IBS-D stool consistency responders).Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores,and 55%experienced the same for mean weekly discomfort scores(IBS-D pain and discomfort responders).Participants experienced a mean-109.4(95% confidence interval:-130.1,-88.8)point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of>95 points.An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants.For functional symptoms,76% of participants reported symptom relief on the GIS.CONCLUSION The amino acid-based medical food was well-tolerated,when added to the standard of care,and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.
基金Supported by Evaluation of the clinical effect of acupuncture on diarrhea-type irritable bowel syndrome:2017S382。
文摘Objective:To verify the effectiveness of acupuncture for diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:Sixty-five patients with IBS-D were randomized into an acupuncture group(33 cases)and a sham-acupuncture group(32 cases).In the acupuncture group,Tiānshū(天枢ST25),Zhōngwǎn(中脘CV12),Zúsānlǐ(足三里ST36),Shàngjùxū(上巨虚ST37),Gōngsūn(公孙SP4),Fēnglóng(丰隆ST40),Zhāngmén(章门LR13)and Yīnlíngquán(阴陵泉SP9)were selected and stimulated with routine acupuncture technique,once every two days,3 times weekly,for 8 weeks consecutively,24 times in total.In the shamacupuncture group,the sham-acupoints were selected,0.5 cun or 1 cun superior,inferior,lateral or medial to the corresponding points separately.The blunt-tip needles were used to stimulate only the skin surface of each point.The treatment frequency and courses were the same as the acupuncture group.Before treatment,in 4 weeks of treatment,after treatment and in follow-up,the changes in the score of IBS symptom severity scale(IBS-SSS),Bristol stool form scale and defecation satisfaction were observed in the patients of two groups.After treatment,the effectiveness was assessed in the two groups.Results:In 4 weeks of treatment,after treatment and in follow-up,IBS-SSS score,Bristol stool form scale and defecation satisfaction were all lower than those before treatment in either group(all P<0.01).Bristol stool form scale in the acupuncture group was lower than that in the sham-acupuncture group in4 weeks of treatment,after treatment and in follow-up,while,IBS-SSS score and defecation satisfaction were lower than the sham-acupuncture group in follow-up(all P<0.05).Conclusion:Acupuncture can effectively relieve diarrhea and improves defecation satisfaction in the patients with IBS-D.