Background： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and ...Background： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome （PDS）-predominant FD. Methods： The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by 〈50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared. Results： （1） The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group （38.82% vs. 8.75%, P 〈 0.001; 69.14% vs. 16.25%, P 〈 0.001＇ 77.65% vs. 21.25%, P 〈 0.001 ）. （2） The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. （3） The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. （4） The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. （5） Qi-Zhi-Wei-Tong granules did not have more adverse eflbcts than the placebo. Conclusion： Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo. Trial Registration： https：//clinicaltrials.gov/, NCT02460601.展开更多
BACKGROUND Obese patients(Ob)with a binge eating disorders(BED)behavior pattern have a higher prevalence of postprandial distress syndrome(PDS)compared to Ob without a BED behavior pattern,while an increase of PDS has...BACKGROUND Obese patients(Ob)with a binge eating disorders(BED)behavior pattern have a higher prevalence of postprandial distress syndrome(PDS)compared to Ob without a BED behavior pattern,while an increase of PDS has been described in Ob after sleeve gastrectomy(SG).Hedonic response to a meal is dissociable from satiation in healthy subjects.Anhedonia is the lowered ability to experience pleasure.There are no studies investigating the presence of anhedonia in Ob with and without SG and its relationship to PDS symptoms.AIM To assess the relationship among anhedonia,BED and upper gastrointestinal symptoms in two group of morbidly Ob with and without SG.METHODS Eighty-one Ob without SG,45 Ob with SG and 55 healthy controls(HC)were studied.All subjects fulfilled the binge eating scale(BES)to investigate BED,the validated 14 items Snaith-Hamilton pleasure scale(SHAPS)to assess Anhedonia as well as the Beck Depression Inventory-II(BDI II)and State Trait Anxiety Inventory(STAI)questionnaires to screen for depression and anxiety.All patients underwent a standardized questionnaire investigating the intensity-frequency scores(0-6)of upper gastrointestinal symptoms and were diagnosed for the presence of functional dyspepsia(FD)and its subtypes according to ROME IV criteria.RESULTS Ob without SG who were positive for BED had a 4.7 higher risk of FD compared to Ob without SG who were negative for BED(OR:4.7;95.0%CI 1.23-18.24;P=0.02).STAI-Y2 scores were significantly higher in Ob without SG positive for BED(42.2±1.5 vs Ob negative for BED:39.6±1.0,P=0.04),while SHAPS scores and BDI II did not differ in the two groups(1.16±1.30 vs 0.89±1.02,P=0.49).A lower prevalence of BED(BES>17:11.4%vs 40.7%,P=0.001)and BDI-II(6.8±1.2 vs 13.8±1.9,P=0.005)was reported in Ob with SG than Ob without SG,on the contrary total mean scores of STAI-Y1 and STAI-Y2 were significantly higher in Ob with SG than Ob without SG.Thirty-five percent of Ob with SG fulfilled the diagnosis of FD.SHAPS mean scores and the prevalence of anhedonia did not differ among the two groups(18.2 vs 8.1%,P=0.2).Fifty-four percent of Ob with SG achieved surgical success excess weight loss>50%.Excess weight loss was negatively related to SHAPS total mean scores[adjusted B:-7.099(95%CI:-13.91 to-0.29),P=0.04].CONCLUSION Ob without SG showed a higher prevalence of PDS,mood disorders and anxiety when positive for BE behavior compared to those negative for BE behavior,whereas no differences were found in SHAPS score.Ob with SG showed a higher prevalence of PDS compared to Ob without SG.Concerning psychological aspect,BED and depression are less frequent in the Ob with SG,while both state and trait anxiety are significantly higher.Moreover,the more an Ob with SG is anhedonic,less surgical success was achieved.展开更多
文摘Background： Functional dyspepsia （FD） is a common tipper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome （PDS）-predominant FD. Methods： The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by 〈50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared. Results： （1） The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group （38.82% vs. 8.75%, P 〈 0.001; 69.14% vs. 16.25%, P 〈 0.001＇ 77.65% vs. 21.25%, P 〈 0.001 ）. （2） The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. （3） The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. （4） The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. （5） Qi-Zhi-Wei-Tong granules did not have more adverse eflbcts than the placebo. Conclusion： Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo. Trial Registration： https：//clinicaltrials.gov/, NCT02460601.
文摘BACKGROUND Obese patients(Ob)with a binge eating disorders(BED)behavior pattern have a higher prevalence of postprandial distress syndrome(PDS)compared to Ob without a BED behavior pattern,while an increase of PDS has been described in Ob after sleeve gastrectomy(SG).Hedonic response to a meal is dissociable from satiation in healthy subjects.Anhedonia is the lowered ability to experience pleasure.There are no studies investigating the presence of anhedonia in Ob with and without SG and its relationship to PDS symptoms.AIM To assess the relationship among anhedonia,BED and upper gastrointestinal symptoms in two group of morbidly Ob with and without SG.METHODS Eighty-one Ob without SG,45 Ob with SG and 55 healthy controls(HC)were studied.All subjects fulfilled the binge eating scale(BES)to investigate BED,the validated 14 items Snaith-Hamilton pleasure scale(SHAPS)to assess Anhedonia as well as the Beck Depression Inventory-II(BDI II)and State Trait Anxiety Inventory(STAI)questionnaires to screen for depression and anxiety.All patients underwent a standardized questionnaire investigating the intensity-frequency scores(0-6)of upper gastrointestinal symptoms and were diagnosed for the presence of functional dyspepsia(FD)and its subtypes according to ROME IV criteria.RESULTS Ob without SG who were positive for BED had a 4.7 higher risk of FD compared to Ob without SG who were negative for BED(OR:4.7;95.0%CI 1.23-18.24;P=0.02).STAI-Y2 scores were significantly higher in Ob without SG positive for BED(42.2±1.5 vs Ob negative for BED:39.6±1.0,P=0.04),while SHAPS scores and BDI II did not differ in the two groups(1.16±1.30 vs 0.89±1.02,P=0.49).A lower prevalence of BED(BES>17:11.4%vs 40.7%,P=0.001)and BDI-II(6.8±1.2 vs 13.8±1.9,P=0.005)was reported in Ob with SG than Ob without SG,on the contrary total mean scores of STAI-Y1 and STAI-Y2 were significantly higher in Ob with SG than Ob without SG.Thirty-five percent of Ob with SG fulfilled the diagnosis of FD.SHAPS mean scores and the prevalence of anhedonia did not differ among the two groups(18.2 vs 8.1%,P=0.2).Fifty-four percent of Ob with SG achieved surgical success excess weight loss>50%.Excess weight loss was negatively related to SHAPS total mean scores[adjusted B:-7.099(95%CI:-13.91 to-0.29),P=0.04].CONCLUSION Ob without SG showed a higher prevalence of PDS,mood disorders and anxiety when positive for BE behavior compared to those negative for BE behavior,whereas no differences were found in SHAPS score.Ob with SG showed a higher prevalence of PDS compared to Ob without SG.Concerning psychological aspect,BED and depression are less frequent in the Ob with SG,while both state and trait anxiety are significantly higher.Moreover,the more an Ob with SG is anhedonic,less surgical success was achieved.
