A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia

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.

Gastrointestinal symptoms and associated factors in Chinese patients with functional dyspepsia

AIM: To study the evolution of gastrointestinal symptoms and associated factors in Chinese patients with functional dyspepsia (FD).METHODS: From June 2008 to November 2009, a total of 1049 patients with FD (65.3% female, mean age 42.80 ± 11.64 years) who visited the departments of gastroenterology in Wuhan, Beijing, Shanghai, Guangzhou, and Xi’an, China were referred for this study. All of the patients fulfilled the Rome III criteria for FD. Baseline demographic data, dyspepsia symptoms, anxiety, depression, sleep disorder, and drug treatment were assessed using self-report questionnaires. Patients completed questionnaires at baseline and after 1, 3, 6 and 12 mo follow-up. Comparison of dyspepsia symptoms between baseline and after follow-up was explored using multivariate analysis of variance of repeated measuring. Multiple linear regression was done to examine factors associated with outcome, both longitudinally and horizontally.RESULTS: Nine hundred and forty-three patients (89.9% of the original population) completed all four follow-ups. The average duration of follow-up was 12.24 ± 0.59 mo. During 1-year follow-up, the mean dyspeptic symptom score (DSS) in FD patients showed a significant gradually reduced trend (P < 0.001), and similar differences were found for all individual symptoms (P < 0.001). Multiple linear regression analysis showed that sex (P < 0.001), anxiety (P = 0.018), sleep disorder at 1-year follow-up (P = 0.019), weight loss (P < 0.001), consulting a physician (P < 0.001), and prokinetic use during 1-year follow-up (P = 0.035) were horizontally associated with DSS at 1-year follow-up. No relationship was found longitudinally between DSS at 1-year follow-up and patient characteristics at baseline.CONCLUSION: Female sex, anxiety, and sleep disorder, weight loss, consulting a physician and prokinetic use during 1-year follow-up were associated with outcome of FD.

Secretion of melatonin and 6-sulfatoxymelatonin urinary excretion in functional dyspepsia

To evaluate blood concentration of melatonin and urinary excretion of its metabolite, 6-sulfatoxymelatonin （6-OHMS）, in functional dyspepsia （FD）. METHODS： Ninety individuals were enrolled in the study： 30 in each study group： patients with postprandial distress syndrome （PDS）, epigastric pain syndrome （EPS）, and controls. Blood samples were drawn at 02：00 and 09：00 h and 24-h urine collection was performed. Serum melatonin and urinary 6-OHMS concentrations were measured by enzyme-linked immunosorbent assay. RESULTS： Serum melatonin concentration at night and in the morning was significantly （P 〈 0.001） higher inPDS patients [at 02：00 h-93.3 pg/mL, quartile range （QR）： 79.8-116.2; at 09.00 h-14.3 pg/mL, QR： 7.06-19.0] than in EPS （57.2 pg/mL, QR： 42.6-73.1, 8.1 pg/mL, QR： 4.2-9.3） and control patients （57.7 pg/mL, QR： 51.2-62.5; 8.1 pg/mL, QR： 5.4-10.3）. A similar relationship was observed for urinary 6-OHMS excretion. Patients with severe PDS symptoms had a higher melatonin concentration than these with moderate syndromes, whereas patients with severe EPS had a lower urinary 6-OHMS excretion than patients with moderate symptoms.CONCLUSION： Evaluation of melatonin serum concentrations and 24-h urinary 6-OHMS excretion are useful methods for differential diagnosis of various clinical forms of FD.

Anhedonia and functional dyspepsia in obese patients:Relationship with binge eating behaviour

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.