Gastrointestinal Symptom Rating Scale Research Articles

Effect of Prolong-life-with-nine-turn-method (Yan Nian Jiu Zhuan) Qigong on fatigue and gastrointestinal function in patients with chronic fatigue syndrome: Study protocol for a randomized controlled trial.

Chronic fatigue syndrome (CFS) is a physical and mental disorder in which long-term fatigue is the main symptom. CFS patients are often accompanied by functional gastrointestinal diseases (FGIDs), which lead to decreased quality of life and increased fatigue. Prolong-life-with-nine-turn-method (PLWNT) is a kind of physical and mental exercise. Its operation includes adjusting the mind, breathing and cooperating with eight self-rubbing methods and one upper body rocking method. PLWNT was used to improve the digestive function in ancient China and to treat FGIDs such as functional dyspepsia and irritable bowel syndrome in modern times. Previous studies have shown that PLWNT can reduce fatigue in patients with CFS. But it is unclear whether the effect of PLWNT on CFS fatigue is related to gastrointestinal function. The aim of this study was to explore the relationship between PLWNT and fatigue and gastrointestinal function in patients with CFS. This study is a non-inferiority randomized controlled trial (RCT). The whole study period is 38 weeks, including 2 weeks of baseline evaluation, 12 weeks of intervention and 6 months of follow-up. Ninety-six CFS patients will be stratified random assigned to the intervention group (PLWNT) and the control group (cognitive behavior treatment) in the ratio of 1:1 through the random number table generated by SPSS. In the evaluation of results, Multidimensional Fatigue Inventory-20 (MFI-20), Gastrointestinal Symptom Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), and Short Form 36 item health survey (SF-36) will be evaluated at week 0 (baseline), week 6 (midterm), week 12 (endpoint) and month 9 (follow up). The intestinal flora will be evaluated at week 0 (baseline) and week 12 (endpoint). The data results will be processed by statistical experts. The data analysis will be based on the intention to treat principle and per-protocol analysis. In the efficacy evaluation, repeated measurement analysis of variance will be used for data conforming to normal distribution or approximate normal distribution. The data which do not conform to the analysis of repeated measurement variance will be analyzed by the generalized estimation equation Linear discriminant analysis will be used to clarify the difference species of intestinal flora. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. This trial will provide evidence to PLWNT exerting positive effects on fatigue and gastrointestinal function of CFS. It will further explore whether the improvement of PLWNT on CFS fatigue is related to gastrointestinal function. The trial was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/showproj.aspx?proj=151456 (Registration No.: ChiCTR2200056530). Date: 2022-02-07.

ВЛИЯНИЕ ЭЛЕКТРОННЫХ СИГАРЕТ НА КИСЛОТООБРАЗУЮЩУЮ И МОТОРНУЮ ФУНКЦИИ ЖЕЛУДКА

Abstract. Introduction. Currently, the use of electronic cigarettes is becoming the most popular with and widespread among young people. In Russia, one third of electronic cigarettes consumers are people aged 18 to 29 years. The impact of vaping on various body organs and systems is still understudied now. The aim of our study is to investigate the acid-forming and motor functions of the stomach in people consuming electronic cigarettes. Materials and methods. The study involved 54 people, of which 27 were consumers of electronic cigarettes, all without any diagnosed organic diseases in their digestive systems. The severity of gastroenterological symptoms was assessed using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, while motor and acid-forming functions of the stomach were assessed according to pH-impedance measurements. The findings were processed statistically using nonparametric tests with the Microsoft Office Excel 2013 and Statistica 10.0 computer programs. Results and discussions. Vaping participants had significantly more gastrointestinal symptoms according to the Gastrointestinal Symptom Rating Scale as compared to their non-smoking peers. In the group of subjects consuming electronic cigarettes, there was a greater number of pathological gastroesophageal refluxes and increased acidity in the lower esophagus and stomach as compared to the control group. Conclusions. Our findings indicate the adverse effects provided by electronic cigarettes on the functional activity of the upper gastrointestinal tract.

A Case Report of Abdominal Pain with Acute Kidney Injury and Elevated Pancreatic Enzymes

Objectives: The aim of this study is to report the effectiveness and safety of herbal medicine treatment for abdominal pain with acute kidney injury.Methods: A 80-year-old female patient presented with abdominal pain. Blood test results showed increased blood urea nitrogen, serum creatinine, amylase, and lipase. The patient was treated with acupuncture and herbal medicine, specifically <i>Hyangsayukgunja-tang-gahwangryeon</i> for 4 days and <i>Gagam-gunbi-tang</i> for 11 days. Gastrointestinal symptoms were assessed using the Numerical Rating Scale, Gastrointestinal Symptom Rating Scale, and abdominal examination.Results: Gastrointestinal symptoms improved after taking Korean herbal medicine. Additionally, blood urea nitrogen, serum creatinine, amylase, and lipase levels showed improvement compared to values before treatment.Conclusions: Korean medicine treatment can improve clinical symptoms without damaging the kidneys of patients with acute kidney injuries.

Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery

Antireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed. To assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD. A double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population. Closure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft). The primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, χ2, or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs. Of 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01). Findings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD. ClinicalTrials.gov Identifier: NCT05069493.

Chronic Hyperkalaemia with Patiromer in Haemodialysis: A Single-Center, Prospective Observational Study in the Clinical Practice

Introduction: Chronic Kidney Disease (CKD) patients on Hemodialysis (HD) experience increased risk of hyperkalemia, a serious potential fatal electrolyte disorder. Although novel effective strategies for managing hyperkalaemia are available, experience in routine clinical practice is still insufficient. Here we report chronic hyperkalemia prevalence and analyze the effects of different treatments on potassium management, adherence ratio and gastrointestinal symptoms in HD population. Methods: 12-week, prospective, single-center study in HD patients with chronic hyperkalaemia (>5.5 mmol/l). Three study phases were established: Phase 1, Dietary Advice (DA); Phase 2, Calcium Polystyrene Sulfonate Resins (CPSRs); and Phase 3, patiromer. Sociodemographic and biochemical data, treatment adherence and compliance (Simplified Medication Adherence Questionnaire), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale, GSRS), HD characteristics and usual medical treatment were analyzed in each phase. Results: Serum potassium values decreased significantly (p<0.05) only in phase 3 (–0.75 mmol/l), with a higher patient percentage reaching optimal K range. Compared with CPSRs, patiromer yielded significantly better overall GSRS scores: abdominal pain (3.7 versus 2.5), constipation (7.1 versus 5.3), indigestion (6.2 versus 5.6); and better treatment compliance. No significant changes were found in other biochemical data, HD characteristics or usual medication over the course of the study. Conclusions: Chronic hyperkalemia is a highly prevalent disorder on our HD unit. Compared to DA and traditional potassium binders; patiromer was effective in managing chronic hyperkalemia, improving gastrointestinal symptoms and treatment adherence with no associated severe adverse effects. Therefore, patiromer can be considered a first-line treatment for chronic hyperkalemia in patients with HD.

Mediterranean diet is associated with better gastrointestinal health and quality of life, and less nutrient deficiency in children/adolescents with disabilities.

Children and adolescents with disabilities face various nutritional problems. This study aimed to examine dietary characteristics, nutritional status and problems, gastrointestinal health, and quality of life in children and adolescents with disabilities. This study included 5-18 years old children and adolescents (n = 1,991) with disabilities. We used the Mediterranean Diet Quality Index (KIDMED), the Gastrointestinal Symptom Rating Scale (GSRS), and the Pediatric Quality of Life Inventory (PedsQL) to assess diet characteristics, gastrointestinal problems, and life quality. We collected retrospective 24-h food record to assess energy and nutrient intakes. The rate of stunting in children with disabilities varies between 16.5% and 19.8%. When comparing disability types, more children with physical disabilities were underweight (8.8% vs. 6.7%) and stunted (19.8% vs. 16.5%), while more children with intellectual disabilities were tall (7.9% vs. 5.5%) and overweight/obese (21.1 vs. 17.2%; p < 0.05). Wasting (9.3%) and overweight/obesity (23.8%) were more common in children with disabilities aged 5-7 years (p < 0.001). Eating problems such as loss of appetite, food refusal, food neophobia, and food selectivity were more common in children aged 5-7 years, and problems with fast eating and overeating were more common in adolescents aged 13-18 years (p < 0.05). Among children and adolescents with disabilities, the nutrients with inadequate intakes were vitamin E, vitamin B1, folate, potassium, calcium, and iron, while the nutrients with intakes above the requirements were proteins, carbohydrates, vitamins A, B2, B6, B12, and C, phosphorus, zinc, and sodium. Participants with good Mediterranean diet quality had higher energy and nutrient intakes and higher percentages of meeting nutrient requirements (p < 0.05). KIDMED scores were negatively correlated with GSRS total (r = -0.14, p < 0.001) and subcomponent scores (abdominal pain, diarrhea, reflux, indigestion, and constipation; p < 0.05), and significantly and positively correlated with PedsQL total (r = 0.12, p < 0.001). A one-unit increase in the GSRS score resulted in a 14.4 times decrease in the PedsQL score, and a one-unit increase in the KIDMED score resulted in a 10.8 times increase in the PedsQL score (p = 0.001). Overweight/obesity, stunting/wasting, nutritional problems, and deficiencies are common among disabled children and adolescents. Mediterranean diet is associated with a better quality of life, and gastrointestinal health in children with disabilities.

Efficacy and safety of Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 as an adjuvant for Helicobacter pylori eradication: a double-blind, randomized, placebo-controlled study

BackgroundHelicobacter pylori eradication is recommended as a way of providing symptomatic relief for dyspepsia. The limited efficacy of triple therapy is a major problem in many countries, including Thailand. Some probiotics have been shown to improve the H. pylori eradication rate and reduce side effects. This study aimed at evaluating the efficacy of probiotic (Lacidofil® STRONG) as adjuvant to standard triple therapy.MethodsThis randomized, double-blind, placebo-controlled study was conducted between July 2020 and June 2022. Eligible patients with H. pylori gastritis (i.e., n=90 out of the 160 patients screened) were randomized to receive 14-day standard triple therapy either with probiotics or with a placebo (N=45/group). The treatment regimen entailed 30 mg lansoprazole administered twice daily, 1,000 mg amoxicillin administered twice daily, and 1 g clarithromycin modified-release formulation administered once daily. A probiotic capsule containing Lacticaseibacillus rhamnosus R0011 and Lactobacillus helveticus R0052 (Lacidofil® STRONG) or placebo were given twice daily during the eradication therapy and for an additional 4 weeks. Successful H. pylori eradication was defined as a negative 13C-urea breath test at least 4 weeks after complete eradication.ResultsAs per-protocol analysis, eradication rates after the 14-day regimen with probiotic or placebo were 90.9% and 75.0% (p=0.047), respectively. Antibiotic susceptibility testing demonstrated high clarithromycin resistance (24%). For clarithromycin-resistant strains, there was no statistical difference in eradication rates between the probiotic and placebo groups. Furthermore, probiotic supplementation significantly reduced treatment side effects, including bloating (OR 0.27 [95% CI 0.10 to 0.75], p=0.012), diarrhea (OR 0.23 [95% CI 0.28 to 0.65], p=0.006), nausea (OR 0.05 [95% CI 0.01 to 0.36], p=0.003), and bitter taste (OR 0.14 [95% CI 0.03 to 0.69], p=0.015). In addition, the probiotic group had lower gastrointestinal symptom rating scale (GSRS) scores (1.46 ± 0.36 vs. 2.65 ± 0.66, p&amp;lt;0.001) and higher SF-36 health-related quality-of-life scores (63.3 ± 10.2 vs. 57.3 ± 13.4, p=0.020) after treatment than the placebo group.ConclusionThe probiotic adjuvant with 14-day standard triple therapy improved the H. pylori eradication rate. Supplementation with Lacidofil® STRONG during the 2-week eradication treatment and 4-week follow-up phase can help to reduce the gastrointestinal side effects of eradication therapy and increase patients’ general health-related quality of life.

454. GASTROINTESTINAL QUALITY OF LIFE, BODY COMPOSITION AND INFLUENCING FACTORS, IN ESOPHAGEAL CANCER SURVIVORS FOLLOWING CURATIVE ESOPHAGECTOMY

Abstract Background Recent improvements in treatment modalities for locally advanced esophageal cancer have resulted in markedly improved survival outcomes. This has resulted in an increasing population of esophageal cancer survivors. Surgery is the mainstay of treatment, which has a high risk of post-operative morbidity. This study focused on characterising health-related quality of life with a specific interest in the gastrointestinal quality of life of esophageal cancer survivors following curative esophagectomy. Methods This was a cross-sectional cohort study of patients who underwent oesophageal cancer surgery between 2010 and 2015. A multicomponent questionnaire was distributed to disease-free patients at least one year post completion of treatment. Body composition was assessed using surveillance computed tomography scans. Linear and logistic regression analyses were utilised to determine the impact of treatment and pathologic variables on survivorship issues. Results Gastrointestinal symptoms were common, with persistent eating symptoms independently predictive of overall poor HR-QL on multivariable analysis (P = 0.026, odds ratio [OR] 1.05 [95% confidence interval [95% CI] 1.01–1.10]). Persistent eating symptoms were independently associated with impaired physical and role function (both P &amp;lt; 0.001). Cervical anastomosis was associated with increased risk of dumping syndrome (P = 0.013, OR 0.34 [95% CI 0.14–0.80]), while squamous histology was independently associated with increased Gastrointestinal Symptom Rating Scale (P = 0.027) and Sigstad dumping syndrome scores (P = 0.034). Conclusion Persistent gastrointestinal and nutritional issues are common after esophagectomy. These eating symptoms are associated with impaired health-related quality of life. Further research is warranted to investigate how patient pathways can be enhanced to minimise the long-term impact of curative treatment for patients with esophageal cancer.

Protocol for the safety and efficacy of fecal microbiota transplantation liquid in children with autism spectrum disorder: a randomized controlled study.

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interaction, repetitive behavior and language impairment, and its worldwide prevalence has been found to be increasing annually in recent years. Till now, ASD is uncurable as its pathogenesis remains unknown. However, studies on both animals and humans have demonstrated that fecal microbiota transplantation (FMT) may ameliorate the symptoms of ASD, as well as gastrointestinal symptoms. Nonetheless, there is still no agreement regarding the optimal dosage or duration of FMT treatment for individuals with ASD. This clinical study is a double-blind, randomized, interventional trial conducted at a single center. The aim is to investigate the safety and efficacy of a pediatric formulation of FMT for ASD. A total of 42 children between the ages of 3-9 with ASD will be randomly assigned in a 2:1 ratio to either an FMT treatment group (n = 28) or a placebo group (n = 14), forming cohort 1. Additionally, 30 healthy children of similar age and gender will be recruited as the control group (cohort 2). Cohort 1 will be assessed using a variety of scales, including the Autism Behavior Checklist, Childhood Autism Rating Scale, Social Responsiveness Scale, Gastrointestinal Symptom Rating Scale, Children's Sleep Habits Questionnaire, and Psychoeducational Profile (Third Edition). These assessments will evaluate the effectiveness of FMT in reducing core symptoms and comorbidities (such as gastrointestinal symptoms and sleep disturbances) in children with ASD. The study will use metagenomic and metabolomic sequencing to assess changes in the composition and structure of the intestinal flora and its metabolites in blood, urine, and feces following treatment. Furthermore, the study will evaluate the acceptability of the FMT formulation by participants' legal guardians and investigate differences in the intestinal flora and metabolism in the FMT group before and after treatment compared to 30 healthy children. https://www.chictr.org.cn/, identifier ChiCTR2200058459.

Washed microbiota transplantation targeting both gastrointestinal and extraintestinal symptoms in patients with irritable bowel syndrome

ObjectiveFecal microbiota transplantation (FMT) has been reported with the treatment potential for irritable bowel syndrome (IBS). However, the knowledge of its effect on extraintestinal symptoms of IBS is limited. This study aimed to evaluate the efficacy of the improved methodology of FMT, washed microbiota transplantation (WMT), on sleep disturbances, and psychological and gastrointestinal symptoms among patients with IBS. MethodsThis was a prospective observational study involving patients with IBS who underwent WMT. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The Gastrointestinal Symptom Rating Scale (GSRS) and IBS Severity Scoring System (IBS-SSS) were used to evaluate gastrointestinal symptoms and IBS severity, respectively. The Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS) were used to evaluate depression and anxiety, respectively. All the symptoms were evaluated at baseline and one month after WMT. A multiple logistic regression model was used to determine the predictive factors of sleep improvement one month after WMT. ResultsSeventy-three patients with IBS were included in the study. Sleep quality (Z = −4.211, P < 0.001), anxiety (Z = −4.775, P < 0.001), depression (Z = −4.610, P < 0.001), gastrointestinal symptoms (Z = −5.364, P < 0.001), and IBS severity (Z = −6.468, P < 0.001) significantly improved one month after WMT in all patients. The scores of the five components of PSQI including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances decreased in 52 patients with poor sleep quality (all P < 0.05). Baseline sleep duration scores were identified as an independent predictive factor of sleep improvement one month after WMT in patients with poor sleep quality (OR 2.180 [95% CI = 1.017–4.673]; P = 0.045). Patients that experienced sleep improvement demonstrated greater alleviation in depression (Z = −1.990, P = 0.047) and IBS severity (Z = −2.486, P = 0.013) compared with patients without sleep improvement. ConclusionThis study suggested that WMT might be a promising therapy for patients with IBS, especially those with comorbid sleep and psychological disorders.

A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves constipation and improves bowel function: A proof-of-concept clinical investigation

Ethnopharmacological relevanceWithania somnifera (L.) Dunal (WS) and Abelmoschus esculentus (L.) Moench (AE) are known as Ashwagandha and Okra, respectively, important herbs in traditional medicine for their diverse therapeutic values. WS root is an adaptogen that relieves stress and anxiety and promotes sleep. AE fruit or Okra is widely consumed as a vegetable and is traditionally used to treat diabetes, gastric irritations, ulcers, and obesity. Aim of the studyThe present randomized, double-blind, placebo-controlled study aimed to establish a proof-of-concept evaluating the efficacy and tolerability of a proprietary blend of standardized extracts of WS root and AE fruit, CL18100F4 in relieving constipation and improving quality of life in adults. Materials and methodsForty-eight male and female participants (age: 25–60 years) with functional constipation (following Rome-III criteria) were randomized into placebo, 300 or 500 mg of CL18100F4 groups, and supplemented for fourteen consecutive days. ResultsCL18100F4 supplementation significantly (p < 0.0001) reduced the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), and Gastrointestinal Symptom Rating Scale (GSRS) scores. CL18100F4 supplementation improved sleep quality and reduced stress (p < 0.0001). At the end of the study, CL18100F4-500 subjects showed significant increases in serum serotonin, gastrin, and interleukin-10 and decrease in interleukin-6 and cortisol levels. Participants’ hematology, total blood chemistry, vital signs, and urinalysis parameters were within the normal ranges. No adverse events were reported. ConclusionsThis short-duration, single-site clinical investigation demonstrates that CL18100F4 supplementation is tolerable, helps relieve constipation, reduces stress, and improves gastrointestinal function, sleep quality, and general wellness in adults. Trial registrationClinical Trials Registry- India (CTRI/2020/11/029320); Registered on 24/11/2020. Available at: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49391&EncHid=&userName=CL18100F4.

Evaluating the efficacy and safety of acotiamide in patients with esophagogastric junction outflow obstruction: study protocol for an investigator-initiated, multi-center, randomized, double-blind, placebo-controlled phase II trial

BackgroundWe have determined that the impaired accommodation of the lower esophageal sphincter (LES) underlies the pathogenesis of esophagogastric junction outflow obstruction (EGJOO). We have also found that acotiamide may treat EGJOO by improving impaired LES accommodation. The effects of acotiamide in patients with EGJOO need to be further confirmed in a prospective study.MethodsThis trial is a multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of acotiamide (300 mg/day or 600 mg/day) with those of a placebo in the treatment of patients with EGJOO. The primary endpoint will be the proportion of patients who report an improvement in symptom of food sticking in the chest after 4 weeks of treatment period 1. The secondary endpoints will be the proportion of patients with normalized integrated relaxation pressure (IRP), the value of change from baseline in the distal contractile integral, basal LES pressure, EGJOO–quality of life score, Gastrointestinal Symptom Rating Scale, and the correlation between IRP and each symptom score. During the 2-year trial period, 42 patients from five institutions will be enrolled.DiscussionThis trial will provide evidence to clarify the efficacy and safety of acotiamide as a treatment for patients with EGJOO. Acotiamide might help improve the quality of life of patients with EGJOO and is expected to prevent the progression of EGJOO to achalasia.Trial registrationThis study was approved by the Institutional Review Board (IRB) of Kyushu University Hospital as well as the local IRBs of the participating sites for clinical trials and registered in the Japan Registry of Clinical Trials (jRCT: 2071210072). The registration date is on October 11, 2021.

Efficacy of inclusion of vitamin U and provitamin B5 combination in the complex therapy of primary osteoarthritis against the background of gastrogenic exocrine pancreatic insufficiency

Clinical comorbidities at osteoarthritis (OA) complicate its treatment. The number and nature of various comorbid conditions determine the severity of the condition in patients with multimorbidity. However, apart from the common risk factors such as aging and obesity, little is known about the biological plausibility of explaining the co‑occurrence of OA and comorbidities. According to the European Alliance of Associations for Rheumatology, EULAR, and the National Institute of Health and Nursing, the diagnosis and treatment of specific comorbidities, as well as understanding their nature in OA, are important for choosing the best treatment tactics.&#x0D; Objective — to investigate efficacy of inclusion of vitamin U and provitamin B5 combination in the complex therapy of patients with primary OA in comorbidity with gastrogenic exocrine pancreatic insufficiency (EPI) for the correction of clinical syndromes.&#x0D; Materials and methods. Examinations involved 61 patients with primary OA in comorbidity with gastrointestinal diseases, accompanied by EPI of gastrogenic genesis without exacerbation. The comparison group consisted of 30 practically healthy people. All patients were divided into two comparable groups: group 1 (n=30) received a course of basic therapy drugs, namely: nonsteroidal anti‑inflammatory drugs, chondroprotectors and/or chondrostimulators, antispasmodics, prokinetics, proton pump inhibitors, enzyme agents (pancreatin); group 2 (n=31), in addition to the course of basic therapy, received a course of the vitamin drug combination of vitamin U and provitamin B5, 2 tablets once a day for 6 weeks. The calculation of the WOMAC index (Western Ontario and McMaster University) was used to assess the articular status of patients with primary OA, as well as the effectiveness of the treatment measures. Gastrointestinal Symptom Rating Scale (GSRS) questionnaire was used to assess gastrointestinal symptoms.&#x0D; Results. The proposed complex treatment of patients with primary OA with gastrogenic EPI with the additional inclusion of a vitamin preparation combination of vitamin U and provitamin B5 contributed to more significant regression of WOMAC indices compared to that during protocol treatment (the total WOMAC index decreased by 16.03% against 9.10%, respectively) and indicators of the scales of the GSRS questionnaire in comparison with the subgroup that received treatment according to the protocol (in total — by 35.96% vs. 22.19%, p &lt;0.05),&#x0D; Conclusions. The study results showed the advisability of using a vitamin medication, a combination of vitamin U and provitamin B5. in the treatment of patients with primary OA with gastrogenic EPI.

#4287 GASTROINTESTINAL SYMPTOMS IN PATIENTS RECEIVING HEMODIALYSIS: PREVALENCE, SEVERITY AND ASSOCIATED FACTORS

Abstract Background and Aims Gastrointestinal (GI) symptoms are common among patients with chronic renal failure, especially in those treated with maintenance hemodialysis (HD), and may adversely affect patients'' quality of life. A variety of GI symptoms has been reported, but previous studies present conflicting results regarding their association with age, sex, comorbidities, concomitant medications and dialysis modality. This study aimed to assess the prevalence and severity of GI symptoms in the maintenance HD population and explore possible associated factors. Method A total of 188 stable patients (55.3% male, 53.7% ≥65 years of age, age range 24–85, 30.9% with diabetes, 19.9% smokers) from three HD centres were enrolled in this observational cross-sectional study. Gastrointestinal symptoms were assessed by the self-administered Gastrointestinal Symptoms Rating Scale (GSRS). The scale includes 15 items graded by a 7-point Likert scale that can be grouped into five dimensions: abdominal pain syndrome, reflux syndrome, indigestion syndrome, diarrhoea syndrome, and constipation syndrome. A dimension score is calculated as the mean value of the items belonging to the specific syndrome, and the final score is the mean of dimension scores. Standard blood analyses, Kt/V, body mass index (BMI) and malnutrition-inflammation score (MIS) were determined in all patients. Other relevant demographic and clinical data were obtained from the patient's medical records. The results were analyzed with SPSS software, version 22 (IBM Corporation, New York, USA). Results The average BMI was 25.04±4.29. Half of the patients (50.3%) were overweight, 45.3% had normal weight, and 4.3% were underweight. The average MIS was 5.64±2.87. The average number of symptoms per patient was 4.01±3.20 (range 0 – 15). At least one GI symptom was reported by 84.6% of patients (33.0% reported 1 – 3 symptoms, and 49.5% reported 4 or more symptoms). The mean GSRS scores for eating dysfunctions were 1.59±1.08 for reflux, 1.74±0.98 for abdominal pain, 1.75±1.14 for constipation, 1.94±1.01 for indigestion, and 1.38±0.90 for diarrhoea. Total GSRS was 1.70±0.61. Elderly patients had a significantly lower overall number of GI symptoms (3.49±2.83 vs 4.57±3.51; p = 0.023), lower abdominal pain score (1.60±0.96 vs 1.91±1.09; p = 0.031), and indigestion score (1.74±0.85 vs 2.18±1.15; p = 0.005), but higher constipation (1.94±1.27 vs 1.54±0.96;p = 0.017) score than individuals under 65 years of age. Patients smoking cigarettes and those longer on HD had a significantly higher overall number of GI symptoms (3.44±0.56 vs 3.10±0.25; p = 0.035 and 3.78±2.99 vs 2.46±2.23; p = 0.016 respectively). Average abdominal pain score was significantly higher in non-diabetic (1.87±1.04 vs 1.44±0.75; p = 0.002) and underweight (2.62±1.51 vs 1.71±0.94 vs 1.65±0.90; p = 0.023) compared to diabetic, normal weight and overweight patients respectively. Patients taking ASA or NSAIDs had significantly higher total GSRS scores (1.84±0.72 vs 1.60±0.50; p = 0.016 and 1.88±0.64 vs 1.65±0.59; p = 0.044 respectively). Sex, dialysis adequacy and malnutrition-inflammation status were not significantly related to any of the GSRS dimensions. Conclusion The present study demonstrates a high prevalence of GI symptoms in maintenance HD patients and identifies age, cigarette smoking, diabetes, dialysis vintage, and certain medications as important elements to consider when addressing specific groups of GI symptoms in this population.

#5951 INFLUENCE OF DIETARY INTAKE ON GASTROINTESTINAL SYMPTOMS AND INFLAMMATION MARKERS IN PERITONEAL DIALYSIS PATIENTS IN SLOVENIA

Abstract Background and Aims Gastrointestinal symptoms are prevalent in patients with end-stage renal disease. Gastrointestinal symptoms in such patients are related to gastric hypomotility, increased medication intake, uremia, and changes in diet. In addition GI symptoms and problems associated with bowel dysfunction are a common cause of technique failure and poor dialysis efficacy. The reason for presence of some gastrointestinal symptoms is also chronic inflammatory state. Inflammation can have many negative effects, including decreased appetite, accelerated protein skeletal muscle breakdown and hypercatabolism. Method 14 peritoneal dialysis patients were included in single Department of Nephrology in the University Medical Center in Ljubljana. All patients were interviewed by a dietitian and nutritional assessment was conducted. Gastrointestinal symptom Rating Scale (GSRS) with 7-grade Likert scale was used to evaluate the intensity of GI symptoms and Bristol Stool Form Scale (BSFS) to classify patient's stool. The dietary intake of peritoneal dialysis patients was assessed using 7-day food diaries and analyzed with Prodi program (PRODI® 6.4 Expert program, Stuttgart, Deutschland). Body composition has been measured with bio impedance spectroscopy. Routine blood analysis was performed. Results Among 14 patients undergoing peritoneal dialysis, most of them were male (71.4%) with average age of 53.07 ± 12.32 years. Average energy intake of 14 patients was 21.05 ± 5.72 kcal/kg body weight per day, average protein intake was 0.87 ± 0.39 g/ kg body weight per day and average fiber intake was 13.75 ± 7.25 g per day. They were inadequate according to the dietary guidelines for peritoneal dialysis patients. Average dietary protein-fiber index was 6.86 ± 3.81 per day. Average PRAL value was 15.84 ± 13.44 for women and 6.52 ± 17.99 for men. Average dietary potassium intake was 1917.80 ± 790.08 mg per day which corresponds to the guidelines for peritoneal dialysis patients and average potassium serum value 4.45 ± 0.42 mmol/L. GSRS questionnaire showed peritoneal patients had minor to mild discomfort in abdominal pain, constipation and indigestion GI symptom cluster. Patients’ self-analysis of stool showed BSFS Types 3.23 ± 1.64 if BSFS Types 3–5 are defined as normal stools. Dietary protein intake strongly correlated with dietary energy intake (r = 0.76, p = 0.003), dietary protein-fiber index strongly correlated with PRAL value (r = 0.70, p = 0.007) and dietary potassium intake moderately to strongly correlated with dietary fiber intake (r = 0.62, p = 0.025). Serum value of IL-6 strongly correlated with dietary potassium intake (r = 0.72, p = 0.006) and moderately to strongly correlated with dietary fiber intake (r = 0.6, p = 0.034). The correlation between dietary potassium intake and serum hsCRP was significant (p = 0.042). The correlation between Bristol stool consistency value and serum hsCRP was significant (p = 0.0255). The correlation between total GSRS score and serum value of albumin was significant (p = 0.0010). The correlation between total GSRS score and dietary potassium intake was significant (p = 0.0015). The correlation between total GSRS score and dietary protein-fiber index was significant (p = 0.0403). Conclusion Gastrointestinal diseases in peritoneal dialysis patients are comparatively understudied in the literature, despite having a significant impact on dialysis efficacy and the quality of life. Analysis of GSRS questionnaire showed that abdominal pain, constipation and indigestion caused minor to mild discomfort in PD patients. The analysis also showed that fiber intake, potassium intake and gastrointestinal symptoms are significantly associated with inflammation markers and are important contributing factors to chronic inflammatory state in these patients. Patients still lack the basic knowledge of nutrition, thus in the future nutritional consultations, innovative teaching techniques and help will be crucial to prevent the decline in nutritional status.

Gastrointestinal reported outcomes following one anastomosis gastric bypass based on a multicenter study

ABSTRACT Objectives To describe gastrointestinal-related side-effects reported following the One Anastomosis Gastric Bypass (OAGB). Methods A multicenter study among OAGB patients across Israel (n = 277) and Portugal (n = 111) who were recruited to the study based on time elapsed since surgery was performed. An online survey with information on demographics, anthropometrics, medical conditions, and gastrointestinal outcomes was administered in both countries simultaneously. Results Respondents from Israel (pre-surgery age of 41.6 ± 11.0 years, 75.8% females) and Portugal (pre-surgery age of 45.6 ± 12.3 years, 79.3% females) presented mean excess weight loss of 51.0 ± 19.9 and 62.4 ± 26.5%, 89.0 ± 22.0 and 86.2 ± 21.4%, and 89.9 ± 23.6 and 98.2 ± 20.9% (P < 0.001 for both countries), at 1–6 months, 6–12 months, and 1–5 years post-surgery, respectively. Median Gastrointestinal Symptom Rating Scale score was similar between time elapsed since surgery groups among respondents from Israel and Portugal (≤1.97 and ≤2.12). A notable proportion of respondents from Israel and Portugal at all time points reported 1–3 bowel movements per day (≤62.8 and ≤87.6%), Bristol stool scale categories which represent diarrhea-like stools (≤51.9 and ≤56.3%), having discomfort due to flatulence (≤79.4 and ≤90.2%), and mild to severe dyspepsia symptoms (≤50.5 and ≤73.0%). Conclusions A notable proportion of OAGB patients might experience certain gastrointestinal symptoms postoperatively, including flatulence, dyspepsia, and diarrhea-like stools.

Electroacupuncture for acute exacerbation of chronic obstructive pulmonary disease complicated with gastrointestinal dysfunction: a randomized controlled trial

To observe the clinical effect of electroacupuncture (EA) for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with gastrointestinal dysfunction.A total of 100 patients with AECOPD complicated with gastrointestinal dysfunction were randomly divided into an EA group (50 cases, 2 cases dropped off, 1 case excluded) and a medication group (50 cases). Both groups were treated with symptomatic and supportive treatment such as low flow oxygen, nebulized inhalation of short-acting β2 agonist (SABA) or short-acting muscarinic antagonist (SAMA) combined with inhaled corticosteroid (ICS). The EA group was treated with EA at Zusanli (ST 36), Yinlingquan (SP 9), Zhongwan (CV 12), Shuifen (CV 9), Tianshu (ST 25), Chize (LU 5) and Lieque (LU 7), with discontinuous wave, 2 Hz in frequency, 30 min each time, once a day. In the medication group, oral mosapride citrate tablets were given, 3 times a day, 5 mg each time. Both groups were treated for 5 d. Before and after treatment, the gastrointestinal symptom rating scale (GSRS) score was observe, serum procalcitonin (PCT), C-reactive protein (CRP), and plasma oxygenation index (PaO2/FiO2) were detected, and patient satisfaction degree was evaluated in the two groups.Compared with before treatment, except for diarrhea dimension in the medication group, the total scores and each dimension scores of GSRS were decreased (P<0.05), serum PCT and CRP were decreased (P<0.05), plasma PaO2/FiO2 was increased (P<0.05) in the two groups after treatment. After treatment, in the EA group, the total score and abdominal pain, dyspepsia, constipation and diarrhea scores of GSRS were lower than those in the medication group (P<0.05), meanwhile serum PCT and CRP were lower and plasma PaO2/FiO2 was higher than those in the medication group (P<0.05). The improvement of gastrointestinal symptoms, life quality and overall satisfaction degree in the EA group were superior to those in the medication group (P<0.05).EA could improve the symptoms of patients with AECOPD complicated with gastrointestinal dysfunction, reduce inflammatory response, improve oxygenation and patient satisfaction degree.目的：探讨电针干预慢性阻塞性肺疾病急性发作期（AECOPD）合并胃肠功能障碍的临床疗效。方法：将100例AECOPD合并胃肠功能障碍患者随机分为电针组（50例，脱落2例、剔除1例）和药物组（50例）。两组均予低流量吸氧、短效β2激动剂（SABA）或短效胆碱受体拮抗剂（SAMA）联合吸入型糖皮质激素（ICS）雾化吸入等对症及支持治疗。电针组予电针刺激足三里、阴陵泉、中脘、水分、天枢、尺泽、列缺，予断续波，频率2 Hz，每次30 min，每日1次；药物组予口服枸橼酸莫沙必利片，每日3次，每次5 mg。两组均治疗5 d。观察两组患者治疗前后胃肠道症状评定量表（GSRS）评分，检测两组患者治疗前后降钙素原（PCT）、C反应蛋白（CRP）、氧合指数（PaO2/FiO2），并评价患者满意度。结果：与治疗前比较，除药物组腹泻维度，两组治疗后GSRS总分及各个维度评分均降低（P<0.05），PCT、CRP降低（P<0.05），PaO2/FiO2升高（P<0.05）；治疗后，电针组GSRS总分及腹痛、消化不良、便秘、腹泻评分均低于药物组（P<0.05），PCT、CRP低于药物组（P<0.05），PaO2/FiO2高于药物组（P<0.05）。电针组患者胃肠道症状改善、生活质量改善及总体满意度优于药物组（P<0.05）。结论：电针可改善AECOPD合并胃肠功能障碍患者症状，降低机体炎性反应，改善氧合情况，提升患者满意度。.

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

Background: Patients who undergo gastrectomy for gastric cancer are susceptible to osteoporosis. To prevent a decrease in bone mineral density, an appropriate prophylaxis is considered important to adjust the post-gastrectomy condition. In this study, we will compare two different routes of administration of ibandronic acid (oral or intravenous) plus eldecalcitol as a potentially more suitable treatment for patients at a high risk of fragile fracture. Protocol: This study protocol describes a randomized, active-controlled, non-blind, single-center, phase II trial. For patients in the investigational arm (Group A), sodium ibandronate hydrate will be administered intravenously once a month with daily oral intake of eldecalcitol; for those in the control arm (Group B), sodium ibandronate hydrate will be administered orally once a month with daily oral intake of eldecalcitol. We will recruit patients aged 45–85 years who have undergone gastrectomy for gastric cancer and are at a risk of fragility fractures. The study will include patients with existing vertebral fractures and/or femoral proximal fractures, or with lumbar and/or proximal femur bone mineral density of less than 80% of the young adult mean. The primary outcome of this study will be the change in lumbar bone mineral density. We will also evaluate the changes in femur bone mineral density, bone metabolism markers, health-related quality of life as evaluated using the EuroQol 5 Dimension (EQ-5D), and digestive symptoms as evaluated using the Gastrointestinal Symptom Rating Scale after 52 weeks of treatment. Conclusions: We believe that appropriate treatments that are adjusted to the condition of patients after gastrectomy are important for the prevention of bone mineral loss. Registration: This study was accepted by the Japan Registry of Clinical Trials (jRCT1041200059, November 6, 2021).

A Novel Nutrient Intervention of Probiotics, Glutamine, and Fish Oil in Psychological Distress: A Concurrent Multiple Baseline Design.

Objectives: The aim of this study was to investigate whether a combination of nutrients designed to promote gut and brain health also lowers psychological distress. The hypothesis is that a probiotic with fish oil, and glutamine supplement will reduce psychological distress. Design: A multiple baseline design was used to collect data from seven naturopathic patients in private naturopathic clinics in Australia. Patients were between 18 and 65 years of age, and had a Kessler-10 (K10) score between 16 and 30 and symptoms associated with mild gastrointestinal discomfort experienced several times most weeks for 3 months. They were randomized into one of three pathways to stagger the introduction of the intervention. Interventions: Participants received either a supplement incorporating a probiotic formulation (including Lactobacillus rhamnosus), a glutamine powder formulation, and fish oil, or matched placebos. The primary outcome measure was psychological distress as measured by the K10 scale of psychological distress. Results: The data showed a general trend toward lower K10 scores during the active phase compared with the baseline phase, with a marked reduction in the variances between phases. After controlling for time and baseline values, no significant difference between the phases for the K10 and the Perceived Stress Scale was found, but there was still a significant reduction in symptoms on the Gastrointestinal Symptom Rating Scale. Conclusions: A combination of a probiotic formulation, a glutamine powder formulation, and fish oil did not affect psychological distress and perceived stress, but had a significant beneficial effect on gastrointestinal symptoms in patients with high distress and concurrent gut symptomology. Clinical trial registration number: ACTRN12620000928910.

Comparing Hemodialysis and Peritoneal Dialysis Patients for Gastrointestinal Symptoms

Objective: The purpose of this research was to compare gastrointestinal (GI) symptoms in ESRD patients receiving PD and HD to see whether there were any significant changes. Methods: After the ethical approval from the institute review board, this crossectional study was conducted at shahida Islam medical complex ,lodhran. From 01/01/22 to 30/06/22. A modified 15-item gastrointestinal symptom rating scale (GSRS) questionnaire was used to assess GI symptoms; this questionnaire included questions on eating dysfunction. Age, a etiology of ESRD, and most recent adequacy evaluation of dialysis were collected through the follow-up database, patient interviews, and chart reviews. Results: Total seventy patients were included in the present study, N=35 was on hemodialysis and N=35 on peritoneal dialysis. HD and PD patients were similar with respect to age, sex, the occurrence of diabetes mellitus, and average dialysis duration. In ESRD patients’ overall prevalence of GI symptoms (GSRS &gt;1) was 68.5% (48/70 patients). Patients with a GSRS &gt; 1 were more common among those with HD group (28/35; 80%) than those with PD (57%; 20/35) (P 0.058*). In the HD group, more patients suffered from abdominal pain, constipation, and diarrhea (74%, 60% and 68.5%, respectively), compared with those in the PD group (34%, 28.5% and 32%, respectively; P value is 0.003, 0.001, and 0.008 respectively) Conclusion: Gastrointestinal (GI) symptoms vary in frequency, intensity, and variety across HD and PD individuals. Keywords: Gastrointestinal symptom, Hemodialysis, Peritoneal dialysis, End-stage renal disease