Short-Form Nepean Dyspepsia Index Research Articles

Health-related quality of life in patients with dyspepsia presenting at the University of Benin Teaching Hospital, Benin City, South-South Nigeria: a cross-sectional study.

Health-related quality of life (HRQoL) examines the impact of the symptoms of dyspepsia on the daily life of sufferers. There are a few published studies related to HRQoL of persons with dyspepsia in Africa. this was a hospital-based cross-sectional study involving 324 dyspeptic patients referred for upper gastrointestinal endoscopy to the University of Benin Teaching Hospitals (UBTH) The ROME IV criteria were used to recruit patients with dyspepsia. The short form Nepean Dyspepsia Index (SF NDI) was used to assess HRQoL in all participants. Upper gastrointestinal endoscopy was performed on all 324 dyspeptic patients. the mean age of patients was 47.6 ± 15.6 years. Three hundred (92.6%) patients had significantly impaired HRQoL with an SF NDI mean score of 31.3 ± 9.1. Interference with daily activities and eating and drinking subdomains were more impaired than other subdomains of HRQoL (p < 0.001). There was no statistical difference between the impaired HRQoL in patients with functional dyspepsia and organic dyspepsia (p = 0.694). Among patients with organic dyspepsia, those with upper gastrointestinal cancers had significantly worse HRQoL SF NDI mean (sd) scores (39.7 ± 5.9) compared with patients with gastritis, peptic ulcer disease and GERD with (30.3 ± 9.2, 31.5 ± 9.7 and 32.9 ± 7.1 respectively) (p = 0.01). health-related quality of life is significantly impaired in patients with dyspepsia and those with upper gastrointestinal cancers having overall worse scores. The physical, social and psychological well-being of a majority of patients with dyspepsia in South-South Nigeria is negatively affected by dyspepsia.

Cannabidiol for Functional Dyspepsia With Normal Gastric Emptying: A Randomized Controlled Trial.

Cannabidiol (CBD), a CBR2 agonist with limited psychic effects, antagonizes CB1/CB2 receptors. Allelic variation CNR1 (gene for CBR1) rs806378 and FAAH rs324420 were associated with altered gut motility and sensation. This study aimed to compare the pharmacodynamics and clinical effects of a 4-week treatment with pharmaceutical-grade CBD vs placebo and assess the interactions of FAAH and CNR1 gene variants on the effects of CBD in patients with functional dyspepsia (FD). We performed a randomized, double-blinded, placebo-controlled (1:1 ratio) study of CBD b.i.d. (20 mg/kg/d according to the US Food and Drug Administration escalation guidance) in FD patients with nondelayed gastric emptying (GE) at baseline. Symptoms were assessed by validated daily symptom diary (0-4 scale for upper abdominal pain, nausea, and bloating), weekly assessment of adequate relief, Leuven Postprandial Distress Scale (8 symptoms, adjectival scores rated 0-4 for severity), and quality of life (Short-Form Nepean Dyspepsia Index [average of 10 dimensions each on a 5-point scale]). After the 4-week treatment, all patients underwent measurements of GE of solids, gastric volumes, and Ensure nutrient satiation test. Statistical analysis compared 2 treatments for all endpoints and the effects of CBD in association with FAAH rs324420 and CNR1 rs806378. CBD and placebo effects on physiological functions and patient response outcomes were not significantly different. There were borderline CBD treatment-by-genotype interactions: rs806378 CNR1 with Leuven Postprandial Distress Scale ( P = 0.06) and GE solids ( P = 0.12). Approved doses of CBD used off-label do not relieve FD with normal baseline GE of solids or alter gastric motor functions and satiation. CBD treatment-by-gene interactions suggest potential benefits for postprandial distress with CNR1 rs806378 T allele.

Functional dyspepsia symptom diary is correlated with other questionnaires and associated with severity in patients with functional dyspepsia: a multicenter, prospective observational study.

Functional dyspepsia symptom diary (FDSD) is a newly designed questionnaire of functional dyspepsia (FD). The relationships between FDSD and other FD-related questionnaires and patient-reported severity remain unclear. This study aims to investigate the correlations between FDSD and other questionnaires and to determine the relationships between FDSD and FD severity. Consecutive outpatients with FD were prospectively enrolled in four tertiary hospitals. All patients were evaluated by six FD-related questionnaires, including FDSD, Dyspepsia Symptom Severity Index (DSSI), Gastrointestinal Symptom Rating Scale, Short-Form Nepean Dyspepsia Index, and Hamilton Depression and Anxiety Scale (HAMD and HAMA). The severity of FD was also graded as mild, moderate, and severe by patients themselves. Correlations between different scores were assessed by Spearman correlation coefficient (ρ), and risk factors for patient-reported severity were identified. For 512 enrolled FD patients, the overall median FDSD score was 19 (2-42). FDSD was well correlated with DSSI (ρ=0.64) and fairly correlated with the other four scores (ρ=0.32-0.55) (all P<0.001). Mild, moderate, and severe FD were reported by 18.5%, 55.9%, and 25.6% of patients, respectively. There were seven factors associated with the severe FD, including education level, duration, and subtypes of FD, prior treatment, FDSD, HAMD, and HAMA scores (all P<0.10). FDSD≥20 (odds ratio [OR] 3.3, 95% confidence interval [CI]: 2.0-5.2, P<0.001) and HAMD≥13 (OR 2.9, 95% CI: 1.8-4.6, P<0.001) were independently associated with patient-reported severe FD. This study firstly revealed that the newly developed FDSD correlated with other FD-related questionnaires. FDSD≥20 and HAMD≥13 were independently associated with severe FD reported by patients (clinicaltrials.gov number: NCT04953975).

Quality of life in Indian patients with functional dyspepsia: Translation and validation of the Hindi version of Short-Form Nepean Dyspepsia Index.

Patients with functional dyspepsia (FD) have poor health-related quality of life (HRQOL), but Indian data are lacking. Also, there is non-availability of validated disease-specific questionnaire to assess HRQOL in Hindi-speaking patients withdyspepsia. We aimed to develop and validate a reliable translation of Short-Form Nepean Dyspepsia Index (SF-NDI) in Hindi, and assess the impact of FD on HRQOL in Indian patients. Cross-cultural adaptation of English version of SF-NDI, translation to Hindi, and adaptation of Hindi version were performed using standard procedures. English and Hindi versions were assessed against Short Form-36 (SF-36), examining for internal consistency, test-retest reliability, and validity. Total 211 FD patients (144 Hindi speaking, 67 English speaking) were enrolled (mean age 40.8 ± 11.7years; male:female = 115:96). Median total SF-NDI scores for both languages were 38.75 and 40.0, respectively. Test-retest reliability intraclass correlation coefficients were 0.85 (Hindi) and 0.89 (English). Internal consistency evaluation revealed Cronbach's α coefficient of 0.79-0.86 (Hindi) and 0.78-0.89 (English). SF-NDI sub-scales showed moderate to good correlation with various domains of SF-36 (content validity). There was significant (p &lt; 0.001) decline of HRQOL in patients with severe dyspepsia relative to those with mild dyspepsia (construct validity). On multivariate analysis, factors independently associated with HRQOL were duration of symptoms and dyspepsia severity. Both English and Hindi versions of SF-NDI are reliable and valid for HRQOL assessment in Indian FD patients, and will be useful in future epidemiological and clinical studies. Indian FD patients have poor HRQOL, being worse in those with severe dyspepsia and longer duration of symptoms.

Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet versus traditional dietary advice for functional dyspepsia: a randomized controlled trial.

Prospective trials evaluating efficacy of specific diet restriction in functional dyspepsia (FD) are scarce. We aimed to assess efficacy of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet in FD, compared with traditional dietary advice (TDA). In this prospective, single-blind trial, patients with FD (Rome IV) were randomized into low FODMAP diet (LFD) and TDA groups, for 4weeks (phase I). In phase II (4-12weeks), LFD group was advised systematic re-introduction of FODMAPs. Symptom severity and quality of life were assessed using "Short-Form Nepean Dyspepsia Index (SF-NDI)." Primary outcome was symptomatic response (symptom score reduction of ≥50%), at 4weeks. Study was registered with CTRI (2019/06/019852). Of 184 patients screened, 105 were randomized to LFD (n=54) and TDA (n=51) groups. At 4weeks, both groups showed significant reduction in SF-NDI symptom scores compared with baseline, with no significant difference in inter-group response rates [LFD: 66.7% (36/54); TDA: 56.9% (29/51); P=0.32]. On sub-group analysis, patients with postprandial distress syndrome or bloating had significantly better symptomatic response with LFD (P=0.04). SF-NDI quality of life scores improved significantly in both groups. On multivariate analysis, factors predicting response to LFD were bloating and male gender. Incidences of adverse events (minor) were similar in both groups. In patients with FD, LFD and TDA lead to significant symptomatic and quality of life improvement. Patients with postprandial distress syndrome or bloating respond significantly better to LFD. Therefore, dietary advice for FD should be individualized according to FD subtype.

Efficacy and Safety of Acotiamide Versus Mosapride in Patients With Functional Dyspepsia Associated With Meal-Induced Postprandial Distress Syndrome: A Phase III Randomized Clinical Trial.

Background: Acotiamide is a novel prokinetic drug that acts by enhancing the release of acetylcholine and is used in the treatment of functional dyspepsia-postprandial distress syndrome (FD-PDS). Mosapride is indicated to FD-PDS as per the Rome III treatment guidelines. Mosapride 5 mg three times daily (TID) is approved by the Drugs Controller General of India (DCGI) for the treatment of FD-PDS. The objective of this study was to determine the efficacy and safety of Acotiamide in comparison with Mosapride on FD-PDS.Methods: The 220 patients of either gender (aged 18-64 years) with active PDS included in the study were centrally randomized 1:1 to receive either 100 mg Acotiamide (test product) or 5 mg Mosapride (reference product) TID for four weeks. Responder rates for the overall treatment effect (OTE) at the end of four weeks were the primary efficacy endpoint. Secondary efficacy endpoints included the elimination rate of postprandial fullness, upper abdominal bloating, and early satiation. The study also evaluated the OTE at each week, individual symptom scores, and quality of life (QoL) assessed by the Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI). The safety endpoints included assessments of treatment-emergent adverse events (TEAEs).Results: At the end of four weeks, the responders in the Acotiamide versus Mosapride group for OTE was 98% versus 93.27% in the per-protocol (PP) population. Among the intent to treat (ITT) population, the comparison of Acotiamide versus Mosapride stood at 95.15% versus 89.81%. Secondary efficacy endpoints were significantly improved with 100 mg TID Acotiamide, which was evident from the improvement in postprandial fullness (14.56%), upper abdominal bloating (15.53%), early satiation (10.68%), and QoL (13.7 ± 4.67).Conclusions: Our study results demonstrated that Acotiamide is effective, safe, and well-tolerated and had significantly improved the QoL over a four-week treatment period in FD-PDS patients. The efficacy and safety profiles of Acotiamide were similar to Mosapride.

Pilot Study of a Self-Administered Hypnosis Intervention for Functional Dyspepsia.

Functional dyspepsia (FD) is a chronic disorder of the upper gastrointestinal tract that currently lacks substantially effective therapy options. To evaluate the feasibility and potential impact on FD symptoms and well-being of a fully automated gut-directed hypnosis intervention delivered via audio recordings. FD patients were enrolled at a single medical center and given access to a password-protected website where they completed 7 bi-weekly audio-recorded hypnosis sessions over a 3-month period. Study questionnaires including the Patient assessment of upper gastrointestinal symptom severity index, Short-Form Nepean Dyspepsia Index, the Visceral Sensitivity Index, and the Brief Symptom Inventory (BSI-18) were completed online pre-treatment, mid-treatment, post-treatment and at 3-month follow-up. Of 23 enrolled patients (18 females; mean age = 38years), 96% completed the entire treatment program and 3-month follow-up. Intention-to-treat analyses showed significant improvement at both end of treatment and 3-month follow-up in dyspepsia severity and quality of life, as well as in gut-specific anxiety and psychological distress. 68% of treatment completers reported that their FD symptoms were improved. Improvement in FD severity was significantly positively correlated with baseline PAGI-SYM total scores and BSI Global Severity Index scores. The fully automated hypnosis audio treatment program, which requires no therapist or clinician involvement, demonstrated excellent feasibility and resulted in significant improvement in FD symptoms, quality of life and emotional well-being. The results indicate that the intervention has high potential as adjunctive therapy for FD and warrants further investigation in a randomized controlled trial.

Mindfulness-based cognitive therapy in functional dyspepsia: A pilot randomized trial.

Patients with functional dyspepsia (FD) often have concomitant anxiety and depression. Mindfulness-based cognitive therapy (MBCT) combines the principles of cognitive behavioral therapy and mindfulness. It is a group-based therapy and has been shown to be efficacious in functional gastrointestinal disorders. There are no randomized controlled trials (RCTs) evaluating MBCT in FD. We aimed to evaluate feasibility and efficacy of MBCT in FD management. We performed a mixed-method single-center pilot randomized trial of 28 patients fulfilling ROME-III criteria for FD. Fifteen patients were randomized to an 8-week MBCT program while 13 underwent treatment-as-usual (TAU). Patients completed questionnaires at baseline and at week 8. Two focus-groups were conducted. Feasibility of recruitment, acceptability of randomization, procedures and intervention, handout compliance and feasibility of quantitative measures were assessed. The primary outcome was subjective-clinical-assessment of FD symptoms (SCA-FD). Secondary outcome measures included Short-form Nepean Dyspepsia Index (SF-NDI), subjective-clinical-assessment of general health (SCA-GH), EuroQoL-Visual Analog Scale (EuroQoL-VAS), and Depression, Anxiety and Stress Scale-21 Items (DASS-21). Twelve of 15 patients in the MBCT group completed the program. There was a trend towards symptom improvement, with 90% in the MBCT group reporting improvement in SCA-FD compared with 45% in TAU(P=0.063). Patients who underwent MBCT reported greater improvement in SF-NDI (mean change: -8.8 (SD: 7.5) vs -0.7 (7.2), P=0.018) and DASS-21 (-19.8 (29.5) vs -5.5 (6.6) P=0.13) compared with TAU. There was no difference in SCA-GH and EuroQoL-VAS. Based on SCA-FD improvement, the eventual RCT will require 50 patients (25 in each group). Mindfulness-based cognitive therapy is likely efficacious for FD, and it would be feasible to conduct a RCT.

The prevalence of uninvestigated dyspepsia and the association of physical exercise with quality of life of uninvestigated dyspepsia patients in Indonesia: An internet-based survey.

Epidemiological data on the prevalence of uninvestigated dyspepsia (UD) and its impact on the health-related quality of life (HRQOL) in Indonesian population are still lacking. There is no study investigating the association between exercise and the HRQOL in UD patients. We aimed to investigate the prevalence of UD and its association with physical exercise, and its impact on HRQOL in Indonesian patients with UD. This was a population-based, cross-sectional study, conducted using an internet-based questionnaire which was randomly distributed throughout Indonesia using the social media. The questionnaire contained socio-demographic details, exercise levels, Rome III criteria for dyspepsia, and SF-NDI (Short Form-Nepean Dyspepsia Index). The frequency, duration, the intensity of exercise, and the classification of exercise according to ACSM (American College of Sports Medicine) were included in the assessment. The screening for UD was conducted using the Rome III criteria and the SF-NDI score was calculated to assess the HRQOL in patients with UD. A total of 2725 valid responses were collected. The overall prevalence of UD in the study was 49.75%. Multiple logistic regression analysis showed that gender (female) and lack of exercise were independently associated with UD (OR 2.07, 95% CI 1.74-2.47, p < 0.001 and OR 1.72, 95% CI 1.42-2.07, p <0.001). The median SF-NDI score among 1295 UD subjects in non-exercising and exercising groups was 21.00 and 18.00 (p <0.001), respectively. This study demonstrated the prevalence of UD and the association between exercise and HRQOL among UD patients in Indonesia.

Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome.

BackgroundShort‐chain fatty acids (SCFAs) may play a role in the pathophysiology of irritable bowel syndrome (IBS). This study analyzed fecal SCFAs after performing fecal microbiota transplantation (FMT) in the IBS patients who were included in our previous study of the efficacy of FMT.MethodsThis study included 142 of the 164 IBS patients who participated in our previous study. They were belonging to three groups: placebo (own feces), 30‐g (superdonor feces), and 60‐g (superdonor feces) FMT. The patients completed the IBS Severity Scoring System (IBS‐SSS) Birmingham IBS Symptom, Fatigue Assessment Scale (FAS), the IBS Quality of Life (IBS‐QoL) and Short‐Form Nepean Dyspepsia Index (SF‐NDI) questionnaires and delivered fecal samples at the baseline and 1 month after FMT. The SCFA levels were determined by vacuum distillation followed by gas chromatography.Key ResultsThe fecal butyric acid level was significantly increased after FMT in both the 30‐g and 60‐g groups (both P ≤ 0.001). In the 60‐g group, the levels of total SCFAs and isobutyric, isovaleric, and valeric acids increased after FMT. Butyric acid levels in the responders in both the 30‐g and 60‐g FMT groups were significantly inversely correlated with IBS‐SSS and FAS scores (P = 0.001, r = −0.3 and P = 0.0001. r=‐ 0.3, respectively). There were no differences in the SCFA levels in the placebo group after FMT.Conclusion and InferencesFMT increases the fecal SCFA levels in IBS patients. The increase in the butyric acid level is inversely correlated with symptoms in IBS patients following FMT, suggesting that SCFAs might play a role in the pathophysiology of IBS. www.clini​caltr​ials.gov (NCT03822299).

Prevalence and sociodemographic determinants of dyspepsia in the general population of Rwanda.

IntroductionDyspepsia accounts for a significant burden of worldwide disease, but there is a relative paucity of data from the sub-Saharan African setting. We undertook to describe the burden, risk factors and severity of dyspepsia across Rwanda.MethodsWe performed a population-based clustered cross-sectional survey between November 2015 and January 2016, nationwide in Rwanda, using the Short Form Leeds Dyspepsia Questionnaire to describe the presence and severity of dyspepsia, and the Short Form Nepean Dyspepsia Index to describe the concomitant quality of life effects. Univariate and multivariate logistic regression models were constructed to correlate measured sociodemographic factors with dyspepsia.ResultsThe prevalence of clinically significant dyspepsia in the general Rwandan population was 14.2% (283/2000). The univariate factors that significantly predicted severity were gender, profession, socioeconomic status, and non-steroidal anti-inflammatory drug, aspirin and alcohol use, with gender, current smoking, aspirin use both in the past and currently, and alcohol use in the past remaining significant on multivariate modelling. Dyspeptics had a significantly lower gastrointestinal-related quality of life, though the sociodemographic factors measured did not modify the observed quality of life.ConclusionDyspepsia is prevalent in the Rwandan setting and is associated with a significant burden on quality of life. More work is required to determine the pathological entities involved, and the optimal approach to mitigating this burden.

Real-World, Non-Interventional, Observational Study to Evaluate Effectiveness and Tolerability of Acotiamide Hydrochloride Hydrate in Treatment of Functional Dyspepsia.

Functional dyspepsia (FD) is a highly prevalent condition which reduces patients' quality of life (QoL) and imparts a significant economic burden on the healthcare system. Acotiamide is a novel prokinetic agent useful in treatment of FD, and this study evaluated the effectiveness of acotiamide hydrochloride hydrate in management of FD over a 4-week period in a real-world setting. This study was a prospective, observational, real-world data collection of 132 patients (85 male, 47 female) over 18years of age diagnosed with FD as per Rome III criteria and treated with acotiamide for 4weeks at a gastroenterology unit of a medical school in India. Those receiving prokinetics and cholinergic drugs, having any structural lesion on endoscopy, with coexisting irritable bowel syndrome and having heartburn in the past 12weeks were excluded. Primary outcome was responders based on overall treatment efficacy (OTE) recorded on a seven-point Likert scale for postprandial distress syndrome (PDS; postprandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (EPS; upper abdominal pain and upper abdominal discomfort) and associated symptoms (nausea, vomiting and excessive belching) at the end of 2 and 4weeks. Secondary outcomes were elimination of symptoms of PDS, QoL assessed on the Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and clinical safety after 2 and 4weeks. The responder rates with acotiamide at 2 and 4weeks were 51.5% and 65.9%, respectively, for PDS. Similarly, the responder rates for EPS were 31.8% and 41.7%, respectively, at 2weeks and 4weeks. The responder rates for associated symptoms of nausea, vomiting and excessive belching were respectively 18.2%, 17.4% and 16.7% at 2weeks and 18.2%, 17.4% and 18.2% at 4weeks. Symptom elimination rates were 9.8% and 18.9% for postprandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for abdominal bloating at 2 and 4weeks, respectively. Significant improvement (p < 0.0001) in the SFNDI total scores from 25.91 (5.00) at 2weeks to 23.76 (4.84) at 4weeks were found at 4weeks compared to 2weeks. A total of 7 (5.30%) patients reported mild adverse events which were dizziness (4), headache (3) and nausea (1). The current study demonstrates that treatment with acotiamide improves symptoms, QoL and is well tolerated in Indian patients with FD. Clinical Trial Registry of India, CTRI/2017/11/010421. Dr. Reddy's Laboratories, India.

Efficacy of Helicobacter pylori eradication regimens in Rwanda: a randomized controlled trial

BackgroundSuccessful H. pylori treatment requires the knowledge of local antimicrobial resistance. Data on the efficacy of H. pylori eradication regimens available in sub-Saharan Africa are scant, hence the optimal treatment is unknown.Our goals were to determine the efficacy of available regimens in Rwanda as well as evaluate the effect of treatment on health-related quality of life (HRQoL) in patients undergoing esophagogastroduodenoscopy.MethodsThis is a randomized controlled trial conducted from November 2015 to October 2016 at a tertiary hospital in Rwanda. Enrollees were 299 patients (35% male, age 42 ± 16 years (mean ± SD)) who had a positive modified rapid urease test on endoscopic biopsies. After a fecal antigen test (FAT) and HRQoL assessment by the Short Form Nepean Dyspepsia Index (SF-NDI) questionnaire, patients were randomized 1:1:1:1 to either a triple therapy combining omeprazole, amoxicillin and one of clarithromycin/ciprofloxacin/metronidazole or a quadruple therapy combining omeprazole, amoxicillin, ciprofloxacin and doxycycline. All therapies were given for a duration of 10 days. The outcome measures were the persistence of positive FAT (treatment failure) 4 to 6 weeks after treatment and change in HRQoL scores.ResultsThe treatment success rate was 80% in the total population and 78% in patients with a history of prior triple therapy. Significant improvement in HRQoL in the total group (HRQoL mean scores before and after treatment respectively: 76 ± 11 and 32 ± 11, p < 0.001) and the group with functional dyspepsia (HRQoL mean scores before and after treatment respectively: 73 ± 11 and 30 ± 9, P < 0.001) was observed across all treatment groups.Using clarithromycin based triple therapy (standard of care) as a reference, the group treated with metronidazole had worse HRQoL (p = 0.012) and had a trend towards worse treatment outcome (p = 0.086) compared to the ciprofloxacin based combination therapies.ConclusionClarithromycin and ciprofloxacin based combination therapies are effective and safe to use alternatively for H. pylori eradication and improve HRQoL. Among the regimens studied, metronidazole based triple therapy is likely to be clinically inferior.Trial registrationThe clinical trial was retrospectively registered (PACTR201804003257400) with the Pan African Clinical Trial Registry database, on April 6th, 2018 in South Africa.

PGI3 - Real World, Non-Interventional, Observational Study to Evaluate Effectiveness and Tolerability of Acotiamide Hydrochloride Hydrate in Indian Patients with Functional Dyspepsia

To assess effectiveness & tolerability of Acotiamide hydrochloride hydrate in management of Indian patients with functional dyspepsia over 4 weeks period This was prospective, observational, real world study involving 132 patients (85 male, 47 female), aged >18 years, having functional dyspepsia as per Rome III criteria and treated with Acotiamide 100mg three times daily for 4 weeks at a tertiary care centre in India. Primary outcome was responders based on Overall Treatment Efficacy (OTE) recorded on a 7-point Likert scale for post-prandial distress syndrome (post-prandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (Upper abdominal pain & discomfort) and associated symptoms of dyspepsia (nausea, vomiting and excessive belching) at the end of 2 and 4 weeks. Secondary outcomes were elimination of symptoms (post-prandial fullness, early satiety and upper abdominal bloating), quality of life assessed on Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and tolerability over 4 weeks of treatment The responder rates with Acotiamide at 2 and 4 weeks were 51.5% and 65.9% for post-prandial distress syndrome, 31.8%, and 41.7% for epigastric pain syndrome and 16.7% and 17.4% for associated dyspeptic symptoms respectively. Symptom elimination rates were 9.8% and 18.9% for post-prandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for upper abdominal bloating at 2 and 4 weeks respectively. Significant improvement in quality of life as measured on SFNDI total scores, was reported from 25.91 (5.00) at 2 weeks to 23.76 (4.84) at 4 weeks(p<0.0001). Total 7 (5.30%) patients reported mild intensity adverse events which were dizziness (4 patients), headache (3 patients) and nausea (1 patient). Acotiamide demonstrates effectiveness through improvement in symptoms of post-prandial distress syndrome, epigastric pain syndrome and associated dyspepsia symptoms, along with significant improvement in quality of life over a 4-wk treatment period and is well tolerated in Indian patients with functional dyspepsia.

Does the low FODMAP diet improve symptoms of radiation-induced enteropathy? A pilot study

Rationale: Patients with radiation-induced enteropathy (RE) after cancer treatment show similar symptoms as patients with irritable bowel syndrome (IBS). The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet (LFD) is a widespread management strategy for IBS. We aimed to investigate if there may be a positive effect of LFD on symptoms and health-related quality of life (HRQOL) in patients with RE.Methods: In an open non-controlled pilot study, 11 patients (all female) with RE-related IBS symptoms were recruited largely based on own initiative. All followed LFD for four weeks. IBS Severity Scoring System (IBS-SSS) and IBS Symptom Questionnaire (IBS-SQ) were used to assess symptoms. Short Form Nepean Dyspepsia Index (SF-NDI) and 12-item Short Form Health Survey (SF-12) evaluated HRQOL. A three day food record was used to estimate baseline intake of FODMAPs and to reveal dietary changes.Results: FODMAP intake was successfully reduced, although LFD was found a burdensome intervention. IBS symptoms improved significantly based on mean total score of IBS-SSS and IBS-SQ, which changed from 310.2 ± 60.7 to 171.4 ± 107.2 (p = .001) and 27.4 ± 4.1 to 15.7 ± 10.1 (p = .002). HRQOL improved based on SF-NDI total score (30.5 ± 9.4 to 18.3 ± 8.2, p = .001) and based on mental (p = .047) and physical (p = .134) score of SF-12. Main additional dietary changes were reduced intake of energy, carbohydrates, and fiber.Conclusion: Our findings from this small-scaled pilot study indicate that the LFD may alleviate symptoms and improve HRQOL in patients with RE. Further controlled studies with larger sample size should be conducted to verify our results and hopefully enable implementation of LFD as a future part of the management strategy for RE.

Validation of the Kinyarwanda-version Short-Form Leeds Dyspepsia Questionnaire and Short-Form Nepean Dyspepsia Index to assess dyspepsia prevalence and quality-of-life impact in Rwanda

ObjectivesWe aimed to develop and validate Kinyarwanda versions of Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) and Short-Form Nepean Dyspepsia Index (SF-NDI) to measure the frequency and severity of dyspepsia and associated...

Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

ObjectivesThe aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires’ use in regulated clinical trials to assess treatment efficacy claims intended for product labeling.MethodsA literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA’s PRO Guidance for Industry.ResultsFifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim.ConclusionsNo existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product labeling. As such, the development of a new FD symptom PRO instrument is supported.

Dyspepsia prevalence and impact on quality of life among Rwandan healthcare workers: A cross-sectional survey.

Dyspepsia has been demonstrated worldwide to have major personal and societal impacts, but data on the burden of this disease in Africa are lacking. To document the prevalence of dyspepsia and its quality-of-life impact among healthcare workers (HCWs) at Butare University Teaching Hospital (BUTH), Rwanda. A cross-sectional survey among consenting HCWs at BUTH was conducted. Multilingual interviewers guided participants through validated questionnaires, including the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), to detect the presence and frequency of dyspeptic symptoms, and the Short-Form Nepean Dyspepsia Index (SF-NDI), to examine the impact of dyspepsia on quality of life. The study included 378 enrolled HCWs, all of whom provided responses to the SF-LDQ and 356 of whom responded to the SF-NDI. The prevalence of dyspepsia in the study population was 38.9% (147/378). Of these 147 HCWs, 79 (53.7%) had very mild dyspepsia, 33 (22.4%) had mild dyspepsia, 20 (13.6%) had moderate dyspepsia and 15 (10.2%) had severe dyspepsia. Females were more likely to complain of dyspepsia than males (98/206 v. 49/172; odds ratio (OR) 2.3; 95% confidence interval (CI) 1.5-3.5; p<0.001). Participants with dyspepsia of at least mild severity had SF-NDI scores reflecting reduced quality of life when compared with non-dyspeptic participants (OR 17.0; 95% CI 5.0-57.1; p<0.001), with most marked effects on the 'tension' and 'eating and drinking' subdomains of the SF-NDI. The prevalence of dyspepsia among HCWs in Rwanda is high and is associated with lowered quality of life.

Effects of cognitive factors on quality of life in patients with functional dyspepsia

One hundred and eighty two outpatients with functional dyspepsia(FD)were enrolled. The cognitive questionnaire and the short form Nepean Dyspepsia Index (NDI) were used for survey. Spearman analysis showed that the cognitions of symptoms affected by emotion (r=0.284, P=0.006), somatisation symptoms induced by other diseases (r=0.211, P=0.045), and fears of cancer (r=0.217, P=0.039) were positively correlated with NDI scores. Multiple linear regression analysis demonstrated that cognition of symptoms affected by emotion (β=3.709, P=0.009), somatisation symptoms induced by other diseases (β=3.259, P=0.020), need of hospitalization (β=4.533, P=0.006), and need of medication for several years (β=-3.207, P=0.029) were associated with NDI scores. These results suggest that the quality of life might be effected by cognitive factors, and the correction of cognitive mistakes may improve quality of life of FD patients. Key words: Dyspepsia; Cognition; Questionnaires

An Extract ofGlycyrrhiza glabra(GutGard) Alleviates Symptoms of Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract of Glycyrrhiza glabra, in patients with functional dyspepsia. The primary outcome variables of the study were the change in the severity symptoms and the global assessment of efficacy. The quality of life was evaluated as a secondary outcome measure. The patients received either placebo or GutGard (75 mg twice daily) for 30 days. Efficacy was evaluated in terms of change in the severity of symptoms (as measured by 7-point Likert scale), the global assessment of efficacy, and the assessment of quality of life using the short-form Nepean Dyspepsia Index. In comparison with placebo, GutGard showed a significant decrease (P ≤ .05) in total symptom scores on day 15 and day 30, respectively. Similarly, GutGard showed marked improvement in the global assessment of efficacy in comparison to the placebo. The GutGard group also showed a significant decrease (P ≤ .05) in the Nepean dyspepsia index on day 15 and 30, respectively, when compared to placebo. GutGard was generally found to be safe and well-tolerated by all patients. GutGard has shown significant efficacy in the management of functional dyspepsia.