Quality Of Life In Reflux And Dyspepsia Scores Research Articles

Effect of Fermented Soybean (FSB) Supplementation on Gastroesophageal Reflux Disease (GERD).

Gastroesophageal reflux disease (GERD) is a prevalent chronic condition affecting the well-being of both adults and children in general medical practice. Research on the effects of fermented soybean (SB) supplementation in managing GERD is relatively new, with limited studies available. The existing research often lacks sufficient dosing regimens and study durations to differentiate between transient placebo effects and sustained benefits. In this study, the beneficial effects of FSB supplementation were investigated in 110 voluntary participants (NCT06524271). The participants were required to take 1 g of FSB supplement once daily for 12 weeks. GERD symptoms were evaluated using the Reflux Disease Questionnaire (RDQ), while inflammatory markers, including interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-8 (IL-8), were measured to assess inflammation. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to evaluate participants' quality of life. The results indicated that FSB supplementation significantly (p < 0.05) alleviated heartburn and regurgitation symptoms and reduced levels of IL-4, IL-6, and IL-8, indicating a notable anti-inflammatory effect. Additionally, significant (p < 0.05) improvements were observed in QOLRAD scores, particularly in vitality, emotional distress, and physical/social functioning. Collectively, our findings support the use of FSB as an adjuvant approach in managing GERD, with notable improvements in patients' quality of life.

5-Year Collis-Nissen Gastroplasty Outcomes for Type III-IV Hiatal Hernia with Short Esophagus: A Prospective Observational Study.

To assess the 5-year outcomes of patients undergoing Collis-Nissen gastroplasty for type III-IV hiatal hernia with short esophagus. From a prospective observational cohort of patients who underwent antireflux surgery for type III-IV hiatal hernia between 2009 and 2020, those with short esophagus (abdominal length <2.5 cm) in whom a Collis-Nissen procedure was performed and reached at least 5 years of follow-up were identified. Hernia recurrence, patients' symptoms, and quality of life were assessed annually by barium meal x-ray, upper endoscopy, and validated symptoms and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. Of the 114 patients with Collis-Nissen gastroplasty, 80 patients who completed a 5-year follow-up were included (mean age 71 years). There were no postoperative leaks or deaths. Recurrent hiatal hernia (any size) was identified in 7 patients (8.8%). Heartburn, regurgitation, chest pain, and cough were significantly improved at each follow-up interval (p < 0.05). Preoperative dysphagia disappeared or improved in 26 of 30 patients, while new-onset dysphagia occurred in 6. Mean postoperative QOLRAD scores significantly improved at all dimensions (p < 0.05). Collis gastroplasty combined with Nissen fundoplication provides low hernia recurrence, good control of symptoms, and improved quality of life in patients with large hiatal hernia and short esophagus.

Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy

ObjectiveLimited data exist on the impact of regurgitation on health-related quality of life (HRQOL) in gastro-oesophageal reflux disease (GORD). We assessed the relationship between regurgitation frequency and HRQOL before and...

The impact of intensifying acid suppression on sleep disturbance related to gastro‐oesophageal reflux disease in primary care

Sleep disturbance is common in patients with GERD but there has been little evaluation of this problem in primary care in patients already taking therapy. To evaluate the impact of administering a questionnaire (PASS test) to identify patients with sleep problems and evaluate the efficacy of esomeprazole to improve sleep disturbance in patients with GERD. This was a primary care based cluster-randomised, open-label study where practices were assigned to intervention or control groups. PASS test failures continued current therapy (control) or were switched to 4weeks' once-daily esomeprazole 20 or 40mg (intervention). Patients were evaluated at the end of 4weeks and the outcomes that were assessed were the sleep questions from the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the presence or absence of sleep disturbance from the PASS test questionnaire. A total of 1388 patients with evaluable data at 4weeks were included in the analysis and 825 reported GERD-related sleep disturbance at baseline. At 4weeks, 161 of 291 of control patients (55%) reported continued sleep disturbance compared to 120 of 534 (22.5%) of intervention patients [number needed to treat of 3: 95% confidence intervals (CI): 2.5-4]. There was a mean improvement in QOLRAD scores related to sleep in the intervention patients compared to control patients (mean improvement=4.91; 95% CI: 3.73-6.09). A PASS strategy identifies GERD patients with sleep disturbance in primary care that will benefit from a change in acid-suppressive therapy. ClinicalTrials.gov identifier: NCT00392002; study code: D9612L00096.

Open Access Capture of Patients With Gastroesophageal Reflux Disease Using an Online Patient-Reported Outcomes Instrument

BackgroundPersons with gastroesophageal reflux disease (GERD) frequently search online for information about causes and treatment options. The GerdQ self-assessment questionnaire can be used for diagnosis of GERD and follow-up of symptoms.ObjectivesTo assess whether it is feasible (1) to study the prevalence and impact of GERD in persons visiting a GERD information website, and (2) to identify partial responsiveness to proton pump inhibitor (PPI) therapy using the GerdQ.MethodsAll visitors (aged 18–79 years) to a GERD information website between November 2008 and May 2011 were invited to complete the GerdQ online. The GerdQ questionnaire consists of 6 questions (score per question: 0–3). In respondents who did not use PPIs, we used the questionnaire to identify those with GERD (total score ≥8) and assess the influence of these symptoms on their daily life, divided into low (total score <3 on impact questions) and high impact (total score ≥3 on impact questions). In PPI users, we used the GerdQ to quantify partial responsiveness by any report of heartburn, regurgitation, sleep disturbance, or over-the-counter medication use for more than 1 day in the preceding week. We subsequently asked GerdQ respondents scoring ≥8 to complete the disease-specific Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.ResultsA total of 131,286 visitors completed the GerdQ, of whom 80.23% (n = 105,329) did not use a PPI. Of these, we identified 67,379 respondents (63.97%) to have GERD (n = 32,935; 48.88% high impact). We invited 14,028 non-PPI users to complete the QOLRAD questionnaire, of whom 1231 (8.78%) completed the questionnaire. Mean total QOLRAD scores were 5.14 (SEM 0.04) for those with high-impact GERD and 5.77 (SEM 0.04) for those with low-impact GERD (P < .001). In PPI users, 22,826 of 25,957 respondents (87.94%) reported partial responsiveness. We invited 6238 PPI users to complete the QOLRAD questionnaire, of whom 599 (9.60%) completed the disease-specific quality-of-life questionnaire. Mean total QOLRAD scores were 4.62 (SEM 0.05) for partial responders and 5.88 (SEM 0.14) for adequate responders (P < .001).ConclusionsThe GerdQ identified GERD in many website respondents and measured partial responsiveness in the majority of PPI users. Both non-PPI users with GERD and PPI users with partial responsiveness were associated with a decreased health-related quality of life. We have shown the feasibility of GERD patient identification online.

Use of the Montreal global definition as an assessment of quality of life in reflux disease

According to the Montreal Consensus Group's classification, gastroesophageal reflux disease develops when the reflux of stomach contents causes troublesome symptoms and/or complications such as esophagitis. The characteristic gastroesophageal reflux disease symptoms included in this statement are retrosternal burning and regurgitation. Troublesome is meant to imply that these symptoms impact on the well-being of affected individuals; in essence, quality of life (QOL). Whether heartburn and regurgitation symptoms would be characterized as more troublesome in those with confirmed pathologic acid reflux was determined. A second purpose was to assess how well troublesome scores correlated with the results of a validated, disease-specific QOL instrument. Subjects who underwent esophagogastroduodenoscopy (EGD) with 48-hour wireless esophageal pH testing off proton pump inhibitor therapy were interviewed. Esophagitis on EGD or pH < 4.0 for ≥4.5% of time over the 2-day period was considered positive for acid reflux. Assessment of how troublesome their symptoms of heartburn and regurgitation were made using separate 0-100 visual analog scales (VAS). Subjects were then asked to complete the Quality of Life in Reflux and Dyspepsia (QOLRAD) 25-item questionnaire. Sixty-seven patients (21 males, 46 females) with mean age 47.8 ± 15.6 years were identified. Forty (59.7%) had an EGD or pH study positive for acid reflux. Overall 35/40 (87.5%) complained of either heartburn or regurgitation. There was no difference (P= 0.80) in heartburn VAS troublesome ratings for those with (54.0 ± 43.9) and without (56.7 ± 37.6) confirmed acid reflux. The same was true for regurgitation VAS troublesome ratings (P= 0.62). Likewise, mean QOLRAD scores did not differ between those with and without confirmed acid reflux by pH or EGD (4.5 ± 1.7 vs. 4.3 ± 1.7; P= 0.61). There was a moderately strong inverse correlation between patient self-rated VAS troublesome scores for both heartburn and regurgitation with each dimension (emotional distress, sleep disturbance, eating problems, physical/social functioning, and vitality) of the QOLRAD (P < 0.05 for all comparisons). In regression analysis, both heartburn and regurgitation troublesome ratings were associated with the overall QOLRAD score independent of pH data, frequency of reflux episodes, age, and gender. Use of the term troublesome in the Montreal Consensus Group classification is supported by our findings. It correlates well with the results of a validated disease-specific QOL instrument. Use of heartburn and regurgitation VAS may serve as accurate measures of the burden of reflux disease on patients. It is likely that these scales will not have sufficient discriminate value to identify individuals with pathologic acid reflux from those with negative studies.

Use of the Montreal Global Definition as an Assessment of Quality of Life in Reflux Disease

Purpose: According to the Montreal Group's Classification, GERD develops when the reflux of stomach contents causes troublesome symptoms and/or complications such as esophagitis. The characteristic GERD symptoms included in this statement are retrosternal burning and regurgitation. Troublesome is meant to imply that these symptoms impact on the well-being of affected individuals; in essence, quality of life. We sought to determine whether heartburn and regurgitation symptoms would be characterized as more troublesome in those with confirmed pathologic acid reflux. A second purpose was to assess how well troublesome scores correlated with the results of a validated, disease-specific quality of life instrument. Methods: We interviewed subjects who underwent EGD with 48 hour wireless esophageal pH testing off PPI therapy. Esophagitis on EGD or pH < 4.0 for ≥ 4.5% of time over the two day period was considered positive for acid reflux. We assessed how troublesome their symptoms of heartburn and regurgitation were using separate 0-100 visual analog scales. We then asked them to complete the Quality of Life in Reflux and Dyspepsia (QOLRAD) 25- item questionnaire. Results: We identified 67 patients (21M, 46 F); mean age 47.8 ± 15.6 years. Forty (59.7%) had an EGD or pH study positive for acid reflux. Overall 35/40 (87.5%) complained of either heartburn or regurgitation. There was no difference (P = 0.80) in heartburn VAS troublesome ratings for those with (54.0 ± 43.9) and without (56.7 ± 37.6) confirmed acid reflux. The same was true for regurgitation VAS troublesome ratings (P = 0.62). Likewise, mean QOLRAD scores did not differ between those with and without confirmed acid reflux by pH or EGD (4.5 ± 1.7 vs. 4.3 ± 1.7; p = 0.61). There was a strong inverse correlation between patient self-rated VAS troublesome scores for both heartburn and regurgitation with each dimension (Emotional Distress, Sleep Disturbance, Eating Problems, Physical/Social Functioning, and Vitality) of the QOLRAD (p < 0.05 for all comparisons). In regression analysis, both heartburn and regurgitation troublesome ratings were associated with the overall QOLRAD score independent of pH data, frequency of reflux episodes, age, and gender. Conclusion: Use of the term troublesome in the Montreal Classification is supported by our findings. It correlates well with the results of a validated diseasespecific quality of life instrument. Use of heartburn and regurgitation VAS may serve as accurate measures of the burden of reflux disease on patients. It is likely that these scales will not have sufficient discriminate value to identify individuals with pathologic acid reflux from those with negative studies.

Psychometric validation of the Dutch translation of the quality of life in reflux and dyspepsia (QOLRAD) questionnaire in patients with gastroesophageal reflux disease

BackgroundThe Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire is one of the best-characterized disease-specific instruments that captures health-related problems and symptom-patterns in patients with gastroesophageal reflux disease (GERD). This paper reports the psychometric validation of a Dutch translation of the QOLRAD questionnaire in gastroenterology outpatients with GERD.MethodsPatients completed the QOLRAD questionnaire at visit 1 (baseline), visit 2 (after 2, 4 or 8 weeks of acute treatment with esomeprazole 40 mg once daily), and visit 4 (after 6 months with on-demand esomeprazole 40 mg once daily or continuous esomeprazole 20 mg once daily). Symptoms were assessed at each visit, and patient satisfaction was assessed at visits 2 and 4.ResultsOf the 1166 patients entered in the study, 97.3% had moderate or severe heartburn and 55.5% had moderate or severe regurgitation at baseline. At visit 2, symptoms of heartburn and regurgitation were mild or absent in 96.7% and 97.7%, respectively, and 95.3% of patients reported being satisfied with the treatment. The internal consistency and reliability of the QOLRAD questionnaire (range: 0.83-0.92) supported construct validity. Convergent validity was moderate to low. Known-groups validity was confirmed by a negative correlation between the QOLRAD score and clinician-assessed severity of GERD symptoms. Effect sizes (1.15-1.93) and standardized response means (1.17-1.86) showed good responsiveness to change. GERD symptoms had a negative impact on patients' lives.ConclusionsThe psychometric characteristics of the Dutch translation of the QOLRAD questionnaire were found to be satisfactory, with good reliability and responsiveness to change, although convergent validity was at best moderate.

Counselling by Primary Care Physicians May Help Patients with Heartburn-Predominant Uninvestigated Dyspepsia

To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life. Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician's discretion. The primary end point was the baseline change in Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire score. A total of 135 patients from nine centres were included in the intention-to-treat analysis. There was a statistically significant baseline improvement in all domains of the QOLRAD questionnaire in both study arms at four and seven months (P<0.0001). After four months, the overall mean change in QOLRAD score appeared greater in the comprehensive counselling group than in the basic counselling group (1.77 versus 1.47, respectively); however, this difference was not statistically significant (P=0.07). After seven months, the overall mean baseline change in QOLRAD score between the comprehensive and basic counselling groups was not statistically significant (1.69 versus 1.56, respectively; P=0.63). A standardized, comprehensive counselling intervention showed a positive initial trend in improving quality of life in patients with heartburn-predominant uninvestigated dyspepsia. Further investigation is needed to confirm the potential benefits of providing patients with comprehensive counselling regarding disease management.

Health‐related quality of life in patients with gastro‐oesophageal reflux disease under routine care: 5‐year follow‐up results of the ProGERD study

Gastro-oesophageal reflux disease (GERD) is a common disorder associated with substantial reductions in health-related quality of life (HRQL). To describe patterns of change in HRQL during 5 years of follow-up in a large population of GERD patients. In 2000, a total of 6215 GERD patients were enrolled in the Progression of GERD (ProGERD) study. During follow-up, patients received any medication considered necessary. HRQL was assessed yearly with the Short-Form 36 and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. Associations between patient characteristics and changes in HRQL were analysed using multiple logistic regression models. After 5 years, data on HRQL were available for 4597 (74%) patients. Both generic and disease-specific HRQL improved after baseline and remained well above baseline levels in the following years. A clinically relevant decrease in QOLRAD scores was reported by 3-5% of patients. According to our multivariate analysis, a decrease in HRQL was associated with a higher reflux symptom load and the presence of night-time heartburn. Only a small minority of the ProGERD population reported a clinically relevant decrease in HRQL, which was associated most strongly with nocturnal heartburn.

Medical or Surgical Management of GERD Patients with Barrett’s Esophagus: The LOTUS Trial 3-Year Experience

IntroductionThe long-term management of gastroesophageal reflux in patients with Barrett’s esophagus (BE) is not well supported by an evidence-based consensus. We compare treatment outcome in patients with and without BE submitted to standardized laparoscopic antireflux surgery (LARS) or esomeprazole treatment. MethodsIn the Long-Term Usage of Acid Suppression Versus Antireflux Surgery trial (a European multicenter randomized study), LARS was compared with dose-adjusted esomeprazole (20–40 mg daily). Operative difficulty, complications, symptom outcomes [Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD)], and treatment failure at 3 years and pH testing (after 6 months) are reported. ResultsOf 554 patients with gastroesophageal reflux disease, 60 had BE—28 randomized to esomeprazole and 32 to LARS. Very few BE patients on either treatment strategy (four of 60) experienced treatment failure during the 3-year follow-up. Esophageal pH in BE patients was significantly better controlled after surgical treatment than after esomeprazole (p = 0.002), although mean GSRS and QOLRAD scores were similar for the two therapies at baseline and at 3 years. Although operative difficulty was slightly greater in patients with BE than those without, there was no difference in postoperative complications or level of symptomatic reflux control. ConclusionIn a well-controlled surgical environment, the success of LARS is similar in patients with or without BE and matches optimized medical therapy.

An International Comparison of the Burden of Illness in Patients with Dyspepsia

Background/Aims: This study investigates the symptoms and the impact of symptoms on health-related quality of life (HRQL) in patients consulting with dyspepsia. Methods: Consecutive patients with a diagnosis of dyspepsia were recruited from primary and secondary care in Germany, Hungary, Italy, Poland, South Africa and Spain. Investigators assessed symptom frequency and severity, and subjects completed the following questionnaires: the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire, the Hospital Anxiety and Depression (HAD) scale and the Short Form 36 (SF-36). Results: 853 dyspepsia patients were included. Mean GSRS scores showed that patients were most troubled by abdominal pain and indigestion. QOLRAD scores indicated that symptoms caused emotional distress, food/drink problems and reduced vitality, with a lesser effect on sleep and physical functioning. Mean SF-36 scores were lower than mean normative values for all domains, indicating that patients had a worse HRQL than the normal population, particularly for Bodily Pain, Role Physical and Role Emotional. Of patients in each country, 18–43% were anxious and 11–21% were depressed. Conclusions: Patients with dyspepsia have reduced HRQL because their symptoms – particularly abdominal pain and indigestion – cause emotional distress, problems with food and drink, and impaired vitality.

Medium‐term Outcome of Endoluminal Gastroplication With the EndoCinch Device in Children

Endoluminal gastroplication (EG) is emerging as a minimally invasive procedure for the treatment of gastroesophageal reflux disease (GERD). The aim of this study is to evaluate the medium-term outcomes after EG in a pediatric patient population. Seventeen children with a median age of 12.4 years (range 6.1-15.9 years) with GERD underwent EG using a flexible endoscopic sewing device (EndoCinch) over a period of 3 years. Three plications were placed in the gastric tissue below the lower esophageal sphincter. Drug dose requirement, pH measurements, symptom severity and frequency, and validated Quality of Life in Reflux and Dyspepsia (QOLRAD) scores were compared before EG and 1 and 3 years after EG. Statistical analysis was performed using a Wilcoxon rank-sum test and P < 0.05 was the threshold for significance. All patients showed an immediate posttreatment improvement in symptom severity, symptom frequency, and quality of life scores. Completed 1- and 3-year data were obtained from 16 patients. Four cases (25%) required a repeat procedure as a result of recurrence of symptoms after 2 to 24 months. Fourteen patients (88%) at 1 year and 9 patients (56%) at 3 years remained without a need for any antireflux medication. A sustained improvement in heartburn (P = 0.004), regurgitation (P = 0.017), and vomiting (P = 0.018) was seen at 3 years. The total QOLRAD score (maximum of 175) improved from a median of 87 (range 69-142) to 156 (range 111-175) at 1 year (P < 0.0001) and 153.5 (range 55-174) at 3 years (P = 0.002). EG is an effective and safe procedure in children. It is a viable option for the treatment of GERD refractory to or dependent on antireflux medications.

Long-term evaluation of patient satisfaction and reflux symptoms after laparoscopic fundoplication with Collis gastroplasty

Esophageal shortening is a complication of advanced gastroesophageal reflux disease (GERD). For patients with short esophagus, Collis gastroplasty combined with fundoplication provides excellent symptomatic relief from GERD disease. The literature lacks studies comparing satisfaction and reflux symptoms between patients who underwent Nissen fundoplication with Collis gastroplasty and those who had primary fundoplication alone. This study aimed to assess long-term satisfaction and GERD-related quality of life after laparoscopic Collis-Nissen fundoplication, and to compare them with those for Nissen fundoplication alone. A nested case-control study was conducted. In this study, 14 cases of laparoscopic Collis-Nissen fundoplications were matched for age, gender, and length of the follow-up period to a cohort of 120 control subjects who underwent laparoscopic Nissen fundoplication. All the patients were mailed a follow-up survey which included a Short Form-12 (SF-12) health status (quality-of-life) questionnaire (a validated quality-of-life instrument), a Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire (a GERD-specific quality-of-life instrument), and queries regarding long-term satisfaction and medication use. Both groups showed a significant postoperative increase in QOLRAD mean scores (p = 0.01). However, the difference in the delta (postoperative-preoperative) score between the two groups was not significant (Fig. 1). There were no differences in mental (MCS) or physical (PCS) SF-12 scores between the two groups. The rate of satisfaction with the surgery was similar in the Nissen-Collis fundoplication (87.5%) and Nissen fundoplication (87%) groups. Collis gastroplasty combined with Nissen fundoplication is an effective procedure for patients with a shortened esophagus diagnosed intraoperatively during antireflux surgery. Patient satisfaction, postoperative quality of life, and QOLRAD score improvement after this procedure are comparable with those observed in patients treated with Nissen fundoplication alone.

Measuring change in quality of life in response to Helicobacter pylori eradication in peptic ulcer disease: the QOLRAD.

This study was designed to determine if a new condition-specific quality of life measure, the Quality Of Life in Reflux And Dyspepsia (QOLRAD), was responsive to clinical change over a four-week period when evaluating peptic ulcer disease patients undergoing Helicobacter pylori (Hp) eradication. A secondary aim was to evaluate QOLRAD's psychometric performance. Hp-positive patients with peptic ulcer disease were recruited from primary care and gastroenterology clinics (N = 155). QOLRAD scores improved significantly (P < 0.0001) and mean total score increase was 1.07 points on a 7-point scale among 111 subjects who responded to Hp eradication. Effect sizes were moderate for responders (0.64) and low for nonresponders (0.36). Score changes below 0.60 were associated with the smallest improvement in patient and physician condition rating; scores above 1.2 were associated with the greatest improvement. The QOLRAD demonstrates reliability and validity. Changes in QOLRAD score can be meaningfully related to clinical changes, aiding evaluation of health-related quality of life in peptic ulcer disease.