Quality Of Life In Reflux And Dyspepsia Research Articles

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.

Heartburn relief with bicarbonate-rich mineral water: results of the randomised, placebo-controlled phase-III trial STOMACH STILL

ObjectiveWe assessed whether the bicarbonate-rich mineral water Staatl. Fachingen STILL is superior over conventional mineral water in relieving heartburn.DesignMulticentre, double-blind, randomised, placebo-controlled trial STOMACH STILL in adult patients with frequent...

GERD is Common and Causes Significant Quality of Life Impairment: Results from Outpatients in Dar es Salaam, Tanzania

Background: Gastroesophageal reflux disease (GERD) is reported to occur in 10-20% of general population in Western countries and in about 5% in Asian countries. There is little data regarding its prevalence, pattern, associated factors and impact on the quality of life in African countries. The aim of this study was to determine the prevalence, pattern, quality of life and factors associated with GERD among outpatients in the city of Dar es Salaam in Tanzania. Methods: Between 01 June 2013 and 31 July 2013, a total of 1062 adults aged 18 years and above were recruited into this cross-sectional study and completed Swahili-language self-administered questionnaires. The Frequency Scale for the Symptoms of GERD questionnaire was used as a diagnostic tool for GERD and quality of life was assessed using the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. Results: The mean age ± standard deviation of the study participants was 46.0±19.5years and 60.5% were females. The prevalence of GERD was 31.5% and was higher among females compared to males (p = 0.001). The quality of life in patients with GERD was lower in all five domains of the QOLRAD questionnaire. About two thirds (59.7%) of patients with GERD had previously sought medical advice and 59.6% had used medications for their GERD symptoms. Conclusions: The prevalence of GERD was high in this patient population and was significantly higher among females compared to men. Participants with GERD demonstrated significant impairment in the quality of life.

Osteopathic treatment in addition to standard care in patients with Gastroesophageal Reflux Disease (GERD) – A pragmatic randomized controlled trial

BackgroundLong-term Proton Pump Inhibitor use is associated with low response rates and the risk of adverse events. ObjectiveThe objective of this study was to assess the effectiveness of Osteopathic Treatment in patients with Gastroesophageal Reflux Disease (GERD). MethodsThis study was a randomized controlled trial with a series of osteopathic interventions and an untreated control group. Patients in the osteopathic group (OG) received 4 osteopathic treatments within a time of eight weeks. The control group (CG) did not receive any osteopathic treatment. Primary outcome parameters were gastrointestinal symptoms, assessed by means of the Reflux Disease Questionnaire (RDQ). Secondary outcome parameters were Quality of life with regards to GERD symptoms, assessed by means of the Quality of Life in Reflux and Dyspepsia (QUOLRAD) questionnaire, medication use and osteopathic dysfunctions. ResultsSeventy patients were randomized. RDQ mean scores decreased statistically significantly in the OG but did not change in the CG; however, these data cannot be interpreted due to a large number of incorrectly completed questionnaires. The between group difference of the changes for the QOLRAD score was statistically significant 0.69 [95%CI = 0.35 to 1.0]. At week 20, changes in the QOLRAD of the OG were sustainable. Medication use decreased substantially in the OG whilst it remained the same in the CG. ConclusionA series of osteopathic treatments might potentially be beneficial for patients suffering from GERD. Future studies should include longer follow-up times and establish the clinical significance of results by introducing a global rating of change measurement.

Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial.

Background: Non-cardiac chest pain is common with two-thirds due to gastroesophageal reflux disease (GERD).Objective: To evaluate the effectiveness and safety of guided vs. empirical therapy in non-cardiac chest pain.Methods: Adults with normal angiogram or stress test were randomized into either a guided or empirical group. In the guided group, after the ambulatory pH-impedance test, if GERD then dexlansoprazole 30 mg/day for 8 weeks, but if functional or hypersensitive chest pain, then theophylline SR 250 mg/day for 4 weeks. In the empirical group, dexlansoprazole 60 mg/day was given for 2 weeks. The primary outcome was global chest pain visual analog score (VAS) and secondary outcomes were Quality of Life in Reflux and Dyspepsia (QOLRAD), GERD questionnaire (GERDQ), and pH parameters, all determined at baseline, 2nd and 8th weeks.Results: Of 200 screened patients, 132 were excluded, and of 68 randomized per-protocol, 33 were in the guided group and 35 in the empirical group. For between-group analysis, mean global pain scores were better with guided vs. empirical group at 8th week (P = 0.005) but not GERDQ or QOLRAD or any of pH measures (all P > 0.05). For within-group analysis, mean QOLRAD improved earliest at 8th week vs. baseline (P = 0.006) in the guided group and 2nd week vs. baseline (P = 0.011) in the empirical group but no differences were seen in other secondary outcomes (P > 0.05). No serious adverse events were reported.Conclusions: Guided approach may be preferred over short-term empirical therapy in symptom response, however QOLRAD, acid-related symptoms, or pH measures are not significantly different (trial registration ID no. NCT03319121).

Quality of life and gastric acid-suppression medication 20 years after laparoscopic fundoplication.

Laparoscopic fundoplication is an effective treatment for gastro-oesophageal reflux disease (GERD). We aimed to assess quality of life (QoL), long-term residual symptoms, patient satisfaction and use of acid-suppression medication at 5, 10 and 20 years after surgery. We identified a cohort of 100 patients who underwent laparoscopic fundoplication between 1993 and 1998. The validated QoL questionnaires Short Form health survey (SF-36), and Quality-of-Life in Reflux and Dyspepsia (QOLRAD), as well as a specific questionnaire regarding post-fundoplication symptoms, were sent to the patients at 5, 10 and 20 years after surgery. Furthermore, patients who reported using the acid-suppression medication after 20 years were interviewed by telephone regarding their reason for taking it. Eighty-eight percent of the patients responded at 5 and 10 years post-surgery. Twenty years following fundoplication, 68 (84% of those still alive) patients completed the questionnaires. The patients had equivalent health-related QoL scores in both the QOLRAD and SF-36 questionnaires after 10 and 20 years, and those scores were in line with a Swedish age-matched population. After 20 years, 87% were satisfied with the results, and 84% of the patients would recommend reflux surgery to a relative or a friend. At the telephone interview, 32% (22/68) confirmed using acid-suppression medication, but only half (11/68) used it because of reflux symptoms. The long-term, satisfying outcomes in GERD symptoms and QoL 5 and 10 years after surgery were maintained at a 20-year follow-up. Half of the patients used acid-suppression medication for reasons other than GERD symptoms.

Validity and reliability of the Quality of Life in Reflux and Dyspepsia (QoLRAD) questionnaire in patients with gastroesophageal reflux disease for the Turkish population.

Gastroesophageal reflux disease negatively affects quality of life. The aim is to improve quality of life because of high recurrence rate. There is a strong need for patient-reported outcome measures. The present study aimed to evaluate the validity and reliability of the Quality of Life in Reflux and Dyspepsia Questionnaire (QoLRAD) to adopt it into Turkish. A total of 142 patients with complaints of heartburn or regurgitation once a week or commonly diagnosed with 24-hour intraesophageal impedance-pH monitoring and/or upper gastrointestinal endoscopy were included in this study. Sociodemographic Data Collection Form, QoLRAD-TR, and Short Form-36 (SF-36) were applied to patients who were off proton pump inhibitors. The Cronbach's alpha coefficient value of the questionnaire was 0.97, and the intraclass correlation coefficient (ICC) value of the result of test-retest method was between 0.97 (Vitality) and 0.99 (Eating/Drinking Disorders). There was a positive correlation between all subdomains of QoLRAD-TR and SF-36 scales. The lowest correlation (0.10) was between Emotional Distress and Role-emotional Limitations, and the highest (0.34) was between Energy and Vitality. The QoLRAD test measuring quality of life, except some subdomains in our study that we performed on patients diagnosed with GERD, was found to be valid and reliable.

Efficacy and tolerability of hydrogen carbonate-rich water for heartburn.

To investigate the efficacy and safety of mineral water with a high content of hydrogen carbonate in patients with heartburn. This open, single-center, single-arm clinical pilot study enrolled 50 patients, 18-64 years old, who had been suffering from heartburn at least twice a week for at least 3 mo before entering the study. Pharmacological treatment of heartburn was not permitted, and patients with severe organic diseases were excluded. After a run-in period of one week, the participants received 1.5 L of the test water for the following 6 wk; 300 mL with meals t.i.d., the remainder to be drunk throughout the day. During the trial, there were five visits at the study center (screening, baseline, two interim visits and the final visit). The efficacy endpoints included incidence and duration of heartburn episodes per week by patient's self-assessment (heartburn diary) as well as changes in symptom severity as per symptom specific questionnaires [Reflux Disease Questionnaire (RDQ); Quality of Life in Reflux and Dyspepsia (QOLRAD); Gastrointestinal Quality of Life Index] and overall health-related quality of life per SF-12 (12-question short form) at each visit. At the end of the study, patients and investigators independently rated the overall efficacy of the test water on a 4-point Likert scale. Safety was assessed by evaluation of adverse events (AEs), vital signs (heart rate, blood pressure) and laboratory parameters. Changes from initial to final examinations were assessed by the non-parametric Wilcoxon test; categorical variables were compared using the χ(2) test, and for more than 5 categories, by the U-test. Twenty-eight participants were men, 22 women. The mean age of the patients in the full analysis set/intention-to treat population (FAS/ITT) was 40.6 years. Forty-two participants completed the study according to the study protocol and formed the per-protocol set (PP population); 48 participants drank the water at least once as requested and were analyzed as ITT population. The occurrence of heartburn was statistically significantly reduced at wk 6 in both the ITT and the PP populations. At wk 6, the mean number of heartburn episodes/week decreased by 5.1 episodes (P < 0.001) and the mean duration of heartburn symptoms by 19 min (ITT) (P = 0.002). The frequency of heartburn symptoms was reduced in 89.6% of the patients (P < 0.001), and the duration of symptoms in 79.2% of patients (ITT) (P < 0.001). All dimensions of the RDQ (heartburn, regurgitation, gastro-esophageal reflux disease symptoms, dyspepsia) showed a significant improvement at 6 wk. Likewise, disease-specific quality of life improved significantly (QOLRAD, GIQLI). Overall, 89.4% of patients rated the efficacy of the test water as "good" or "very good", as did the investigators for 91.5% of the patients. There were no serious AEs. After 6 wk, systolic and diastolic blood pressure values decreased slightly but significantly [-3.5 and -3.0 mmHg, respectively (P = 0.008 and P = 0,002)]. Ninety-six percent of patients and investigators for the same percentage of patients rated the tolerability of the water as "good" or "very good". The data demonstrate effectiveness of a hydrogen carbonate-rich mineral water in alleviating heartburn frequency and severity, thereby improving quality of life. The water has excellent tolerability.

PTH-160 Laparoscopic repair of giant hiatus hernia significantly improves quality of life – a single centre experience

Introduction Centralisation of Upper Gastrointestinal cancer services has been associated with increase in number of referrals of giant hiatus hernia (GHH) over last 5 years. Laparoscopic repair (LR) of GHH is associated with recurrence rate of up to 30% and high mortality and morbidity. Therefore, we offer surgery only to symptomatic patients presenting with reflux, dysphagia, chest symptoms and intermittent gastric volvulus. The aim of this study is to evaluate quality of life (QoL) of these patients after LR of GHH. Method This is a postal questionnaire study of all the patients undergoing GHH repair between 2010 to 2014 in a tertiary referral centre. Patients were sent 2 questionnaires, 1. The Quality of Life in Reflux and Dyspepsia (QOLRAD) and 2. Our own short questionnaire. The QOLRAD questionnaire was made up of 25 questions; each scored out of 7 with 7 representing a high quality of life and 1 representing a low quality of life. A combination of these questions made up 5 dimensions namely emotional distress, sleep disturbance, food/drink problems, physical/social functioning and vitality. The second questionnaire assessed improvement in patient’s individual symptoms namely heartburn/reflux, weight loss, abdominal or chest pain/discomfort, vomiting, shortness of breath, nausea, bloating, difficulty swallowing and also overall improvement in health and QoL on a scale of 0 to 10, 0 being no improvement and 10 being excellent results. Results From a total of 68 patients, 2 died post-operatively (1 was an emergency and the other was an elective case). The other 2 died of unrelated causes. Of the remaining 64 patients, 27 (42.2%) responded. Mean score for each dimension in QOLRAD (out of 7) were as follows-emotional distress (6.15), sleep disturbance (6.22), food/drink problems (6.07), physical/social functioning (6.43) and vitality (6.02). In the second questionnaire, patients scored overall improvement of their symptoms out of 10. Of the 27 patients, 1 (3.7%) scored 1–3, 5 (18.5%) scored 4–6, 3 (11.1%) scored 7–8 and 18 (66.7%) scored 9–10. Similar findings were reported for improvement in QoL. Conclusion Our case series showed acceptable operative mortality of 2.9%; with a significant improvement in QoL in approximately two thirds of patients. Patient selection and standardisation of operation may be responsible for these results. Disclosure of interest None Declared.

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.

Rabeprazole and esomeprazole in mild-to-moderate erosive gastroesophageal reflux disease: A comparative study of efficacy and safety

Objective:To compare the efficacy and safety of rabeprazole and esomeprazole in mild-to-moderate erosive gastroesophageal reflux disease (GERD).Materials and Methods:A randomized, single-blinded, outdoor-based clinical study was conducted on 60 patients of mild-to-moderate erosive GERD. After baseline clinical assessment and investigations, rabeprazole (40 mg) was prescribed to 30 patients and esomeprazole (40 mg) to another 30 patients for 4 weeks. The efficacy variables were change in GERD symptom scoring, endoscopic findings, and Quality of Life in Reflux and Dyspepsia (QOLRAD) scoring over 4 weeks.Result:Heartburn, acid regurgitation, and overall GERD symptom scoring (P = 0.01) were significantly decreased with rabeprazole in comparison to esomeprazole. The comparative study of all five domains of the QOLARD questionnaire including overall scoring revealed a statistically significant improvement in the rabeprazole group. Endoscopic findings in the rabeprazole group showed an absolute improvement of 30% and relative improvement of 55% over esomeprazole. Both the drugs were well tolerated having no significant difference in the incidence of adverse effects.Conclusion:Rabeprazole (40 mg) is a better choice for mild-to-moderate GERD compared with esomeprazole (40 mg) because of its better efficacy and safety profile.

Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole - results from the STARS II study

Patients with dyspepsia often experience troublesome symptoms. To assess the burden of uninvestigated dyspepsia (symptoms, health-related quality of life [HRQL] and work productivity) before and after 8 weeks' esomeprazole treatment. Patients (n=1250) with uninvestigated dyspepsia (no endoscopy within 6 months and ≤ 2 endoscopies within 10 years) underwent a 1-week esomeprazole acid-suppression test before randomisation to 7 weeks' esomeprazole or placebo. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia (QOLRAD) and Work Productivity and Activity Impairment (WPAI) questionnaires were completed at baseline (1-week off-treatment) and 8 weeks. WPAI results were further analysed among patients who responded to the acid-suppression test. The highest baseline symptom score was for the RDQ dyspepsia domain, and the highest disease burden was for QOLRAD vitality and food/drink problems. After 8 weeks, significant improvements vs. placebo were observed for all RDQ and QOLRAD domains. The sub-population of acid-suppression test responders, but not the total WPAI population, had a significant work productivity improvement vs. placebo. Uninvestigated dyspepsia is associated with high symptom load and impacts on HRQL and work productivity. Esomeprazole improves HRQL among such patients, and improves work productivity among 1-week acid-suppression trial responders. ClinicalTrials.gov identifier: NCT00251992.

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.

Impact of gastroesophageal reflux disease on the quality of life of Spanish patients: the relevance of the biometric factors and the severity of symptoms

Gastroesophageal reflux disease (GERD) has a negative impact on health-related quality of life (HRQoL). (i) To evaluate HRQoL in the general Spanish population with GERD. (ii) To analyze the influence of biometric factors and symptoms profile on HRQoL. A multicenter and population-based evaluation was performed. Surveys were sent out to the general population and 335 responders (16%) fulfilled symptomatic criteria of GERD. They filled out two HRQoL questionnaires [Short Form-36 (SF-36) and Quality of Life in Reflux and Dyspepsia]. Biometric factors and symptoms profile were collected. The SF-36 physical and mental component summary scores were calculated. Two hundred and fifty-two individuals (75.2%) participated. SF-36 and Quality of Life in Reflux and Dyspepsia (QoLRAD) punctuations were lower compared with the general population. Female sex, severity of symptoms, and nocturnal symptoms were associated with a greater deterioration of HRQoL. Obese participants had a negative impact on the physical component summary score, but mental component summary score was better than in participants with normal weight. Adjusted by age, punctuations of smokers, exsmokers, and nonsmokers were similar. No differences in HRQoL with regard to alcohol consumption were observed. In participants who fulfill symptomatic criteria of GERD, the HRQoL is very deteriorated. The factors that worsen the QoL are being female, increase in BMI, and nocturnal symptoms.

Validación del Cuestionario sobre Alteraciones de Reflujo (RDQ) y de la Escala de Impacto de la Enfermedad por Reflujo Gastroesofágico (GIS) para población española

To assess the feasibility, reliability, validity and sensitivity of changes in the Reflux Disease Questionnaire (RDQ) and the Gastrointestinal Impact Scale (GIS). An observational, prospective, multicenter study was conducted in primary care centers on two visits (baseline and 16 days later) in a sample of patients with a diagnosis of gastroesophageal reflux disease (GERD) or suspicion of GERD requiring a therapeutic intervention (sensitivity to change group, n=230) and in another sample of patients with clinically controlled GERD (reliability group, n=51). The RDQ questionnaire and GIS scale, both overall and for each domain, showed a Cronbach's alpha of greater than or equal to 0.70. All RDQ domains and the total score, as well as the total GIS score and impact dimension, showed a high correlation between the baseline evaluation and that performed 16 days later in stable patients. The RDQ and GIS showed very high correlations between the total scores and those of the quality of life in reflux and dyspepsia (QOLRAD) (-0.73 and 0.80, respectively), a reflux- and dyspepsia-specific quality of life scale, and a high correlation with the gastrointestinal symptoms rating scale (GSRS) (0.54 and -0.55, respectively), a general scale of gastrointestinal symptoms. Both the RDQ questionnaire and the GIS scale showed significant changes with a high effect size on improvement responses. The RDQ and GIS questionnaires show very good psychometric properties, making them suitable for use in primary care.