Dyspepsia-related Health Research Articles

Author's reply: "A question on dyspeptic patients analyzed by psychometric scores".

First of all, we want to thank Pellicano et al. for their comments on our article "New psychometric data from the Spanish versions of the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health scale measures". The aim is always the scientific improvement of the manuscript.

New psychometric data from the Spanish versions of the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale measures.

There are no structural abnormalities in functional dyspepsia, therefore it is essential to have a viable questionnaire to measure treatment outcome according to patient perception. The aim of the study was to extensively document psychometric characteristics of the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale that are currently available in Spanish. Patients with functional dyspepsia (n = 158) were recruited from a randomized trial that assessed standard vs. standard and psychological treatment. Participants had completed the validation questionnaires and the Medical Outcome Study Short-form 36. Reliability (Cronbach's alpha), validity (Confirmatory Factor Analysis, convergent and known group validity) and responsiveness (minimal clinically important difference) were analyzed. A Confirmatory Factor Analysis of the Glasgow Dyspepsia Severity Score showed a one-factor solution model, but a low Cronbach's alpha (0.61). With regard to the Dyspepsia-Related Health Scale, the Cronbach's alpha (0.80-0.97) and Confirmatory Factor Analysis supported a model with four inter-correlated dimensions and suggested a need to improve the "Satisfaction with dyspepsia-related health" dimension (Cronbach's alpha < 20). Finally, the global scores for both the Glasgow Dyspepsia Severity Score and the Dyspepsia-Related Health Scale were responsive at six months post-treatment, with a minimal clinically important difference of 4 and 6, respectively. Our findings support the continued application of the Dyspepsia-Related Health Scale and the need to improve the "Satisfaction with dyspepsia-related health" dimension. Although the Glasgow Dyspepsia Severity Score is a promising questionnaire, further review of the content is required to eliminate and add items in order to provide greater consistency to the evaluated construct.

Efecto del tratamiento erradicador para Helicobacter pylori en pacientes con dispepsia funcional

This study evaluated Helicobacter pylori eradication therapy in terms of symptomatic response in patients with functional dyspepsia. On the other hand, we analyzed the importance of histologic findings as a predictor of treatment response. In particular, we studied whether antral gastritis (which is associated with peptic ulcer) may predict a greater symptomatic response to Helicobacter pylori eradication in functional dyspepsia. This prospective, randomized, single-center trial included 48 patients with functional dyspepsia and Helicobacter pylori infection (27 women and 21 men, mean age 37 +/- 13.5 years). Twenty-seven patients received a 10-day course of rabeprazole, amoxicillin, and clarithromycin (eradication group), followed by 20 mg of rabeprazole for 3 months. Twenty-one patients received 20 mg of rabeprazole for 3 months (control group). Patients were followed up over a 1-year period. All patients completed the Dyspepsia-Related Health Scale Questionnaire, which studies four dimensions: pain intensity, pain disability, non-pain symptoms, and satisfaction with dyspepsia-related health. There was significant symptomatic improvement (p < 0.002) after 6 and 12 months, which was similar with both treatments. In the multivariate analyses, eradication therapy and less severe symptoms before treatment were the only independent factors. The symptomatic response to Helicobacter pylori eradication after 6 months was significantly greater as compared to control therapy (p = 0.01) in patients with antral gastritis and in the non-pain symptoms dimension of the questionnaire. Both treatments proved to be clinically beneficial in patients with functional dyspepsia. We observed a tendency to greater symptomatic benefit with Helicobacter pylori eradication therapy when compared to control treatment in patients with functional dyspepsia and in a population with a high prevalence of this infection. There is a tendency to symptomatic benefit with Helicobacter pylori eradication therapy in patients with antral gastritis.

Características clinicopatológicas de la dispepsia no investigada en España

Most patients with uninvestigated dyspepsia are diagnosed with functional dyspepsia. Various types of Helicobacter pylori gastritis have been described, each of which is associated with a distinct natural history of the infection (i.e. a different risk of ulcer or gastric cancer). To determine the clinical and pathological characteristics of patients with uninvestigated dyspepsia in our area and the prevalence of the distinct types of H. pylori gastritis among patients with functional dyspepsia. Ninety-eight patients (47 men and 51 women, mean age 35.8+/-13 years) with uninvestigated dyspepsia were included in this study. All the patients completed the Dyspepsia-Related Health Scale and all patients underwent gastroscopy with biopsy and the C13-urea breath test. Fourteen patients had organic causes of dyspepsia and 78 had functional dyspepsia. Fifty-one patients with functional dyspepsia (65%) had H. pylori infection; of these, 27 had pangastritis, 21 had antrum-predominant gastritis, 2 had multifocal atrophic gastritis and 1 had normal gastric mucosa. Among uninfected patients, 2 had multifocal atrophic gastritis. The prevalence of functional dyspepsia in this series was 85%. Twenty-seven percent of patients with functional dyspepsia had a combination of H. pylori infection and antrum-predominant gastritis, the type of gastritis predisposing to duodenal ulcer. Only 5% of the patients had multifocal atrophic gastritis, which is associated with a high risk of gastric cancer.

A Community Screening Program for Helicobacter pylori Saves Money: 10-Year Follow-up of a Randomized Controlled Trial

Population screening and treatment of Helicobacter pylori has been advocated as a means of reducing mortality from gastric cancer, as well as dyspepsia and dyspepsia-related resource use. Previous programs have failed to demonstrate a significant effect on mortality or resource use, but follow-up was only for 1 or 2 years. We aimed to determine the effect of screening for H pylori on dyspepsia and dyspepsia-related resource use over 10 years. H pylori-positive individuals, aged 40-49 years, enrolled in a community screening program, randomized to eradication therapy or placebo in 1994, were sent a validated dyspepsia questionnaire by mail 10 years later, and primary care records were reexamined. Consultation, referral, prescribing, and investigation data related to dyspepsia were extracted. United Kingdom costs were applied to derive total cost per person (1 pound = 1.8 dollars). Of 2324 original participants, 1864 (80%) were traced and contacted. Of these, 1086 (47%) responded, and 919 (40%) agreed to a review of their primary care records. There was a 10-year mean saving in total dyspepsia-related costs of 117 dollars per person (95% confidence interval [CI] = 11 dollars-220 dollars, P = .03) with eradication therapy. Those symptomatic at baseline showed a nonsignificant trend toward resolution of symptoms at 10 years with eradication therapy (relative risk of remaining symptomatic, 0.89; 95% CI: 0.77-1.03). There were significant reductions in total dyspepsia-related health care costs. The savings made were greater than the initial cost of H pylori screening and treatment.

Polymorphisms in genes encoding acetylsalicylic acid metabolizing enzymes are unrelated to upper gastrointestinal health in cardiovascular patients on acetylsalicylic acid

As acetylsalicylic acid is metabolized by UDP-glucuronosyltransferase 1A6 (UGT1A6) and cytochrome P450 2C9 (CYP2C9), interindividual differences in activity of these enzymes may modulate the effects and side-effects of acetylsalicylic acid. The objective of this study was to assess whether polymorphisms in UGT1A6 and CYP2C9 genes are related to the prevalence of upper gastrointestinal symptoms in cardiovascular patients using acetylsalicylic acid for secondary prevention of ischaemic heart disease. Blood samples were taken from acetylsalicylic acid using patients admitted to the Coronary Care Unit. Dyspepsia-related health was evaluated at week 2, using a validated upper gastrointestinal complaint questionnaire. A subset of 160 patients responded to a survey and were eligible to participate in this study. DNA was isolated and UGT1A6 and CYP2C9 genotypes were determined using polymerase chain reaction restricted fragment length polymorphism techniques. Seventy per cent of the patients returned the questionnaire. UGT1A6 and CYP2C9 variant polymorphisms were found in 103 (63%) and 56 (35%) patients, respectively. There was no association between gastrointestinal symptoms and UGT1A6 (OR = 0.80, 95% CI = 0.41-1.56) or CYP2C9 polymorphisms (OR = 0.85, 95% CI = 0.44-1.67). There was no association between polymorphisms in genes encoding for acetylsalicylic acid metabolizing enzymes on the prevalence of gastric complaints in cardiovascular patients on acetylsalicylic acid.

Valdecoxib Is Associated with Improved Dyspepsia-Related Health Compared with Nonspecific NSAIDs in Patients with Osteoarthritis or Rheumatoid Arthritis

Dyspepsia and related gastrointestinal (GI) symptoms are commonly reported by patients taking nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) and significantly impact treatment effectiveness, cost, and quality of life. This study sought to evaluate dyspepsia-related health in osteoarthritis (OA) and rheumatoid arthritis (RA) patients taking valdecoxib compared with patients taking nonspecific NSAIDs. Analysis of two separate, double-blind, placebo-controlled studies: one in RA patients randomized to placebo, valdecoxib (10 and 20 mg once daily [o.d.]) and naproxen (500 mg twice daily [b.i.d.]); one in OA patients randomized to placebo, valdecoxib (10 and 20 mg o.d.), diclofenac (75 mg b.i.d.), or ibuprofen (800 mg three times daily [t.i.d.]). Study population comprised patients with RA in flare or clinically documented OA who required chronic symptomatic treatment with NSAIDs/analgesics. Dyspepsia-related health was evaluated at baseline and weeks 2, 6, and 12 (or early termination) using the validated Severity of Dyspepsia Assessment (SODA) questionnaire. This patient self-report tool consists of scales for evaluating dyspepsia pain intensity, nonpain symptoms, and satisfaction. Analysis was based on the intent-to-treat population with the last observation carried forward. Valdecoxib was significantly better at endpoint than standard doses of naproxen, diclofenac, and ibuprofen for pain intensity scores (p < 0.05), and provided significantly improved nonpain symptom and satisfaction scores compared with naproxen for patients with RA (p < 0.05). For RA patients, the difference between valdecoxib and naproxen pain intensity scores were clinically meaningful; at all the time points, significantly fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increases (>/=10 points) than those receiving naproxen. At 12 wk, fewer patients receiving valdecoxib reported severe dyspepsia pain intensity increases versus those receiving ibuprofen and diclofenac. The GI tolerability of valdecoxib is superior to that of nonspecific NSAIDs, and therefore can potentially have a favorable impact on patient quality of life.

Measuring dyspepsia-related health in randomized trials: the Severity of Dyspepsia Assessment (SODA) and its use in treatment with NSAIDs and COX-2-specific inhibitors.

Dyspepsia is a common problem that is important from the perspectives of both patient health and economics. While there has been variability in the definitions used to describe dyspepsia, there have also been few standardized outcomes tools designed to measure dyspepsia-related health, especially in relation to changes in dyspepsia over time. An evaluative tool was developed, the Severity of Dyspepsia Assessment (SODA), which takes into account the multidimensional nature of dyspepsia using three scales (Pain, Non-pain Symptoms, and Satisfaction with Dyspepsia-related Health) and demonstrates good psychometric properties with respect to validity, reliability and sensitivity to change in the measurement of dyspepsia-related health. Although originally developed for the assessment of uninvestigated dyspepsia, the validation of SODA for use in clinical trials suggested its ability to compare treatment effects of non-specific non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2-specific inhibitors. In comparative trials of celecoxib or valdecoxib with non-specific NSAIDs, COX-2-specific inhibitors were demonstrated to have superior dyspepsia tolerability than non-specific NSAIDs. These data demonstrate that SODA is an effective instrument for measuring dyspepsia-related health with a broad range of applications.

Superior dyspepsia related health in younger and older arthritis patients treated with celecoxib compared with diclofenac

Superior dyspepsia related health in younger and older arthritis patients treated with celecoxib compared with diclofenac

Impact of upper endoscopy on satisfaction in patients with previously uninvestigated dyspepsia

Background: In patients with uninvestigated dyspepsia who undergo endoscopy, the presence of abnormal findings guides subsequent management. However, upper endoscopy is “negative” in the majority of these patients, and the value of endoscopy in these individuals has been questioned. This study evaluated the impact of endoscopy on patient satisfaction in patients with previously uninvestigated dyspepsia. Methods: The study was a secondary analysis of data obtained from a double-blind, randomized placebo-controlled trial, evaluating a 6-week course of omeprazole versus placebo in 140 patients with uninvestigated dyspepsia who were followed for up to 1 year. The setting was the primary care outpatient clinics at the Houston Veterans Affairs Hospital. Participants had to be 18 years of age or older with at least a 1-week history of dyspepsia (epigastric discomfort) without alarm features. Satisfaction was measured at each visit with the Severity of Dyspepsia Assessment, a validated, reliable dyspepsia-related health measure that has a satisfaction scale (scores 2-23; higher scores indicate greater satisfaction). Patients unresponsive to empiric therapy with placebo or omeprazole based on predefined criteria underwent endoscopy. Severity of Dyspepsia Assessment satisfaction scores were analyzed for 5 visits: 2 closest in time to, but before, the day of endoscopy (Times 1 and 2); immediately before endoscopy (Time 3); and the 2 visits closest in time after endoscopy (Times 4 and 5). After determining there was no difference in treatment failure rates between patients who received placebo or omeprazole, data from these groups were combined. The mean Severity of Dyspepsia Assessment satisfaction scores for Times 1 through 5 in all patients who underwent endoscopy were compared as well as for subgroups with positive and negative endoscopic findings with a repeated-measures analysis of variance. Results: Data on all 5 visits were available in 62 patients, 36 of whom had a negative endoscopy. For all patients the mean scores for Time 2 (8.5; 95% CI [7.4, 9.6]), and Time 3 (7.6; 95% CI [6.6, 8.6]) were significantly lower than those for Time 4 (13.7; 95% CI [12.2, 15.3]) and Time 5 (14.4; 95% CI [12.9, 15.9]). The mean score for Time 1 (11.1; 95% CI [9.5, 12.6]) was significantly lower than the mean score for Time 5. Similar significant improvements in satisfaction scores were observed in subgroups with negative and positive findings. Conclusions: In patients with previously uninvestigated dyspepsia, endoscopy leads to improved patient satisfaction regardless of the endoscopic findings. (Gastrointest Endosc 2003;57:295-9.)

A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia

OBJECTIVES: In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS: We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.i.d. versus placebo capsules p.o. b.i.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score ≥29 (scores, 2–47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS: We enrolled 140 patients. The mean age was 51 yr, and seven (5%) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17%) in the omeprazole group failed compared with 24 of 69 (35%) in the placebo group ( p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30%) in the omeprazole group failed compared with 31 of 69 (45%) in the placebo group ( p = 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52%) in the omeprazole group failed compared with 41 of 69 (59%) in the placebo group ( p = 0.28, log rank test). CONCLUSIONS: In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.

Reliability, validity, and responsiveness of Severity of Dyspepsia Assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy

OBJECTIVES: We aimed to assess the Severity of Dyspepsia Assessment (SODA) scales as measures of change in dyspepsia-related health in a blinded, randomized, controlled trial in arthritis patients treated with nonsteroidal anti-inflammatory drugs. METHODS: Three thousand nine hundred seven arthritis patients completed SODA at baseline and weeks 4, 13, 26, and 52 and/or at early termination. Using baseline and 4-wk data, reliability was evaluated with Cronbach’s α and the intraclass correlation coefficient (ICC). Dyspepsia adverse events were defined based on a combined set of World Health Organization Adverse Reaction Terminology terms. The ability of SODA to measure change in dyspepsia-related health was evaluated by comparing SODA change scores by dyspepsia adverse event severity level and withdrawal status. Responsiveness was further evaluated by the area under the curve (AUC) from receiver operating characteristic curves using withdrawal due to dyspepsia as the criterion. RESULTS: The SODA scales—Pain Intensity (α = 0.93), Non Pain Symptoms (α = 0.82), and Satisfaction (α = 0.89)—demonstrated excellent internal consistency reliability using baseline data. Reproducibility was fair to good: Pain Intensity ICC = 0.49, Non Pain Symptoms ICC = 0.61, and Satisfaction ICC = 0.45. SODA change scores (4-wk score − baseline score) increased, or worsened, with increasing dyspepsia severity and differentiated between adjacent levels of dyspepsia severity for eight of nine adjacent comparisons ( p < 0.05). SODA change scores also differentiated between those who did and did not withdraw ( p < 0.001). Responsiveness was highest with the Pain Intensity scale (AUC = 0.78), followed by the Non Pain Symptoms (AUC = 0.74) and Satisfaction (AUC = 0.75) scales. CONCLUSIONS: SODA is a reliable, valid instrument for use as a measure of dyspepsia tolerability in future clinical trials involving cyclo-oxygenase-2-specific and/or traditional nonsteroidal anti-inflammatory drugs.

SODA (severity of dyspepsia assessment): A new effective outcome measure for dyspepsia-related health

The aim of this research was to develop and evaluate an instrument for measuring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up visits to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 years, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Symptoms, and Satisfaction scales were 0.97, 0.90, and 0.92, respectively. The mean change scores for all three scales discriminated between patients who reported they were improved versus those who were unchanged, providing evidence of validity. The effect sizes for the Pain Intensity (.98) and Satisfaction (.87) scales were large, providing evidence for responsiveness. The effect size for the Non-Pain Symptoms scale was small (.24), indicating lower responsiveness in this study sample. SODA is a new, effective instrument for measuring dyspepsia-related health. SODA is multidimensional and responsive to clinically meaningful change with demonstrated reliability and validity.

Evaluation of a Multidimensional Measure of Dyspepsia-Related Health for Use in a Randomized Clinical Trial

In previous work, we developed a multidimensional measure of dyspepsia-related health. To evaluate the adequacy of this instrument as an outcome measure for a large-scale, multicenter, randomized clinical trial, we used Rasch analysis to address three questions: (1) Are the scales interval-level? (2) Do the scales measure precisely across the entire range of dyspepsia outcomes? (3) Do the scales’ items have an optimal number of response categories? We found that the scales were not interval-level and that they did not measure effectively at low or high levels of the dyspepsia-related outcomes. Our results also suggest that patients were capable of discriminating among only four- to seven-item response categories. Further studies are needed to identify items that effectively measure high and low levels of dyspepsia-related outcomes and to validate that decreasing the number of response categories improves the psychometric properties of these scales.

Dyspepsia: How Should We Measure It?

This study developed and validated a multidimensional measure of dyspepsia. A questionnaire was administered to 126 patients with dyspepsia who presented for care at a VA outpatient clinic and a family physician's private office. Dyspepsia-specific health was measured by self-report using: (1) an existing dyspepsia scale that produces an aggregate score by summing ratings across pain and non-pain symptoms; (2) adaptations of two scales originally designed to measure back pain; and (3) a new scale measuring satisfaction with dyspepsia-related health. Generic health was measured using the SF-36. Results from factor analysis revealed four dimensions of dyspepsia-related health: pain intensity, pain disability, non-pain symptoms, and satisfaction with dyspepsia-related health. After refinements, scales representing the four dimensions conformed to psychometric standards for reliability, and convergent and discriminant validity. The importance of measuring dyspepsia using a multidimensional approach was confirmed by demonstrating that classification of dyspepsia severity depended on the dimension that was assessed. We conclude that dyspepsia is best measured using a multidimensional approach.