Therapeutics

MANAGEMENT OF DYSPEPSIA: REPORT OF A WORKING PARTY☆

Dyspepsia represents a symptom domain rather than a diagnostic condition and covers a wide range of complex, underlying pathophysiologies that are not well understood. The review explores comparative effectiveness interventions for the treatment of symptomatic dyspepsia along a pragmatic-explanatory continuum. The aim is to identify relevant design characteristics applicable to future upper gastrointestinal comparative effectiveness research employing integrative medicine.

Medline, CINAHL, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL) and WHO Clinical Trials were systematically searched until January 2019. Included articles were original research with two or more comparative intervention arms for the primary outcome; relief of symptomatic dyspepsia. Evaluation of the studies was conducted using the pragmatic-explanatory continuum indicator summary (PRECIS-2) tool.

Thirty-six articles were included in the review. A total of 68 Patient Reported Outcome Measurements (PROMs), utilizing 50 different formats were deployed across the studies. The appraisal process revealed eligibility, flexibility in adherence, flexibility in delivery and organization domains further aligned towards an explanatory design.

This review identified three design characteristics relevant for future comparative effectiveness research for the treatment of upper gastrointestinal disorders in a community setting. Extensive exclusion eligibility criteria limited the generalization of comparative effectiveness study results by removing sub-groups of the target populations more at risk of dyspeptic symptoms. The requirement for entry endoscopy was found to be common and not always pragmatically justifiable. Development of validated PROMs appropriate for a generic application to upper gastrointestinal disorders would be advantageous for future comparative effectiveness research within integrative medicine.

Dyspepsia is a common complaint that can confer significant burden on one's quality of life and may also be associated with serious underlying conditions. The objective of this study was to determine if patients admitted to the emergency department observation unit (EDOU) for severe or persistent dyspepsia would have cost effective management in terms of investigations performed, length and cost of hospital stay. The secondary objective was to determine if any patient characteristics could predict a need for admission to the inpatient unit.

Retrospective chart reviews of patients admitted to the EDOU under the Dyspepsia protocol between January 2008 and August 2014 were conducted. Baseline demographics, investigations performed, outcomes related to EDOU stay, admission and 30-day re-presentation outcomes were recorded.

A total of 1304 patients were included. Median length of stay was 1 day. Cumulative bed-saved days were 38 per month. Two hundred eighteen (16.7%) patients required admission to the inpatient service for further management, while 533 (40.9%) and 313 (24.0%) patients underwent esophagogastroduodenoscopy and hepatobiliary ultrasonography, respectively. No major adverse events were attributed to the EDOU admissions or delays in treatment. No significant clinically relevant factors were associated with a need for admission from the EDOU to the inpatient unit. Median cost of the EDOU admission was approximately one-third that of a similar admission to the inpatient unit.

The EDOU is an appropriate setting to facilitate investigations and treatment of patients with dyspepsia with considerable bed-saved days.

Dyspepsia and gastroesophageal reflux are highly prevalent in the general population, but they are believed to be separate entities. We conducted a systematic review and meta-analysis to estimate the prevalence of dyspepsia in individuals with gastroesophageal reflux symptoms (GERS), and to quantify overlap between the disorders.

We searched MEDLINE, EMBASE, and EMBASE Classic databases to identify population-based studies reporting the prevalence of dyspepsia and GERS in adults, defined using specific symptom-based criteria or based on answers to questionnaires. We calculated pooled prevalence values, according to study location and criteria used to define weekly GERS or dyspepsia, as well as odds ratios (ORs) with 95% CIs. The degree of overlap between dyspepsia and GERS was examined.

Of 14,132 papers evaluated, 79 reported prevalence of weekly GERS. Nineteen of these study populations, comprising 111,459 participants, also reported the proportion of individuals with dyspepsia. The prevalence of dyspepsia in individuals with weekly GERS was 43.9% (95% CI, 35.1%–52.9%). The pooled OR for dyspepsia in individuals with weekly GERS, compared with those without, was 6.94 (95% CI, 4.33%–11.1%). The OR for dyspepsia in individuals with weekly GERS was significantly higher in all geographical regions studied and for all diagnostic criteria. The pooled degree of overlap between dyspepsia and GERS was 25.9% (95% CI, 19.9%–32.4%).

The odds of dyspepsia in individuals with weekly GERS is almost 7-fold that of individuals without GERS; dyspepsia and GERS overlap in more than 25% of individuals. Reasons for this remain speculative, but might include shared pathophysiological mechanisms or residual confounding factors. However, patients with GERS should be questioned about coexistent dyspepsia, to optimize treatment approaches.

Although the Rome III criteria for functional dyspepsia were defined 7 years ago, they have yet to be validated in a rigorous study. We addressed this issue in a secondary-care population.

We analyzed complete symptom, upper gastrointestinal (GI) endoscopy, and histology data from 1452 consecutive adult patients with GI symptoms at 2 hospitals in Hamilton, Ontario, Canada. Assessors were blinded to symptom status. Individuals with normal upper GI endoscopy and histopathology findings from analyses of biopsy specimens were classified as having no organic GI disease. The reference standard used to define the presence of true functional dyspepsia was epigastric pain, early satiety or postprandial fullness, and no organic GI disease. Sensitivity, specificity, and positive and negative likelihood ratios (LRs), with 95% confidence intervals (CIs), were calculated.

Of the 1452 patients, 722 (49.7%) met the Rome III criteria for functional dyspepsia. Endoscopy showed organic GI disease in 170 patients (23.5%) who met the Rome III criteria. The Rome III criteria identified patients with functional dyspepsia with 60.7% sensitivity, 68.7% specificity, a positive LR of 1.94 (95% CI, 1.69-2.22), and a negative LR of 0.57 (95% CI, 0.52-0.63). In contrast, the Rome II criteria identified patients with functional dyspepsia with 71.4% sensitivity, 55.6% specificity, a positive LR of 1.61 (95% CI, 1.45-1.78), and a negative LR of 0.51 (95% CI, 0.45-0.58). The area under a receiver operating characteristics curves did not differ significantly for any of the diagnostic criteria for functional dyspepsia.

In a validation study of 1452 patients with GI symptoms, the Rome III criteria performed only modestly in identifying those with functional dyspepsia, and were not significantly superior to previous definitions.

Recent studies have shown that the high prevalence and the various clinical presentations of gastro-oesophageal reflux disease (GERD) and dyspepsia impose an enormous economic burden on society. Economic cost data have unique characteristics: they are counts, and they have zero inflation. Therefore, these data require special models. Poisson regression (PR), negative binomial regression (NB), zero inflated Poisson (ZIP) and zero inflated negative binomial (ZINB) regression are the models used for analysing cost data in this paper.

In this study, a cross-sectional household survey was distributed to a random sample of individuals between May 2006 and December 2007 in the Tehran province of Iran to determine the prevalence of gastrointestinal symptoms and disorders and their related factors. The cost associated with each item was calculated. PR, NB, ZIP and ZINB models were used to analyse the data. The likelihood ratio test and the Voung test were used to conduct pairwise comparisons of the models. The log likelihood, the Akaike information criterion (AIC) and the Bayesian information criterion (BIC) were used to compare the performances of the models.

According to the likelihood ratio test and the Voung test and all three criteria used to compare the performance of the models, ZINB regression was identified as the best model for analysing the cost data. Sex, age, smoking status, BMI, insurance status and education were significant predictors.

Because the NB model demonstrated a better fit than the PR and ZIP models, over-dispersion was clearly only due to unobserved heterogeneity. In contrast, according to the likelihood ratio test, the ZINB model was more appropriate than the ZIP model.

The ZINB model for the cost data was more appropriate than the other models.