Proton pump inhibitor failure in gastro-oesophageal reflux disease: a perspective aided by the Gartner hype cycle.

Some patients with gastro-oesophageal reflux disease (GORD) experience symptoms despite proton pump inhibitor (PPI) treatment. In the early years of their availability, these drugs were thought to be a highly effective treatment for GORD and realisation that symptom relief was often incomplete came as a disappointment. This review considers the evolution of thinking with the aid of the Gartner hype cycle - a graphical depiction of the process of innovation, evolution and adoption of new technologies. Acknowledging that over-simplistic concepts of GORD have been largely responsible for inflated expectations of PPI therapy is an important step forward in establishing how patients with persistent symptoms, despite PPIs, should be assessed and treated.

Discrepancies between upper GI symptoms described by those who have them and their identification by conventional medical terminology: a survey of sufferers in four countries.

OBJECTIVE: The objective of this study was to develop a self-administered questionnaire for upper gastrointestinal (GI) symptoms using lay vocabulary uninfluenced by established medical terminology or concepts and to conduct a survey of symptom occurrence among sufferers in four countries. METHODS: The questionnaire was designed by integrating information gained from the vocabulary used by 38 upper GI symptom sufferers. There was no medical input to its development. The questionnaire was then used, after appropriate translation, in Brazil, Russia, the UK and the USA. Details of 10 659 symptom episodes were obtained from 2665 individuals. RESULTS: Nine symptoms described in lay vocabulary were identified during questionnaire development. Of these, one corresponded to regurgitation, whereas two that were distinguished by survey participants might both be interpreted as heartburn. One chest symptom for which a corresponding medical term was uncertain occurred in ∼30% of the respondents. Five different 'stomach' or abdominal symptoms were identified. The predominant symptom and the pattern of concurrent symptoms often varied from one symptom episode to another. Use of the terms 'heartburn', 'reflux', 'indigestion' and 'burning stomach' to describe symptoms varied between countries. CONCLUSION: Some common upper GI symptoms described by those who suffer them have no clear counterpart in conventional medical terminology. Inadequacy of the conventional terminology in this respect deserves attention, first, to characterize it fully, and thereafter to construct enquiry that delivers more precise symptom identification. Our results suggest that improvement may require the use of vocabulary of individuals suffering the symptoms without imposing conformity with established symptom concepts.

Gastroesophageal and extraesophageal reflux symptoms: similarities and differences.

OBJECTIVES/HYPOTHESIS: The association between extraesophageal reflux (EER) and symptoms of gastroesophageal reflux disease (GERD) is inadequately understood. We used the Comprehensive Reflux Symptom Scale (CReSS) to evaluate EER and reflux-symptom prevalence in gastroenterology and otolaryngology outpatients and symptom awareness among UK gastroenterologists. STUDY DESIGN: Cross-sectional cohort survey. METHODS: Six hundred thirty-nine participants were surveyed: 103 controls, 359 patients undergoing esophagogastroduodenoscopy (EGD), and 177 otolaryngology clinic patients with throat symptoms. Participants completed the CReSS questionnaire. The study was undertaken in the Endoscopy Unit and the Department of Otolaryngology-Head and Neck Surgery, Newcastle upon Tyne Hospitals, Newcastle-upon-Tyne, United Kingdom. Registered members of the British Gastroenterology Society were asked to rate how frequently reflux patients might complain of each CReSS item. RESULTS: The median CReSS total in volunteers (4) was significantly lower (P < .002) than in ear, nose, and throat (ENT) patients (26) or EGD patients with (42) or without (32) esophageal inflammation. All items were scored as ≥1 by >15% of ENT patients and 28% of EGD patients. Three major, robust CReSS factors: esophageal, pharyngeal, and upper airway emerged. Of 259 gastroenterologists, >20% scored 8 of the 34 symptoms as never being reported by reflux patients. CONCLUSIONS: Endorsement of each EER CReSS item by 28% to 58% of patients with endoscopic evidence of GERD supports the Montreal consensus on an EER-GERD continuum. Gastroenterologists vary considerably in their appreciation of EER symptom relevance. The advantages of CReSS include standardized, comprehensive capture of patient experience; discriminant validity of ENT and GERD patients from volunteers; and discrete esophageal, pharyngeal, and upper airway subscales. LEVEL OF EVIDENCE: 4.

Influence of irritable bowel syndrome on treatment outcome in gastroesophageal reflux disease.

AIM: To investigate the influence of irritable bowel syndrome (IBS)-like symptoms on treatment outcomes with pantoprazole in gastroesophageal reflux disease (GERD) in a real life setting. METHODS: For this prospective, open-label, multinational, multicentre study, 1888 patients assessed by the investigators as suffering from GERD were recruited. The patients were additionally classified as with or without IBS-like symptoms at baseline. They were treated with pantoprazole 40 mg once daily and completed the Reflux Questionnaire™ (ReQuest™) short version daily. Response rates and symptom scores were compared after 4 and 8 wk of treatment for subgroups defined by the subclasses of GERD [erosive (ERD) and non-erosive reflux disease (NERD)] and the presence of IBS-like symptoms. RESULTS: IBS-like symptoms were more prevalent in NERD than in ERD (18.3% vs 12.7%, P = 0.0015). Response rates after 4 and/or 8 wk of treatment were lower in patients with IBS-like symptoms than in patients without IBS-like symptoms in both ERD (Week 4: P < 0.0001, Week 8: P < 0.0339) and NERD (Week 8: P = 0.0088). At baseline, ReQuest™ "lower abdominal complaints" symptom scores were highest in NERD patients with IBS-like symptoms. Additionally, these patients had the strongest symptom improvement after treatment compared with all other subgroups. CONCLUSION: IBS-like symptoms influence treatment outcome and symptom burden in GERD and should be considered in management. Proton pump inhibitors can improve IBS-like symptoms, particularly in NERD.

Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole.

BACKGROUND: Management of patients with gastro-oesophageal reflux disease (GORD) can be assisted by information predicting the likely response to proton pump inhibitor (PPI) treatment. The aim was to undertake a study of GORD patients designed to approximate ordinary clinical practice that would identify patient characteristics predicting symptomatic response to pantoprazole treatment. METHODS: 1888 patients with symptoms of GORD were enrolled in a multicentre, multinational, prospective, open study of 8 weeks pantoprazole treatment, 40 mg daily. Response was assessed by using the ReQuest™ questionnaire, by the investigator making conventional clinical enquiry and by asking patients about their satisfaction with symptom control. Factors including pre-treatment oesophagitis, gender, age, body mass index (BMI), Helicobacter pylori status, anxiety and depression, and concurrent IBS symptoms were examined using logistic regression to determine if they were related to response, judged from the ReQuest™-GI score. RESULTS: Poorer treatment responses were associated with non-erosive reflux disease, female gender, lower BMI, anxiety and concurrent irritable bowel syndrome symptoms before treatment. No association was found with age, Helicobacter pylori status or oesophagitis grade. Some reflux-related symptoms were still present in 14% of patients who declared themselves 'well-satisfied' with their symptom control. CONCLUSIONS: Some readily identifiable features help to predict symptomatic responses to a PPI and consequently may help in managing patient expectation. ClinicalTrial.gov identifier: NCT00312806.

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial.

OBJECTIVE: To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD). DESIGN: Multicentre, pragmatic randomised trial (with parallel preference groups). SETTING: 21 hospitals in the United Kingdom. PARTICIPANTS: 357 randomised participants (178 surgical, 179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months. INTERVENTION: The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care. MAIN OUTCOME MEASURES: The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications. MAIN RESULTS: Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group. CONCLUSION: At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD. TRIAL REGISTRATION: ISRCTN15517081.

Non-erosive reflux disease--some clinical case scenarios.

The consensus meeting attempted to clarify concepts associated with the clinical entity often termed 'NERD' and to define it in a way that would permit physicians to communicate accurately amongst each other when they use the term, so that there may be a common understanding of the condition. In this paper, eight clinical case scenarios are presented that illustrate some points of potential uncertainty and ambiguity in the use of the term NERD and the clinical management of patients. They are discussed in relation to views reached by the consensus group.

The nonerosive reflux disease-gastroesophageal reflux disease controversy.

PURPOSE OF REVIEW: To analyse the concept of nonerosive reflux disease (NERD), examining its evolving definition and its relationship to reflux disease and functional gastrointestinal disorders. RECENT FINDINGS: The advent of the Montreal definition of gastroesophageal reflux disease (GERD) and the Rome III definition of functional upper gastrointestinal disorders has refined the concept of NERD. The high prevalence of GERD symptoms and the strong overlap between GERD and irritable bowel syndrome is due to the influence of NERD. Subtle differences exist between patterns of acid exposure in NERD and erosive disease on pH testing. Symptom generation in NERD may be influenced by altered mucosal permeability. Improvements in endoscopic technology demonstrate esophageal mucosal changes in NERD which are not seen in controls. There is a general acknowledgement that the inferior symptomatic response to acid suppression reported in NERD is attributable, at least in part, to contamination of study populations by patients with functional heartburn. SUMMARY: NERD is common and its definition continues to evolve. For the present, however, this should be considered to be heartburn with and without regurgitation due to gastroesophageal reflux in the absence of esophageal mucosal erosions. Future studies examining treatment response of GERD subgroups must exclude functional heartburn if NERD is to be properly understood.

Debate: endoscopy is unnecessary in the management of uncomplicated GERD.

The case of a 56-year-old man with recurrent retrosternal heartburn no longer relieved by antacids is discussed. Arguments for and against conducting endoscopy in this patient are presented. Initial therapy with a standard dose proton pump inhibitor, without endoscopy is the suggested treatment strategy. The main purpose of conducting an endoscopy in a patient with chronic gastrointestinal reflux is to detect the presence of Barrett's esophagus. However, data indicate that the presence of Barrett's esophagus is unrelated to symptoms and that it is not significantly associated with heartburn. Additionally, there is no certainty that survival is improved by the detection of Barrett's esophagus. Nonetheless, many clinical practice guidelines support conducting endoscopy in patients with GERD.