Christina Reimer

Randomised clinical trial: alginate (Gaviscon Advance) vs. placebo as add‐on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor

Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression.

Discontinuation of long-term proton pump inhibitor therapy in primary care patients: a randomized placebo-controlled trial in patients with symptom relapse.

Background A significant proportion of patients treated empirically with a proton pump inhibitor (PPI) present with symptoms of functional dyspepsia with a high placebo-response to therapy. It is possible that a subgroup of empirically treated patients redeem repeated prescriptions because of a positive response to therapy despite symptoms that are not acid related. Objectives To study whether discontinuation of long-term PPI therapy is possible in symptomatically treated patients. To investigate the effect of a PPI in patients with symptom relapse without abnormal endoscopic findings. Methods Seventy-eight long-term primary care PPI users without verified indication for therapy discontinued treatment. In case of symptom recurrence, an endoscopy was performed. Patients without abnormal endoscopic findings were randomized to 7 days oesomeprazole 40 mg once daily or placebo. Results A total of 11 of 78 (14%) patients discontinued the therapy successfully. Fifty-three of 78 patients (68%) experienced symptom recurrence. Thirty-one of 53 patients (59%) had a normal endoscopy. Successful effect of therapy after 7 days was observed in 12 of 15 patients (80%) in the oesomeprazole group versus two of 16 (13%) in the placebo group (P<0.001). Conclusion Discontinuation of long-term PPI therapy is possible in a minority of primary care patients. Short-term oesomeprazole was superior to placebo in patients with symptom recurrence and a normal endoscopy.

A population-based survey to assess troublesome symptoms in gastroesophageal reflux disease.

Objective. A simple frequency and severity threshold for categorizing reflux symptoms as troublesome has been suggested, but there is a lack of confirmatory studies for this threshold. The objectives of this study were to examine the characteristics for troublesome symptoms and to compare different ways of categorizing reflux symptoms as troublesome. Material and methods. Members of a web panel responding to an e-mail invitation (1623/3506, median age interval 40–44 years, 51% female) who reported reflux symptoms during the preceding 4 weeks (n=1284) were linked to the full questionnaire. Associations between self-reported troublesome symptoms (10-graded VAS) and troublesome symptoms (mild symptoms >1 day/week or moderate/severe symptoms ≥ 1 day/week) and clinical characteristics were analyzed. Results. Out of 1284 subjects, 482 (38%) reported reflux symptoms. Agreement on the classification of troublesome symptoms based on frequency and severity and self-reported troublesome symptoms was poor to fair. Using 4 as the cut-off point on the VAS showed the best agreement (kappa = 0.35). Of the 482 symptomatic respondents, 266 (55%) had troublesome symptoms based on frequency and severity and 274 (57%) had self-reported troublesome symptoms. Subjects (n=80) who had self-reported troublesome symptoms, but were not categorized as having troublesome symptoms based on frequency and severity, reported health concerns, work productivity loss and medical treatment significantly more often (p≤0.03) than subjects (n=194) with troublesome symptoms according to both categorizations. Conclusions. Classification of troublesome reflux symptoms based on frequency and severity is too simplistic. Health concerns, disrupted work productivity and night-time symptoms add to the perception of symptoms as troublesome.

Management of laryngopharyngeal reflux with proton pump inhibitors.

There is a lack of consistent guidelines and consensus for the diagnosis of laryngopharyngeal reflux (LPR). A therapeutic trial with a proton pump inhibitor (PPI) has been suggested to identify patients with LPR. This review focuses on the current difficulties in diagnosing the disease and examines the evidence for the effectiveness of PPI therapy in suspected reflux-related laryngeal symptoms. Additionally, mode of action, safety, and tolerability of PPIs are described. A total of 7 placebo-controlled trials were identified and included in the review. All studies evaluated the effect of a PPI on symptoms and objective laryngoscopic findings in suspected LPR. Data from these trials show that PPI therapy is no more effective than placebo in producing symptom relief in patients suspected of LPR. Symptoms, laryngoscopic findings, or abnormal findings on pH monitoring will not predict response to PPI therapy. High placebo response levels suggest a much more complex and multifactorial pathophysiology of LPR than simple acid reflux. Further studies are needed to characterize subgroups of patients with reflux-associated laryngeal symptoms that might benefit from treatment with PPI. Future studies should use validated patient reported outcome measures with endpoints that represent a predefined clinically meaningful change in symptom scores.

Use of antacids, alginates and proton pump inhibitors: a survey of the general Danish population using an internet panel

Abstract Objective. Both over-the-counter medicine, such as antacids or alginates, and proton pump inhibitors (PPI) are used for treating acid-related disorders. We sought to describe what characterizes users of these different medicines, including long-term PPI users within the general population. Method. A cross-sectional survey was conducted in an internet panel representative of the Danish adult population in 2012. Data queried included antacid/alginate and PPI use, reason for therapy, co-medication, and presence of upper gastrointestinal symptoms. Long-term PPI use was defined as using PPI ≥1/3 of the last year (∼120 days). Risk of long-term PPI use was estimated by logistic regression. Results. A total of 18,223 people received the questionnaire, of which 52% (9390) responded. Antacid/alginate use was reported by 23%; 16% reported use of only antacid/alginate. PPI use was reported by 13.6%; 6.2% were defined as long-term PPI users. Antacid/alginate users were younger, used less co-medication, had most often started on therapy because of reflux symptoms, and had less often ongoing symptoms. Risk of long-term PPI use appeared to be increased in male gender, by renewing PPI prescription by phone/e-mail, using co-medication, and having started on PPI for several reasons. Combination of antacid/alginate and PPI was reported by approximately 50% of those on therapy with weekly or daily symptoms. Conclusion. 23% of Danish adults were using antacids or alginates and 14% were using PPI, of which one-half were on long-term therapy. Prescription renewal by phone or e-mail and use of other prescription medication were associated with long-term PPI use, indicating a behavioral pattern, in which unnecessary PPI therapy may be maintained.

Perceptions and Beliefs concerning Gastroesophageal Reflux Disease: Physicians and Patients Disagree

Background/Aim: There is insufficient evidence to support an association between lifestyle and gastroesophageal reflux disease (GERD). Furthermore, perceptions concerning the impact of GERD on lifestyle are largely unknown. We aimed at investigating physicians’ perceptions about GERD and lifestyle and at evaluating physician-patient agreement concerning the impact of GERD on the quality of life. Methods: A questionnaire was mailed to all Danish primary care physicians (n = 3,603, response rate 36%) and to all Danish gastroenterologists (n = 624, response rate 50%). Another questionnaire was completed by 176 GERD patients on medical therapy (84% on proton pump inhibitors). Results: 35% of the physicians believe GERD is predominantly caused by lifestyle and 51% always recommend lifestyle modifications. According to the physicians, the three most frequently affected aspects of quality of life were sleep disturbances (24%), limitations in physical activities (22%) and tiredness (18%). However, according to the patients, the three most frequently reported aspects were dietary restrictions (63%), tiredness/lack of energy (49%) and health concerns (44%). 70% of the physicians considered complete absence of symptoms as a useful goal for therapy. 72% of the patients reported recent symptoms, despite therapy and self-imposed lifestyle restrictions. Conclusions: Physicians and GERD patients disagree on impairments of quality of life. Many patients reported frequent symptoms despite therapy and self-imposed lifestyle restrictions.

Psychometric evaluation of a daily gastro-oesophageal reflux disease symptom measure

Abstract Objective: The objective of this study was to evaluate the validity of the Heartburn Reflux Dyspepsia Questionnaire (HRDQ), a newly developed measure of gastro-oesophageal reflux disease (GORD) symptoms. Specifically, the HRDQ was developed for patients, who still experience symptoms with proton pump inhibitor (PPI) treatment. Material and methods: The psychometric properties of HRDQ were evaluated based on data from two clinical trials of patients with GORD with a partial response to PPIs, one from the UK and one from Denmark and Germany. Results: The HRDQ had good internal consistency (Cronbach’s alpha range .83–.88) and test–retest reliability (intraclass correlation coefficient range .71–.90). Convergent and discriminant validity were supported by high correlations with ReQuest™ and ability to differentiate between groups based on ReQuest™ cut-off values. Responsiveness of HRDQ was demonstrated by moderate to high correlations with ReQuest™ change scores and time with symptoms. An HRDQ cut-off value of 0.70 for definition of ‘bad day’ was also evaluated. Conclusions: Based on existing evidence, the HRDQ is a valid and reliable measure of GORD symptoms that can be used as a study outcome in clinical trials.

Contents Vol. 76, 2007

C. Beglinger, Basel (Switzerland) B. Göke, Munich (Germany) International Journal of Gastroenterology Founded as ‘Archiv für Verdauungskrankheiten’ 1895 by I. Boas Continued as ‘Gastroenterologia’ 1939–1967 Former Editors: P. Morawitz (1934–1936), R. Staehelin (1937–1943), A. Hurst (1940–1945), W. Löffl er (1943–1961), T.C. Hunt (1947–1967), N. Henning (1953–1962), B. Ihre (1953–1967), H. Bartelheimer (1963–1967), M. Demole (1963–1971), H. Kapp (1968–1970), R. Lambert (1972–1978), W. Creutzfeldt (1979–1992), R. Arnold (1993–2003)