Novel Measurement of Rapid Treatment Success with ReQuestTM: First and Sustained Symptom Relief as Outcome Parameters in Patients with Endoscopy-Negative GERD Receiving 20 mg Pantoprazole or 20 mg Esomeprazole

Mönnikes, Hubert; Pfaffenberger, Bernd; Gatz, Gudrun; Hein, J; Bardhan, Karna Dev

doi:10.1159/000085576

Cited by 21 publications

(19 citation statements)

References 52 publications

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“…Therapeutic studies that used the ReQuest as an evaluative tool clearly demonstrated a significant reduction in lower abdomen and dyspepsia-like symptoms in response to proton pump inhibitor (PPI) therapy. [39][40][41].…”

Section: Hypothesis 2 Ibs-like Symptoms Are Part Of Gerd Manifestationsmentioning

confidence: 99%

Gastroesophageal Reflux Disease (GERD) and Irritable Bowel Syndrome (IBS)—Is It One Disease or an Overlap of Two Disorders?

2008

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Up to 79% of IBS patients report gastroesophageal reflux disease (GERD) symptoms, and up to 71% of GERD patients report irritable bowel syndrome (IBS) symptoms. There are two principal hypotheses for the common presence of IBS symptoms in GERD patients. The first theory suggests that GERD and IBS overlap in a significant number of patients. The second theory suggests that IBS-like symptoms are part of the spectrum of GERD manifestation. The first theory is supported by genetic studies and similarities in gastrointestinal sensory-motor abnormalities potentially due to general gastrointestinal disorder of smooth muscle or sensory afferents. The other theory is primarily supported by studies demonstrating improvement of IBS-like symptoms in GERD patients receiving anti-reflux treatment. The close relationship between GERD and IBS could be explained by either GERD affecting different levels of the GI tract or a high overlap rate between GERD and IBS due to similar underlying GI dysfunction.

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Section: Hypothesis 2 Ibs-like Symptoms Are Part Of Gerd Manifestationsmentioning

confidence: 99%

Gastroesophageal Reflux Disease (GERD) and Irritable Bowel Syndrome (IBS)—Is It One Disease or an Overlap of Two Disorders?

2008

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“…First symptom relief was reached at a median of 2.0 days for both pantoprazole and esomeprazole (PP), and sustained symptom relief was achieved at a median of 16.5 days (pantoprazole, PP) and 16.0 days (esomeprazole, PP). Equal time periods were found for time to first symptom relief in patients with endoscopy-negative GERD [33], whereas the time to sustained symptom relief was 4–7 days shorter.…”

Section: Discussionmentioning

confidence: 99%

“…Pantoprazole has shown rapid and sustained symptom relief in acute treatment [10, 11, 33]. But as a chronic disease, the recurring GERD symptoms must also be managed.…”

Section: Discussionmentioning

confidence: 99%

Pantoprazole 40 mg Is as Effective as Esomeprazole 40 mg to Relieve Symptoms of Gastroesophageal Reflux Disease after 4 Weeks of Treatment and Superior regarding the Prevention of Symptomatic Relapse

Glatzel

Abdel-Qader

Gatz³

et al. 2006

Digestion

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Background/Aim: Little is known about the symptom course during and after treatment of gastroesophageal reflux disease (GERD). Here we address this question in patients with erosive GERD treated with pantoprazole or esomeprazole 40 mg once daily using the validated reflux questionnaire ReQuest^TM. Methods: Of 585 patients enrolled, 561 (intention-to-treat; ITT) patients with endoscopically confirmed GERD grades A–D (Los Angeles Classification) were randomized. To assess the GERD symptomatology, the patients completed the ReQuest daily, and analysis was done prior to (7 days), during (28 days), and after treatment (7 days). The mean scores (last 3 treatment days) of the subscale ReQuest^TM-GI (gastrointestinal complaints) were compared between both groups. After the end of treatment, the number of symptom episodes and the rate of relapses were calculated. Results: Noninferiority of pantoprazole versus esomeprazole during treatment was shown (mean ReQuest-GI score). During the posttreatment period, the proportion of patients experiencing a symptomatic relapse (51 vs. 61%, p = 0.0216, ITT) and the number of symptom episodes (0.56 vs. 0.74, p = 0.0095, ITT) were significantly lower on pantoprazole than on esomeprazole. Conclusions: Pantoprazole 40 mg was at least as effective as esomeprazole 40 mg for relieving GERD symptoms. During the posttreatment phase, patients on pantoprazole had a significantly lower risk to relapse and experienced significantly fewer symptom episodes.

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“…The median time to first relief was 2 days and to sustained relief 10 days with pantoprazole and 13 days with esomeprazole (ITT population, differences not significant) [20]. …”

Section: Request™ In Gerd and Its Treatment: Widening The Applicationsmentioning

confidence: 99%

Look – But Also Listen!

Bardhan

Berghöfer²

2007

Digestion

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The ReQuest™ (Reflux Questionnaire) is a new instrument: a diary developed specifically to allow patients to measure the totality of their gastroesophageal reflux disease (GERD) symptoms and to track changes each day during treatment, an increasingly important need in clinical trials. This paper reviews the background, development, testing, and validation of the instrument and shows how its flexibility allows it to be used in new ways to assess different aspects of GERD. Development: There were four key steps. (1) A full symptom spectrum was gathered from experts, literature and, crucially, from GERD patients, and comprised 67 symptom descriptions. (2) By expert consensus, these symptom descriptions were empirically condensed into six easier-to-handle ‘dimensions’ (acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints, nausea, sleep disturbances, other complaints), to which the seventh, general well-being, was added, a key feature of the instrument. The symptom burden of each dimension is measured as frequency × intensity (general well-being: intensity only). (3) This prototype instrument was tested in PPI clinical trials involving patients with erosive and non-erosive GERD, while the data generated were used to validate the prototype. (4) Finally, the scale was refined by factor analysis, a statistical process. Outcome: Detailed statistical testing validating the scale and factor analysis confirmed that empirically condensing the symptom descriptions into dimensions did not affect the measurement properties of the instrument. Further Application: The structure of ReQuest™ and its product, which is numerical, makes the instrument highly flexible and allows for its use in other GERD areas. (1) Its subscales, ReQuest™-GI and ReQuest™-WSO, measure symptoms traditionally associated with reflux and with general well-being, respectively, and permit these to be quantified and tracked independently. (2) Minor degrees of reflux symptoms are common amongst the healthy. The level was determined in a large population without evidence of disease, and a ‘GERD symptom threshold’ calculated. Reduction below this threshold to ‘background levels’ is a more realistic end point in clinical trials than the rarely achieved ‘complete absence’. (3) ReQuest™-GI was re-scaled and integrated with the modified Los Angeles scale used to grade esophageal appearances at endoscopy. The new instrument is a matrix, the ReQuest™/LA-classification, which allows both symptoms and endoscopy appearances to be expressed by a single set of numbers in individual patients and in populations. (4) This in turn allows identification of patients who on treatment achieve ‘complete remission’, i.e. healing and symptom relief. PPI clinical trials confirm that it takes a longer period of treatment to reach this endpoint than healing or symptom relief alone. Thus the conventional 4–8 weeks of PPI therapy may unwittingly result in under-treatment. (5) Studies are in progress to determine the ‘minimum clinically important differen...

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Novel Measurement of Rapid Treatment Success with ReQuestTM: First and Sustained Symptom Relief as Outcome Parameters in Patients with Endoscopy-Negative GERD Receiving 20 mg Pantoprazole or 20 mg Esomeprazole

Cited by 21 publications

References 52 publications

Gastroesophageal Reflux Disease (GERD) and Irritable Bowel Syndrome (IBS)—Is It One Disease or an Overlap of Two Disorders?

Gastroesophageal Reflux Disease (GERD) and Irritable Bowel Syndrome (IBS)—Is It One Disease or an Overlap of Two Disorders?

Pantoprazole 40 mg Is as Effective as Esomeprazole 40 mg to Relieve Symptoms of Gastroesophageal Reflux Disease after 4 Weeks of Treatment and Superior regarding the Prevention of Symptomatic Relapse

Look – But Also Listen!

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