A double-blind, randomized comparison of omeprazole Multiple Unit Pellet System (MUPS) 20 mg, lansoprazole 30 mg and pantoprazole 40 mg in symptomatic reflux oesophagitis followed by 3 months of omeprazole MUPS maintenance treatment: a Dutch multicentre trial

Mulder, Chris J.; Westerveld, B. D.; Smit, J. M.; Pool, M. Oudkerk; Otten, M.H.; Tan, T.G.; Wit, A.W.M. van Milligen de; Groot, Gerrit H. de

doi:10.1097/00042737-200206000-00010

Cited by 27 publications

(16 citation statements)

References 29 publications

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“…Figure 2 shows the flow of this meta‐analysis, listing studies excluded and citing reasons for exclusion. A total of 59 randomized controlled trials met the criteria for inclusion in the meta‐analysis comprising a total of 26 885 patients in active treatment arms (see supplementary Table S1 online) 15,16,24–80 . The studies were published between 1988 and 2009.…”

Section: Resultsmentioning

confidence: 99%

PPI therapy is equally effective in well‐defined non‐erosive reflux disease and in reflux esophagitis: a meta‐analysis

Weijenborg

Cremonini

Smout

et al. 2012

Neurogastroenterology Motil

129

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Background Symptomatic response to proton pump inhibitor (PPI) therapy in patients with non-erosive reflux disease (NERD) is often reported as lower than in patients with erosive reflux disease (ERD). However, the definition of NERD differs across clinical trials. This meta-analysis aims to estimate the rate of symptom relief in response to PPI in NERD patients. Methods MEDLINE (1966, Cochrane Comprehensive Trial Register (1997 and EMBASE (1985EMBASE ( -2010 databases were searched and manual searches from studies' references were performed. Randomized clinical trials were selected that included patients with heartburn, and analyzed the effect of short-term PPI treatment. The primary outcome of selected studies was defined as complete or partial heartburn relief. Two reviewers independently extracted data and assessed study quality of selected articles. Random effects models and meta-regression were used to combine and analyze results. Key Results The pooled estimate of complete relief of heartburn after 4 weeks of PPI therapy in patients with ERD was 0.72 (95% CI 0.69-0.74) (32 studies), vs 0.50 (0.43-0.57) (eight studies) in empirically treated patients, 0.49 (0.44-0.55) (12 studies) in patients defined as non-erosive by negative endoscopy, and 0.73 (0.69-0.77) (two studies) in patients defined as non-erosive by both negative endoscopy and a positive pH-test. Conclusions & Inferences In well-defined NERD patients, the estimated complete symptom response rate after PPI therapy is comparable to the response rate in patients with ERD. The previously reported low response rate in studies with patients classified as NERD is likely the result of inclusion of patients with upper gastrointestinal symptoms that do not have reflux disease.

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Section: Resultsmentioning

confidence: 99%

PPI therapy is equally effective in well‐defined non‐erosive reflux disease and in reflux esophagitis: a meta‐analysis

Weijenborg

Cremonini

Smout

et al. 2012

Neurogastroenterology Motil

129

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“…The sub‐classes of randomized controlled trials in the English language were as follows: omeprazole and GERD, 104 trials; omeprazole and ulcer disease, 726 trials; lansoprazole and GERD, 24 trials; lansoprazole and ulcer disease, 193 trials; rabeprazole and GERD, 10 trials; rabeprazole and ulcer disease, 34 trials; pantoprazole and GERD, 11 trials; pantoprazole and ulcer disease, 70 trials; esomeprazole and GERD, 110 trials; esomeprazole and ulcer disease, 496 trials. Of these numerous studies, 36 met our a priori criteria for analysis and/or were relevant to our specific aims and were abstracted 6–41 . On further detailed evaluation during the abstraction process, one of these studies was found to have been carried out without blinding and was excluded, 12 two were found to have a Jadad score of only two and were excluded from further analysis 13 , 29 and one study's primary outcome was based on surrogate end‐points (intra‐oesophageal pH) and was also excluded 18 .…”

Section: Resultsmentioning

confidence: 99%

Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastro‐oesophageal reflux disease and peptic ulcer disease

Vakil

Fennerty

2003

Aliment Pharmacol Ther

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Summary Background : Five proton pump inhibitors are now available for use in North America. Claims of differences in the clinical efficacy of different strengths and/or agents have been made. Aim : To identify any consistent evidence of differences in outcomes between agents or doses within this class of drugs. Methods : A search of the medical literature was performed in two electronic databases, and randomized controlled trials of higher quality were included in the assessment. Results and conclusions : Thirty‐two trials met our criteria. No convincing data were found to indicate that low doses of proton pump inhibitors are as effective as standard doses of proton pump inhibitors in the healing of erosive oesophagitis or in the relief of symptoms of gastro‐oesophageal reflux disease; however, they may be as effective as maintenance therapy for gastro‐oesophageal reflux disease and peptic ulcer disease. Differences were found between the standard doses of proton pump inhibitors with regard to the onset of symptom relief in gastro‐oesophageal reflux disease (lansoprazole was faster than omeprazole, and esomeprazole was faster than both lansoprazole and omeprazole) and the healing of oesophagitis (esomeprazole was superior to both omeprazole and lansoprazole). Despite these differences, there are as yet insufficient data to establish the superiority of any one agent over all others across all disease states treated with these agents.

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“…Decrease of symptom scores and the proportion of patients who maintain symptom control were chosen as primary outcomes for the first and second phase of the study, respectively, in order to reflect the characteristics of symptomatic responses to PPI in RE patients. Because treatment with lansoprazole for 4 weeks generally leads to significant symptom relief in responsive patients, it may be less appropriate to consider magnitude of symptom improvement as the study outcome in the second phase [28, 29]. Moreover, after receiving different study medications in the first phase, patients could not be regarded as comparable at entry to the second phase.…”

Section: Discussionmentioning

confidence: 99%

Mosapride as an adjunct to lansoprazole for symptom relief of reflux oesophagitis

Hsu

Yang

Hsu

et al. 2010

Brit J Clinical Pharma

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Reflux oesophagitis is a common clinical disorder associated with significant morbidity. Proton pump inhibitors are the current pharmacotherapy of choice, but not all treated patients achieve symptom relief. Little is known about the efficacy of mosapride, a prokinetic agent which decreases episodes of gastro-oesophageal reflux, as an adjunct to proton pump inhibitors in improving the symptoms of reflux oesophagitis. WHAT THIS STUDY ADDS Mosapride was generally not more effective than placebo as an adjunct therapy to a standard dose of lansoprazole in decreasing the symptom burden of patients with reflux oesophagitis. However, in a subgroup with more severe symptoms, combination therapy with lansoprazole and mosapride was possibly superior to monotherapy with lansoprazole. AIMS To investigate if mosapride, a prokinetic agent, was an effective adjunct to acid suppression in improving the symptoms of reflux oesophagitis. METHODS Patients (n = 96) with reflux oesophagitis were randomly assigned to either mosapride (5 mg three times daily) or placebo for 4 weeks. Symptom severity was assessed by a validated questionnaire at enrolment, 4 and 8 weeks after medication. The primary outcome for the first 4 weeks was decrease in symptom scores. After a 3 day washout period, patients initially allocated to mosapride crossed over to placebo and vice versa for the next 4 weeks. The outcome of the second phase was maintenance of symptom control. All patients received lansoprazole (30 mg once daily) throughout study. RESULTS The decreased symptom score after 4 weeks of treatment with lansoprazole and mosapride (n = 50) was 13.42 1.16 (mean SEM), similar to that of lansoprazole plus placebo (10.85 1.03, n = 46), with an insignificant difference of 2.57 (95% CI-0.53, 5.67, P = 0.103). However, a subgroup analysis for patients with pre-treatment scores of >18 points (n = 48) revealed that lansoprazole plus mosapride achieved a greater reduction of symptom score than lansoprazole plus placebo (18.22 1.91 vs. 12.88 1.65; mean difference of 5.34, 95% CI 0.28, 10.40, P = 0.039). In the second phase, there was no difference between lansoprazole with mosapride or placebo in maintaining symptom control (39/44 or 86.64% vs. 41/50 or 82%, P = 0.401). Subgroup analysis for those with substantial residual symptoms revealed similar results. CONCLUSION Compared with placebo, mosapride generally does not provide additional benefit to a standard dose of lansoprazole in patients with reflux oesophagitis, except possibly in the subgroup of severely symptomatic patients.

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A double-blind, randomized comparison of omeprazole Multiple Unit Pellet System (MUPS) 20 mg, lansoprazole 30 mg and pantoprazole 40 mg in symptomatic reflux oesophagitis followed by 3 months of omeprazole MUPS maintenance treatment: a Dutch multicentre trial

Abstract: Omeprazole MUPS 20 mg and pantoprazole 40 mg have equivalent efficacy in the treatment of reflux oesophagitis. Based on patient satisfaction, omeprazole MUPS 20 mg, lansoprazole 30 mg and pantoprazole 40 mg are equally effective.

Cited by 27 publications

References 29 publications

PPI therapy is equally effective in well‐defined non‐erosive reflux disease and in reflux esophagitis: a meta‐analysis

PPI therapy is equally effective in well‐defined non‐erosive reflux disease and in reflux esophagitis: a meta‐analysis

Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastro‐oesophageal reflux disease and peptic ulcer disease

Mosapride as an adjunct to lansoprazole for symptom relief of reflux oesophagitis

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