The Rome III subgroups of functional dyspepsia significantly overlap. Patients fulfilling criteria for both subgroups had symptoms that were psychopathologically more severe than those of patients without overlapping. Diagnosis of postprandial distress syndrome, but not epigastric pain syndrome, is independently associated with psychopathological factors.
The effectiveness of proton pump inhibitor therapy and that of prokinetic therapy in functional dyspepsia are not different, and cannot be predicted by Rome III subgroups (ClinicalTrials.gov number, NCT00663897).
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.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• An adjunct to endoscopy, proton pump inhibitor (PPI) is effective pharmacotherapy in high‐risk patients with peptic ulcer bleeding (PUB).
• An intravenous 80‐mg bolus and 192 mg day−1 successive infusion for 3 days is the currently recommended dosing modality in administering PPI.
WHAT THIS STUDY ADDS
• Clinical outcomes are not different in PUB patients receiving infusional pantoprazole at either 192 mg or 160 mg day−1 for 3 days.
• The effective dosage of PPI may not be as high as currently recommended.
• In view of cost‐effectiveness, a lower dosage (160 mg day−1) of infusional PPI may be adopted in the management of PUB.
AIM The optimal dosage of proton pump inhibitor in bleeding peptic ulcers remains controversial.
The aim was to compare the clinical effectiveness of two doses of infusional pantoprazole in peptic ulcer bleeding.
METHODS Peptic ulcer patients (n= 120) with bleeding stigmata were enrolled after successful endoscopic therapy. After an initial bolus injection of 80 mg pantoprazole, patients were randomized to receive continuously infused pantoprazole at either 192 mg day−1 or 40 mg every 6 h (i.e. 160 mg day−1) for 3 days. Clinical outcomes between the two groups within 14 days were compared, with 14‐day recurrent bleeding regarded as the primary end‐point.
RESULTS Both groups (n= 60 each) were well matched in demographic and clinical factors upon entry. Bleeding totally recurred in 11 (9.2%) patients, with six (10%) in the 192 mg day−1 group and five (8.3%) in the 160 mg day−1 group (relative risk of bleeding recurrence between two treatments 1.2; 95% CI 0.39, 3.72). All secondary outcomes between the two groups were similar, including the amount of blood transfusion (mean 1179 ml vs. 1203 ml, P > 0.1), hospital stay (mean 9.5 days vs. 9.9 days, P > 0.1), need for surgery (n= 1 vs. n= 0, P > 0.1), and mortality (n= 1 vs. n= 0, P > 0.1).
CONCLUSIONS Following endoscopic haemostasis, infusional pantoprazole at either 192 mg day−1 or 40 mg every 6 h appear similar.
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