88467
document
Levosulpiride in functional dyspepsia : a multicentric , double-blind , controlled trial . Abnormalities in gastrointestinal motility have been reported in a substantial proportion of patients with functional dyspepsia , supporting the use of prokinetic drugs for treatment of dyspeptic symptoms . To evaluate efficacy and safety of levosulpiride in short-term treatment , 1298 patients were enrolled in a double-blind multicentric study carried out in 45 Italian Gastroenterology Departments . Patients were randomly assigned to either levosulpiride ( 25 mg tid ) , domperidone ( 10 mg tid ) , metoclopramide ( 10 mg tid ) or placebo ( 1 tablet tid ) for 4 weeks . Patients were selected on the basis of : a ) occurrence in the last 4 weeks of at least 5/10 selected symptoms ( anorexia , nausea , vomiting , upper abdominal pain , postprandial bloating , abdominal fullness , early satiety , belching , heartburn , regurgitation ) , severity of which should reach/exceed a total score of 8 , as assessed by a specific scale ranging from 0 ( absent ) to 3 ( severe ) ; b ) normal results of routine biochemical , ultrasound and endoscopic examinations . In addition , each patient subjectively evaluated efficacy of treatment by a visual analogue scale . Significant improvement was recorded for all symptoms at days 10 and 28 in all groups ( p < 0.001 ) , but levosulpiride was significantly ( p < 0.01 ) superior to domperidone , metoclopramide and placebo both in the overall clinical improvement scale as well as in a subgroup of symptoms ( postprandial bloating , epigastric pain , heartburn ) . Active treatments and placebo were comparable as far as concerns occurrence of side-effects ( 12-20 % ) including galactorrhoea , breast tenderness and menstrual changes .
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Intervention_Pharmacological
Levosulpiride
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Intervention_Pharmacological
prokinetic drugs
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Intervention_Pharmacological
levosulpiride
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Intervention_Pharmacological
levosulpiride
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Intervention_Pharmacological
domperidone
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Intervention_Pharmacological
metoclopramide
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Intervention_Control
placebo
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Intervention_Pharmacological
levosulpiride
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Intervention_Pharmacological
domperidone
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Intervention_Pharmacological
metoclopramide
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Intervention_Control
placebo
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Intervention_Pharmacological
Active treatments
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Intervention_Control
placebo
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Outcome_Other
efficacy and safety
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Outcome_Physical
anorexia , nausea , vomiting , upper abdominal pain , postprandial bloating , abdominal fullness , early satiety , belching , heartburn , regurgitation
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Outcome_Other
efficacy
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Outcome_Pain
(
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Outcome_Physical
postprandial bloating
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Outcome_Pain
epigastric pain
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Outcome_Physical
heartburn
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Outcome_Physical
galactorrhoea , breast tenderness and menstrual changes
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Participant_Condition
functional dyspepsia
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Participant_Condition
functional dyspepsia ,
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Participant_Condition
dyspeptic symptoms
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Participant_Sample-size
1298
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Participant_Condition
anorexia , nausea , vomiting , upper abdominal pain , postprandial bloating , abdominal fullness , early satiety , belching , heartburn , regurgitation )