de Groot 1997.
Methods | Randomised. double‐blind. placebo‐controlled trial. Single‐centre. Criteria for FD: equivalent symptom to Rome with both type of FD | |
Participants | N = 121 Female: 54% Mean age: 40.9 years for the prokinetic group and 43.9 years for the placebo group Country : the Netherlands |
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Interventions | Intervention: cisapride 10 mg three times a day Comparator: placebo No rescue medication Duration of treatment: 4 weeks |
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Outcomes | Physician's assessment of overall result as on 4‐point scales (excellent, good, moderate, poor), data reported as excellent or good | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessed by doctor but we do not know if he was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7% not included in the analyses |
Selective reporting (reporting bias) | Unclear risk | Combined excellent and good global response |
Other bias | Low risk | No other risk found |