Kellow 1995.
Methods | Randomised. double‐blind, placebo‐controlled trial. Single‐centre. Criteria for FD: equivalent symptom with mixed ulcer‐ like and dysmotility‐like | |
Participants | N = 61 Female: 70% Mean age: 50 ±18 years for prokinetic group and 46 ± 15 years for placebo group Country : Australia |
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Interventions | Intervention: cisapride 10 mg orally three times a day Comparator: placebo Rescue medication: antacid Duration of treatment: 4 weeks |
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Outcomes | Total score of symptoms based on scale 0 to 3 assessed by doctor Global assessment: marked improvement‐complete or near complete resolution of symptoms: moderate improvement‐partial remission of symptoms; minimal improvement‐slight improvement of symptoms: unchanged‐no change in symptoms; deteriorated‐symptoms worsened as compared to before treatment assessed by participants |
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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 | Low risk | Assessed by both investigators and participants who were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8% participants withdrawn (6.5% from prokinetic versus 10% from placebo), balanced between two groups |
Selective reporting (reporting bias) | Low risk | Reported all pre‐defined outcomes |
Other bias | Low risk | No other risk found |