Tack 2009.
Methods | Randomised, double‐blind, placebo‐controlled trial. Multi‐centre (8). Criteria for FD: Rome II with both type of FD | |
Participants | N = 71 Female: 54% Mean age: 40 years for the prokinetic group and 49.1 years for the placebo group Countries: Belgium, the Netherlands, UK, Norway, Poland |
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Interventions | Intervention: acotiamide 50 mg, 100 mg and 300 mg three times a day Comparator: placebo Rescue medication: not mentioned Duration of treatment: 3 weeks |
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Outcomes | Participants assessed the severity (0 = absent; 1 = mild; 2 = moderate; 3 = severe) and the frequency (0 = absent; 1 = rarely; 2 = occasionally; 3 = often; 4 = whole day) of nine dyspeptic symptoms (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomiting, excessive belching and heartburn). An overall symptom score was calculated as the sum of the mean weekly individual symptom scores. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised |
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 patient who was blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 13% were excluded from the efficacy analysis but unbalance in each group. |
Selective reporting (reporting bias) | Low risk | Reported all pre‐defined outcomes |
Other bias | Unclear risk | Imbalance in age and gender, although did not reach statistical significance |