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. 2018 Oct 18;2018(10):CD009431. doi: 10.1002/14651858.CD009431.pub3

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
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
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