Matsueda 2010b.

Methods	Randomised, double‐blind, placebo‐controlled trial. Multi‐centre (46). Criteria for FD: Rome II with PDS
Participants	N = 462 Female: 65.4% Mean age: range 38.0 to 40.6 years Country: Japan
Interventions	Intervention: acotiamide 50 mg, 100 mg or 300 mg three times a day Comparator: placebo Rescue medication: not allowed Duration of treatment: 4 weeks
Outcomes	Daily basis, 9 symptoms, on 0 to 3 severity scale, on weekly basis, global assessment of overall treatment efficacy (OTE) on 7‐point Likert scales, elimination rate of postprandial fullness by participants
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed through a computer‐generated program.
Allocation concealment (selection bias)	Low risk	Eligible participants were assigned a randomization number according to a predetermined list at each site. These numbers were allocated in sequential order and registered in the patient enrolment list, and ensured appropriate concealed allocation
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	Only 5% were excluded or discontinued but did not provide the reasons of exclusion, it is not clear if balanced between two groups
Selective reporting (reporting bias)	Low risk	Reported all pre‐defined outcomes
Other bias	Low risk	No other risk found