Talley 2008b.

Methods	Randomised, double‐blind. placebo‐controlled trial. Multi‐centre (170). Criteria for FD: Rome II with both types of FD
Participants	N = 525 Female: 64.7% Mean age: 42.9 +/‐12.9 years for the prokinetic group and 43.3 +/‐12.9 years for the placebo group Countries: Germany, France, the Netherlands, Belgium, Poland, UK , USA, and Canada
Interventions	Intervention: itopride 100 mg three times a day Comparator: placebo Rescue medication: not mention Duration of treatment: 8 weeks
Outcomes	(1) global patient assessment (GPA) of efficacy; ‐ symptom‐free, markedly improved, slightly improved, unchanged, worse’’. Symptom‐free or markedly improved was defined as a responder.and (2) Leeds Dyspepsia Questionnaire (LDQ).‐LDQ questions 1 and 8,measuring pain in the upper abdomen and feeling of fullness, respectively, were the primary end point questions by participants. We used the information from LDQ.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	All participants had a four‐digit number assigned. The randomisation code was generated by Quintiles Inc. using a computer‐generated program.
Allocation concealment (selection bias)	Low risk	At the baseline visit, eligible participants were assigned a randomisation number according to the pre‐determined list at each site. These numbers were allocated in sequential order and registered in the patient enrolment list.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blinded, participants took identical active or placebo medication, and participants and investigators were blinded at all sites.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessed by patient who was blinded.Emergency envelopes were provided to the investigators with the study code and randomisation, and these were examined at the end of the study to ensure the study blind being maintained
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	525 participants were included in ITT analysis. However, 14% (80) from intervention group versus 12% (69) from placebo group did not complete the study (both studies combined).(in two studies, 1170 were randomised, data only reported for 1150 without further information for each group in each study) (see table 1 and table 3).
Selective reporting (reporting bias)	Low risk	Reported all pre‐defined outcomes
Other bias	Low risk	No other risk seen