Shen 2014.
Methods | Randomised to two drugs. (aimed to assess the add‐on effect of itopride to azintamide.Single‐centre. Criteria for FD: Rome III and assessed only abdominal distension.(PDS) | |
Participants | N = 80 Female 41% Mean age: 57.42 years for the intervention group and 64.17 years for the control group (P > 0.05) Country of study: China |
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Interventions | Intervention: itopride one tablet three times a day + azintamide three times a day (no dose provided) Comparator: azintamide three times a day (no dose provided) Rescue medication: azintamide Duration of treatment: 2 weeks |
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Outcomes | Physicians assessed abdominal distension, duration 0 to 3 scores, severity 0 to 3 | |
Notes | Mean age was significant different between two groups Article In Chinese |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Low risk | Reported all pre‐defined outcomes |
Other bias | Low risk | No other risk found |