Yeoh 1997.
Methods | Randomised, double‐blind,placebo‐controlled trial. Single‐centre, Criteria for FD: equivalent symptom and included both types of FD | |
Participants | N = 104 Female: 53% Mean age:43.5+/‐2.2 years for the gastritis group and 35.6+/‐1.5 years for the non‐gastritis group Country: Singapore |
|
Interventions | Intervention: cisapride 10 mg orally three times a day Comparator: placebo Rescue medication: antacid (open‐labelled) Duration of treatment: 4 weeks |
|
Outcomes | Symptoms of epigastric pain, bloating, nausea, belching, early satiety and heartburn were graded on a 4‐point scale were assessed by participants A global response by physicians‐(i) poor, no change or deterioration of symptoms; (ii) fair, clear but limited improvement; (iii) good, considerable overall improvement; and (iv) excellent, complete or almost complete disappearance of symptoms |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly allocated" |
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 | Unclear risk | Scores were assessed by participants, global response was assessed by physicians. It is not clear if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 27% (28/104) participants did not complete the study |
Selective reporting (reporting bias) | Low risk | Reproted all pre‐defined outcomes |
Other bias | Low risk | No other risk of bias found |