Talley 2000.
Methods | Randomised, double‐blind, placebo‐controlled trial. Multi‐centre (at least 2). Criteria for FD: equivalent symptom. with both types of FD | |
Participants | N = 609 Female: 69% Mean age: 46.3 years for the prokinetic group and 46.1 years for the placebo group Countries: USA and Europe |
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Interventions | Intervention: ABT‐229 1.25 mg, 2.5 mg, 5 mg and 10 mg twice a day Comparator: placebo Rescue medication: not mentioned Duration 4 weeks |
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Outcomes | Participant questionnaire, VAS 0‐100 used to assess severity, frequency and impact measured by 5‐graded Likert scale, duration one a 7‐graded Likert scale. Patient diary, severity of postprandial fullness, bloating, epigastric discomfort and postprandial nausea recorded on 7‐point Likert scale. Global evaluation at week 4 for excellent (complete or near complete resolution of symptoms), good (distinct improvement), moderate (some improvement), or poor (no change or deterioration). Assesed by participants. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomized" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐bledind. Placebo was identical to active therapy. |
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 | 8% (47/609) participants prematurely discontinued, the reasons were balanced between groups. The authors only reported outcome for 589 (96%) participants who had baseline data and at least one follow up assessment no more than 5 days and considered these participants as ITT population, which were 99%, 98%, 98% and 96% in active treatment but 95% in placebo group. |
Selective reporting (reporting bias) | Low risk | Reported all pre‐defined outcomes |
Other bias | Unclear risk | Difference in number baseline scores in table 1 and figure 2 |