Ma 2012.
Methods | Randomised, double‐blind, placebo‐ (sham acupuncture) controlled trial. 8 Multi‐centre. Criteria for FD: Rome III with both type of FD | |
Participants | N = 239 Female: 70% Mean age: 36.2± 13.9 years for the prokinetic group and 36.8 ±13.1 years for the control group Country: China |
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Interventions | Intervention: itopride 50 mg three times a day Comparator: sham acupuncture Rescue medication:not allowed Duration of treatment: 4 weeks but follow‐up at 12 weeks |
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Outcomes | Symptom Index of Dyspepsia scale (0 to 4). The improvement of at least two scores or no occurrence of any symptom included in the Symptom Index of Dyspepsia scale was regarded as the positive response. All assessed by participants | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation process was pre‐programmed and carried out by central computer. |
Allocation concealment (selection bias) | Low risk | The allocation sequence was generated by a permuted‐block randomisation.Investigators received a confirmation email at the same time, containing a random number, the group assignment code and the patient’s basic information. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Although participants were blinded for which acupoints, participants and doctors could not be blinded for treatment interventions (sham acupuncture versus drugs) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessed by patient who was blinded Quote: "the outcome assessors and statistical analysis were unaware of the intervention assignments throughout the trial" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5.4% (8 from prokinetic group versus 5 from control group) could not complete 4‐week treatment (including dropout and violations), balanced between two groups |
Selective reporting (reporting bias) | Low risk | Reported all pre‐defined outcomes |
Other bias | Low risk | No other risk found |