Bower 1961.
Methods | Study described as a randomised controlled trial. Oldchurch Hospital, Essex, UK. | |
Participants | 100 pregnant women who failed to obtain relief from antacid treatment for heartburn were recruited when attending outpatient antenatal care. Degree of heartburn of women was not stated at the study entry. | |
Interventions | Intervention group: intramuscular prostigmine 0.5 mg (N = 50) Comparison group: intramuscular water (N = 50) |
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Outcomes | Relief of heartburn (complete relief, useful relief), injection useless. | |
Notes | The authors stated that the average duration of relief obtained from the injections was 5 days. Otherwise, follow‐up is unclear. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Pharmacy prepared identical ampoules with treatment and placebo, so that staff would not have been aware of the next group assignment when women were recruited. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical treatment and placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treatment allocation unknown to obstetric staff. Code broken after outcome data recorded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all women randomised. |
Selective reporting (reporting bias) | Low risk | Planned outcomes appear to have been reported. |
Other bias | Unclear risk | Duration of follow‐up not stated. |