Ranchet 1990.
Methods | RCT. Publication is in Italian and the report has been translated. Location of trial is still unclear. | |
Participants | 66 pregnant women between the age of 19 and 36, both primipara and multipara, with at least 1 symptom of gravidic pyrosis. Degree of heartburn of women was not stated at the study entry. Exclusion criteria not stated. |
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Interventions | Intervention group: sucralfate 1 g, 3 times daily. N = 42. Comparison group: advice on dietary and lifestyle choices. N = 24. Follow‐up recorded at 15 and at 30 days. |
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Outcomes | Symptom relief of heartburn and acid regurgitations, epigastric pain, sialorrhoea, remission of symptoms, side effects. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information on how randomisation was carried out. Study described as randomised. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study described as single‐blind. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No dropouts or withdrawals reported. Denominators suggest missing data for the outcome of total remission of heartburn (1 active, 3 no treatment). |
Selective reporting (reporting bias) | Low risk | Relevant outcomes seem to be reported. |
Other bias | Unclear risk | Randomised treatment groups are unequal in size. |