Barrington 2003.
Methods | Number randomised: 50 Losses to follow‐up: 4 (2 in each group) No power calculation described Source of funding: not reported Years: not reported | |
Participants | Inclusion criteria: women with menorrhagia refractory to medical therapy Exclusion criteria: uterine cavity over 12 cm long, malignant or premalignant pathology (pre‐treatment endometrial biopsy taken) |
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Interventions | Surgery: thermal balloon ablation Medical treatment: LNG‐IUS |
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Outcomes | PBAC score Amenorrhoea | |
Notes | No measures of variance or tests of significance were reported for the change from baseline in each group nor for the difference in change between the groups: we have made attempts to contact the author for more data | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding not feasible. Our primary review outcomes are subjective and therefore susceptible to bias related to lack of blinding. |
Incomplete outcome data (attrition bias) Primary outcomes | Low risk | All women received their allocated treatment. 44/50 analysed for primary outcome at 6 months. Reasons for withdrawal/dropout given. |
Selective reporting (reporting bias) | Unclear risk | Adverse effects/tolerability not reported. Follow‐up only 6 months. |
Other bias | High risk | PBAC scores significantly higher in the surgical group at baseline |