Ergun 2012.
Methods | Randomised controlled trial Number randomised: 58 Failures to receive allocated treatment Losses to follow‐up: 16 Analysis by ITT: no Power calculation: not reported Source of funding: not stated |
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Participants | Included: women with abnormal uterine bleeding not responding to medical treatment (progesterone, oral contraceptive, NSAIDs etc.) aged over 35, regular menstrual cycle, score of 100 on PBAC Mean age: Not reported Excluded: pregnancy, pelvic infection, uterine abnormality, suspicious endometrial pathology on TVUS |
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Interventions | Surgical arm: rollerball endometrial ablation (n = 31) Medical arm: LNG‐IUS (n = 27) Actual treatment received: all |
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Outcomes | Blood loss: PBAC (end scores), satisfaction on a 5‐point scale, need for additional treatment | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised ..." |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
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 | High risk | 58 patients randomised (31 in rollerball group and 27 in LNG‐IUS group). 7/31 (22.6%) withdrew from the rollerball group and 9/27 (33%) withdrew from the LNG‐IUS group, so only 72% (42/58) were included in the analysis. These latter numbers were used in the analysis with no method described for analysing missing data. |
Selective reporting (reporting bias) | Unclear risk | The authors noted that they investigated adverse effects but these were not adequately reported |
Other bias | Unclear risk | Not possible to determine how similar the groups were at baseline; no measure of statistical variation (e.g. SD) reported |