Inki 2002.

Study characteristics
Methods	Location: five university hospitals in Finland Randomised controlled trial: using numbered, opaque, sealed envelopes to receive either LNG‐IUS (N = 119) or hysterectomy (N = 117).
Participants	Number of women randomised: 236 (only 73 had uterine fibroids examined by ultrasound) Inclusion criteria                                            Women referred for menorrhagia; mean age 43 years (range 35 to 49 years); all had regular menstrual cycles; all had completed family                                                     Exclusion criteria Women with large enough fibroids to cause bowel or urinary symptoms, with submucous fibroids; no indication for hysterectomy; metrorrhagia as a main complaint; previous treatment failure with LNG‐IUS; severe depression; history of malignancies; uterine malformation; or with ovarian cysts exceeding 55 mm in diameter, or with adnexal tumours, regardless of the size
Interventions	LNG‐IUS (N = 38) LNG‐IUS (Mirena, Leiras, Turku, Finland) was inserted during the randomisation visit Hysterectomy (N = 35) Hysterectomy was performed
Outcomes	Presence and location of any uterine fibroids exceeding 20 mm in diameter measured in two dimensions. The outcome was measured by using transvaginal ultrasound examinations at baseline, 6‐month, and 12‐month follow‐up visits by eight experienced gynaecologists. The examinations were performed using real‐time linear array ultrasound machines, equipped with a high frequency (5.0 MHz to 7.5 MHz) endovaginal convex probe (Toshiba SSA 270 sonolayer, Tokyo, Japan)
Notes	There were only 73 randomised women who satisfied this review's inclusion criteria, of having uterine fibroids examined by ultrasound. Diameter of fibroid was the only outcome reported in the trial. 46% of women with fibroids initially randomised into the LNG‐IUS group, subsequently had hysterectomy (data not shown). We contacted one study author for missing data, but did not get any response. Trial registration number: not stated Study dates: not stated Conflicts of interest: none stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Low risk	Quote "Patients were randomised using numbered, opaque, sealed envelopes to receive either LNG‐IUS (N = 119) or hysterectomy (N = 117)."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	It was not possible to blind LNG‐IUS and hysterectomy from the gynaecologists.The outcomes were unlikely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information available
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	In LNG‐IUS group: Quote "At the 6‐month follow‐up visit, uterine fibroids were found in 19 out of 98 patients (19.4%), and at the 12‐month follow‐up, in 16 out of 82 (19.5%)". There was no report on the hysterectomy group.
Selective reporting (reporting bias)	Unclear risk	No trial protocol available
Other bias	Unclear risk	No other obvious biases