Gupta 2013.

Study characteristics
Methods	Parallel group RCT, multicentre (n = 63 in UK) No. of women randomised: 571 No. of women analysed: At 2 years, 231 in medical treatment group and 247 in LNG‐IUS group but sensitivity analysis with imputation of missing data was undertaken Power calculation for sample size: 90% power to detect small to moderate (0.3 SD) differences in primary outcome at any 1 time point ‒ allowed for 20% dropout ITT analysis Funding: NIHR Health Technology Assessment Programme
Participants	Country: UK Mean age: 42 years Inclusion criteria Aged between 25 and 50 years Presenting to primary care physicians with menorrhagia involving at least 3 consecutive Menstrual cycles Exclusion criteria Intention to become pregnant over the next 5 years Taking hormone therapy or tamoxifen Intermenstrual bleeding Post coital bleeding Findings suggestive of fibroids or other disorders Contraindications to or a preference for either the LNG‐IUS or usual medical treatments Heavy irregular bleeding
Interventions	(1) Levonorgestrel‐releasing IUS (2) Usual medical treatment (mefenamic acid, tranexamic acid, norethindrone, combined oestrogen‐progestogen or progesterone‐only oral contraceptive pill, medroxyprogesterone acetate injection, chosen by the physician and patient according to contraceptive needs and desire to avoid hormone therapy) Women are permitted to change treatments, as well as between groups or could discontinue treatment ‒ to replicate usual practice. Duration: 6 months, 2, 5 and 10 years
Outcomes	Primary Patient reported score on the Menorrhagia Multi‐Attribute Scale (MMAS) Secondary General health‐related quality of life (measured on SF‐36, EQ‐5D descriptive system and EQ‐5D visual analogue scale Sexual activity scale (Sexual Activity Questionnaire) Further requirement for surgery Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computerised minimised randomisation procedure"
Allocation concealment (selection bias)	Low risk	Quote: "assigned by telephone or web based central randomisation service" at clinical trials unit in University of Birmingham
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded, lack of blinding likely to influence outcome
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin All outcomes	Unclear risk	Haematin alkaline and haemoglobin were not measured
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not blinded, lack of blinding likely to influence outcome
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin) All outcomes	Unclear risk	Haematin alkaline or haemoglobin were not measured
Incomplete outcome data (attrition bias) All outcomes	Low risk	Clear explanations given for missing data and sensitivity analyses performed where values were imputed for missing data
Selective reporting (reporting bias)	Low risk	Clear and comprehensive protocol
Other bias	Low risk	Groups comparable at baseline