Abu Hashim 2013.

Study characteristics
Methods	Randomised controlled trial Single‐centre
Participants	Country: Egypt Population: women complaining of abnormal uterine bleeding attending the gynaecology outpatient clinic in Mansoura University Hospitals, Egypt Age range 40 to 50 years N = 120 (pre‐menopausal) Inclusion criteria: those with histologically confirmed non‐atypical simple or complex endometrial hyperplasia, age between 40 and 50 years with an ongoing menstrual cycle for at least 6 months before the onset of AUB and no contraindication to either LNG‐IUS or NET e.g. current or a history of deep venous thrombosis, active thrombophlebitis, thromboembolic disorder, or cerebrovascular accident, myocardial infarction or ischaemic heart disease and liver disease Exclusion criteria: endometrial hyperplasia with atypia, age > 50 years, other pathology e.g. submucosal myomas or polyps, adnexal abnormality, genital infection, hormone therapy or any medication which might affect the menstrual blood loss within the previous 6 months e.g. steroid hormones or anticoagulants, previous endometrial ablation, diabetic and/or hypertensive patients and those unwilling for medical management Recruitment from May 2009 to November 2011
Interventions	1. LNG‐IUS (Mirena, Bayer Schering Pharma Oy, Turku, Finland) (n = 59). Duration of treatment for 12 months. versus 2. Norethisterone acetate (Cidolut Nor, Chemical Industries Development, Cairo, Egypt) (n = 61). 5 mg tablet 3 times daily for 3 weeks over 3 months. Ongoing treatment depending on outcomes.
Outcomes	1. Regression of endometrial hyperplasia. This was measured by pipelle catheter biopsy and the authors also reported on the median time to regression during the 12 months' follow‐up period 2. Proportion of women undergoing hysterectomy 3. Adverse effects associated with hormones
Notes	Funding source not reported Ethical approval obtained Informed consent obtained Study protocol was registered on ClinicalTrials.gov (Identifier: NCT01499602) Sample size power calculation performed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Women were randomised according to a computer‐generated random numeric table."
Allocation concealment (selection bias)	Low risk	"...prepared by an independent statistician with concealment of treatment allocation by use of sealed opaque envelopes that were given to a third party (nurse) who assigned patients to study arms."
Blinding of participants and personnel (performance bias): EH regression All outcomes	Low risk	No blinding/not possible; the review authors judge that the outcome (regression of endometrial hyperplasia) was not likely to be influenced by lack of blinding. This was considered in the discussion “because of different nature of treatments.”
Blinding of participants and personnel (performance bias): Other outcomes All outcomes	High risk	For adverse effects as per review protocol: "for subjective measures, if the patients are aware of the type of treatment they are on, and there is no placebo arm to the trial, then we will rate this as at high risk of bias." For hysterectomy rate, some hysterectomies done due to patient request/symptoms with potential bias.
Blinding of outcome assessment (detection bias): EH regression All outcomes	Low risk	Outcome assessment i.e. those performing histological diagnosis (2 independent gynaecological pathologists) and statistical analysis were blinded to the treatment groups.
Blinding of outcome assessment (detection bias): Other outcomes All outcomes	High risk	Adverse effects were self‐reported/measured. Hysterectomy rate was influenced by patient preference.
Incomplete outcome data (attrition bias) All outcomes	Low risk	After randomisation and allocation some participants were lost to follow‐up. 5% (3/59) attrition rate in LNG‐IUS group and 6.5% (4/61) attrition rate in NET group is similar. Both intention‐to‐treat and per protocol analysis done.
Selective reporting (reporting bias)	Low risk	Primary outcomes listed in the trial registry were reported in the results.
Other bias	Low risk	"No significant differences between both groups as regards baseline characteristics, clinical presentation and histological types of EH."