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. 2020 Sep 6;2020(9):CD012658. doi: 10.1002/14651858.CD012658.pub2

Karimi‐Zarchi 2013.

Study characteristics
Methods Prospective randomised controlled study
Single‐centre
Participants Country: Iran
Population: women with endometrial hyperplasia suffering from abnormal uterine bleeding who referred to Shahid Sadoughi Hospital for treatment
Age range 22 to 47 years
N = 40
Inclusion criteria: abnormal uterine bleeding due to endometrial hyperplasia confirmed by pathology, women of reproductive age group who intend to preserve their fertility
Exclusion criteria: not specified
Interventions 1. LNG‐IUD which releases 20 mcg levonorgestrel per day (n = 20). Treatment duration for 3 months
versus
2. Medroxyprogesterone acetate (n = 20). 20 mg daily for 10 days in each menstrual cycle, for 3 months
Outcomes 1. Regression of endometrial hyperplasia. The authors defined this as response to treatment 3 months following treatment (evaluated using vaginal ultrasound and reviewing of pathology reports)
Pathological status after treatment (progestational effect, proliferative, atrophic, simple, atypia)
Endometrial thickness compared
Menstrual conditions of patients compared
2. Adverse effects associated with hormones
3. Satisfaction with treatment
Notes Recruitment period not specified
Funding source not specified
Ethics approval not specified
No trial registration or study protocol found; searches included the Iranian Registry of Clinical Trials
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information: "...patients were randomly divided."
Allocation concealment (selection bias) Unclear risk Not specified.
Blinding of participants and personnel (performance bias): EH regression
All outcomes Low risk No blinding/not possible. 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."
Blinding of participants and personnel (performance bias): Other outcomes
All outcomes High risk For adverse effects and satisfaction. 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."
Blinding of outcome assessment (detection bias): EH regression
All outcomes High risk Not stated. As per review protocol: "if the pathologists reading the slides are aware of the type of treatment the patient is on, or it is not stated whether they are blinded, then we will rate this as at high risk of bias."
Blinding of outcome assessment (detection bias): Other outcomes
All outcomes High risk No blinding of participants ‒ self‐report.
Incomplete outcome data (attrition bias)
All outcomes Low risk After randomisation, no missing data.
Selective reporting (reporting bias) Unclear risk Primary outcomes listed in the paper's methods were reported in the results. No trial registration or study protocol identified.
Other bias Unclear risk Baseline characteristics reported and no obvious significant differences.
Discrepancy in table 2 and text on response to treatment data (different denominator).