Karimi‐Zarchi 2013.
Study characteristics | ||
Methods | Prospective randomised controlled study Single‐centre |
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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 |
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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 |
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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 |
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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 |
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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). |