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. 2020 Jun 12;2020(6):CD002126. doi: 10.1002/14651858.CD002126.pub4

Ghazizadeh 2014.

Study characteristics
Methods Parallel randomised controlled trial
Participants Department of Obstetrics and Gynecology and Maternal‐Fetal and Neonatal Research Center and Breastfeeding Research Center, Tehran University of Medical Sciences
Inclusion criteria
  • Menorrhagia; hysterectomy candidate

  • Age 35 to 45

  • Hormonal treatment for at least 6 months without adequate improvement


Exclusion criteria
  • Pregnancy; null gravid; abnormal Pap smear; genital infection

  • Hormonal disorder

  • Hormonal treatment

  • Anomalous uterus

  • Any disorder inside the uterine cavity or abnormal endometrial biopsy

  • Coagulative disorder

  • Submocusal myomas > 2 cm and intramural myomas that moved the endometrial layer

  • Uterine cavity > 11 cm


Setting: Tehran, Iran
Time frame: October 2009 to November 2010
Interventions Bipolar endometrial ablation (Novasure) (n = 30)
Hysteroscopic endometrial resection (HER) (n = 32)
Mirena (lg‐IUS) (n = 48)
Outcomes Decreased menstrual blood loss
Interaction between bleeding and normal activity
Anaemia (estimated 6.8 mg/dL as cut‐off for anaemia)
Patients’ satisfaction (checklist 6 months' follow‐up; some up to 12)
Notes Funding: not specified; includes the statement "No competing financial interest"
Outcomes do not match correctly on the report. Study authors contacted for more details, no response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The title says RCT, but no data provided on the randomisation process
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias)
All outcomes High risk Open label, lack of blinding likely to influence outcome.
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin
All outcomes Low risk Not blinded, lack of blinding unlikely to influence the outcome.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified, lack of blinding likely to influence outcome.
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin)
All outcomes Unclear risk Not blinded, lack of blinding unlikely to influence the outcome.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Numbers in tables do not match numbers in text; study authors have been contacted for confirmation
Selective reporting (reporting bias) High risk No quantification of bleeding; not specified at what time satisfaction was measured
Other bias High risk Past medical history was positive in 12% Mirena, 13.3% Novasure, and 53.1% of HER (P < 0.0001)
Ultrasonography was performed in 35.4% of patients in the Mirena group, 66.7% in the Nova‐Sure group, and 96.8% in the hysteroscopic endometrial resection group (P < 0.0001)