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

Ashraf 2017.

Study characteristics
Methods Parallel, prospective, randomized multicentre clinical study
Participants Setting: conducted at the gynaecology units of Bahawal Victoria Hospital (BVH), Jubilee Female Hospital, Civil Hospital and private clinics of consultant gynaecologists in Bahawalpur, Pakistan.
Inclusion criteria
  • Women aged 18 to 45 with dysfunctional uterine bleeding measuring PBAC score > 100 for 2 consecutive cycles

  • Uterus size less than 10 cm on ultrasonography

  • Negative cervical cytology on Pap smear.


Exclusion criteria
  • Contraindications for levonorgestrel intrauterine system and norethisterone use

  • Pregnancy

  • Post‐menopausal bleeding

  • Uterine neoplastic disease

  • Patients with concomitant use of medications that could influence the study objectives including sex steroids, any treatment for menorrhagia (including tranexamic acid and NSAIDs)

  • Patients who had intramural or subserous fibroids of mean diameter > 4 cm or submucous fibroids

  • Adenomyosis, or endometrial abnormalities

  • Coagulation disorders, liver disease or pelvic inflammatory disease.


Follow‐up: 6 months
Interventions A. norethisterone containing tablet was given orally at a dose of 5 mg ×3/day for 5 to 26 days of cycle over consecutive cycles: 40
B. LNG‐IUS (Mirena®): 40
Outcomes PBAC at baseline, 3 and 6 months
Notes time frame: March to August 2014
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly allocated by lottery method into two equal groups: A and B
Allocation concealment (selection bias) Unclear risk No details provided
Blinding of participants and personnel (performance bias)
All outcomes High risk Only outcome was PBAC (scored by participants) which could be influenced by participants' knowledge of treatment
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin
All outcomes Unclear risk Alkaline haematin and haemoglobin were not measured
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated. Very unlikely for the difference of the treatments (one oral and one IUS)
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin)
All outcomes Unclear risk Alkaline haematin and haemoglobin were not measured
Incomplete outcome data (attrition bias)
All outcomes Low risk No apparent dropouts after participants withdrawn for hysterectomy (2 in each arm)
Selective reporting (reporting bias) Low risk All the outcomes previously stated were reported. Objective of authors was only to measure PBAC, however they acknowledged that oral NET is associated with adverse events .
Other bias Low risk Similar at baseline
Disclaimer: none
Conflict of Interest: none
Source of funding: the study was funded by the departmental grant of the Post Graduate Medical College (PGMC), Islamia University of Bahawalpur