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
Exclusion criteria
Follow‐up: 6 months |
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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 |
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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Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent dropouts after participants withdrawn for hysterectomy (2 in each arm) |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 |