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. 2019 Aug 14;2019(8):CD001016. doi: 10.1002/14651858.CD001016.pub3

Goshtasebi 2013.

Methods RCT, with parallel‐group technique
Block randomization technique
Participants unable to be blinded, given the differences between the regimens
Participants Country: Iran
Number of participants: 90, 19 of whom withdrew by the end of the follow‐up period
Age: 20‐45 years old
Inclusion criteria: reported regular HMB; BMI 19‐29
Exclusion criteria: “organic cause of HMB”, iron‐deficiency anaemia, previous VTE, history of chronic diseases, history of diseases known to interfere with menstrual bleeding (e.g. fibroids, anticoagulant use, COCP or other hormonal drug use), IUS in situ
Interventions
  1. TXA 500 mg 4 times daily for days 1‐5 of menses

  2. MPA 5 mg twice daily, for days 5‐26 of the menstrual cycle

Outcomes Subjective assessment of MBL, using a modified PBAC (end scores)
Serum Hb and ferritin
SF‐36 for QoL (Farsi version)
HMB questionnaire (Farsi version)
Side effects
Notes Funded by Tarbiat Modares University
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomization
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 PBAC, satisfaction, Adverse effect, response to treatment, bleeding High risk Unable to blind participants due to different regimens. Potential knowledge of treatment may have influenced the primary outcome of MBL, which was measured by PBAC
Blinding of participants and personnel (performance bias) 
 Haematin alkaline Unclear risk Alkaline haematin was not measured.
Blinding of outcome assessment (detection bias) 
 PBAC, satisfaction, Adverse effect, response to treatment Unclear risk It is unclear whether or not personnel were blinded
Blinding of outcome assessment (detection bias) 
 Haematin Alkaline Unclear risk Alkaline haematin was not measured.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Significant loss to follow‐up, but similar numbers and reasons for each group
71/90 randomized women (79%) included in analysis
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported
Other bias Low risk Similar at baseline: groups balanced on baseline
Disclaimer: not stated
 CoI: not stated
 Source of funding: funded by Tarbiat Modares University