Goshtasebi 2013.
| Methods | RCT, with parallel‐group technique Block randomization technique Participants unable to be blinded, given the differences between the regimens |
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| 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 |
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| Interventions |
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| 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 |
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| 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 |