Jaisamrarn 2006.
Methods | Multi‐centre RCT Central computer‐generated randomization schedule used for allocation Described as open label trial |
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Participants | Country: Thailand (4 sites) Mean age: 34.6 years Number of participants: 169 women were randomized and 167 completed the trial Inclusion criteria: aged between 18 and 45 years, regular menstrual cycle (21 to 35 days), serum progesterone during 5 to 9 days before menstruation of ≥ 5.0 ng/mL, PBAC score > 130 during run‐in phase, no contraindication to treatment drugs, normal renal and liver function, normal pelvic examination Exclusion criteria: concomitant diseases, organic disease, VTE, haemorrhagic or fibrinolytic disorder, hormone therapy during last 3 months, taking any medication that might affect MBL, need or desire for contraception, need for iron supplementation, inability to comply and no consent |
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Interventions | (1) TXA 3 g daily on days 1 to 5 of cycle (2) MFA 1.5 mg daily on days 1 to 5 of cycle (3) NET 10 mg daily on days 19 to 26 of cycle, for 2 consecutive cycles |
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Outcomes | MBL using PBAC (end scores) Cure rate (success rate) (defined as PBAC ≤ 130) Adverse events QoL using a 'standardized questionnaire' Acceptability of treatment Hb Duration of menstruation |
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Notes | Unpublished copy of trial sighted, also conference abstract Source of funding not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization scheme |
Allocation concealment (selection bias) | Low risk | Centralised randomization scheme separate from study investigators |
Blinding (performance bias and detection bias) All outcomes | High risk | Described as "open label" Potential knowledge of treatment may have influenced the primary outcome of MBL as this was measured by PBAC |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Minimal drop‐outs |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Low risk | Groups appeared comparable at baseline |