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. 2018 Apr 15;2018(4):CD000249. doi: 10.1002/14651858.CD000249.pub2

Jaisamrarn 2006.

Methods Multi‐centre RCT
Central computer‐generated randomization schedule used for allocation
Described as open label trial
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
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
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
Notes Unpublished copy of trial sighted, also conference abstract
Source of funding not stated
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