Objective: The aim of the study was to compare the efficacy of micronised flavonoids versus tranexamic acid in reducing menstrual blood loss (MBL) associated with the use of the TCu 380A intrauterine contraceptive device (IUD) in women with heavy menstrual bleeding (HMB).
Methods: We conducted a randomised double-blind clinical trial between October 2016 and August 2017 in 100 women with HMB (defined as a pictorial blood assessment chart [PBAC] score >100) secondary to IUD use. After assessment of MBL using PBAC score in a baseline cycle, participants were randomised to receive either oral tranexamic acid 500 mg or oral micronised flavonoids 500 mg every 6 h for the first three days of menstruation. PBAC scores were collected in the three subsequent treatment cycles. The primary outcome was the difference in PBAC scores between the groups. Two-way repeated measures ANOVA was used to assess the primary outcome of the change in PBAC scores.
Results: Mean PBAC scores were significantly improved in the tranexamic acid group compared with the micronised flavonoids group (236 ± 48, 105 ± 26, 97 ± 16 and 93 ± 15 at the baseline, first, second and third study cycle, respectively, versus 227 ± 52, 139 ± 29, 128 ± 25 and 125 ± 24 in the micronised flavonoids group; p = .01). Moreover, the number of bleeding days and number of pads used were significantly reduced in the tranexamic acid group compared with the micronised flavonoids group (p = .009 and p = .03, respectively). Side effects were comparable between the two groups.
Conclusion: Oral tranexamic acid compared with oral micronised flavonoids is more effective in reducing HMB associated with copper IUD use. Treating IUD-induced HMB using tranexamic acid was more effective compared with micronised flavonoids in decreasing MBL volume and the number of bleeding days.
Keywords: Contraception; IUD; heavy menstrual bleeding; intrauterine contraceptive device; micronised flavonoids; tranexamic acid.