A Cochrane «Antifibrinolytics for heavy menstrual bleeding»1 «Bryant-Smith AC, Lethaby A, Farquhar C et al. Anti...»1 review included 13 trials with a total of 1312 women with heavy menstrual bleeding. Antifibrinolytic therapy compared to placebo showed a significant reduction in mean blood loss and significant change in mean reduction of blood loss (table «Antifibrinolytics compared to no treatment or placebo for heavy menstrual bleeding...»1). Antifibrinolytic therapy was more efficacious than other medications (NSAIDs, norethisterone, or ethamslate), but not better than levonorgestrel intrauterine system (table «Antifibrinolytics compared with other medical therapies for heavy menstrual bleeding...»2). The dose of tranexamid acid varied from 2.4 g to 4 g and the reduce in blood loss was 30 to 55 %. There were no significant differences in the frequency of reported gastrointestinal side effects with tranexamic acid when compared with either NSAIDs, oral luteal phase progestagens, or ethamsylate.
| Outcome | Relative effect (95% CI) | Risk with control - No treatment or placebo | Risk with intervention - Antifibrinolytics | № of participants |
|---|---|---|---|---|
| Menstrual blood loss: mean loss Assessed with: alkaline haematin method Follow-up 3 to 6 months | - | 206 mL to 252 mL | MD 53.2 mL lower (62.7 lower to 43.7 lower) | 565 (4) |
| Menstrual blood loss (with variety of methods): improvement rates Follow-up 3 to 6 months | RR 3.34 (1.84 to 6.09) | 109 per 1000 | 363 per 1000 (200 to 662) | 271 (3) |
| Adverse events | RR 1.05 (0.93 to 1.18) | 836 per 1000 | 990 per 1000 | 297 (1) |
| Outcome: Menstrual blood loss: improvement rates (overall) Assessed with: patient assessment | Relative effect (95% CI) | Risk with other medical therapy | Risk with antifibrinolytics | Relative effect (95% CI) № of participants (studies) |
|---|---|---|---|---|
| Menstrual blood loss: improvements rates with progestogens Follow-up 2 to 3 months | RR 1.54 (1.31 to 1.80) | 463 per 1000 | 701 per 1000 (607 to 833) | 422 (5) |
| Menstrual blood loss: improvement rates with NSAIDs Follow-up 2 to 3 months | RR 1.43 (1.18 to 1.74) | 608 per 1000 | 869 per 1000 (717 to 1000) | 161 (2) |
| Menstrual blood loss: improvement rates with ethamsylate Follow-up 3 months | RR 1.56 (0.95 to 2.55) | 444 per 1000 | 693 per 1000 (422 to 1000) | 53 (1) |
| Menstrual blood loss: improvement in mean blood loss (PBAC score < 100) Follow-up: outcomes measured at end of treatment | RR 0.43 (0.24 to 0.77) | 850 per 1000 | 364 per 1000 (204 to 655) | 42 (1) |
In a multicenter, double-blind, placebo-controlled, randomized trial «Freeman EW, Lukes A, VanDrie D et al. A dose-respo...»2 women (n = 304) with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.95 g/d or 3.9 g/d of tranexamic acid or placebo for up to 5 days of menstrual bleeding. Primary efficacy endpoints were mean MBL reduction from baseline, mean MBL reductions that were considered "meaningful" by subjects, and mean MBL reductions from baseline > 50 mL/cycle. The 3.9 g/d group met all 3 primary efficacy endpoints whereas the 1.95 g/d dose met 2 primary efficacy endpoints. Adverse effects (AEs) did not significantly differ among the 3 groups. There were no serious study-related AEs.
Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment in half of the studies) and upgraded by large magnitude of effect.
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