COMPARATIVE-STUDY OF TRANEXAMIC ACID AND NORETHISTERONE IN THE TREATMENT OF OVULATORY MENORRHAGIA

Objective To compare the efficacy and safety of tranexamic acid and no rethisterone in the treatment of ovulatory menorrhagia. Design A rando mised, double-blind, placebo controlled study. Setting University Depa rtment of Obstetrics and Gynaecology, Addenbrooke's Hospital, Cambridg e. Subjects One hundred and three women complaining of heavy periods w ith a regular cycle recruited directly from general practitioners with in the hospital catchment area and from consultants' gynaecology clini cs. Interventions There were forty-six women on placebo with confirmed ovulatory menorrhagia, defined as menstrual blood loss greater than 8 0 ml/cycle and mid-luteal serum progesterone concentration greater tha n 9 nmol/l). Twenty-one received norethisterone (5 mg twice a day on d ays 19 to 26) and 25 received tranexamic acid (1 g four times daily on days 1 to 4) for two cycles. Main outcome measures Menstrual blood lo ss was measured using the alkaline haematin method. Haematological ass essments were made both at the beginning and at the end of the study, questionnaires were given to assess subjective endpoints, and patients were asked to report any adverse events during all cycles. Results Tr anexamic acid reduced mean menstrual blood loss by 45%, from 175 ml to 97 ml (95% CI for the difference in menstrual blood loss 52 to 108, P < 0.0001), norethisterone increased mean blood loss by 20% from 173 m l to 208 ml (95% CI for the difference in menstrual blood loss -64 to 2, P = 0.26). Fourteen (56%) women who received tranexamic acid achiev ed a mean menstrual loss of less than 80 mi per cycle during treatment , but only two (9.5%) who received norethisterone achieved this mean m enstrual loss. There were no serious adverse events reported for eithe r drug. Conclusions Tranexamic acid is a safe and effective form of me dical therapy in women with menorrhagia and is highly likely to normal ise blood loss in women losing 80 to 200 ml prior to treatment. Noreth isterone at this dose is not effective therapy for ovulatory menorrhag ia.