A multicenter, prospective, randomized, open comparator study on the treatment of ovulatory menorrhagia with tranexamic acid and norethisterone in mainland China

Abstract

To compare the safety and efficacy of tranexamic acid (TA) and norethisterone (NET) for the treatment of ovulatory menorrhagia in patients in mainland China. Multicenter, prospective, randomized, open comparator study of TA and NET in Chinese patients with ovulatory menorrhagia. One hundred and six patients with proven ovulatory menorrhagia from the gynecologic clinics of four teaching hospitals located in three cities of mainland China were enrolled into the study between July 2004 and March 2006. Patients were randomly allocated into one of two therapeutic regimens: TA 1g tid during menstrual cycle day (D) 1–5 (57 patients, aged 34.39 ± 7.61 years), or NET 5 mg bid on D19–26 (49 patients, aged 36.41 ± 6.60 years). The drugs were administered for two consecutive cycles, after which the drugs were withdrawn and patients were followed-up for one more cycle. Data on menstrual blood loss (estimated by pictorial blood assessment chart, PBAC), length of menstrual period, and a 6-item health-related quality of life (QOL) questionnaire were collected in the second week before, during each treatment cycle, follow-up cycle and were compared. Both treatments led to significant decreases in mean PBAC scores, shorter durations of menstrual periods, and improved QOL rankings during both the first and second treatment cycles. The mean amplitude of PBAC decrement in the first cycle in the TA group was significantly greater than that in the NET group (29.31% vs. 10.64%, P=0.011); however, the difference did not continue into the second treatment cycle (39.87% vs. 28.9%, P=0.088). Improvement in four QOL items during the first cycle in the TA group was also significantly greater than that in the NET group (P=0.032−0.002). The incidence of adverse effects between the two groups was similar (12.72% vs. 15.78%, P=0.530), and was mostly comprised of gastrointestinal symptoms. The number of patients willing to continue the treatment in the second and follow-up cycles in the TA group, respectively, were significantly higher than those in the corresponding cycles of the NET group (96.30% vs. 76.6%, P=0.003; 77.36% vs. 55.56%, P=0.022, respectively). TA 3g daily during cycle D1–5 is a more effective and tolerable treatment than NET on D19–26 in the first treatment cycle in patients with ovulatory menorrhagia.