[A multicenter prospective randomized open comparative study on the treatment of ovulatory menorrhagia with tranexamic acid and norethisterone in China].
OBJECTIVE
To compare the efficacy and safety of tranexamic acid (TA) and norethisterone (NET) for the treatment of patients with ovulatory menorrhagia in China.


METHODS
One hundred and thirty one patients with proven ovulatory menorrhagia from gynecologic clinics of 5 teaching hospitals located in 4 different cities in China were enrolled during Jul 2004 to Dec 2006. Among them 128 completed the study. Patients were randomly divided into two therapeutic regimen groups: TA 1 g thrice daily during menstrual cycle days (D) 1-5, 69 cases; or NET 5 mg twice daily on D19-26, 59 cases. The drugs were administered for 2 consecutive cycles, then withdrawn and patients were followed-up for 1 more cycle. Data on menstrual blood loss [estimated by pictorial blood assessment chart (PBAC)], length of menstrual periods, quality of life (QOL) evaluated by a 6 item health-related questionnaire were collected before, during each cycle and were compared.


RESULTS
Both treatments led to significant decreases of mean PBAC scores and shorter duration of menstrual periods, and improved the QOL ranking during the two treatment cycles. The mean percentages of PBAC decrements in the TA first and second cycles were significantly greater than those in the NET corresponding cycles(35% vs 17% , P = 0.004; 44% vs 34%, P = 0.04 respectively). The success rate of TA second cycle was higher than that of the NET second cycle (41% vs 24%, P = 0.04). Improvement of QOL ranking in the TA first cycle was also significantly better than those in the NET first cycle (P = 0.03). The percentage of patients with at least 1 adverse event in TA group (19%) was significantly lower than that in NET group (35%, P = 0.04). Patients' willingness to continue the treatment in the TA second and follow-up cycles (94%, 79% respectively) were significantly higher than those in the corresponding cycles of NET groups (79%, 59% respectively; P = 0.01, P = 0.02).


CONCLUSIONS
The regimen of TA 3 g daily during menstrual days 1-5 is a more effective and tolerable treatment than luteal phase norethisterone for patients with ovulatory menorrhagia.
Zhang
Yi-Wen
YW
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China. zhayw@sina.com
He
Fang-Fang
FF
Sun
Zheng-Yi
ZY
Li
Shang-Wei
SW
Bi
Shi-Liang
SL
Huang
Xiu-Ling
XL
Cao
Zan-Sun
ZS
Lü
Shu-Lan
SL
Lu
Jun-Li
JL
Zhang
Zhen-Yu
ZY
Zhu
Yi-Min
YM
Huang
He-Feng
HF
Miao
Mao-Hua
MH
D000284:Administration, Oral; D000328:Adult; D000933:Antifibrinolytic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008595:Menorrhagia / Q000188:drug therapy*; D008598:Menstruation / Q000187:drug effects*; D008875:Middle Aged; D009640:Norethindrone / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D014148:Tranexamic Acid / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid; D009640:Norethindrone