Treatment of Women with Heavy Menstrual Bleeding with a Combination Therapy of Agnus Castus and Tranexamic Acid - Experiences of a German Single Centre

Background:

Heavy menstrual bleeding (HMB) is a common gynaecological problem and is the reason for 18-30% of gynaecological visits. In a European study in 4,502 women, 27.2% were diagnosed with HMB (Fraser et al., 2015). On the other hand, HMB is often associated with bleeding disorders (Shankar et al., 2004). The definition of HMB has different perspectives; from a subjective perspective HMB is defined as e excessive menstrual blood loss impacting on women's physical, social, emotional and/or mental quality of life, whereas from an objective perspective it is defined as excessive blood loss >80 ml per cycle (Munro et al., 2012). There are different approaches for treating HMB such as the administration of non-steroidal drugs, Desmopressin, herbal Vitex Agnus Castus (VAC), Tranexamic acid (TXA) or a hormonal therapy; moreover, HMB can also be treated surgically.

The aim of this study was to test the efficacy of the specific HMB management used in our center: Women with HMB are treated usually with VAC, which optimizes the relation of estrogen to progesterone in the female body (Yavarikia et al., 2013). VAC can be used without using any hormones (Shahnazi et al, 2016), providing a treatment with a low impact on women's bodies. Additionally, TXA is given during the menstruation due to its antifibrinolytic effect. Furthermore, the "Pictural Blood-Loss-Assessment- Chart" (PBAC Score) is administered to analyze the menstrual blood loss.

Methods:

Two ad hoc patient-reported questionnaires were developed to test the efficacy of the HMB management in our center The baseline questionnaire includes the following aspects: menarche, duration, regularity, number of sanitary products, pain level, medical background and family history. During the first visit in our center women with HMB filled in the baseline questionnaire. In addition, laboratory tests are done including a comprehensive coagulation test and the examination of iron and hemoglobin levels. Moreover, we presented an application called "My Flow Score" to the patients, which calculates the PBAC score as a result of all entered sanitary products women use during their period. Women are prescribed VAC and/or TXA for the management of their HMB. After four months patients are scheduled for a follow up appointment. At that time they complete the follow-up questionnaire including the following aspects: compliance with the medication or the reason for the non-compliance, health complaints due to the medication, duration of the period, improvement, pain level, PBAC score if the patient did use the APP "My Flow Score" or if not the number of sanitary products. A blood test was taken and the HMB management was adapted to the patients' needs.

Results:

So far, 100 women with HMB with a median age of 14 years (range 9-50) were enrolled in our study. They had their menarche with a median age of 12 years (range 8-17). Diagnosis of women ranged from iron or folic acid deficiency to different forms of bleeding disorders; with the majority suffering from von Willebrand disease (43/100) followed by iron deficiency (14/100). One fifth of the patients had more than one diagnosis. 1/3 of patients received a treatment for the HMB previously, mainly contraceptives, TXA or VAC. 49% reported anomalies with regard to previous other bleeding; 25.8% had increased hematomas and 19.6% recurrent epistaxis. Most of them reported anomalies already in the family (60.2%). Before treatment women had a median PBAC Score of 169 (range 77-800) and reported a median pain level of 6.5 during menstruation on a scale ranging from 1 (low pain) to 10 (extreme pain). 87/100 women received VCA, of these 75.4% regularly and 85/100 women received TXA, of these 84.6% regularly. 81% of them received a combination of both medicines. Compared to before 28.8% of patients reported shorter duration of menstruation and reduced bleeding with treatment, 11.9% did not experience any improvement; the PBAC score decreased significantly (p<.0001).

Conclusions:

Although the type of diagnosis in women suffering from HMB had a great variation, these patients had a high disease burden with a relatively high level of pain and a high loss of blood assessed with the PBAC score. Thanks to a combination of VAC and TXA the disease burden in these women could be reduced, especially for the time of menstruation and amount of bleeding. VAC proved to be highly accepted by women due to its low treatment burden.