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GAZZETTA MEDICA ITALIANA ARCHIVIO PER LE SCIENZE MEDICHE
A Journal on Internal Medicine and Pharmacology
Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Gazzetta Medica Italiana Archivio per le Scienze Mediche 2015 September;174(9):391-8
Severity of bleeding is a predictor of quality of life in women with heavy menstrual bleeding under dydrogesterone treatment in a prospective, multicentre, observational study
Tajjamal A. 1, Zaman F. 2
1 Allama Iqbal Medical College and Jinnah Hospital, Lahore, Pakistan;
2 Rashid Latif Medical College, Lahore, Pakistan
AIM: Heavy menstrual bleeding (HMB) is a condition that interferes with a woman’s physical, social, emotional, and/or material quality of life. It is a significant problem for otherwise healthy women, with about one third of all menstruating women reporting heavy periods. The effects of dydrogesterone treatment on cycle and severity of menstruation have been published before, however, no data on the relation between changes in menstrual bleeding under dydrogesterone treatment and health related quality of life (HRQoL) have been published to date.
METHODS: This was a multi-centre, observational study in 210 women diagnosed with HMB. Only women with a pictorial blood assessment chart (PBAC) score of >100 were considered to have HMB. The 5-Dimensional EuroQol (EQ-5D) was used for assessing HRQoL. Eligible subjects received dydrogesterone treatment (Duphaston®, 10 mg, twice daily) during the second part of the cycle for three consecutive cycles. At entry (visit 2) and at the end of each treatment cycle (visits 3 to 5), women were assessed using HRQoL, PBAC score, and a menstrual cycle diary. The primary endpoint was the change in EQ-5D index from baseline to end of study and was analyzed with a two-sided Student’s t-test. Women with a PBAC score <100 were considered to have improved severity of menstruation.
RESULTS: The EQ-5D index increased significantly from a mean±standard deviation of 0.62±0.09 before treatment to 0.89±0.12 after treatment (P-value <0.001). A lower PBAC score was observed in 185 out of 204 women and dropped from 172.7±105.7 to 60.88±48.6 (P-value <0.001). Before treatment, 201 women described their menstrual flow as heavy and this dropped to only six women after treatment and was accompanied by a marked shift toward medium and light menstrual flow. In general, dydrogestrone treatment was well tolerated with an incidence of 14.3% adverse events. The most common adverse events were pallor (3.8%) and anemia (2.4%).
CONCLUSION: The results of the study show that improvement in HMB observed following treatment with dydrogesterone substantially and significantly improves the HRQoL of women suffering from HMB.