<p>Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study</p>

Abstract

Purpose: Dysmenorrhea negatively affects women's quality of life and poses a considerable economic burden. A recent study in Japanese patients with dysmenorrhea (NCT01892904) reported a significant reduction in the number of days with menstrual pain after treatment with a flexible extended regimen of ethinylestradiol (EE)/drospirenone (DRSP) compared with a cyclic regimen. However, individual patients' menstrual pain patterns and intensities were not indicated. Heatmapping was used to visualize menstrual pain patterns and intensities by re-evaluating the previously published data from NCT01892904. Patients and Methods: NCT01892904 was a Phase III, multicenter, randomized, open-label, active-control study of 212 women aged ≥20 years randomized 1:1 to receive flexible extended or 28-day cyclic EE/DRSP treatment. Daily pain levels were recorded in patient diaries, and menstrual pain patterns and intensities were visualized using heatmapping. Patients were stratified by baseline dysmenorrhea scores and primary or secondary dysmenorrhea. Results: The heatmap data demonstrated that EE/DRSP reduced the degree of menstrual pain. Regular peaks of menstrual pain were alleviated in the extended regimen group but were still observed in the cyclic regimen group. While a decrease in the days with menstrual pain was observed in patients with higher baseline dysmenorrhea scores (5-6), those with lower baseline scores (3-4) were more likely to experience lower intensities of menstrual pain. Although pain relief was less likely in patients with secondary dysmenorrhea, those who had lower baseline dysmenorrhea scores (3-4) and received the flexible extended regimen experienced a greater reduction in the number of days with menstrual pain than those who received the cyclic regimen. Conclusion: Heatmapping effectively visualized the daily burden of menstrual pain in Japanese patients with dysmenorrhea. The analysis using heatmaps suggested that the flexible extended EE/DRSP treatment regimen was more likely to alleviate the regular occurrence of menstrual pain peaks compared with the cyclic regimen.

Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study

“…Our study showed that the cyclic LEP regimen relieved pelvic pain and burdensome symptoms due to dysmenorrhea. However, cyclic regimens allow hormone withdrawal bleeding to occur at regular intervals, and it is known that pain due to dysmenorrhea generally peaks around the time of menstruation [ 26 ]. An extended LEP regimen available in Japan makes it possible to take EE/DRSP or levonorgestrel/EE for up to 120 and 77 days, respectively, resulting in a reduced menstrual frequency, which may reduce the number of painful episodes for patients with dysmenorrhea and may limit situations in which patients miss work or school.…”

Comparison of the Effects of Hysteroscopic Cold Broad Sword Play Combined with Estrogen and Progestin Sequential Therapy and Drospirenone and Ethinylestradiol Tablets in Patients with Severe Intrauterine Adhesion

“…Compared to the estrogen and progestin sequential therapy, drospirenone and ethinylestradiol tablets are lower in ethinylestradiol and have fewer side effects, which ensures patient safety. A recent study [ 18 ] in patients with dysmenorrhoea found a significant reduction in the number and intensity of days of menstrual pain in patients treated with the ethinylestradiol (EE)/drospirenone (DRSP) regimen compared to sequential therapy. In this result, the duration of abdominal pain was shorter in group A patients than in group B after treatment.…”

Effect and safety of drospirenone and ethinylestradiol tablets (II) for dysmenorrhea: A systematic review and meta-analysis

“…Eleven studies ( 6 – 13 , 17 – 22 ) were included involving 2,251 participants. There were 10 English studies ( 6 – 10 , 12 , 13 , 17 – 22 ) and one Chinese study ( 11 ). Six studies ( 6 – 9 , 11 , 12 , 17 – 19 ) were RCTs ( n = 1534), one ( 13 ) was a non-randomized control study ( n = 43), and four studies ( 10 , 20 – 22 ) were single-arm studies ( n = 674).…”

“…Two of the studies ( 11 , 21 ) were single center studies, whereas nine studies ( 6 – 10 , 12 , 13 , 17 – 20 , 22 ) were multicenter studies. The study subjects were primary dysmenorrhea patients (three studies) ( 8 , 11 , 13 , 18 , 19 ), endometriosis patients (three studies) ( 12 , 20 , 22 ), and both primary dysmenorrhea and secondary dysmenorrhea patients (four studies) ( 6 – 10 , 17 ). One study ( 20 ) did not specify the type of dysmenorrhea.…”