Effectiveness of ethinylestradiol/drospirenone for premenstrual symptoms in Japanese patients with dysmenorrhea: Open‐label pilot study

Takeda, Takashi; Kondo, Akiko; Koga, Shin; Hayakawa, Jun; Hayakawa, Kenichi; Hiramatsu, Keizo; Yaegashi, Nobuo

doi:10.1111/jog.12774

Cited by 7 publications

(22 citation statements)

References 16 publications

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“…The pharmaceutical treatment regimens of study participants are shown in Table . Those who were treated with a combined oral contraceptive pill (OCP) all received ethinylestradiol (EE) 20 μg plus drospirenone (DRSP) 3 mg (EE20 + DRSP) with a 24/4 regimen, which is approved by the Japanese Ministry of Health, Labour and Welfare as a treatment for dysmenorrhea . Therefore, those who were taking an OCP had the complication of dysmenorrhea.…”

Section: Methodsmentioning

confidence: 99%

Relation between premenstrual syndrome and equol‐production status

Takeda

Ueno

Uchiyama

et al. 2016

J of Obstet and Gynaecol

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Aim: Consumption of isoflavones, which are predominantly derived from soybeans, reduces the risk of estrogenrelated diseases, such as menopausal symptoms, breast cancer, osteoporosis, and cardiovascular disease. Equol is more bioavailable than other soy isoflavones, and equol producers are believed to benefit to a greater extent. This study was conducted to evaluate the relation between premenstrual syndrome (PMS) and equol-production status in Japanese reproductive-age women.Methods: This was a cross-sectional, observational study. The study included 144 Japanese women aged 20-45 years. PMS patients (n = 46) were recruited at three obstetrics and gynecology clinics. Control group women (n = 98) who were not receiving therapy for PMS were recruited from the local area by advertisement. The participants' equol-production status was determined using urine samples collected after a soy challenge test. Results: The prevalence of equol producers was 41.8% in the control group and 23.9% in the patient group (P = 0.042). Using univariate analysis, significant risk factors for equol non-producers were being a PMS patient and being younger. In multivariate analysis with a step-wise model, being a PMS patient (odds ratio, 2.342; 95% confidence interval, 1.021-5.698) was shown to be a significant risk factor for being an equol non-producer. Conclusion: This study showed a relation between PMS and equol-production status in Japanese women.

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Section: Methodsmentioning

confidence: 99%

Relation between premenstrual syndrome and equol‐production status

Takeda

Ueno

Uchiyama

et al. 2016

J of Obstet and Gynaecol

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“…In addition, evidence indicates that PMS-like symptoms may be introduced or re-introduced during cyclical and continuous progesterone treatment (Baker and O’Brien, 2012). Fewer studies, however, have examined possible associations between oestradiol and PMS, although there is some evidence that combined estrogen-progesterone contraception may have some benefits in the treatment of PMS (Freeman et al, 2012; Lopez et al, 2012; Takeda et al, 2015). Such benefits have not been universally demonstrated across studies (Bakhshani et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Lowered Plasma Steady-State Levels of Progesterone Combined With Declining Progesterone Levels During the Luteal Phase Predict Peri-Menstrual Syndrome and Its Major Subdomains

et al. 2019

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BackgroundIt is unknown whether lowered steady state levels of sex hormones coupled with changes in those hormones during the menstrual cycle are associated with premenstrual syndrome (PMS).ObjectiveTo examine associations between levels of progesterone and oestradiol during the menstrual cycle and PMS considering different diagnostic criteria for PMS.MethodsForty-one women aged 18–45 years with a regular menstrual cycle completed the Daily Record of Severity of Problems (DRSP) for all 28 consecutive days of the menstrual cycle. Blood was sampled at days 7, 14, 21, and 28 to assay oestradiol and progesterone.ResultsWe developed a new diagnosis of peri-menstrual syndrome, which is characterized by increased DRSP severity in pre and post-menstrual periods and increased scores on the major DRSP dimensions, i.e., depression, physio-somatic symptoms, breast tenderness and appetite, and anxiety. This new diagnosis performed better than classical diagnoses of PMS, including that of the American College of Obstetricians and Gynecologists (ACOG). Lowered steady state levels of progesterone, when averaged over the menstrual cycle, together with declining progesterone levels during the luteal phase predict severity of peri-menstrual symptoms. Steady state levels of oestradiol and declining oestradiol levels during the cycle are also related to DRSP severity although most of these effects appeared to be mediated by progesterone.ConclusionA significant increase in menstrual-cycle related symptoms can best be conceptualized as “peri-menstrual syndrome” and may result from insufficient progesterone production (relative corpus luteum insufficiency), which, in part may result from lowered oestradiol production indicating suboptimal pre-ovulatory follicular development.

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“…The remaining 50 potentially eligible records and one additional record (unpublished research report) were inspected in full, and subsequently 36 records were excluded. Finally, 11 studies with 14 references were included (6)(7)(8)(9)(10)(11)(12)(13)(17)(18)(19)(20)(21)(22). The PRISMA flow diagram is presented in Figure 1.…”

Section: Literature Search Resultsmentioning

confidence: 99%

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

Shi

Leng

2022

Front. Med.

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AimThis systematic review aimed to assess the efficacy and safety of Drospirenone and Ethinylestradiol Tablets (II) in the treatment of dysmenorrhea.MethodsElectronic databases, namely PubMed, Embase, Cochrane Controlled Register of Trials (CENTRAL), Scopus, Science, CBM, CNKI, Wanfang, and VIP, were searched before September 2022. Randomized controlled trials (RCTs), non-randomized controlled trials, cohort studies, case-control studies, and single-arm studies were included. Furthermore, the Cochrane Risk of Bias Tool for Systematic Reviews version 1 was used for the risk of bias assessment on RCTs. The Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool was used for risk of bias assessment on non-randomized studies. The risk ratio (RR) was calculated for dichotomous data. Mean difference (MD) or standardized MD (SMD) were used as the effect size for continuous data.ResultsA total of 11 studies involving 2,251 participants with dysmenorrhea were included. When Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen was compared with placebo, the total efficiency rate (defined as pain symptom disappearing or being relieved) in Drospirenone and Ethinylestradiol Tablets (II) 24/4-day regimen group was higher than in placebo group (RR = 5.55, 95%CI: 2.48–12.39, P < 0.0001). No clear differences were found on risk of overall adverse events or specific adverse events. When Drospirenone and Ethinylestradiol Tablets (II) was compared with active control drugs, no clear differences were found on the total efficiency rate or visual analog scale (VAS) scores for dysmenorrhea and other related pain. The risk of overall adverse events decreased in Drospirenone and Ethinylestradiol Tablets (II) conventional 24/4-day regimen (13/53 vs. 66/148, RR = 0.55, 95%CI: 0.33–0.91) when compared with active control drugs group. When Drospirenone and Ethinylestradiol Tablets (II) flexible extended regimen was compared with conventional 24/4-day regimen, the number of days of dysmenorrhea (MD=−3.98, 95%CI: −5.69 to −2.27), and dysmenorrhea associated with unscheduled bleedings (MD = −1.6, 95%CI: −2.8 to −0.5), were fewer in flexible extended regimen. In addition, there were no differences found on risk of adverse events (including mood changes, spotting, headache, breast pain, nausea, and vomiting) between compared groups (P > 0.05).ConclusionDrospirenone and Ethinylestradiol Tablets (II) could improve symptoms of dysmenorrhea and decrease other related pain symptoms. More high-quality evidence is needed to confirm the advantages.Systematic review registration[https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021271605], identifier [CRD42021271605].

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Effectiveness of ethinylestradiol/drospirenone for premenstrual symptoms in Japanese patients with dysmenorrhea: Open‐label pilot study

Abstract: This study showed that EE20 + DRSP could be a useful treatment strategy for premenstrual symptoms in Japanese women.

Cited by 7 publications

References 16 publications

Relation between premenstrual syndrome and equol‐production status

Relation between premenstrual syndrome and equol‐production status

Lowered Plasma Steady-State Levels of Progesterone Combined With Declining Progesterone Levels During the Luteal Phase Predict Peri-Menstrual Syndrome and Its Major Subdomains

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

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