Safety and efficacy of Ninjin'yoeito along with iron supplementation therapy for preoperative anemia, fatigue, and anxiety in patients with gynecological disease: an open-label, single-center, randomized phase-II trial
BMC women's health. 2022;22(1):229
BACKGROUND Preoperative anemia affects perioperative outcomes and often causes fatigue and psychological disorders. Therefore, anemia should be treated before a patient undergoes surgery. Ninjin'yoeito (NYT), a Japanese Kampo medicine composed of ginseng and Japanese angelica root with the other 10 herbs, is administered for anemia, fatigue and anxiety; however, there are a few reports that have prospectively examined the effects of NYT before surgery for gynecological diseases. Hence, we tended to investigate its efficacy and safety. METHODS In this open-label randomized trial, women with gynecological diseases accompanied by preoperative anemia (defined as < 11.0 g/dL Hemoglobin [Hb]) were randomly assigned (1:1) into the iron supplementation and NYT groups. Patients of the iron supplementation group and the NYT group received 100 mg/day iron supplementation with and without NYT (7.5 g/day) for at least 10 days before surgery. The primary endpoint was improvement in Hb levels before and after treatment, and Cancer Fatigue Scale (CFS) and Visual Analogue Scale for Anxiety (VAS-A) scores between groups. Statistical analyses were performed with Wilcoxon signed rank test, Wilcoxon rank sum test, and Fisher's exact test as appropriate. RESULTS Forty patients were enrolled of whom 30 patients were finally analyzed after allocating 15 to each group. There was no difference in the characteristics between both groups. Hb significantly increased in both groups (iron supplementation group, 9.9 ± 0.8 g/dL vs. 11.9 ± 1.6 g/dL; NYT group, 9.8 ± 1.0 g/dL vs. 12.0 ± 1.0 g/dL); the difference in the elevations in Hb between both groups was statistically insignificant (P = 0.72). Contrarily, CFS (17.9 ± 10.2 vs. 8.1 ± 5.2) and VAS-A (56 mm (50-70) vs. 23 mm (6-48)) scores were significantly decreased only in the NYT group and these changes were greater in the NYT group (∆CFS, P = 0.015; ∆VAS-A, P = 0.014). Liver dysfunction occurred in one patient of the NYT group. CONCLUSIONS For treating preoperative anemia in women with gynecological conditions, NYT administration along with iron supplementation safely and efficiently improved the preoperative fatigue and anxiety in addition to the recovery from anemia. TRIAL REGISTRATION jRCT1051190012 (28/April/2019, retrospectively registered).
The association of endometriosis with placenta previa and postpartum hemorrhage: A systematic review and meta-analysis
American journal of obstetrics & gynecology MFM. 2021;:100417
OBJECTIVE This study aimed to review the effect of endometriosis on the prevalence of placenta previa, postpartum hemorrhage, and surgical outcomes in placenta previa patients with endometriosis. DATA SOURCES In compliance with the Preferred Reporting Items for Systematic Reviews guidelines, a systematic review of the literature was conducted through December 31, 2020, using PubMed, Scopus, and the Cochrane Library. STUDY ELIGIBILITY CRITERIA Comparative studies between pregnant women with and without endometriosis, as well as studies that investigated the surgical outcomes in placenta previa patients with and without endometriosis, were included. STUDY APPRAISAL AND SYNTHESIS METHODS Two reviewers independently screened the titles and abstracts, completed data extraction, and assessed the reporting quality using the Risk Of Bias In Nonrandomized Studies of Interventions tool. RESULTS Nineteen studies (2010 to 2020) met the inclusion criteria (98,463 pregnancies with endometriosis and 7,184,313 pregnancies without endometriosis). In the adjusted-pooled analysis, endometriosis was associated with a higher rate of placenta previa (adjusted odds ratio [aOR] 3.17, 95% confidence interval [CI] 2.58-3.89), whereas the incidence of postpartum hemorrhage was similar between pregnant women with and without endometriosis (aOR 1.15, 95%CI 0.99-1.34). When the analysis was restricted to histologically confirmed endometriosis cases, the relationship of endometriosis with placenta previa (aOR 4.23, 95%CI 1.74-10.30) and postpartum hemorrhage (aOR 1.29, 95%CI 0.50-3.34) was consistent with results from the nonrestricted analysis. No study examined surgical outcomes in placenta previa patients with endometriosis. Three studies examined the effect of endometriosis on surgical outcomes during cesarean delivery: one study showed that endometriosis was associated with increased intraoperative bleeding during emergent cesarean delivery, the other study showed that endometriosis was associated with an increased incidence of postpartum hemorrhage during cesarean delivery (aOR 1.1, 95%CI 1.0-1.2), especially in primiparous, singleton pregnant women (aOR 1.7, 95%CI 1.5-2.0), and another study suggested a significantly higher rate of hysterectomy (7.1%) and bladder injury (7.1%) in those with endometriosis than in those without. CONCLUSIONS Endometriosis can potentially be associated with adverse surgical outcomes during cesarean delivery. Although there is a correlation between endometriosis and increased rate of placenta previa, surgical outcomes in placenta previa patients with endometriosis remain understudied.