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.

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).

Obstetric outcomes and acceptance of alternative therapies to blood transfusion by Jehovah's Witnesses in Japan: a single-center study.

We sought to investigate obstetric outcomes and acceptance rates for blood products or types of autotransfusion by Jehovah's Witnesses (JWs) at a single institution in Japan. We retrospectively reviewed cases of 84 pregnant JW patients and 95 deliveries from April 2001 to August 2017. We examined the acceptance rates of blood transfusions, blood products, and autotransfusion types in patients who experienced postpartum hemorrhage (PPH), and investigated estimated hemorrhage volume at delivery and PPH treatments. Of the 84 JW patients, none accepted blood transfusion; however, 75 patients (89.3%) accepted blood products, 57 (67.9%) accepted autotransfusion using intraoperative cell salvage, and four (4.8%) refused all alternatives to blood transfusion. Furthermore, PPH > 1000 mL occurred in 18 of the 95 (18.9%) deliveries. Of these 18 patients, four (22.2%) required blood products and three (16.7%) required supracervical hysterectomy to control PPH. No maternal deaths occurred. Approximately 95% of the patients observed accepted all or some alternatives to blood transfusion. To treat JW patients in a safer manner, understanding their individual acceptance of alternatives to blood transfusion is important for the strategic use of such alternatives.