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
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | BMC Women's Health |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12905-022-01824-9 |
| _version_ | 1811344922840662016 |
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| author | Taro Yagi Kenjiro Sawada Mayuko Miyamoto Yasuto Kinose Satoshi Nakagawa Tsuyoshi Takiuchi Michiko Kodama Eiji Kobayashi Kae Hashimoto Seiji Mabuchi Takuji Tomimatsu Kiyoshi Yoshino Tadashi Kimura |
| author_facet | Taro Yagi Kenjiro Sawada Mayuko Miyamoto Yasuto Kinose Satoshi Nakagawa Tsuyoshi Takiuchi Michiko Kodama Eiji Kobayashi Kae Hashimoto Seiji Mabuchi Takuji Tomimatsu Kiyoshi Yoshino Tadashi Kimura |
| author_sort | Taro Yagi |
| collection | DOAJ |
| description | Abstract 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). |
| first_indexed | 2024-04-13T19:55:22Z |
| format | Article |
| id | doaj.art-2cefe2fd05494fcab6410b321a652b25 |
| institution | Directory Open Access Journal |
| issn | 1472-6874 |
| language | English |
| last_indexed | 2024-04-13T19:55:22Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Women's Health |
| spelling | doaj.art-2cefe2fd05494fcab6410b321a652b252022-12-22T02:32:22ZengBMCBMC Women's Health1472-68742022-06-0122111010.1186/s12905-022-01824-9Safety 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 trialTaro Yagi0Kenjiro Sawada1Mayuko Miyamoto2Yasuto Kinose3Satoshi Nakagawa4Tsuyoshi Takiuchi5Michiko Kodama6Eiji Kobayashi7Kae Hashimoto8Seiji Mabuchi9Takuji Tomimatsu10Kiyoshi Yoshino11Tadashi Kimura12Department of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Gynecologic Oncology, Osaka International Cancer InstituteDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineDepartment of Obstetrics and Gynecology, University of Occupational and Environmental HealthDepartment of Obstetrics and Gynecology, Osaka University Graduate School of MedicineAbstract 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).https://doi.org/10.1186/s12905-022-01824-9AnemiaAnxietyFatigueFerritinHerbal medicineIron deficiency |
| spellingShingle | Taro Yagi Kenjiro Sawada Mayuko Miyamoto Yasuto Kinose Satoshi Nakagawa Tsuyoshi Takiuchi Michiko Kodama Eiji Kobayashi Kae Hashimoto Seiji Mabuchi Takuji Tomimatsu Kiyoshi Yoshino Tadashi Kimura 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 Anemia Anxiety Fatigue Ferritin Herbal medicine Iron deficiency |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Anemia Anxiety Fatigue Ferritin Herbal medicine Iron deficiency |
| url | https://doi.org/10.1186/s12905-022-01824-9 |
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