Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study

Okada, Ken-ichi; Kawai, Manabu; Hirono, Seiko; Miyazawa, Motoki; Kitahata, Yuji; Kobayashi, Ryohei; Ueno, Masaki; Hayami, Shinya; Shimokawa, Toshio; Yamaue, Hiroki

doi:10.1016/j.curtheres.2020.100605

Cited by 7 publications

(9 citation statements)

References 19 publications

(34 reference statements)

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“…There were no complications that affected the treatment of gynecological conditions, such as by prolonging hospitalizations, which indicates that the formula can be used safely. Moreover, NYT has been suggested to be effective not only perioperatively but also as a supportive therapy for managing complications associated with radiation and chemotherapy [ 23 – 25 , 44 , 61 ]. As it can provide a comprehensive treatment at any stage of patients with gynecological diseases, it has been concluded as a promising Kampo formula.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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).

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Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…Previous studies have shown that Hozai is effective for treating fatigue because of its immune-stimulatory effects [ 8 , 9 , 14 , 15 ]. However, no study has focused on the differences among HET, JTT, and NYT or those among these agents from different pharmaceutical industries in Japan, including their immunological effects on PBMCs.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, JTT increases the regulatory activities of T cells by decreasing the forkhead box p3 (Foxp3) + regulatory T cell (Treg) population in patients with advanced pancreatic cancer [ 8 ]. The symptoms of fatigue caused by nab-paclitaxel plus gemcitabine treatment administered to patients with unresectable pancreatic cancer have been reported to be improved by NYT [ 9 ]. Furthermore, NYT has been shown to synergistically enhance the effects of a tumor vaccine mediated by CD8 + T cells [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

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Immunological Differences in Human Peripheral Blood Mononuclear Cells Treated with Traditional Japanese Herbal Medicines Hochuekkito, Juzentaihoto, and Ninjin’yoeito from Different Pharmaceutical Companies

Kiyomi

Matsuda

Nara

et al. 2021

Evidence-Based Complementary and Alternative Medicine

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Hochuekkito (HET), Juzentaihoto (JTT), and Ninjin’yoeito (NYT) have been used as Hozai, a group of traditional Japanese herbal medicines, to treat physically and mentally weak cancer patients. Their compositions are quite different, and Japanese pharmaceutical companies have been using different types or quantities of herbs for formulations with the same name. Here, we compared the immunological differences between HET, JTT, and NYT with respect to the induced T cell subsets and cytokines. Peripheral blood mononuclear cells (PBMCs) were isolated from healthy volunteers and treated with 0 (control), 25, 50, 100, 200, or 400 μg/mL HET, JTT, or NYT (manufactured by Tsumura [TJ], Kracie [KR], and Kotaro [KO]). PBMC proliferation, CD4+ T cell, CD8+ T cell, and regulatory T cell (Treg) proportions and interleukin (IL) concentrations (IL-6, IL-10, IL-17A, interferon-γ, tumor necrosis factor-α, and transforming growth factor (TGF)-β) secreted by PBMCs were measured using Cell Counting Kit-8 or flow cytometry bead analysis. PBMC proliferation and CD4+ T cell percentages were similar in the HET, JTT, NYT, and control groups; however, the percentage of CD8+ T cells tended to increase after treatments. Tregs were suppressed by HET, JTT, and NYT, and TJ-JTT significantly decreased Treg numbers (compared with control). The concentrations of all cytokines except TGF-β were increased in a concentration-dependent manner ( p < 0.05 ); particularly, KR-HET induced IL-6 secretion (compared with the control, TJ-HET, and KO-HET; 37-, 7-, and 17-fold, respectively; p < 0.05 ). The TGF-β concentration was decreased in a concentration-dependent manner by HET, JTT, and NYT (compared with the control). These results suggest that, compared with TJ-HET and KO-HET, KR-HET should be administered with caution. Although HET, JTT, and NYT belong to the same Hozai group and have the same names among companies, their differing effects on immune activity must be considered and they must be administered with caution.

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“…As it translates to "ginseng nutritive decoction," based on its main ingredient, it is known to improve the nutritional status and used as herbal medicine for symptomatic treatment of "post-illness weakness, fatigue, loss of appetite, night sweats, cold extremities, and anemia." Previous clinical and preclinical studies concluded on its effectiveness in anemia [17,18], fatigue [19][20][21][22][23][24][25], and psychological conditions, namely anxiety and depression, as well as lethargy and apathy associated with Alzheimer's and Parkinson's diseases [26][27][28][29][30]. However, very little prospective research has been performed to investigate the effects of administering NYT in patients having preoperative anemia with unspeci ed symptoms, especially for gynecological diseases.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Ninjin’yoeito for Preoperative Anemia, Fatigue, and Anxiety in Patients with Gynecological Disease: an Open-Label, Single-Center, Randomized Phase-II Trial.

Yagi

Sawada

Miyamoto

et al. 2021

Preprint

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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: 40 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 anemia, fatigue and anxiety.Trial registration: jRCT1051190012 (28/April/2019, retrospectively registered).

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Impact of Ninjin'Yoeito on Fatigue in Patients Receiving Nab-Paclitaxel Plus Gemcitabine Therapy: A Prospective, Single-Arm, Phase II Open Label, Nonrandomized, Historically-Controlled Study

Cited by 7 publications

References 19 publications

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

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

Immunological Differences in Human Peripheral Blood Mononuclear Cells Treated with Traditional Japanese Herbal Medicines Hochuekkito, Juzentaihoto, and Ninjin’yoeito from Different Pharmaceutical Companies

Efficacy of Ninjin’yoeito for Preoperative Anemia, Fatigue, and Anxiety in Patients with Gynecological Disease: an Open-Label, Single-Center, Randomized Phase-II Trial.

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