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Clinical Trial
. 2022 Jun 14;22(1):229.
doi: 10.1186/s12905-022-01824-9.

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

Taro Yagi  1 , Kenjiro Sawada  2 , Mayuko Miyamoto  1 , Yasuto Kinose  1 , Satoshi Nakagawa  1 , Tsuyoshi Takiuchi  1   3 , Michiko Kodama  1 , Eiji Kobayashi  1 , Kae Hashimoto  1   4 , Seiji Mabuchi  5 , Takuji Tomimatsu  1 , Kiyoshi Yoshino  6 , Tadashi Kimura  1
Affiliations
Clinical 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

Taro Yagi et al. BMC Womens Health. .

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).

Keywords: Anemia; Anxiety; Fatigue; Ferritin; Herbal medicine; Iron deficiency; Ninjin'yoeito.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT Flow Diagram of the participants in this study
Fig. 2
Fig. 2
Comparison of the treatment effectiveness between the iron supplementation group and the NYT group. A Plot of the Cancer Fatigue Scale (CFS) scores; B the Visual Analogue Scale for Anxiety (VAS-A) scores, examining the treatment effect between the two groups; NYT, Ninjin’yoeito; *P < 0.05
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