Ninjin'yoeito is associated with attenuation of postoperative decline in Prognostic Nutritional Index in patients with oral squamous cell carcinoma: a single-center, open-label, single-arm study.

Authors

Hajime Suzuki, Takuya Yoshimura, Haruka Amitani, Koshiro Tagawa, Yuka Hirano, Ryohei Tada, Hirono Migita, Masahiro Tezuka, Takayuki Ishida, Kiyohide Ishihata, Hiroko Watanabe, Masayuki Hirose, Toshitaka Futagawa, Eishi Kuroda, Nanami Sameshima Uto, Marie Amitani, Norifumi Nakamura, Hideto Saijo, Akio Inui

Published in

Frontiers in nutrition. Volume 13. Pages 1851978. Epub Aug 14, 2026.

Abstract

Postoperative nutritional deterioration and immunosuppression are clinically important in patients undergoing surgery for oral squamous cell carcinoma (OSCC). The Prognostic Nutritional Index (PNI), calculated from serum albumin and total lymphocyte count, is associated with the prognosis of OSCC. Ninjin'yoeito (NYT), a traditional Japanese Kampo medicine, has been reported to exert orexigenic and immunomodulatory effects. We evaluated whether perioperative NYT administration was associated with attenuation of postoperative PNI decline in patients with OSCC.
This single-center, open-label, single-arm interventional study was conducted at Kagoshima University Hospital, approved by a Certified Review Board, and registered with the Japan Registry of Clinical Trials (jRCTs071230055). Patients with OSCC scheduled for curative surgery received NYT (7.5 g/day) from the preoperative period through postoperative week 8. The primary endpoint was the change in PNI from baseline to postoperative week 8, compared with a prespecified historical threshold (-4.95) using one-sample t-test. Secondary endpoints were summarized descriptively with 95% confidence intervals (CIs).
Nineteen patients completed the study protocol and were included in the efficacy and safety analyses. The mean change in PNI at postoperative week 8 was -2.576 (95% CI, -4.743 to -0.410), which was significantly better than the historical threshold (p = 0.0335). The exploratory secondary outcomes, including body weight and selected inflammatory indices, showed postoperative trajectories compatible with gradual recovery during follow-up. No grade ≥3 treatment-related adverse events or serious adverse events were observed. Given the single-arm design with a historical comparator, these findings should be interpreted cautiously and warrant confirmation in controlled trials.
Perioperative NYT administration was associated with attenuation of postoperative PNI decline in patients undergoing OSCC surgery. NYT was well tolerated, supporting the feasibility of its perioperative use. Controlled trials are warranted to confirm clinical benefits and evaluate long-term outcomes of NYT use.

PMID:
42666240
Bibliographic data and abstract were imported from PubMed on 29 Aug 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.