Randomized phase II study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal and lung malignancy patients

Sugano,Nobuhiro; Aoyama,Toru; Sato,Tsutomu; Kamiya,Mariko; Amano,Shinya; Yamamoto,Naoto; Nagashima,Takuya; Ishikawa,Yoshihiro; Masudo,Katsuhiko; Taguri,Masataka; Yamanaka,Takeharu; Yamamoto,Yuji; Matsukawa,Hiroshi; Shiraisi,Ryuji; Oshima,Takashi; Yukawa,Norio; Rino,Yasushi; Masuda,Munetaka

doi:10.3892/mco.2017.1357

Randomized phase II study of TJ-54 (Yokukansan) for postoperative delirium in gastrointestinal and lung malignancy patients

Authors:
- Nobuhiro Sugano
- Toru Aoyama
- Tsutomu Sato
- Mariko Kamiya
- Shinya Amano
- Naoto Yamamoto
- Takuya Nagashima
- Yoshihiro Ishikawa
- Katsuhiko Masudo
- Masataka Taguri
- Takeharu Yamanaka
- Yuji Yamamoto
- Hiroshi Matsukawa
- Ryuji Shiraisi
- Takashi Oshima
- Norio Yukawa
- Yasushi Rino
- Munetaka Masuda
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Affiliations: Department of Surgery, Yokohama City University, Yokohama 236‑0004, Japan, Department of Biostatistics, Yokohama City University, Yokohama 236‑0004, Japan
Published online on: August 1, 2017 https://doi.org/10.3892/mco.2017.1357
Pages: 569-573
Copyright: © Sugano et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

The present study evaluated the efficacy and safety of TJ‑54 (Yokukansan; a traditional Japanese medicine) for the prevention and/or treatment of postoperative delirium in a randomized phase II trial of patients receiving surgery for gastrointestinal and lung malignancies. Patients ≥70 years of age who underwent surgery for gastrointestinal or lung malignancy were eligible for participation in the study. The 186 eligible patients were randomly assigned at a 1:1 ratio to receive TJ‑54 or control during their peri‑operative care (between 7 days prior to surgery and 4 days following surgery, except for the operation day). The signs and symptoms of delirium were assessed using the Diagnostic and Statistical Manual of Mental Disorders‑IV by the investigator during the peri‑operative period. A total of 186 eligible gastrointestinal or lung malignancy patients were analyzed (93, TJ‑54; 93, control). There were no marked differences between the two randomized groups. The incidence of delirium was 6.5% (6 patients) in the TJ‑54 group and 9.7% (9 patients) in the control group, with no significant difference (P=0.419). However, of the patients categorized with a mini-mental state examination (MMSE) score of ≤26, the incidence of postoperative delirium was 9.1% in the TJ‑54 group and 26.9% in the control group [risk ratio, 0.338; 95% confidence interval (0.078‑1.462), P=0.115]. Treatment with TJ‑54 reduced the incidence of postoperative delirium compared with the control group. Although TJ‑54 did not demonstrate any contribution to preventing or treating postoperative delirium in patients following surgery for gastrointestinal or lung malignancy, TJ‑54 reduced the risk of postoperative delirium in the patients who were classified as MMSE ≤26. Further phase III studies with a larger sample size are required in order to clarify the effects of TJ‑54 against postoperative delirium.

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