• Saho Wada, Ryoichi Sadahiro, Yutaka J Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Tetsufumi Sato, Kazuaki Shimada, Seiichi Yoshimoto, Hiroyuki Daiko, Yukihide Kanemitsu, Akira Kawai, Tomoyasu Kato, Hiroyuki Fujimoto, and Ken Shimizu.
• Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan.
• J Pain Symptom Manage. 2021 Jan 1; 61 (1): 71-80.

ContextNo standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in patients with cancer.ObjectivesTo clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in patients with cancer as well as to confirm its safety profile.MethodsThis is a randomized, double-blind, and placebo-controlled trial conducted at a single center in Tokyo, Japan. About 195 patients with cancer scheduled to undergo tumor resection took one packet of the study drug, which was administered orally. Coprimary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n = 74) of the target number of registered patients.ResultsBecause this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean Hospital Anxiety and Depression Scale-Anxiety score (intervention group [SD] 0.4 [3.0] vs. placebo group 0.5 [3.0]; P = 0.796) or the incidence of postoperative delirium (32% vs. 30%; P = 0.798). There were no serious adverse events in either group.ConclusionIn patients with cancer undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.Copyright © 2020. Published by Elsevier Inc.

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