We evaluated the efficacy and safety of TJ-54 (Yokukansan; a traditional Japanese medicine [Kampo]) 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 this study. The 186 eligible patients were randomly assigned at a 1:1 ratio to receive TJ-54 or control during their perioperative care (between day 7 before surgery and day 4 after surgery, except for the operation day). The signs and symptoms of delirium were assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV by the investigator during the perioperative period.
We analyzed 186 eligible gastrointestinal or lung malignancy patients (TJ-54; 93, control; 93). 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, among the patients who were MMSE ≤ 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 tended to reduce 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 tended to reduce the risk of postoperative delirium in the patients who were MMSE ≤ 26. Further phase III studies with a larger sample size are needed to clarify the effects of TJ-54 against postoperative delirium.
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All authors have declared no conflicts of interest.