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Evidence-Based Complementary and Alternative Medicine
Volume 2015, Article ID 201592, 11 pages
http://dx.doi.org/10.1155/2015/201592
Research Article

Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

1Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan
2Research Institute of Traditional Asian Medicine, Kinki University, Higashi-Osaka, Japan
3Center for Advance Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan
4Psychiatry & Neurology, Hamamatsu University School of Medicine, Hamamatsu, Japan
5Psychiatry, Kanazawa University School of Medicine, Kanazawa, Japan
6Psychiatry, Chiba University School of Medicine, Chiba, Japan
7Psychiatry, Ehime University School of Medicine, Matsuyama, Japan
8Medical Center for Translational Research, Osaka University Hospital, Suita, Japan
9Psychiatry, Takeda General Hospital, Fukushima, Japan
10Psychiatry, Matsue Aoba Hospital, Matsue, Japan

Received 18 November 2014; Accepted 16 March 2015

Academic Editor: Yuping Tang

Copyright © 2015 Tsuyoshi Miyaoka et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: ; placebo: , ), tension (TJ-54: ; placebo: , ), and poor impulse control (TJ-54: ; placebo: , ). Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.