Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial
Joint Authors
Wake, Rei
Ueno, Shu-ichi
Miyaoka, Tsuyoshi
Furuya, Motohide
Hashioka, Sadayuki
Thoyama, Masaya
Murotani, Kenta
Mori, Norio
Minabe, Yoshio
Iyo, Masaomi
Ezoe, Sachiko
Hoshino, Syuzo
Seno, Haruo
Horiguchi, Jun
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-04-14
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Abstract EN
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: − 0.23 ± 0.08 ; placebo: − 0.03 ± 0.08 , P < 0.018 ), tension (TJ-54: − 0.42 ± 0.09 ; placebo: − 0.18 ± 0.09 , P < 0.045 ), and poor impulse control (TJ-54: − 0.39 ± 0.10 ; placebo: − 0.07 ± 0.10 , P < 0.037 ).
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.
American Psychological Association (APA)
Miyaoka, Tsuyoshi& Furuya, Motohide& Horiguchi, Jun& Wake, Rei& Hashioka, Sadayuki& Thoyama, Masaya…[et al.]. 2015. Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine،Vol. 2015, no. 2015, pp.1-11.
https://search.emarefa.net/detail/BIM-1061232
Modern Language Association (MLA)
Miyaoka, Tsuyoshi…[et al.]. Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine No. 2015 (2015), pp.1-11.
https://search.emarefa.net/detail/BIM-1061232
American Medical Association (AMA)
Miyaoka, Tsuyoshi& Furuya, Motohide& Horiguchi, Jun& Wake, Rei& Hashioka, Sadayuki& Thoyama, Masaya…[et al.]. Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine. 2015. Vol. 2015, no. 2015, pp.1-11.
https://search.emarefa.net/detail/BIM-1061232
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1061232