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- Title
Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial.
- Authors
Tsuyoshi Miyaoka; Motohide Furuya; Jun Horiguchi; Rei Wake; Sadayuki Hashioka; Masaya Thoyama; Kenta Murotani; Norio Mori; Yoshio Minabe; Masaomi Iyo; Shuichi Ueno; Sachiko Ezoe; Syuzo Hoshino; Haruo Seno
- 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: -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.
- Subjects
JAPAN; DRUG therapy for schizophrenia; THERAPEUTIC use of plant extracts; ANTIPSYCHOTIC agents; COMBINATION drug therapy; CONFIDENCE intervals; MEDICAL cooperation; ORAL drug administration; PLACEBOS; PATHOLOGICAL psychology; RESEARCH; RESEARCH funding; STATISTICAL sampling; SCHIZOPHRENIA; PLANT extracts; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; SEVERITY of illness index; DATA analysis software
- Publication
Evidence-based Complementary & Alternative Medicine (eCAM), 2015, p1
- ISSN
1741-427X
- Publication type
journal article
- DOI
10.1155/2015/201592