Study of Efficacy and Safety of <i>Tianwangbuxin-dan</i> for Poststroke Depression:
A Randomized, Double Blinded, Non-inferiority Trial

Lee, Il-suk; Kim, Mun-soo; Lee, Sang-kwan

The Journal of Internal Korean Medicine > Volume 35(2); 2014 > Article

Original Article

The Journal of Internal Korean Medicine 2014;35(2): 145-156.

뇌졸중 후 우울증에 대한 천왕보심단의 유효성 및 안전성 연구 : 무작위 배정, 이중맹검, 비열등성 연구

이일석¹, 김문수², 이상관¹

¹원광대학교 한의과대학 심계내과학교실
²전남대학교 사회과학대학 심리학과

Study of Efficacy and Safety of Tianwangbuxin-dan for Poststroke Depression: A Randomized, Double Blinded, Non-inferiority Trial

Il-suk Lee¹, Mun-soo Kim², Sang-kwan Lee¹

¹Dept. of Internal Medicine and Neuroscience, College of Korean Medicine, Won-Kwang University
²Dept. of Psychology, College of Social Science, Chon-Nam National University

Correspondence

Sang-kwan Lee ,Tel: 062-670-6407, Email: sklee@wku.ac.kr

Published online: June 30, 2014.

ABSTRACT

Objectives:
The aim of this study was to compare Tianwangbuxin-dan to Fluoxetine for antidepressive efficacy and safety in poststroke depression (PSD).

Methods :
A randomized, double blinded, non-inferiority trial was conducted. 113 PSD patients were recruited from a stroke center. Except for the 25 excluded patients, 88 PSD patients were randomly given either Tianwangbuxin-dan 1100 mg or Fluoxetine 20 mg per a day for 16 weeks. PSD was evaluated using Beck’s depression inventory (BDI) and Hamilton depression rating scale (HDRS) and followed every fourth week. Repeated measure analysis of variance (ANOVA) was used to compare and contrast the depression scores of the two groups and to compare them among the evaluation times, at the beginning, 4^th, 8^th, 12^th and 16^th weeks. In addition, independent t-tests were used to find the difference between two groups at every evaluation time.

Results:
Finally, 88 PSD patients were included in the study, 63 PSD patients completed the procedure and 25 PSD patients were dropped out by the incompliance or withdrawal of consent. Tianwangbuxin-dan (or Fluoxetine) improved the depression of stroke patients and the efficacy of Tianwangbuxin-dan was not inferior to that of Fluoxetine. In addition, there was no significant side effect in two groups.

Conclusions:
This study showed that antidepressive efficacy and safety of Tianwangbuxin-dan in PSD patients.

Key words: Tianwangbuxin-dan, Fluoxetine, poststroke depression, Beck’s depression inventory, Hamilton depression