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KMID : 0363320140350020145
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Journal of Korean Oriental Internal Medicine
2014 Volume.35 No. 2 p.145 ~ p.156
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Study of Efficacy and Safety of Tianwangbuxin-dan for Poststroke Depression: A Randomized, Double Blinded, Non-inferiority Trial
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Lee Il-Suk
Kim Mun-Soo
Lee Sang-Gwan
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Abstract
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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, 4th, 8th, 12th and 16th 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.
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KEYWORD
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Tianwangbuxin-dan, Fluoxetine, poststroke depression, Beck's depression inventory, Hamilton depression rating scale
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