여성의 주요우울장애에 대한 육울탕의 유효성 및 안전성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 연구 = A Study of Efficacy and Safety of Yukwool-tang for Major Depressive Disorder in Women: A Randomized, Double Blinded, Placebo Controlled, Parallel Trial

다국어 초록 (Multilingual Abstract)

Objectives :
The purpose of this study was to evaluate the efficacy and safety of Yukwool-tang for major depressive disorder(MDD) in women.

Methods :
A randomized, double blinded, placebo controlled trial was conducted. 72 patients diagnosed as MDD and K-HDRS ≥ 14 points were recruited from December, 2016 to January, 2019. They were randomly assigned to Yukwool-tang or placebo and took 1 bottle (30㎎) at a time, 3 times a day for 8 weeks. The evaluation was conducted through Korean version of the Hamilton Depression Rating Scale(K-HDRS), Korean version of the Beck Depression Inventory(BDI-K), Korean version of the Beck Hopelessness Scale(K-BHS), Korean version of the Insomnia Severity Index(ISI-K), State-Trait Anxiety Inventory(STAI-K), EuroQol-5 dimension(EQ-5D), Korean Symptom Checklist-95(KSCL-95) and Pattern Identifications Tool for Depression(PITD) before administration, 4 and 8 weeks after administration and 4 weeks after the end of administration.

Result :
With 22 patient dropping out, total of 50 patients completed the trial. The scores of K-HDRS, BDI-K, K-BHS, ISI-K, STAI-K and EQ-5D changed significantly 8 weeks after administration, but there were no significant difference with placebo. In the subgroup with an initial K-HDRS of less than 18, K-BHS score was significantly decreased compared to placebo 4 weeks after the end of administration. The score of the Obsessive-compulsive personality disorder(OPD) part in KSCL-95 was significantly reduced compared to placebo 4 weeks after administration. In the Yukwool-tang group, the ratio of Stagnation of Liver Gi(肝氣鬱結) was the highest but Duel Deficiency of the Heart and Spleen(心脾兩虛) became the highest after administration, and in the placebo group, Duel Deficiency of the Heart and Spleen was the highest in both pre and post-administration. And in each subgroup with PITD score of Stagnation of Liver Gi and Duel Deficiency of the Heart and Spleen is over 50, the scores of K-HDRS, BDI-K and STAI-K were reduced significantly 8 weeks after administration, but there were no significant difference with placebo.

Conclusion :
It was concluded that Yukwool-tang improved depression and accompanying symptoms in women with MDD and there was no significant side effect and adverse event. If further research is performed to supplement some weak points, the effectiveness of Yukwool-tang is expected to be clearer.

목차 (Table of Contents)

• Ⅰ. 서 론 1
• Ⅱ. 연구 대상 및 방법 3
• 1. 연구 기관과 대상 3
• 2. 연구 방법 3
• 1) 기관생명윤리위원회 임상연구 승인 3
• 2) 시험대상자 동의 3
• 3) 선정 및 제외기준 3
• (1) 선정기준 3
• (2) 제외기준 4
• 4) 시험약물 5
• 5) 연구 절차 및 평가 방법 7
• 6) 통계 분석 11
• Ⅲ. 결 과 12
• 1. 인구학적 특성 12
• 2. 주요지표들의 점수변화 14
• 1) Korean version of the Hamilton Depression Rating Scale 14
• 2) Korean version of the Beck Depression Inventory 18
• 3) Korean version of the Beck Hopelessness Scale 21
• 4) Korean version of the Insomnia Severity Index 24
• 5) State-Trait Anxiety Inventory-Form Korean 27
• (1) 상태불안 27
• (2) 특성불안 30
• 6) EuroQol-5 Dimension 33
• 7) Korean Symptom Checklist-95 36
• 8) 우울증 변증도구 43
• 9) 안전성 평가 47
• (1) 임상병리검사 47
• (2) 이상반응 50
• 10) 눈가림 평가 51
• Ⅳ. 고 찰 52
• Ⅴ. 결 론 63
• 참 고 문 헌 65
• 영 문 초 록 77
• 감 사 의 글 80