A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with <i>St. John's Wort</i> Trials

Jung, Hee; Lee, Ji-hyung; Jang, Bo-hyoung; Ko, Seong-gyu

The Journal of Internal Korean Medicine > Volume 28(2); 2007 > Article

Original Article

The Journal of Internal Korean Medicine 2007;28(2): 363-376.

성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구

정희^2,3, 이지형^2,3, 장보형^1,2,3, 고성규^1,2,3

¹경희대학교 한의과대학 기초한의과학과
²경희대학교 한의과대학 한의학임상연구및유전체센터
³경희대학교 한의과대학 예방의학교실

A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials

Hee Jung^2,3, Ji-hyung Lee^2,3, Bo-hyoung Jang^1,2,3, Seong-gyu Ko^1,2,3

¹Department of Basic Science of Oriental Medicine, Kyunghee University
²Center for Clinical Research and Genomics, Institute of Oriental Medicine, Kyunghee University
³Department of Preventive Medicine, College of Oriental Medicine, Kyunghee University

Correspondence

Seong-gyu Ko ,Tel: 02-961-0329, Fax: 02-966-1165, Email: epiko@khu.ac.kr

Published online: June 30, 2007.

ABSTRACT

Objectives:
This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant.

Methods :
Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression.

Results:
Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression.

Conclusions:
Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-Ⅳcriteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

Key words: Clinical Trial, Methodology, Herbal Medicine, Antidepressant