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김석환 ( Seok Hwan Kim ),박보라 ( Bo Ra Park ),최금애 ( Keum Ae Choi ),임현주 ( Hyun Ju Lim ),이상룡 ( Sang Ryong Lee ),정대규 ( Dae Gyu Jung ),김락형 ( Rak Hyung Kim ),김태헌 ( Tae Hun Kim ),김경옥 ( Kyung Ok Kim ),정인철 ( In Ch 대한한방신경정신과학회 2009 동의신경정신과학회지 Vol.20 No.2
Objectives: To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design: A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods: Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Jadad scale and self-designed tool for this study. Results: Thirty four RCT studies(10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8±0.79, in Chinese 1.94±0.77, and in Korean 2.75±0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions: There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.