Lee Kyung Ho, Bahk Won-Myong, Lee Soo-Jung, Pae Chi-Un
Department of Dermatology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Clin Psychopharmacol Neurosci. 2020 Nov 30;18(4):621-626. doi: 10.9758/cpn.2020.18.4.621.
: To test clinical effectiveness and tolerability of Korean Red Ginseng augmentation (RGA) in major depressive disorder (MDD) patients with difficult-to-treat.
Thirty six patients were enrolled in this 6 weeks, prospective, clinical trial. Rating scales were MontgomeryÅsberg Depression Rating Scale (MADRS), Patient Health Questionnaire-15, Clinical Global Impression-improvement (CGI-I), and Patient Satisfaction Score. The primary endpoint was a remission rate measured by MADRS score at the end of study (≤ 10). Clinical outcomes and tolerability were assessed at baseline, week 2, and week 6.
Among 36 patients, 26 patients completed the study and 28 patients had post-baseline visit data. The remission rate by MADRS score was 39.3% (11/28) and 57.1% by CGI-I scores of 1 or 2 at the end of the study. The mean change of MADRS score was significantly decreased by 44.4% from baseline to the end of study. The most frequent adverse events were headache (7/28, 25.0%) during the study.
Our study indicates the putative effectiveness and tolerability of RGA for treating MDD with difficult-to-treat in clinical practice. However, adequately powered, randomized, controlled trials will be needed to confirm these results.
测试韩国红参增效疗法（RGA）对难治性重度抑郁症（MDD）患者的临床疗效和耐受性。
36名患者参与了这项为期6周的前瞻性临床试验。评定量表包括蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、患者健康问卷-15、临床总体印象改善量表（CGI-I）和患者满意度评分。主要终点是研究结束时通过MADRS评分测量的缓解率（≤10）。在基线、第2周和第6周评估临床结果和耐受性。
36名患者中，26名患者完成了研究，28名患者有基线后访视数据。研究结束时，根据MADRS评分的缓解率为39.3%（11/28），根据CGI-I评分为1或2的缓解率为57.1%。从基线到研究结束，MADRS评分的平均变化显著降低了44.4%。研究期间最常见的不良事件是头痛（7/28，25.0%）。
我们的研究表明RGA在临床实践中对治疗难治性MDD具有假定的有效性和耐受性。然而，需要充分有力的随机对照试验来证实这些结果。
