• 1. Institute of Mental Health, West China Hospital, Sichuan University, Chengdu 610041, China 2. Xi Yuan Hospital of China Academy of Traditional Chinese Medicine, Beijing 100021, China 3. Anding Hospital of Capital University of Medical Sciences Beijing 100009, China 4. First Teaching Hospital of Xi’an Jiaotong University 5. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjing 300193, China;
Export PDF Favorites Scan Get Citation

Objective  To evaluate the clinical effectiveness and safety of Jiu Wei Lv Ping particle in the treatment of generalized anxiety disorder (GAD).
Methods  The multi-center, randomized double-blind method was used to observe 227 GAD patients who were divided into the treatment group (n=114, treated with Jiu Wei Lv Ping particle 6 g, three times a day) and the control group (n=113, treated with buspirone 10 mg, three times a day). HAMD score, and CGI-GI score were used to evaluate the clinical efficacy. TESS score and the list of symptom-recording were used to observe the safety. All the outcomes for evaluation before and after treatment at week 1, week 2, week 3 and week 4.
Results  According to intention-to-treat analysis (ITT), the level of decrease of HAMA score from baseline at each observational point of the treatment group was similar to that of the control group (t test, P gt;0.05). At the end point, the effective rate of treatment group was 87.72%, and the effective rate of the control group was 87.61%. There was no significant difference between the two groups (CMH test, P gt;0.05). According to the score of CGI-GI at each observational point, there was no difference of the effective rate between the treatment group and the control group (student test, P gt;0.05). The side effect rate of the treatment group was 16.67%, The frequent symptoms were thirst (8.77%), dizziness (7.02%), nausea (2.63%), constipation (2.63%) and diarrhea (1.75%). The side effect rate of the control group was 30.97%, The frequent symptoms were thirst (15.04%), constipation (6.19%), nausea (4.42%), diarrhea (4.42%), dizziness (3.45%) and tachycardia (1.77%). The side effect of the treatment group was lower than that of the control group. But there was no significant difference between the two groups according to the score of TESS (F test, P gt;0.05).
Conclusions  The therapeutic action of Jiu Wei Lv Ping particle in the treatment of GAD is affirmed with less side effects. It is valuable to use clinically.

Citation: KUANG Weihong,LI Jin,LI Jing,WANG Xue,HUANG Mingsheng,WANG Shuchen,LI Tao,HUANG Shuzhen,WENG Yongzhen,GAO Chengge,YAN Hong. Randomized Double -Blind Controlled Trial on Effectiveness and Safety of Jiu Wei Lv Ping Particle in the Treatment of Generalized Anxiety Disorder. Chinese Journal of Evidence-Based Medicine, 2004, 04(8): 523-527. doi: Copy