Effectiveness and safety of Jiuwei Zhenxin granules for treating generalized anxiety disorder: A randomized controlled trial

Xue Wang; Peiran Chen; Shenxun Shi; Wei Chen; Hongyan Zhang; Ronghua Tang; Zhibing Wu; Yan Li; Jun Wu; Li Zong; Lianying Ji; Ping Feng; Jing Li

doi:10.3389/fpsyt.2022.898683

Effectiveness and safety of Jiuwei Zhenxin granules for treating generalized anxiety disorder: A randomized controlled trial

Front Psychiatry. 2022 Oct 4:13:898683. doi: 10.3389/fpsyt.2022.898683. eCollection 2022.

Authors

Xue Wang¹, Peiran Chen², Shenxun Shi³, Wei Chen⁴, Hongyan Zhang⁵, Ronghua Tang⁶, Zhibing Wu⁷, Yan Li⁸, Jun Wu⁹, Li Zong¹⁰, Lianying Ji¹⁰, Ping Feng², Jing Li¹

Affiliations

¹ Mental Health Center, West China Hospital, Sichuan University, Chengdu, China.
² National Medical Products Administration Key Laboratory for Clinical Research and Evaluation of Innovative Drugs, Clinical Trial Center, West China Hospital, Sichuan University, Sichuan, China.
³ Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai, China.
⁴ Mental Health, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁵ Drug Clinical Trial Institution, Peking University Sixth Hospital, Beijing, China.
⁶ Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
⁷ Department of Encephalopathy, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, China.
⁸ Department of Sleep Psychology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
⁹ Department of Neurology, Peking University Shenzhen Hospital, Shenzhen, China.
¹⁰ R&D Center, Beijing Beilu Pharmaceutical Co., Ltd., Beijing, China.

Abstract

Background: Generalized anxiety disorder (GAD) is a chronic disorder characterized by excessive, pervasive, persistent worrying that is difficult to control. Jiuwei Zhenxin granules may be safer and more effective than non-benzodiazepine anti-anxiety drugs for treating GAD. This study aimed to assess the efficacy and safety of Jiuwei Zhenxin granules alone or in combination with the benzodiazepine alprazolam.

Materials and methods: A total of 710 patients were recruited from outpatient clinics and were randomly divided into two groups to receive Jiuwei Zhenxin granules (single drug group) or Jiuwei Zhenxin granules and alprazolam (combination group). The primary outcome was the response rate, which was defined as a ≥ 50% reduction from the baseline total score on the Hamilton Anxiety Scale (HAMA). Secondary outcome measures included mean changes in HAMA total score, psychological and somatic factors, Hamilton Depression Rating Scale total score, and SF-36 health survey score.

Results: At 4 weeks after treatment, the single and combination treatment groups showed significant improvement in the HAMA total score and they did not differ significantly in response rate (77.58 vs. 79.17%) or rate of adverse drug reactions (16.22 vs. 16.07%).

Conclusion: Jiuwei Zhenxin granules are an effective, safe, and well-tolerated treatment against GAD. Combining them with alprazolam may not significantly improve efficacy.

Clinical trial registration: [www.ClinicalTrials.gov], identifier [CHICTR1800020095].

Keywords: Hamilton Anxiety Scale; Jiuwei Zhenxin granules; alprazolam; blood urea nitrogen; generalized anxiety disorder; serum creatinine; traditional Chinese medicine.