Fuladi Sara, Emami Seyed A, Mohammadpour Amir H, Karimani Asieh, Manteghi Ali A, Sahebkar Amirhossein
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Pharmacogenosy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Curr Rev Clin Exp Pharmacol. 2021;16(2):191-196. doi: 10.2174/1574884715666200413120413.
Anxiety disorders are the most universal psychiatric problems in the general population. Due to their chronic nature, these diseases are managed with a multi-drug regimen lasting for a long period of time. Medication discontinuation leads to 25% and 80% recurrence in the first month and the first year, respectively. Despite several treatment approaches, there is no specific and optimal method for patient management. Therefore, it is necessary to find some new therapeutic approaches with fewer side effects. Withania somnifera is a plant with GABAergic property responsible for its anxiolytic effect. The aim of this study was to investigate the effect of W. somnifera root extract as an alternative therapy to reduce standard Generalized Anxiety Disorder (GAD) symptoms.
Forty patients who met the inclusion criteria (with a confirmed diagnosis of GAD as stated in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) took part in this randomized double-blind placebo-controlled trial and were randomly selected for participation in the treatment group (W. somnifera extract, 1g/day; n = 22) or the placebo group (n = 18). All patients were under treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) and were prescribed one capsule of the extract or placebo per day for six weeks. The Hamilton anxiety rating scale (HAM-A) was used to assess the severity of GAD symptoms at baseline as well as the second and sixth weeks of the trial.
Comparison of the HAM-A scores during the course of the trial revealed a significant amelioration ofHAM-A score in the treatment group versus placebo (14 and 8 units reduction, respectively (P < 0.05)). Moreover, there was a significant difference in the reduction of GAD score between the second (P =0.04) and sixth week (P =0.02) in the treatment group. The extract was safe and no adverse effect was observed during the trial.
W. somnifera extract offers some potential advantages as a safe and effective adjunctive therapy to SSRIs in GAD. The clinical trial protocol has been registered under the Iranian Registry of Clinical Trials (IRCT20180615040105N1).
焦虑症是普通人群中最常见的精神疾病。由于其慢性性质，这些疾病采用长期的多药治疗方案进行管理。停药分别导致在第一个月和第一年内复发率为25%和80%。尽管有几种治疗方法，但对于患者管理没有特定的最佳方法。因此，有必要找到一些副作用较少的新治疗方法。印度人参是一种具有GABA能特性的植物，其具有抗焦虑作用。本研究的目的是调查印度人参根提取物作为一种替代疗法减轻标准广泛性焦虑症（GAD）症状的效果。
40名符合纳入标准（根据《精神障碍诊断与统计手册》第四版，修订版（DSM-IV-TR）确诊为GAD）的患者参加了这项随机双盲安慰剂对照试验，并被随机选择参加治疗组（印度人参提取物，1克/天；n = 22）或安慰剂组（n = 18）。所有患者均接受选择性5-羟色胺再摄取抑制剂（SSRIs）治疗，并每天服用一粒提取物或安慰剂胶囊，持续六周。汉密尔顿焦虑量表（HAM-A）用于在基线以及试验的第二周和第六周评估GAD症状的严重程度。
试验过程中HAM-A评分的比较显示，治疗组的HAM-A评分相对于安慰剂有显著改善（分别降低14和8分（P < 0.05））。此外，治疗组在第二周（P = 0.04）和第六周（P = 0.02）GAD评分降低方面存在显著差异。提取物是安全的，试验期间未观察到不良反应。
印度人参提取物作为SSRIs治疗GAD的一种安全有效的辅助疗法具有一些潜在优势。该临床试验方案已在伊朗临床试验注册中心注册（IRCT20180615040105N1）。
