Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.
Neuropsychobiology. 2021;80(3):242-252. doi: 10.1159/000510853. Epub 2020 Oct 16.
Preliminary evidence is promising regarding the anxiolytic effects of statins in animal models of anxiety. Hence, this study aimed to evaluate the efficacy of simvastatin augmentation versus placebo in the treatment of patients with generalized anxiety disorder (GAD) with residual symptoms despite treatment with selective serotonin reuptake inhibitors (SSRIs).
A double-blind, 8-week controlled trial was conducted from August 2018 to December 2019 in an outpatient psychiatry clinic in Hamadan, Iran. A total of 138 patients with a diagnosis of GAD were assessed for eligibility. Of them, 84 patients who met the study criteria were randomly assigned either to the adjuvant simvastatin (20 mg/day) or to the placebo group. Standard medication consisting of SSRIs was consistent 2 months prior to and during the study. The severity of anxiety symptoms for each patient was assessed based on the Hamilton Anxiety Rating Scale (HAM-A) score at baseline, week 4, and week 8 after treatment. Additionally, blood lipid values were assessed at baseline and on completion of the study.
Thirty-three out of 42 patients in the intervention group and 35 out of 42 patients in the control group completed the 8 weeks of the study period. Compared to the placebo group, in the simvastatin group cholesterol, triglycerides, and low-density lipoprotein significantly decreased, and high-density lipoprotein significantly increased over time. General linear model analysis demonstrated that although over time a higher decrease in mean HAM-A scores was observed in the intervention group compared to the control group, this difference was not statistically significant (p = 0.11). In addition, at the end of the study, the number of responders and remitters was comparable in the two groups.
The results from this clinical study did not support the potential efficacy of adjunctive simvastatin in the treatment of patients with GAD. Thus, large-scale and long-term clinical trials are required to more accurately assess the potential efficacy of statins in the treatment of patients with anxiety disorders.
初步证据表明他汀类药物在焦虑动物模型中具有抗焦虑作用。因此，本研究旨在评估辛伐他汀强化治疗与安慰剂相比，在治疗尽管使用选择性 5-羟色胺再摄取抑制剂（SSRIs）治疗仍有残留症状的广泛性焦虑障碍（GAD）患者中的疗效。
2018 年 8 月至 2019 年 12 月，在伊朗哈马丹的一家门诊精神病诊所进行了一项为期 8 周的双盲对照试验。共评估了 138 名符合 GAD 诊断标准的患者的纳入标准。其中，84 名符合研究标准的患者被随机分配至辅助辛伐他汀（20mg/天）或安慰剂组。标准药物包括 SSRIs，在研究前 2 个月和研究期间保持一致。每位患者的焦虑症状严重程度根据治疗前、治疗后第 4 周和第 8 周的汉密尔顿焦虑量表（HAM-A）评分进行评估。此外，在基线和研究结束时评估了血脂值。
干预组 42 名患者中的 33 名和对照组 42 名患者中的 35 名完成了 8 周的研究期。与安慰剂组相比，辛伐他汀组的胆固醇、甘油三酯和低密度脂蛋白随时间推移显著降低，而高密度脂蛋白显著升高。一般线性模型分析表明，尽管随着时间的推移，干预组的 HAM-A 评分平均下降幅度高于对照组，但差异无统计学意义（p=0.11）。此外，在研究结束时，两组的应答者和缓解者人数相当。
这项临床研究的结果不支持辅助辛伐他汀治疗 GAD 患者的潜在疗效。因此，需要进行大规模和长期的临床试验，以更准确地评估他汀类药物治疗焦虑障碍患者的潜在疗效。
