Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
J Ethnopharmacol. 2019 Oct 5;242:112060. doi: 10.1016/j.jep.2019.112060. Epub 2019 Jul 4.
Aloysia polystachya (Griseb.) Moldenke (Verbenaceae) is a plant traditionally used as medicine for anxiety symptoms. This activity was confirmed in preclinical studies. However, its efficacy was never studied in human clinical trials.
We aimed to test the hypothesis that the herbal medicine of A. polystachya is superior to placebo for the treatment of anxiety-related symptoms in adults after 8 weeks.
This was a randomized, double-blind, placebo-controlled, phase-2 clinical trial. Fifty-four adults with self-reported anxiety symptoms were randomly allocated to receive either capsules containing A. polystachya powdered leaves (300 mg, twice a day) or placebo (maltodextrin), for 8 weeks. The intensity of anxiety symptoms was assessed by the Hamilton Anxiety Ranking Scale (HAM-A) at baseline and after 2, 4 and 8 weeks. All analyses were adjusted for physical activity (assessed by the International Physical Activity Questionnaire [IPAQ], short version) and gender.
We confirmed the presence of acteoside (chromatographic analysis) and carvone and limonene (gas chromatography) as major constituents in our plant material. Only patients that received A. polystachya experienced a significant decrease in their HAM-A scores, with none or mild side-effects.
Administration of powdered leaves of A. polystachya, rich in acteoside, carvone and limonene, to adults with anxiety symptoms was significantly superior to placebo in decreasing HAM-A scores after 8 weeks. This finding confirms the ethnopharmacological use of this plant for anxiety symptoms.
Aloysia polystachya (Griseb.) Moldenke（马鞭草科）是一种传统上被用作治疗焦虑症状的药物。这一活性已在临床前研究中得到证实。然而，其疗效从未在人体临床试验中得到研究。
我们旨在检验以下假设，即 A. polystachya 的草药在 8 周后对治疗成人焦虑相关症状优于安慰剂。
这是一项随机、双盲、安慰剂对照、2 期临床试验。54 名自我报告有焦虑症状的成年人被随机分配接受含有 A. polystachya 粉末叶（300mg，每天两次）或安慰剂（麦芽糊精）的胶囊，为期 8 周。焦虑症状的严重程度通过汉密尔顿焦虑量表（Hamilton Anxiety Rating Scale，HAM-A）在基线和 2、4 和 8 周时进行评估。所有分析均针对身体活动（通过国际体力活动问卷[IPAQ，短版]评估）和性别进行调整。
我们确认了我们植物材料中的主要成分紫草酸（色谱分析）、香芹酮和柠檬烯（气相色谱）的存在。只有接受 A. polystachya 治疗的患者的 HAM-A 评分显著下降，且无或仅有轻度副作用。
在 8 周后，给有焦虑症状的成年人服用富含紫草酸、香芹酮和柠檬烯的 A. polystachya 粉末叶，在降低 HAM-A 评分方面明显优于安慰剂。这一发现证实了该植物在治疗焦虑症状方面的民族药理学应用。
