Gibbert Judith, Kreimendahl Fabian, Lebert Jennifer, Rychlik Reinhard, Trompetter Inga
Complement Med Res. 2017;24(2):83-89. doi: 10.1159/000464342. Epub 2017 Apr 12.
The passion flower dried ethanolic extract investigated in this non-interventional study has well-documented calmative effects and good tolerability. We investigated the effects of this extract on the stress resistance (resilience) and quality of life (QoL) of patients suffering from nervous restlessness. The addiction potential of the drug and the course of symptoms were also evaluated.
Adult patients aged ≤ 95 years with the diagnosis 'nervous restlessness' were treated for 12 weeks with a dried ethanolic extract of passion flower (Passiflora incarnata L.). Standardized questionnaires were used to evaluate the resilience (RS-13), QoL (EQ-5D including EQ-VAS), and the addiction potential (BDEPQ).
After 12 weeks of treatment, significant (p < 0.001) improvements were measured in the patients' resilience (RS-13: from 52.1 to 67.7 points) and QoL (EQ-VAS: from 47.9 to 75.0 points). Also, the mean BDEPQ score was significantly (p < 0.001) reduced (from 23.0 to 19.3 points). The mean values of all accompanying symptoms (inner restlessness, sleep disturbance, exhaustion, fear, lack of concentration, transpiration, nausea, trembling, and palpitation) improved significantly (p < 0.001). Tolerability of treatment was rated as 'very good' or 'good' by the majority of the patients. Three cases of mild adverse events (tiredness) were reported.
The passion flower extract investigated in the present study appears to be effective in improving resilience and QoL in patients suffering from nervous restlessness and is well tolerated.
在这项非干预性研究中所研究的西番莲干乙醇提取物具有充分记载的镇静作用和良好的耐受性。我们研究了该提取物对患有神经不安的患者的应激抵抗力（恢复力）和生活质量（QoL）的影响。还评估了该药物的成瘾潜力和症状过程。
年龄≤95岁、诊断为“神经不安”的成年患者用西番莲（Passiflora incarnata L.）干乙醇提取物治疗12周。使用标准化问卷评估恢复力（RS - 13）、生活质量（EQ - 5D包括EQ - VAS）和成瘾潜力（BDEPQ）。
治疗12周后，患者的恢复力（RS - 13：从52.1分提高到67.7分）和生活质量（EQ - VAS：从47.9分提高到75.0分）有显著（p < 0.001）改善。此外，BDEPQ平均得分显著（p < 0.001）降低（从23.0分降至19.3分）。所有伴随症状（内心不安、睡眠障碍、疲惫、恐惧、注意力不集中、出汗、恶心、颤抖和心悸）的平均值均有显著（p < 0.001）改善。大多数患者将治疗耐受性评为“非常好”或“好”。报告了3例轻度不良事件（疲倦）。
本研究中所研究的西番莲提取物似乎对改善患有神经不安的患者的恢复力和生活质量有效，且耐受性良好。
