双盲、随机、安慰剂对照研究：评估在急诊科使用草药补充剂预防创伤后应激障碍的早期治疗效果（PHYTéS 研究）

IF 2.2 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Herbal Medicine Pub Date : 2024-09-19 DOI:10.1016/j.hermed.2024.100946

R. Boukef , I. Trabelsi , R. Youssef , H. Yaakoubi , A. Sekma , R. Jaballah , K.B. Ali , H. Ben Salah , S. Mabsout , F. Boukadida , Z. Dhifaoui , F. Graa , S. Nouira , L. Boukadida , A. Zorgati

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引用次数: 0

摘要

导言创伤后应激障碍（PTSD）对心理健康构成了重大挑战。目前的治疗方法主要针对创伤后应激障碍发病后的症状，因此亟需有效的早期干预策略。虽然已有多项研究探讨了包括药物和心理治疗方法在内的各种疗法，但有关预防性干预措施的研究却存在明显空白。本研究调查了草药补充剂 Aleozen® 对高危人群预防创伤后应激障碍的功效。Aleozen® 包含多种植物提取物，如 Griffonia simplicifolia、Rhodiola rosea、Gentiana lutea、Crataegus oxyacantha、Eschscholtzia californica 和 Melissa officinalis。在基线、中期和研究结束时，使用标准化创伤后应激障碍症状量表和压力生理指标对参与者进行评估。主要结果是与安慰剂组相比，创伤后应激障碍症状有所减轻。结果与安慰剂组相比，接受 Aleozen® 治疗的参与者的创伤后应激障碍症状严重程度在统计学上有显著降低。Aleozen®组的创伤后应激障碍症状评分平均降低了35%，而安慰剂组仅降低了12%（p < 0.01）。此外，Aleozen®还改善了次要结果，包括减轻焦虑和提高睡眠质量。没有报告明显的不良反应，表明Aleozen®既有效又耐受性良好。结论本研究表明，创伤后早期给药Aleozen®可显著减轻高危人群的创伤后应激障碍症状和相关困扰。临床注册号于2018年6月26日在ClinicalTrials.gov注册中心（NCT03724448）登记。

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Double-Blind, Randomised, Placebo-Controlled Study Evaluating the Efficacy of an Early Treatment Using Herbal Supplement in the Prevention of Post-traumatic Stress Disorder in the Emergency Department (PHYTéS Study)

Introduction

Post-traumatic stress disorder (PTSD) poses a major challenge to mental health. Current treatments primarily address PTSD symptoms after their onset, and there is a critical need for effective early intervention strategies. While several studies have explored various therapies, including pharmacological and psychotherapeutic approaches, there is a notable gap in research regarding preventive interventions. This study investigates the efficacy of Aleozen®, a herbal supplement, in preventing PTSD among high-risk individuals. Aleozen® contains a blend of plant extracts such as Griffonia simplicifolia, Rhodiola rosea, Gentiana lutea, Crataegus oxyacantha, Eschscholtzia californica, and Melissa officinalis, which have shown promise in mitigating stress and anxiety.

Methods

In a randomized controlled trial, high-risk participants who experienced recent trauma were administered Aleozen® or a placebo over a 12-week period. Participants were assessed using standardized PTSD symptom scales and physiological markers of stress at baseline, mid-point, and end of the study. The primary outcome was the reduction in PTSD symptoms compared to the placebo group.

Results

Participants receiving Aleozen® exhibited a statistically significant reduction in PTSD symptom severity compared to the placebo group. The mean reduction in PTSD symptom scores was 35% in the Aleozen® group versus 12% in the placebo group (p < 0.01). Additionally, Aleozen® was associated with improvements in secondary outcomes, including reduced anxiety and better sleep quality. There were no significant adverse effects reported, suggesting that Aleozen® is both effective and well-tolerated.

Conclusions

This study demonstrates that Aleozen® significantly reduces PTSD symptoms and related distress in high-risk individuals when administered early after trauma.

Clinical registration Number

It was recorded in the ClinicalTrials.gov register (NCT03724448) on June 26, 2018.

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来源期刊

Journal of Herbal Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.90

自引率

0.00%

发文量

期刊介绍： The Journal of Herbal Medicine, the official journal of the National Institute of Medical Herbalists, is a peer reviewed journal which aims to serve its readers as an authoritative resource on the profession and practice of herbal medicine. The content areas of the journal reflect the interests of Medical Herbalists and other health professionals interested in the clinical and professional application of botanical medicines. The objective is to strengthen the research and educational base of herbal medicine with research papers in the form of case studies, original research articles and reviews, monographs, clinical trials and relevant in vitro studies. It also publishes policy statements, opinion pieces, book reviews, conference proceedings and profession related information such as pharmacovigilance reports providing an information source for not only the Herbal Practitioner but any Health professional with an interest in phytotherapy.