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)
IF 2.2 4区 医学Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
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
Abstract
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.
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.