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)

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.