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Double-blind, Randomized, 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)

Published online by Cambridge University Press:  19 July 2023

A. Maktouf Bouhlel ,
R. Youssef ,
A. Bouhoula ,
L. Boukadida ,
A. Loghmari ,
K. mansouri ,
I. Khalifa ,
H. Yaacoubi ,
H. Ben Salah  and
M. Ben othmen
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A. Maktouf Bouhlel
Affiliation:
Emergency Department
R. Youssef
Affiliation:
Emergency Department
A. Bouhoula
Affiliation:
Emergency Department
L. Boukadida
Affiliation:
Emergency Department
A. Loghmari*
Affiliation:
Urology, Sahloul teachin Hospital Sousse, Sousse, Tunisia
K. mansouri
Affiliation:
Emergency Department
I. Khalifa
Affiliation:
Emergency Department
H. Yaacoubi
Affiliation:
Emergency Department
H. Ben Salah
Affiliation:
Emergency Department
M. Ben othmen
Affiliation:
Urology, Sahloul teachin Hospital Sousse, Sousse, Tunisia
R. Jaballah
Affiliation:
Urology, Sahloul teachin Hospital Sousse, Sousse, Tunisia
A. Zorgati
Affiliation:
Emergency Department
R. Boukef
Affiliation:
Emergency Department
*
*Corresponding author.

Abstract

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Introduction

Prevention of Post-traumatic stress disorder (PTSD) is a major public health interestand one of the concerns of any emergency physician.

Objectives

The purpose of this study was to evaluate the efficacy and safety of a herbal supplement in preventing the occurrence of PTSD in high-risk patients.

Methods

: It is a randomized, double-blind, prospective, interventional study including patients exposed to a traumatic event meeting DSM-V Criterion A and having a Peri-traumatic Distress Inventory score and/or Peri-traumatic Dissociative Experience Questionnaire (PDEQ) and/or immediate stress score (L.Crocq score) higher than the thresholds between day 1 and day 3. A total of two hundred patients were included and they were randomly assigned into two groups: Aleozen group and placebo group. Patients included in the aleozen group received Aleozen® for 10 days while patients in the placebo group received a Placebo. A CAPS-5 assessment was performed for all patients at different moments. The main objective was to assess the efficacy of Aleozen® after day 90 of exposure to traumatic events according to PTSD. The secondary objectives were to evaluate the safety of Aleozen® at 10 and 30 days after its administration and to assess PTSD in the involved population after one year.

Results

No statistical differences were noted between the two groups in terms of baseline characteristics, including age, sex, and ISS score. After day 90 of follow-up, and according to the CAPS-5 scale, 85 patients (42.5%) had PTSD. Concerning the primary endpoint, less PTSD was observed in the intervention group compared to the placebo group (38.8% versus 61.2%, respectively; p<0.001). No adverse events were noted during the study

Conclusions

The results of this study suggest the potential preventive effects of an herbal supplement on PTSD for traumatic patients in the emergency department. Further confirmatory studies are required

Disclosure of Interest

None Declared

Type
Abstract
Information
European Psychiatry , Volume 66 , Special Issue S1: Abstracts of the 31st European Congress of Psychiatry , March 2023 , pp. S975
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2023. Published by Cambridge University Press on behalf of the European Psychiatric Association
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