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)

Abstract

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