Double-blind, Randomized, Placebo-Controlled study to evaluate the Efficacy of an early treatment with Herbal Supplement based in the Prevention of Post-Traumatic Stress Disorder in emergency department (PHYTeS Study)

IntroductionThe prevention from Post-traumatic stress disorder (PTSD) is therefore of major public health interest and one of the concerns of any emergency physician. The purpose of our study was to evaluate the efficacy and safety of an herbal supplement to prevent the occurrence of PTSD in high-risk patients. MethodsIt is a randomized, double-blind, prospective, interventional study including patients exposed to a potentially traumatic event that meets DSM-V Criterion A and has a Peri-traumatic Distress Inventory score or the Questionnary for traumatic dissociation experiments (PDEQ) and/or L.Crocq score higher than the thresholds between day 1 and day 3. Two hundred patients were included randomly assigned into two groups: Aleozen group and placebo group. Patients included in aleozen group received Aleozen(R) for 10 days while patients in placebo group received Placebo. A CAPS-5 assessment was performed for all patients at different moments. The main objective was to assess the efficacy of Aleozen(R) after 90 days of an exposition to traumatic events according to PTSD. Secondary objectives were to evaluate the safety of Aleozen(R) at 10 and 30 days after its administration and PTSD in the study population after one year of inclusion. ResultsNo statistical differences were noted between the two groups in term of baseline characteristics including age, sex and the ISS score. After 90 days of follow-up, and according to the CAPS-5 scale, 85 patients (42.5%) of the population study showed PTSD. Concerning primary endpoint, less PTSD were seen in intervention group compared to placebo group (38.8% versus 61.2% respectively; p<0.001). During the study, no adverse events were noted. ConclusionResults of this work suggest the potential preventive effects of an herbal supplement on PTSD for traumatic patient in emergency. Further confirmatory studies are needed. Funding sourcesThis research is supported by << Aleonat >> Laboratories, who provided only the protocol treatments (active and placebo), without other financial support of the study. The sponsor and funder have no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities. Ethical approvalThe study was approved by the local ethics committee (The Ethics Committee of the Faculty of Medicine of Sousse) Ethical reviewA written informed consent was obtained from all participants. Human and animal rights statementAll procedures performed in the study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.