scholarly journals 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 (PHYTéS Study)

Author(s):  
riadh boukef ◽  
rym youssef ◽  
hajer yaacoubi ◽  
imen trabelsi ◽  
adel sekma ◽  
...  

Introduction: The 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. Methods: It 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® 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 after 90 days of an exposition to traumatic events according to PTSD. Secondary objectives were to evaluate the safety of Aleozen® at 10 and 30 days after its administration and PTSD in the study population after one year of inclusion. Results: No 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. Conclusion: Results of this work suggest the potential preventive effects of an herbal supplement on PTSD for traumatic patient in emergency. Further confirmatory studies are needed.

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.


2002 ◽  
Vol 181 (4) ◽  
pp. 315-320 ◽  
Author(s):  
Ferenc Martenyi ◽  
Eileen B. Brown ◽  
Harry Zhang ◽  
Stephanie C. Koke ◽  
Apurva Prakash

BackgroundLittle is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse.AimsTo assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse.MethodThis was a double-blind, randomised, placebo-controlled study. Following 12 weeks of acute treatment, patients who responded were re-randomised and continued in a 24-week relapse prevention phase with fluoxetine (n=69) or placebo (n=62). The primary efficacy assessment was the prevention of PTSD relapse, based on the time to relapse.ResultsPatients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group (P=0.027). There were no clinically significant differences in treatment-emergent adverse events between treatment groups.ConclusionsFluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months.


2016 ◽  
Vol 33 (S1) ◽  
pp. S216-S216
Author(s):  
M. Senyurt ◽  
M. Demiralp ◽  
N. Ozmenler ◽  
C. Acikel

This study was conducted as pre-test and post-test experimental design with the control group in order to identify the effect of psychoeducation on anger management and problem solving skills of the patients with post-traumatic stress disorder. This study was carried out in Gülhane Military Medical Academy, the department of Military Psychology and Battle Psychiatry between May 2012 and May 2013. The study sample included 22 control and 22 intervention group patients with PTSD who admitted to participate in the study and who were asked to receive the drug treatment by staying in the clinic. Psychoeducation was only performed on the intervention group. In the collection of research data, “Sociodemographical Information Form”, “Trait-Trait Anger Expression Inventory”, “Problem Solving Inventory” and “The Impact of Event Scale” were used. Data were assessed by Repeated Measures Variance Analysis via SPSS (15.0). Problem solving skills of the patients who had high-school and up to the level of high-school education were identified to be more insufficient than the ones having undergraduate and graduate educations. Before receiving psychoeducation, it was identified that the levels of trait anger of the patients were high, and that they perceived themselves as mild insufficient individuals in problem solving skills. It was identified that trait anger increased the anger control and problem-solving skills while it decreased inward and outward anger levels in the intervention group of psychoeducation. As a consequence, it has been recommended that the continuity of psychoeducations the psychiatry nurses applied have been provide in psychiatry clinic.Disclosure of interestThe authors have not supplied their declaration of competing interest.


1993 ◽  
Vol 27 (2) ◽  
pp. 288-293 ◽  
Author(s):  
Andrew C. Page ◽  
Rocco D. Crino

Eye-movement desensitisation has been identified in a number of case studies to be an effective treatment for post-traumatic stress disorder (PTSD). A further case study reporting success is presented. The treatment appears rapid and may represent a potentially cost-effective treatment for PTSD. However, no treatment study to date has conformed to the ideal methodology of a double-blind placebo controlled trial and therefore its efficacy remains to be demonstrated. A minimal but stringent set of criteria for identification of treatment efficacy are outlined. The implications of eye-movement desensitisation being identified as an effective treatment for PTSD are discussed.


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