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.
Objective:
To determine the impact of mobile-phone telemonitoring on patients’ adherence and satisfaction to post-trauma pain treatment.
Materials and Methods:
We conducted a prospective randomized clinical trial including patients with minor trauma discharged from the emergency department (ED) with analgesic treatment. Patients were randomized to one of three groups, control group where patients received a phone call on day-7, short message service (SMS) group where patients received a daily text message to remind them to take their treatment during 7 days and mobile-phone based telemonitoring (TLM) group. Patients’ adherence to analgesic treatments using the Morisky Medication Adherence Scale (MMAS-4), current pain by using a visual analogue scale (VAS) and patients’ satisfaction were assessed. For TLM group, assessment was performed at day-2, 4 and 7.
Results:
Good adherence was observed in 418 patients (92.9%) in TLM group versus 398 patients (88.6%) in SMS group and 380 patients (84.8%) in control group (P<0.001). The factor mostly associated with adherence was telemonitoring (OR 2.40 95% CI 1.55 to 3.71). The decrease of pain VAS was highest in TLM group compared to SMS and control groups (P<0.001). Percentage of patients’ satisfaction at 7-day post ED discharge was 93% in TLM group vs 88% in SMS group and 84% in standard group (P=0.02).
Discussion:
Our findings suggest that mobile-phone based telemonitoring is beneficial in the treatment of pain in trauma patients after ED discharge. This approach improved patients’ adherence and satisfaction.
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