Zohar 2011a.
Methods | Design: randomised, double‐blind, placebo‐controlled pilot study Duration of intervention: single dose 1.5 to 5 hours after the traumatic event Follow‐up: 2 weeks, 1 month and 3 months after the trauma Placebo run‐in: no |
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Participants | Sample size: 25 participants were randomised to hydrocortisone and placebo Mean age: 35.16 (14) Gender: 14 males and 11 females Ethnicity: not specified Type of trauma: traffic accidents, work accidents and snake bites Diagnostic measure: specified structured or semi structured measurement Inclusion criteria: Quote: "Seventy consecutive patients who were exposed to a traumatic event, experienced either acute stress reaction or sub‐threshold acute stress reaction, and met the DSM‐IV PTSD A.1 (stressor) and A.2 (response) criteria (fulfilling criteria A, 2 of the symptoms in criteria B, 3 out of 4 of criteria C, D, E, and F, and meeting criterion H of the ASD criteria set out in DSM‐IV) were recruited from the emergency department at the Chaim Sheba Medical Center" Exclusion criteria: Quote: "Exclusion criteria included serious physical injury (a score of 3 or above on the Abbreviated Injury Scale), brain trauma, substance abuse disorders, cardiac pacemaker implant, a history of epilepsy, neurosurgery, chronic medical conditions of any sort. Medication specific exclusion criteria included hypersensitivity to hydrocortisone, pregnancy, or treatment for asthma" Drop‐outs: 6/15 (40%) on hydrocortisone and 2/10 (20%) on placebo Number of participants with MDD: MDD was not assessed |
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Interventions | Pharmacological intervention: Quote: "Hydrocortisone or placebo was given between 1.5 and 5.5 hours following the traumatic event. Patients received hydrocortisone intravenously in a single bolus at a dose ranging from 100 to 140mg based on body weight: 100 mg for weights of 60–69kg, 120 mg for weights of 70–89kg, and 140mg for weights of 90–99kg" | |
Outcomes | Primary outcomes: Clinician‐Administered PTSD Scale (CAPS), visual analogue scales for anxiety (VAS‐A) and depression (VAS‐D) Secondary outcomes: not specified |
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Notes | Industry‐funded: no Medication provided by industry: no Any of the authors work for industry: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The participants were randomised by a predetermined program, and entered in a double blind, placebo‐controlled design" |
Allocation concealment (selection bias) | Low risk | Quote from Dr. Hagit (11 December 2013): "Hydrocortisone or placebo was given intravenously and has been prepared by another physician. IV bags were numbered and were the same for both treatments" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although described as double‐blinded, the procedure employed was not specified. Quote: "The participants were randomised by a predetermined program, and entered in a double blind, placebo‐controlled design" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment was blinded. Quote: "Ratings of ASD and PTSD symptoms, anxiety, and depression were carried out at 4 time points — before the intervention, at 2 weeks, 1 month and 3 months after the trauma — by an expert investigator who was blind to the treatment condition" |
Incomplete outcome data (attrition bias) All outcomes | High risk | A larger proportion of participants were excluded from the hydrocortisone (6/15; 40%) than the placebo groups (2/10; 20%). No information was provided regarding the reasons for treatment withdrawal |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available for this trial |
Other bias | Unclear risk | No other source of bias was identified for this study |
BPM: beats per minute
CAPS: Clinician‐Administered PTSD Scale
CPB: cardiopulmonary bypass
CS: cardiac surgery
DSM‐IV: Diagnostic and Statistical Manual IV
ED: emergency department
GEE: generalised estimating equation
ICU: intensive care unit
MDD: major depressive disorder
NIMH: National Institute of Mental Health
PTSD: post‐traumatic stress disorder
SCID‐IV: Structured Clinical Interview for DSM‐IV
SD: standard deviation
SSRI: selective serotonin reuptake inhibitor