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
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
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
Notes	Industry‐funded: no Medication provided by industry: no Any of the authors work for industry: no
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