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. 2022 Mar 2;2022(3):CD002795. doi: 10.1002/14651858.CD002795.pub3

Ahmadpanah 2014.

Study characteristics
Methods NEW TRIAL ADDED TO UPDATED REVIEW
Design: single‐centre trial, randomised, placebo‐controlled, parallel arm, flexible dose, double‐blind
Duration of intervention: 8 weeks
Placebo run‐in: Not specified
Post‐treatment: Not specified
Participants Setting: Quote: “Attending the psychology section or the infirmary of Farshchian Hospital in Hamadan"
Sample size: 100 randomised to prazosin, hydroxyzine and placebo
Mean age: 35.50 years (SD, 6.40).
Sex: 72 men and 28 women, car accident (37%); Persian Gulf war (51%); disaster (4%); other (7%).
Diagnostic measure: DSM‐IV TR
Inclusion criteria: Quote: “Inclusion criteria were as follows: (1) a diagnosis of PTSD according to the diagnostic criteria
of the DSM‐IV TR, (2) severe sleep disorders and (3) age between 18 and 45 years"
Exclusion criteria: Quote: “Exclusion criteria were the following: (1) further psychiatric comorbidities such as major depressive disorder, anxiety disorders, substance abuse (alcohol, drugs), psychosis and personality disorders, (2) women who were pregnant or intending to get pregnant or who were breast‐feeding, (3) known physical illness such as heart disease and (4) adverse experience with prazosin (hypotension caused by prazosin injection) or hydroxyzine (2 patients were subsequently excluded from the study because of symptoms of hypotension due to prazosin). Moreover, a sudden dramatic drop of the repeatedly and routinely measured blood pressure was a further criterion to exclude a patient from the study"
Comorbidity: Not specified
Dropout rates: Insufficient evidence to determine dropouts by groups
Interventions Pharmacological intervention: Quote: “For the prazosin group, prazosin was administered at 1 mg before going to sleep; over the first 10 days, the dosage was increased to 15 mg and remained at this level for the remaining duration of the 8‐week study. Hydroxyzine dosage was started at 10 mg on the first evening and continually increased over the first 10 days up to 100 mg, remaining thereafter at this level until the end of the study"
Outcomes Outcomes: PSQI, MINI
Time points: Not specified
Notes Dates of trial: Not stated
Industry‐funded: Not specified
Medication provided by industry: Not specified
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: "First, a ballot box containing 3 different colored chips was prepared (35 blue chips for placebo, 35 red chips for prazosin and 35 white chips for hydroxyzine). Patients drew a chip consecutively and received the corresponding compounds"
Allocation concealment (selection bias) Low risk Quote: "The pharmacy provided the compounds with the same appearance and with no recognizable
labels or signs on them, so that the patient, their psychologist and even the nurses could not know the contents"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "The pharmacy provided the compounds with the same appearance and with no recognizable
labels or signs on them, so that the patient, their psychologist and even the nurses could not know the contents"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information was provided on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient evidence to determine dropouts by groups
Quote: "There were no significant differences between the three groups with respect to age, gender distribution, type of experienced trauma, educational level, duration of illness or, most importantly, main medication"
ITT sample was used at baseline and endpoint
Selective reporting (reporting bias) Unclear risk The study protocol was not available for this study
Other bias Low risk No other sources of bias were identified