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 |
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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 |
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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 |
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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 |