Hertzberg 2000.

Study characteristics
Methods	Design: single‐centre, randomised, placebo‐controlled, parallel arm, flexible‐dose, double‐blind Duration of intervention: 12 weeks Placebo run‐in: Not specified Post‐treatment: Not specified
Participants	Setting: Quote: "PTSD outpatient treatment program at the Durham Veterans Affairs Medical Center" Sample size: 12 randomised to fluoxetine and placebo Mean age: 46 years (44 ‐ 48) Sex: 12 men, Vietnam combat veterans, 66% (8/12) MDD Diagnostic measure: DSM‐IV Inclusion criteria: Quote: “All patients met DSM‐IV criteria for a primary diagnosis of PTSD based on clinical interview and the Structured Interview for PTSD (SIP)" Exclusion criteria: Quote: “No concomitant psychotropic medications were permitted" Comorbidity: SCID ‐ DSM‐III‐R: MD, SP, OCD, alcohol and marijuana dependence Dropout rates: 1/12 (1/6 in the fluoxetine and 0/6 in the placebo group)
Interventions	Pharmacological intervention: Quote: “After an initial drug‐free period, patients received study medication as follows: 10 mg/day for 1 week, then 20 mg/day for 2 weeks, then dosages were increased 10 mg/day every week until achieving a maximal response, reaching a maximum dosage of 60 mg/day or upon developing dose‐limiting side effects. Mean fluoxetine dose at endpoint (week 12) was 48 mg/day with a range of 10 mg to 60 mg"
Outcomes	Outcomes: DTS, SDS, SIP, DGRP, Somatic symptoms during treatment were assessed using a 34‐item checklist rated on a 4‐point Likert scale. Patients completed this checklist at baseline and each subsequent visit (no distinction between primary and secondary outcomes) Time points: Quote: "After random allocation to treatment, patients were seen at end of weeks 1, 2, 3, 4, 6, 8, 10, and 12 after receiving study medication" Data estimation: Presumably LOCF (not clear in text)
Notes	Dates of trial: Not stated Industry‐funded: No. Quote: "This study was supported in part by an NIMH Grant MH44740‐01" Medication provided by industry: Yes Any of the authors work for industry: No
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	It was reported that the participants were randomised, but no mention is made of the method of randomisation Quote: "Patients were randomized to a double‐blind treatment with fluoxetine or placebo in a 1:1 ratio"
Allocation concealment (selection bias)	Unclear risk	There was insufficient information provided to determine if study medication allocation was concealed. Quote: "Placebo and fluoxetine were provided by Eli Lilly Co"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The study was described as "double‐blind", though no information was provided on which parties were blinded and how blinding was achieved Quote: "Twelve male veterans with PTSD were enrolled in a 12 week double‐blind evaluation of fluoxetine and placebo"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study was described as "double‐blind", although no information was provided on blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	More participants withdrew from the fluoxetine group (1/6, 17%) compared to the placebo group (0/6; 0%). However, the dropouts across the two groups were low (i.e. 8%). No information was provided on sample characteristics at end point. Reasons for withdrawal were provided. They do not describe which they used, LOCF or ITT Quote: "There were no significant differences between the groups for compensation status, age, or ethnic minority status, type, chronicity or severity of trauma. One of the six fluoxetine patients did not complete the study because of medication side effects. He experienced activation symptoms and dropped out at the end of week two on a dose of 10 mg/day. All the other patients completed the full 12 weeks of the study"
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. Medication was provided by industry, but no authors work for industry