Li 2017.
Study characteristics | ||
Methods |
NEW TRIAL ADDED TO UPDATED REVIEW Design: multi‐centre, randomised, placebo‐controlled, parallel arm, fixed‐dose, double‐blind Duration of intervention: 12 weeks Placebo run‐in: Not specified Post‐treatment: Not specified |
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Participants | Setting: China. Sample size: 72 randomised to sertraline and placebo Mean age: 46 years (SD: 5.95) Sex: 63 men and 9 women, mood or anxiety disorders 7 (10%), military‐related trauma 27 (38%) Diagnostic measure: DSM‐IV Inclusion criteria: Quote: “The following inclusion criteria were applied: (1) age of at least 18 years, (2) fulfilment of the DSM PTSD criteria, (3) illness duration of at least 6 months and (4) CGI‐S score of ≥ 4 at the baseline visit" Exclusion criteria: Quote: “The following exclusion criteria were applied: (1) current or past history of bipolar disorder, schizophrenia, or other psychotic disorder; (2) alcohol or substance abuse or dependence within the preceding 6 months; (3) intolerance of or hypersensitivity to sertraline; (4) any acute or unstable medical condition that could interfere with the safe conduct of the study; (5) pregnancy, nursing or failure to practice a medically accepted form of birth control and (6) receipt of cognitive‐behavioural therapy during the trial" Comorbidity: History of mood and anxiety disorders, and mental illness Dropout rates: 7/72 (4/36 in the sertraline and 3/36 in the placebo group) |
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Interventions | Pharmacological intervention: Quote: “Subjects assigned to the sertraline and placebo groups received sertraline and a placebo (both 135 mg daily), respectively, for 12 weeks. All medication was given as three pills (50, 50, and 35 mg) each day at a fixed dose" | |
Outcomes | Primary outcomes: IES‐R
Secondary outcomes: CGI‐S Time points: not specified Data estimation: completer values |
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Notes | Dates of trial: Not stated Industry‐funded: No. This study was funded by grants Medication provided by industry: Yes 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: "Seventy‐two patients were randomly assigned to 12 weeks of a double‐blind trial of either sertraline (n = 36) or a matched placebo (n = 36), using computer‐generated random numbers. Patients who met all of the inclusion and exclusion criteria were assigned to either the sertraline or placebo group using a computerised number generator and the Statistical Analysis Software stratified block randomisation method" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was performed by a professional statistician, who was blind to treatment allocation. Randomisation assignments were concealed in opaque sequentially numbered sealed envelopes. In addition, all medication was provided and prepared in a double‐blind‐form by the Company Limited of Guangzhou Guanhua Pharmaceutical Industry" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The subjects, researchers, outcome assessors and data analyst were also blind to treatment allocation" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The subjects, researchers, outcome assessors and data analyst were also blind to treatment allocation" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A similar proportion of participants withdrew from the sertraline group (4/36, 11%) compared to the placebo group (3/36; 8%). The 2 groups did not differ by sample characteristics at baseline. Data estimation for completer values. Quote: "Seven patients withdrew from the study; the major reasons for withdrawal included AEs, consent withdrawal, loss to follow up and other reasons. Age, sex, ethnicity, disease duration, educational background, employment, mood and anxiety disorder prevalence, and baseline IES‐R and CGI‐S scores did not differ significantly between groups". |
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, butr no authors work for industry |