Summary of findings 6. Comparison 6: SSRIs versus placebo for posttraumatic stress disorder (PTSD).
Comparison 6: SSRIs versus placebo for posttraumatic stress disorder (PTSD) | ||||||
Population: adults (aged 18‐85)
Settings: single and multi‐centre trials
Intervention: SSRIs
Comparison: placebo Follow‐up: for 1 study at week 10 and for another study 14 days after the last dose of study drug; the remaining studies did not specify follow‐up | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
With placebo | With SSRIs | |||||
Treatment efficacy ‐ treatment response, as measured by the Global Impressions scale change item (CGI‐I or similar): no. of responders (acute phase) | Study population | RR 0.66 (0.59 to 0.74) | 1078 (8 studies) | ⊕⊕⊕⊝ moderatea | There was evidence of a benefit for the number of participants with PTSD who responded to treatment for the SSRI group (58%) compared to the placebo group (35%). This is also indicated by the Risk Ratio of 0.66 which indicates that there is a statistically significantly greater number of people in the SSRI group compared to the placebo group who improved on the CGI‐I scale | |
348 per 1000 | 229 per 1000 (205 to 257) | |||||
Moderate | ||||||
328 per 1000 | 216 per 1000 (194 to 243) | |||||
Treatment tolerability, as measured by Dropouts due to adverse events (acute phase) | Study population | RR 0.98 (0.96 to 1.00) | 2399 (14 studies) | ⊕⊕⊕⊝ moderatea | A similar proportion withdrew due to treatment adverse events (9% versus 7%) | |
66 per 1000 | 65 per 1000 (64 to 66) | |||||
Moderate | ||||||
50 per 1000 | 49 per 1000 (48 to 50) | |||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; CGI‐I: Clinical Global Impressions Improvement scale;RR: risk ratio. | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
aDowngraded by one level due to serious risk of bias (concerns with randomisation procedures).