Summary of findings 4. Comparison 4: NaSSAs versus placebo for posttraumatic stress disorder (PTSD).
Comparison 4: NaSSAs versus placebo for posttraumatic stress disorder (PTSD) | ||||||
Population: adults (aged 18‐85)
Settings: single‐centre trial
Intervention: NaSSA
Comparison: placebo Follow‐up: not specified | ||||||
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 NaSSAs | |||||
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 0.45 (0.22 to 0.94) | 26 (1 study) | ⊕⊕⊝⊝ lowa,b | There was evidence of a benefit for the number of participants with PTSD who responded to treatment (65%) compared to placebo (22%). This is also indicated by the Risk Ratio of 0.45 which indicates that there is a statistically significantly greater number of people in the NaSSA group compared to the placebo group who improved on the CGI‐I scale | |
222 per 1000 | 100 per 1000 (49 to 209) | |||||
Moderate | ||||||
222 per 1000 | 100 per 1000 (49 to 209) | |||||
Treatment tolerability, as measured by Dropouts due to adverse events (acute phase) | Study population | RR 0.87 (0.68 to 1.11) | 36 (1 study) | ⊕⊕⊝⊝ lowa,b | The proportion of dropouts due to adverse events was high in participants receiving the NaSSA (18%) relative to placebo (5%), but there was no evidence of a harm between the numbers of participants that dropped out due to adverse events |
|
53 per 1000 | 176 per 1000 (20 to 1000) | |||||
Moderate | ||||||
53 per 1000 | 178 per 1000 (20 to 1000) | |||||
*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; CAPS: Clinically Administered PTSD 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). bDowngraded by one level due to serious imprecision (wide confidence intervals).