SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .
The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials
Background Thresholds for statistical significance are insufficiently demonstrated by 95 % confidence intervals or P-values when assessing results from r and omised clinical trials . First , a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the null hypothesis is true . Second , a confidence interval or a P-value showing significance may be caused by multiplicity . Third , statistical significance does not necessarily result in clinical significance . Therefore , assessment of intervention effects in r and omised clinical trials deserves more rigour in order to become more valid . Methods Several method ologies for assessing the statistical and clinical  significance of intervention effects in r and omised clinical trials were considered . Balancing simplicity and comprehensiveness , a simple five-step procedure was developed . Results For a more valid assessment of results from a r and omised clinical trial we propose the following five-steps : ( 1 ) report the confidence intervals and the exact P-values ; ( 2 ) report Bayes factor for the primary outcome , being the ratio of the probability that a given trial result is compatible with a ‘ null ’ effect ( corresponding to the P-value ) divided by the probability that the trial result is compatible with the intervention effect hypothesised in the sample size calculation ; ( 3 ) adjust the confidence intervals and the statistical significance threshold if the trial is stopped early or if interim analyses have been conducted ; ( 4 ) adjust the confidence intervals and the P-values for multiplicity due to number of outcome comparisons ; and ( 5 ) assess clinical significance of the trial results . Conclusions If the proposed five-step procedure is followed , this may increase the validity of assessment s of intervention effects in r and omised clinical trials
SSRIs significantly increase the risk of both serious and non-serious adverse events .
The potential small beneficial effects seem to be outweighed by harmful effects .
Background The evidence on selective serotonin reuptake inhibitors ( SSRIs ) for major depressive disorder is unclear .
Methods Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo , ‘ active ’ placebo , or no intervention in adult participants with major depressive disorder .