Fifty-three RCTs (with 59 comparisons) were included in the review (n=at least 4,421 patients).
Forty-eight RCTs (50 comparisons) were included in efficacy analyses and 49 RCTs (53 comparisons) included in tolerability analyses; 29 trials compared fluvoxamine with tricyclic antidepressants, five trials compared fluvoxamine with heterocyclics, 10 trials compared fluvoxamine with selective serotonin reuptake inhibitors, three trials compared fluvoxamine with serotonin-noradrenaline reuptake inhibitors, four trials compared fluvoxamine with newer antidepressants, one trial compared fluvoxamine with sulpiride, and one trial compared fluvoxamine with amitriptyline, doxepin and paroxetine. None of the studies clearly reported allocation concealment. Forty-two trials were double-blind.
At the end of acute phase of treatment (primary outcome, 31 comparisons, n=2,663 patients): There was no statistically significant difference in response or remission rates between fluvoxamine and other antidepressants combined or between fluvoxamine and each class of antidepressant. Results were similar for sensitivity analyses. No significant heterogeneity or evidence of publication bias was found.
Results for early phase treatment were also reported.
Tolerability: There was no statistically significant difference in drop-outs for any reason, or for drop-outs due to side-effects between fluvoxamine and other antidepressants combined or between fluvoxamine and each class of antidepressant.
Side effects profile: The authors stated that few of the trials used standardised methods to record side-effects. Side-effect profiles differed. In particular, fluvoxamine was associated with significantly more nausea or vomiting than tricyclic antidepressants (RR 1.94, 95% CI 1.52 to 2.47).