The prevalence rates of depression among selected samples from an urban and a rural population in Egypt were found to be 11.4% and 19.7%, respectively. Although, the selective serotonin reuptake inhibitors (SSRIs) are the drugs of choice for treating depression and fluvoxamine has a comparatively good profile in terms of adverse events they have been accused in the causation of some infrequent medical adverse effects as extrapyramidal symptoms, cardiac dysrrythmias and bleeding complications. Our objectives were to determine the risk/benefit profile of fluvoxamine compared with other antidepressants in the treatment of depression. We conducted a systematic review with meta-analysis of randomized controlled trials (RCTs). Medline/Ovid and Sciencedirect were searched for RCTs published from January 1996 to December 2005. Double blind, RCTs comparing fluvoxamine with other antidepressants for the treatment of depression were the studies selected for inclusion. The main outcome measures were the relative risk of effectiveness of fluvoxamine to treat depression, as defined by an improvement in depression, relative risk of withdrawal from treatment due to lack of improvement and of withdrawing due to side effects, relative risk of specific side effects related to treatment and the infrequently occurring side effects.
The search results revealed 11 studies (1260 patients) compared fluvoxamine with tricyclic antidepressants (clomipramine, imipramine and nortryptilline) and other serotonin reuptake inhibitors (SRIs) (sertraline, fluoxetine, citalopram, paroxetine and milnacipran). Efficacy between fluvoxamine with other SRIs, tricyclic antidepressants (TCAs) did not differ significantly (Relative risk 1.01, 0.92 with 95% confidence interval 0.89-1.15, 0.78-1.08 and P value = 0.86, 0.30) respectively. No significant difference in the number of withdrawals due to lack of improvement between fluvoxamine and TCAs (Relative risk 1.87 with 95% confidence interval 0.87-4.02 and P value = 0.11). No significant difference in the number of withdrawals due to side effects between fluvoxamine and SRIs and TCAs (Relative risk 1.34, 0.67 with 95% confidence interval 0.92-1.94, 0.43-1.03, and P value = 0.13, 0.07) respectively. No significant difference in the specific side effects between fluvoxamine and SRIs (Relative risk 1.06 with 95% confidence interval 0.89-1.27 and P value = 0.51). Significant difference in side effects was noted between fluvoxamine and TCAs (Relative risk 0.85 with 95% confidence interval 0.75-0.97 and P value = 0.02). Significant difference in the infrequent side effects was noted between fluvoxamine and TCAs (Relative risk 0.47 with 95% confidence interval 0.34-0.64 and P value < 0.0001) while non-significant difference in the infrequent side effects was noted between fluvoxamine and SRIs (Relative risk 1.45 with 95% confidence interval 0.97-2.15 and P value = 0.07).
This meta-analysis shows that fluvoxamine has no difference in its efficacy, acceptability or safety when compared with SRIs. Also it doesn't differ in its efficacy, acceptability when compared with the TCAs. However, it shows a significantly better safety profile in both the occurrence of the specific side effects and the infrequently occurring adverse effects. Thus our study suggests that fluvoxamine has a favorable risk/benefit profile when compared with the TCAs.