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Review
. 2018 Jul;97(28):e11547.
doi: 10.1097/MD.0000000000011547.

Efficacy and tolerability of fluvoxamine in adults with social anxiety disorder: A meta-analysis

Xue Liu  1 , Xinyuan Li, Congxiao Zhang, Mingze Sun, Ziqian Sun, Yanan Xu, Xiujuan Tian
Affiliations
Review

Efficacy and tolerability of fluvoxamine in adults with social anxiety disorder: A meta-analysis

Xue Liu et al. Medicine (Baltimore). 2018 Jul.

Abstract

Background: No meta-analysis for estimating the comprehensive efficacy and tolerability of fluvoxamine in patients with social anxiety disorder (SAD) has been published.

Objective: To investigate the efficacy and tolerability of fluvoxamine in adults with SAD, trials meeting the following criteria were identified: population: ≥18 years of age with a diagnosis of SAD; intervention: fluvoxamine; study design: placebo-controlled randomized controlled trials (RCTs); outcomes: efficacy and tolerability outcomes.

Methods: We conducted a comprehensive search of PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials.gov for RCTs on January 3, 2018. Review Manager 5.3 and Stata Version 12.0 software were used for all statistical analyses. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated for continuous variables, and odds ratios (ORs) with 95% CIs were calculated for dichotomous variables. Cochrane Collaboration's risk of bias tool was used to assess the likelihood of risk of bias. Efficacy was assessed by mean changes in the Liebowitz Social Anxiety scale (LSAS) total score and the Clinical Global Impression Severity of Illness (CGI-S) score as well as the response rate. Tolerability was mainly assessed by the discontinuation rate due to adverse events (AEs) and the incidence of most frequent treatment-emergent AEs (TEAEs).

Results: This meta-analysis included 5 RCTs. Mean changes in LSAS total and CGI-S scores were both significantly greater in patients treated with fluvoxamine than those treated with placebo (LSAS: MD = 11.90, 95% CI = 8.09-15.71, P < .001; CGI-S: MD = 0.52, 95% CI = 0.33-0.72, P < .001). Response rate was higher in fluvoxamine group as compared with placebo (OR = 1.71, 95% CI = 1.30-2.24, P < .001). Additionally, mean change in the Sheehan disability scale score was significantly greater in fluvoxamine group than placebo group (OR = 2.11, 95% CI = 1.03-3.18, P < .001). The discontinuation rate due to AEs was higher in patients that received fluvoxamine compared to those received placebo (OR = 5.99, 95% CI = 2.24-15.99, P < .001), as was the incidence of overall TEAEs (any AE) (OR = 2.66, 95% CI = 1.77-4.02, P < .001). However, the incidence of serious AEs was not significantly different between the 2 groups (OR = 0.99, 95% CI = 0.25-3.89, P = .99).

Conclusion: Fluvoxamine was found to be effective in adult patients with SAD, with acceptable tolerability.

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Figures

Figure 1
Figure 1
Flow diagram of study selection.
Figure 2
Figure 2
Risk of bias in the included studies.
Figure 3
Figure 3
Funnel plot of publication bias. OR = odds ratio, SE = standard error.
Figure 4
Figure 4
Mean changes in LSAS total score and CGI-S score. CGI-S = Clinical Global Impression Severity of Illness, CI = confidence interval, LSAS = Liebowitz Social Anxiety scale, SD = standard deviation.
Figure 5
Figure 5
Forest plots of response rate and mean change in SDS total score. CI = confidence interval, SD = standard deviation, SDS = Sheehan disability scale.
Figure 6
Figure 6
Discontinuation rate due to AEs; the incidence of any AE and SAE. AE = adverse event, CI = confidence interval, SAE = serious adverse event.
Figure 7
Figure 7
Sensitivity analyses of the main efficacy and tolerability outcomes. AE = adverse event.
See this image and copyright information in PMC

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