PMID- 29995828 OWN - NLM STAT- MEDLINE DCOM- 20180727 LR - 20210109 IS - 1536-5964 (Electronic) IS - 0025-7974 (Print) IS - 0025-7974 (Linking) VI - 97 IP - 28 DP - 2018 Jul TI - Efficacy and tolerability of fluvoxamine in adults with social anxiety disorder: A meta-analysis. PG - e11547 LID - 10.1097/MD.0000000000011547 [doi] LID - e11547 AB - 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. FAU - Liu, Xue AU - Liu X AD - Department of Gynaecology and Obstetrics, China-Japan Union Hospital of Jilin University Department of Neurology, Neuroscience Centre Department of Stomatology, The First Teaching Hospital of Jilin University Department of Gastrointestinal Colorectal and Anal Surgery, China-Japan Union Hospital of Jilin University, Changchun, China. FAU - Li, Xinyuan AU - Li X FAU - Zhang, Congxiao AU - Zhang C FAU - Sun, Mingze AU - Sun M FAU - Sun, Ziqian AU - Sun Z FAU - Xu, Yanan AU - Xu Y FAU - Tian, Xiujuan AU - Tian X LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R RN - 0 (Anti-Anxiety Agents) RN - O4L1XPO44W (Fluvoxamine) SB - IM MH - Adult MH - Anti-Anxiety Agents/adverse effects/*therapeutic use MH - Female MH - Fluvoxamine/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Phobia, Social/*drug therapy MH - Severity of Illness Index MH - Treatment Outcome PMC - PMC6076099 EDAT- 2018/07/12 06:00 MHDA- 2018/07/28 06:00 PMCR- 2018/07/13 CRDT- 2018/07/12 06:00 PHST- 2018/07/12 06:00 [entrez] PHST- 2018/07/12 06:00 [pubmed] PHST- 2018/07/28 06:00 [medline] PHST- 2018/07/13 00:00 [pmc-release] AID - 00005792-201807130-00079 [pii] AID - MD-D-18-02048 [pii] AID - 10.1097/MD.0000000000011547 [doi] PST - ppublish SO - Medicine (Baltimore). 2018 Jul;97(28):e11547. doi: 10.1097/MD.0000000000011547.