Efficacy and tolerability of short-term duloxetine treatment in adults with generalized anxiety disorder: A meta-analysis.

Xinyuan Li,Shaokuan Fang,Heqian Du,Chenglin Wang,Jing Liu,Chunkui Zhou,Lijun Zhu,Emilio Russo

doi:10.1371/journal.pone.0194501

Xinyuan Li, Shaokuan Fang + Show 6 more

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https://doi.org/10.1371/journal.pone.0194501

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Abstract

ObjectiveTo investigate the efficacy and tolerability of duloxetine during short-term treatment in adults with generalized anxiety disorder (GAD).MethodsWe conducted a comprehensive literature review of the PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and ClinicalTrials databases for randomized controlled trials(RCTs) comparing duloxetine or duloxetine plus other antipsychotics with placebo for the treatment of GAD in adults. Outcome measures were (1) efficacy, assessed by the Hospital Anxiety and Depression Scale(HADS) anxiety subscale score, the Hamilton Rating Scale for Anxiety(HAM-A) psychic and somatic anxiety factor scores, and response and remission rates based on total scores of HAM-A; (2) tolerability, assessed by discontinuation rate due to adverse events, the incidence of treatment emergent adverse events(TEAEs) and serious adverse events(SAEs). Review Manager 5.3 and Stata Version 12.0 software were used for all statistical analyses.ResultsThe meta-analysis included 8 RCTs. Mean changes in the HADS anxiety subscale score [mean difference(MD) = 2.32, 95% confidence interval(CI) 1.77–2.88, P<0.00001] and HAM-A psychic anxiety factor score were significantly greater in patients with GAD that received duloxetine compared to those that received placebo (MD = 2.15, 95%CI 1.61–2.68, P<0.00001). However, there was no difference in mean change in the HAM-A somatic anxiety factor score (MD = 1.13, 95%CI 0.67–1.58, P<0.00001). Discontinuation rate due to AEs in the duloxetine group was significantly higher than the placebo group [odds ratio(OR) = 2.62, 95%CI 1.35–5.06, P = 0.004]. The incidence of any TEAE was significantly increased in patients that received duloxetine (OR = 1.76, 95%CI 1.36–2.28, P<0.0001), but there was no significant difference in the incidence of SAEs (OR = 1.13, 95%CI 0.52–2.47, P = 0.75).ConclusionDuloxetine resulted in a greater improvement in symptoms of psychic anxiety and similar changes in symptoms of somatic anxiety compared to placebo during short-term treatment in adults with GAD and its tolerability was acceptable.

Highlights

Generalized anxiety disorder (GAD) is one of the most common anxiety disorders in adults
Mean changes in the Hospital Anxiety and Depression Scale (HADS) anxiety subscale score [mean difference(MD) = 2.32, 95% confidence interval(CI) 1.77–2.88, P
Discontinuation rate due to AEs in the duloxetine group was significantly higher than the placebo group [odds ratio(OR) = 2.62, 95%CI 1.35–5.06, P = 0.004]

Summary

Introduction

Generalized anxiety disorder (GAD) is one of the most common anxiety disorders in adults. Epidemiological surveys estimate the lifetime prevalence of GAD at 2.8–6.2% and the 12 month prevalence at 0.2–4.3% [1]. In the National Comorbidity Replication Survey, the 12-month prevalence of GAD was approximately 12% in adults over the age of 55 years[2]. GAD is characterized by pervasive, excessive, and difficult-to-control worry [3], and the presence of psychic and somatic symptoms [4]. Difficulty concentrating, irritability, and feeling keyed up [5]. Somatic symptoms include muscle tension, sleep disturbance, gastrointestinal dysfunction, cardiovascular disease, and impairment in other organ systems [6]. The presence and severity of psychic and somatic anxiety symptoms are commonly assessed using the Hamilton Rating Scale for Anxiety (HAM-A) psychic and somatic anxiety factor scores [7,8]

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