Background and objective: Generalized anxiety disorder (GAD) is a psychiatric disorder characterized by excess worry and anxiety. GAD impacts overall health-related quality of life (HRQL), level of functioning, and disability. This literature review was conducted to understand the impact of pharmacological treatments on HRQL and functional outcomes.
Methods: A literature review was conducted to identify randomized controlled trials (RCTs) comparing GAD pharmacological treatments with one or more patient-reported outcome (PRO) measure assessing HRQL, disability, functioning, or work productivity. Four databases were searched (PubMed, EMBASE, Cochrane Reviews, PsycInfo). Limits included English-language publications from 2004-2014. Abstracts and articles were reviewed to select articles reporting results of RCTs of pharmacological treatments for GAD that included one or more PRO measure. Article abstraction and summarization focused on key elements of the study design and PRO results.
Results: One hundred sixty-three abstracts were reviewed; 44 articles were requested; 12 articles, representing 19 studies, were deemed relevant. The Sheehan Disability Scale (SDS) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) were the most frequently utilized PRO measures. In clinical trials with significant anxiety symptom reductions, the SDS and Q-LES-Q also improved with treatment and differentiated from placebo. Two trials included a measure of work productivity; both demonstrated significant improvements with short-term treatment.
Conclusion: Treatments that reduce anxiety symptoms are also associated with improvements in patient-reported HRQL, function, and disability. In addition to evaluation of treatment impacts on anxiety symptoms, clinical trials should include PRO measures of HRQL, disability, and functioning.