The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder.
OBJECTIVE
To examine the relationship between global functional impairment and the treatment of anxious symptoms and painful somatic symptoms (PSS) in patients with generalized anxiety disorder (GAD).


METHODS
Data from two double-blind, placebo-controlled trials in adult outpatients meeting DSM-IV criteria for GAD were pooled. In the first trial (9-week, fixed-dose treatment period), patients were randomized to duloxetine 60 mg QD (n=168), duloxetine 120 mg QD (n=170), or placebo (n=175). In the second trial (10-week, flexible-dose treatment period), patients were randomized to 60-120 mg QD of duloxetine (n=168) or placebo (n=159). Path analysis was used to assess the relative contributions of changes in psychic and somatic anxiety and PSS on improved functional outcomes.


BACKGROUND
Study 1: NCT00122824; Study 2: study completed before registration required.


METHODS
Sheehan Disability Scale (SDS), Hamilton Anxiety Rating Scale (HAMA), and Visual Analog Scale for overall pain (VAS).


RESULTS
There was a moderate correlation (0.45, p<0.05) at endpoint between changes in global functional impairment and changes in psychic anxiety (controlling for somatic anxiety and PSS); whereas the correlation between changes in global functional impairment and changes in somatic anxiety (controlling for psychic anxiety and PSS) was weak (0.09, p<0.05). The correlation between changes in global functional impairment and changes in PSS (controlling for psychic and somatic anxiety) was weak (0.27, p<0.05). Path analysis revealed that 37% of the total improvement in functional impairment (Sheehan Disability Scale total score) due to duloxetine treatment was independent of improvement in the Hamilton Anxiety Rating Scale (HAMA) psychic and somatic anxiety subscale scores or Visual Analog Scale for overall pain (VAS) score. Improvement in psychic anxiety accounted for 47% of the total treatment effect on improvement of functional impairment, whereas 7% and 9% of the improvement in functional impairment was accounted for by improvements in somatic anxiety and overall pain, respectively.
Sheehan
David V
DV
University of South Florida College of Medicine, Tampa, FL, USA.
Meyers
Adam L
AL
Prakash
Apurva
A
Robinson
Michael J
MJ
Swindle
Ralph W
RW
Russell
James M
JM
Mallinckrodt
Craig H
CH
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D010919:Placebos; D011602:Psychophysiologic Disorders / Q000188:drug therapy*; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D010919:Placebos; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride