Libro

ARTHRITIS & RHEUMATISM
Vol. 50, No. 9, September 2004, pp 2974–2984
DOI 10.1002/art.20485
© 2004, American College of Rheumatology

A Double-Blind, Multicenter Trial Comparing Duloxetine With
Placebo in the Treatment of Fibromyalgia Patients
With or Without Major Depressive Disorder
Lesley M. Arnold,1 Yili Lu,2 Leslie J. Crofford,3 Madelaine Wohlreich,2 Michael J. Detke,4
SmritiIyengar,2 and David J. Goldstein,5 for the Duloxetine Fibromyalgia Trial Group
Impression of Severity (CGI-Severity) scale, Patient
Global Impression of Improvement (PGI-Improvement)
scale, Brief Pain Inventory (short form), Medical Outcomes Study Short Form 36, Quality of Life in Depression Scale, and Sheehan Disability Scale.
Results. Compared with placebo-treated subjects,
duloxetine-treatedsubjects improved significantly more
(P
0.027) on the FIQ total score, with a treatment
difference of 5.53 (95% confidence interval 10.43,
0.63), but not significantly more on the FIQ pain score
(P
0.130). Compared with placebo-treated subjects,
duloxetine-treated subjects had significantly greater
reductions in Brief Pain Inventory average pain severity
score (P
0.008), Brief Pain Inventoryaverage interference from pain score (P 0.004), number of tender
points (P 0.002), and FIQ stiffness score (P 0.048),
and had significantly greater improvement in mean
tender point pain threshold (P
0.002), CGI-Severity
(P 0.048), PGI-Improvement (P 0.033), and several
quality-of-life measures. Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baselinestatus of major depressive disorder.
Compared with placebo-treated female subjects (n
92), duloxetine-treated female subjects (n
92) demonstrated significantly greater improvement on most
efficacy measures, while duloxetine-treated male subjects (n
12) failed to improve significantly on any
efficacy measure. The treatment effect on significant
pain reduction in female subjects was independent ofthe effect on mood or anxiety. Duloxetine was safely
administered and well tolerated.
Conclusion. In this randomized, controlled, 12week trial (with a 1-week placebo lead-in phase), duloxetine was an effective and safe treatment for many of the
symptoms associated with fibromyalgia in subjects with
or without major depressive disorder, particularly for

Objective. To assess the efficacyand safety of
duloxetine, a serotonin and norepinephrine reuptake
inhibitor, in subjects with primary fibromyalgia, with or
without current major depressive disorder.
Methods. This study was a randomized, doubleblind, placebo-controlled trial conducted in 18 outpatient research centers in the US. A total of 207 subjects
meeting the American College of Rheumatology criteria
for primaryfibromyalgia were enrolled (89% female,
87% white, mean age 49 years, 38% with current major
depressive disorder). After single-blind placebo treatment for 1 week, subjects were randomly assigned to
receive duloxetine 60 mg twice a day (n
104) or
placebo (n
103) for 12 weeks. Co–primary outcome
measures were the Fibromyalgia Impact Questionnaire
(FIQ) total score (score range 0–80, with 0indicating no
impact) and FIQ pain score (score range 0–10). Secondary outcome measures included mean tender point pain
threshold, number of tender points, FIQ fatigue, tiredness on awakening, and stiffness scores, Clinical Global
Supported by Eli Lilly and Company.
1
Lesley M. Arnold, MD: University of Cincinnati College of
Medicine, Cincinnati, Ohio; 2Yili Lu, PhD, Madelaine Wohlreich,
MD, SmritiIyengar, PhD: Eli Lilly and Company, Indianapolis,
Indiana; 3Leslie J. Crofford, MD: University of Michigan, Ann Arbor;
4
Michael J. Detke, MD, PhD: Indiana University Medical School and
Eli Lilly and Company, Indianapolis, Indiana, McLean Hospital,
Belmont, Massachusetts, and Harvard Medical School, Boston, Massachusetts; 5David J. Goldstein, MD, PhD: Indiana University Medical
School...