RT Journal Article
SR Electronic
T1 What Makes Patients with Fibromyalgia Feel Better? Correlations Between Patient Global Impression of Improvement and Changes in Clinical Symptoms and Function: A Pooled Analysis of 4 Randomized Placebo-controlled Trials of Duloxetine
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.090139
DO 10.3899/jrheum.090139
A1 James I. Hudson
A1 Lesley M. Arnold
A1 Laurence A. Bradley
A1 Ernest H. S. Choy
A1 Philip J. Mease
A1 Fujun Wang
A1 Jonna Ahl
A1 Madelaine M. Wohlreich
YR 2009
UL http://www.jrheum.org/content/early/2009/10/09/jrheum.090139.abstract
AB Objective To investigate the relationship between changes in clinical rating scale items and endpoint Patient Global Impression of Improvement (PGI-I). Methods Data were pooled from 4 randomized, double-blind, placebo-controlled studies of duloxetine in patients with fibromyalgia (FM). Variables included in the analyses were those that assessed symptoms in FM domains of pain, fatigue, sleep, cognitive difficulties, emotional well-being, physical function, and impact on daily living. The association of endpoint PGI-I with changes from baseline in individual variables was assessed using Pearson product-moment correlations (r). Stepwise linear regression was used to identify those variables for which changes from baseline were statistically significant independent predictors of the endpoint PGI-I ratings. Results Changes in pain variables and interference of symptoms with the ability to work were highly correlated (r ≥ 0.5 or r ≤ –0.5) with endpoint PGI-I. Moderate correlation with endpoint PGI-I (0.30 ≤ r < 0.5 or –0.5 < r ≤ –0.30) included changes in variables that assessed physical functioning, depression, anxiety, fatigue, and several variables related to impact on daily living. Independent predictor variables of endpoint PGI-I identified by stepwise linear regression included assessments for pain, physical function, vitality, anxiety, social function, and tender point thresholds. Conclusion In addition to pain reduction, what makes patients with FM feel better may include improvement in fatigue, physical functioning, mood, and impact on daily living. An assessment of these domains may be important in clinical trials of FM and in the management of patients with FM.