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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
Journal of Rheumatology, 10/16/09

Hudson JI et al. – 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.

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).

Results

Changes in pain variables and interference of symptoms with the ability to work were highly correlated with endpoint Patient Global Impression of Improvement (PGI–I).
Moderate correlation with endpoint PGI–I 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.

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