Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial.

Abstract

OBJECTIVE:

To investigate the efficacy of flexible dose duloxetine 60-120 mg/day on changes in fibromyalgia (FM) symptoms assessed by the Patient Global Impression of Improvement (PGI-I) scale.

METHODS:

Outpatients ≥ 18 years of age who met American College of Rheumatology criteria for FM, and had ≥ 4 score on the Brief Pain Inventory (BPI) average pain item, were randomized to duloxetine (n = 263) or placebo (n = 267) for 24 week double-blind treatment (primary endpoint at Week 12). Key secondary measures included BPI average pain severity, patient-rated scales assessing mood, anxiety, pain, sleep, and stiffness, Clinical Global Impression of Severity (CGI-S), Multidimensional Fatigue Inventory, Cognitive and Physical Functioning Questionnaire, Beck Depression Inventory (BDI), Beck Anxiety Inventory, and Medical Outcome Study Short-Form Health Survey (SF-36).

RESULTS:

At Week 12, duloxetine-treated patients reported significantly greater global improvement with mean PGI-I scores of 2.8 compared to 3.4 in the placebo group (p < 0.001). Significantly more duloxetine- versus placebo-treated patients (57% vs 32%; p < 0.001) reported feeling "much" or "very much better" (PGI-I score ≤ 2). There was significantly greater improvement with duloxetine versus placebo treatment in BPI average pain severity, mood (including BDI total), anxiety (patient-rated only), stiffness, CGI-S, fatigue, all SF-36 domains (except role-physical and physical component summary), and being less bothered by pain or sleep difficulties. Treatment-emergent adverse events occurring significantly more frequently with duloxetine included: nausea, headache, constipation, dry mouth, dizziness, diarrhea, and hyperhidrosis.

CONCLUSION:

Treatment with duloxetine 60, 90, and 120 mg/day was associated with feeling much better, pain reduction, being less bothered by sleep difficulties, and improvement in mood, stiffness, fatigue and functioning. (Clinical trial registry NCT00673452).

• Authors: Lesley M Arnold, Daniel Clauw, Fujun Wang, Jonna Ahl, Paula J Gaynor, Madelaine M Wohlreich
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 37 Issue 12 Pg. 2578-86 (Dec 2010) ISSN: 0315-162X [Print] Canada
• PMID: 20843911 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Placebos
• Serotonin Uptake Inhibitors
• Thiophenes
• Duloxetine Hydrochloride

Topics

• Adult
• Double-Blind Method
• Duloxetine Hydrochloride
• Female
• Fibromyalgia (drug therapy, physiopathology)
• Humans
• Middle Aged
• Placebos
• Selective Serotonin Reuptake Inhibitors (therapeutic use)
• Severity of Illness Index
• Thiophenes (administration & dosage, therapeutic use)
• Treatment Outcome