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See Latest ArticlesA six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia
International Journal of General Medicine, 05/12/09
Chappell AS et al. - Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures.
Methods- phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine.
- There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI) average pain severity from baseline to endpoint (P = 0.053) and the Patient’s Global Impressions of Improvement (PGI-I) at endpoint (P = 0.073).
- Duloxetine-treated patients improved significantly more than placebo-treated patients on the:
- Fibromyalgia Impact Questionnaire pain score,
- BPI least pain score and average interference score,
- Clinical Global Impressions of Severity scale, area under the curve of pain relief,
- Multidimensional Fatigue Inventory mental fatigue dimension,
- Beck Depression Inventory-II total score, and
- 36-item Short Form Health Survey mental component summary and mental health score.
- Nausea was the most common treatment-emergent adverse event in the duloxetine group.
- Overall discontinuation rates were similar between groups.
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