A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain |
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Authors: | V. Skljarevski M. Ossanna H. Liu-Seifert Q. Zhang A. Chappell S. Iyengar M. Detke M. Backonja |
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Affiliation: | Lilly Research Laboratories, Indianapolis, IN, USA;;and University of Wisconsin Medical School, Madison, WI, USA |
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Abstract: | Background: Duloxetine has demonstrated analgesic effect in chronic pain states. This study assesses the efficacy of duloxetine in chronic low back pain (CLBP). Methods: Adult patients with non-radicular CLBP entered this 13-week, double-blind, randomized study comparing duloxetine 20, 60 or 120 mg once daily with placebo. The primary measure was comparison of duloxetine 60 mg with placebo on weekly mean 24-h average pain. Secondary measures included Roland-Morris Disability Questionnaire (RMDQ-24), Patient's Global Impressions of Improvement (PGI-I), Brief Pain Inventory (BPI), safety and tolerability. Results: Four hundred four patients were enrolled, 267 completed. No significant differences existed between any dose of duloxetine and placebo on reduction in weekly mean 24-h average pain at end-point. Duloxetine 60 mg was superior to placebo from weeks 3–11 in relieving pain, but not at weeks 12–13. Duloxetine 60 mg demonstrated significant improvement on PGI-I, RMDQ-24, BPI-average pain and BPI-average interference. Significantly more patients taking duloxetine 120 mg (24.1%) discontinued because of adverse events, versus placebo (8.5%). Conclusions: Duloxetine was superior to placebo on the primary objective from weeks 3–11, but superiority was not maintained at end-point. Duloxetine was superior to placebo on many secondary measures, and was well-tolerated. |
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Keywords: | chronic low back pain duloxetine randomized controlled trial |
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