Abstract | STUDY DESIGN: This was a randomized, double-blind, placebo-controlled clinical trial. OBJECTIVE: SUMMARY OF BACKGROUND DATA: METHODS: In this randomized double-blind trial, adult nondepressed patients with a non-neuropathic CLBP and a weekly mean of the 24-hour average pain score>or=4 at baseline (0-10 scale) were treated with either duloxetine or placebo for 13 weeks. The dose of duloxetine during first 7 weeks was 60 mg once daily. At week 7, patients reporting<30% pain reduction had their dose increased to 120 mg. The primary outcome measure was the Brief Pain Inventory (BPI) 24-hour average pain rating. Secondary measures included Roland-Morris Disability Questionnaire-24; Patient's Global Impressions of Improvement; Clinical Global Impressions-Severity (CGI-S); BPI-Severity and -Interference (BPI-I); and weekly means of the 24-hour average pain, night pain, and worst pain scores from patient diaries. Quality-of-life, safety, and tolerability outcomes were also assessed. RESULTS: Compared with placebo-treated patients (least-squares mean change of -1.50), patients on duloxetine (least-squares mean change of -2.32) had a significantly greater reduction in the BPI 24-hour average pain from baseline to endpoint (P=0.004 at week 13). Additionally, the duloxetine group significantly improved on Patient's Global Impressions of Improvement; Roland-Morris Disability Questionnaire-24; BPI-Severity and average BPI-Interference; weekly mean of the 24-hour average pain, night pain, and worst pain. Significantly more patients in the duloxetine group (13.9%) compared with placebo (5.8%) discontinued because of adverse events (P=0.047). The most common treatment-emergent adverse events in the duloxetine group included nausea, dry mouth, fatigue, diarrhea, hyperhidrosis, dizziness, and constipation. CONCLUSION:
Duloxetine significantly reduced pain and improved functioning in patients with CLBP. The safety and tolerability were similar to those reported in earlier studies.
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Authors | Vladimir Skljarevski, Durisala Desaiah, Hong Liu-Seifert, Qi Zhang, Amy S Chappell, Michael J Detke, Smriti Iyengar, Joseph H Atkinson, Miroslav Backonja |
Journal | Spine
(Spine (Phila Pa 1976))
Vol. 35
Issue 13
Pg. E578-85
(Jun 01 2010)
ISSN: 1528-1159 [Electronic] United States |
PMID | 20461028
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Serotonin Uptake Inhibitors
- Thiophenes
- Duloxetine Hydrochloride
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Topics |
- Adult
- Aged
- Chronic Disease
- Diarrhea
(chemically induced)
- Double-Blind Method
- Duloxetine Hydrochloride
- Fatigue
(chemically induced)
- Female
- Humans
- Low Back Pain
(drug therapy, physiopathology)
- Male
- Middle Aged
- Nausea
(chemically induced)
- Pain Measurement
- Selective Serotonin Reuptake Inhibitors
(adverse effects, therapeutic use)
- Thiophenes
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
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