A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain.
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.
Skljarevski
V
V
Lilly Research Laboratories, Indianapolis, IN, USA. vladimir@lilly.com
Ossanna
M
M
Liu-Seifert
H
H
Zhang
Q
Q
Chappell
A
A
Iyengar
S
S
Detke
M
M
Backonja
M
M
D000704:Analysis of Variance; D002908:Chronic Disease; D018765:Dopamine Uptake Inhibitors / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D018579:Patient Selection; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use; D013876:Thiophenes / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D018765:Dopamine Uptake Inhibitors; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes