A double‐blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain

Abstract

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.

Irrational Suffering – An Impact of Cognitive Behavioural Therapy on the Depression Level and the Perception of Pain in Cancer Patients

“…Benedetti, 2009) demonstrated that in the chronic pain treatment the patient's expectations concerning the efficacy of the medication significantly improve his or her general condition. During the 13-week observation of the patients suffering from chronic back pain no significant differences in pain severity were observed between the patients who were administered duloxetine and those given placebo (Skljarevski et al, 2009). A number of studies have found that the administration of placebo reduces the severity of pain in a substantial proportion of patients suffering from chronic pain.…”

Pharmacotherapy of low back pain: targeting nociceptive and neuropathic pain components

“…Data on the efficacy of the serotonin and noradrenaline reuptake inhibitor duloxetine in chronic LBP are conflicting. In a placebo-controlled study (n ¼ 404), the reduction in average weekly pain (measured on a 0-10 Likert scale) was significantly greater with duloxetine at doses of 60 mg than with placebo from weeks 3-11 (p50.05), but this difference was not maintained through to study endpoint (week 13) 93 . Significant improvements in several pain scales were also observed, including the Patient Global Impression of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), Brief Pain Inventory (BPI)-average pain and BPI-average interference.…”

Pharmacotherapy for Chronic Low Back Pain

“…Active treatment was superior to placebo in both 12-week trials when a 30% improvement in pain was defined as a positive response (Skljarevski et al, 2010a;Skljarevski et al, 2009) but only in 1 trial when a 50% improvement was defined as a positive response (Skljarevski et al, 2010a). Given modest efficacy, duloxetine may be a helpful adjunctive therapy (discussed below).…”

“…Duloxetine has shown modest efficacy in two 12-week trials (Skljarevski et al, 2010a;Skljarevski et al, 2009) and in a 41-week open-label study (Skljarevski et al, 2010b). Active treatment was superior to placebo in both 12-week trials when a 30% improvement in pain was defined as a positive response (Skljarevski et al, 2010a;Skljarevski et al, 2009) but only in 1 trial when a 50% improvement was defined as a positive response (Skljarevski et al, 2010a).…”

“…Duloxetine has only modest efficacy (Skljarevski et al, 2010a;Skljarevski et al, 2009), is associated with patients taking a product that combines a narcotic with acetaminophen and then augmenting it with additional acetaminophen (Larson et al, 2005). Overdose may also be deliberate (Camidge et al, 2003;Larson et al, 2005).…”