Pain
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Randomized Controlled Trial
Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin.
This was a multicenter, double-blind (DB), placebo-controlled, randomized discontinuation trial to evaluate the efficacy of pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain. The trial included a 6-week open-label (OL) pregabalin-treatment period followed by 26-week DB treatment with placebo or pregabalin. Adults with FM and 40-mm score on 100-mm pain visual analog scale (VAS) were eligible. ⋯ At the end of DB, 174 (61%) placebo patients met LTR criteria versus 90 (32%) pregabalin patients. Pregabalin was well tolerated, though 178 (17%) discontinued during OL for treatment-related adverse events (AE), and more pregabalin than placebo patients discontinued for AEs during DB. In those who respond, pregabalin demonstrated durability of effect for relieving FM pain.
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Review Meta Analysis
Doctors' attitudes and beliefs regarding acute low back pain management: A systematic review.
The aim of this systematic review was to determine the attitudes and beliefs of doctors to acute low back pain, and the factors that influence these. The review comprised three phases: a methodological assessment of databases (Medline, EMBASE, Psychinfo, BIOSIS, CINAHL, and the Cochrane Central Register of Controlled Trials) identified potential papers; these were screened for inclusion criteria by two independent reviewers, the extraction of data and the rating of internal validity and strength of the evidence, using valid and reliable scales from accepted papers. Themes were then identified from the accepted literature. ⋯ There was inconsistent evidence that demographic factors (age) and level of education impacted doctors' attitudes and beliefs. Strategies to address/ modify these attitudes and beliefs are required, as in some cases they are at odds with guideline recommendations. Long term, these changes in these areas have the potential to maximise patient-care, and reduce costs to health services.
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Randomized Controlled Trial
Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial.
The primary objectives of this study were to assess the efficacy and safety of duloxetine for reducing pain severity in fibromyalgia patients with or without current major depressive disorder. This was a 6-month, multicenter, randomized, double-blind, placebo-controlled study. In total, 520 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to duloxetine (20 mg/day, 60 mg/day, or 120 mg/day) or placebo, administered once daily, for 6 months (after 3 months, the duloxetine 20-mg/day group titrated to 60 mg/day). ⋯ Duloxetine was efficacious in patients both with and without major depressive disorder. There were no clinically significant differences between treatment groups in changes in vital signs, laboratory measures, or ECG measures. Study results demonstrated that duloxetine at doses of 60 mg/day and 120 mg/day appears to be safe and efficacious in patients with fibromyalgia.
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Randomized Controlled Trial
Supra-additive effects of tramadol and acetaminophen in a human pain model.
The combination of analgesic drugs with different pharmacological properties may show better efficacy with less side effects. Aim of this study was to examine the analgesic and antihyperalgesic properties of the weak opioid tramadol and the non-opioid acetaminophen, alone as well as in combination, in an experimental pain model in humans. After approval of the local Ethics Committee, 17 healthy volunteers were enrolled in this double-blind and placebo-controlled study in a cross-over design. ⋯ Our study provides first results on interactions of tramadol and acetaminophen on experimental pain and hyperalgesia in humans. Pharmacodynamic modeling combined with the isobolographic technique showed supra-additive effects of the combination of acetaminophen and tramadol concerning both, analgesia and antihyperalgesia. The results might act as a rationale for combining both analgesics.