title: Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice.
abstract: OBJECTIVE
  To compare the quality of life of patients with moderate-to-severe chronic low back pain under treatment with the WHO-step III opioids oxycodone/naloxone, oxycodone, or morphine in routine clinical practice.
  
  
  METHODS
  Prospective, 12-week, randomized, open-label, blinded end-point study in 88 medical centers in Germany.
  
  
  METHODS
  A total of 901 patients requiring around-the-clock pain treatment with a WHO-step III opioid were randomized to either morphine, oxycodone, or oxycodone/naloxone (1:1:1). Changes from baseline to week 12 in quality of life were assessed using different validated tools (EuroQoL-5 Dimensions [EQ-5D], Short Form 12 [SF-12], quality of life impairment by pain inventory [QLIP]).
  
  
  RESULTS
  EQ-5D weighted index scores significantly improved over the 12-week treatment period under all three opioids (P<0.001) with significantly greater improvements under oxycodone/naloxone (65.2% vs 49.6% for oxycodone and 48.2% for morphine, P<0.001). The proportion of patients without EQ-5D complaints was also significantly higher under oxycodone/naloxone (P<0.001). Although quality of life ratings with the QLIP inventory showed significant improvements in all the three treatment arms, improvements were significantly higher under oxycodone/naloxone than under oxycodone and morphine (P<0.001): 90.7% of all oxycodone/naloxone patients achieved ≥30% improvements in quality of life, 72.8% had ≥50%, and 33.2% ≥70% improvements. Similarly, both physical and mental SF-12 component scores showed significantly greater improvements under oxycodone/naloxone with both scores close to the German population norm after 12 weeks.
  
  
  CONCLUSIONS
  Treatment with morphine, oxycodone, or oxycodone/naloxone under routine daily practice conditions significantly improved state of health and quality of life of patients with moderate-to-severe low back pain over a 12-week treatment period. Comparison between the treatment groups showed significantly greater improvements for oxycodone/naloxone than for the other two opioids.
authors.affiliation: Institute for Neurological Sciences, Nuernberg, Germany.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Ueberall
authors.affiliation: Mundipharma GmbH, Limburg, Germany.
authors.forename: Alice
authors.initials: A
authors.lastname: Eberhardt
authors.affiliation: Interdisciplinary Center for Pain and Palliative Care Medicine, Goeppingen, Germany.
authors.forename: Gerhard Hh
authors.initials: GH
authors.lastname: Mueller-Schwefe
keywords: EQ-5D; QLIP; SF-12; chronic low back pain; morphine; oxycodone; oxycodone/naloxone; quality of life; routine clinical practice