title: Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.
abstract: OBJECTIVE
  The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks.
  
  
  METHODS
  Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks.
  
  
  RESULTS
  Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance.
  
  
  CONCLUSIONS
  BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain.
authors.affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada.
authors.forename: Allan
authors.initials: A
authors.lastname: Gordon
authors.forename: Saifudin
authors.initials: S
authors.lastname: Rashiq
authors.forename: Dwight E
authors.initials: DE
authors.lastname: Moulin
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Clark
authors.forename: André D
authors.initials: AD
authors.lastname: Beaulieu
authors.forename: John
authors.initials: J
authors.lastname: Eisenhoffer
authors.forename: Paula S
authors.initials: PS
authors.lastname: Piraino
authors.forename: Patricia
authors.initials: P
authors.lastname: Quigley
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Harsanyi
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Darke
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D002047:Buprenorphine / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D013997:Time Factors
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine