title: A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster.
abstract: Although acute pain in patients with herpes zoster can be severe and has a substantial impact on health-related quality of life, there have been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects >or=50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24h >or=3 on a 0-10 rating scale initiated 7 days of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo. Subjects were evaluated for adverse effects of treatment, acute pain, and health-related quality of life. The results showed that CR-oxycodone and gabapentin were generally safe and were associated with adverse events that reflect well-known effects of these medications. Discontinuing participation in the trial, primarily associated with constipation, occurred more frequently in subjects randomized to CR-oxycodone (27.6%) compared with placebo (6.9%). Treatment with CR-oxycodone reduced the mean worst pain over days 1-8 (p=0.01) and days 1-14 (p=0.02) relative to placebo but not throughout the entire 28-day treatment period as pain resolved in most subjects. Gabapentin did not provide significantly greater pain relief than placebo, although the data for the first week were consistent with a modest benefit. By demonstrating that CR-oxycodone is safe, generally adequately tolerated, and appears to have efficacy for relieving acute pain, the results of this clinical trial provide a foundation for evidence-based treatment for acute pain in herpes zoster.
authors.affiliation: Departments of Anesthesiology and Neurology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Avenue, Box 604, Rochester, NY 14642, USA Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Dermatology, University of Texas Health Science Center and the Center for Clinical Studies, Houston, TX, USA Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Departments of Biostatistics and Computational Biology and Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology, McGill University, Montreal, Canada Novartis Pharmaceuticals, East Hanover, NJ, USA Departments of Medicine, Pediatrics, and Microbiology, University of Alabama at Birmingham and Birmingham Veterans Administration Medicine Center, Birmingham, AL, USA Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology, University of Pittsburgh, Pittsburgh, PA, USA Department of Medicine-Geriatrics, Duke University, and GRECC, Durham VA Medical Center, Durham, NC, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Richard L
authors.initials: RL
authors.lastname: Barbano
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Tyring
authors.forename: Robert F
authors.initials: RF
authors.lastname: Betts
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Janet
authors.initials: J
authors.lastname: Pennella-Vaughan
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Bennett
authors.forename: Erhan
authors.initials: E
authors.lastname: Berber
authors.forename: John W
authors.initials: JW
authors.lastname: Gnann
authors.forename: Carrie
authors.initials: C
authors.lastname: Irvine
authors.forename: Cornelia
authors.initials: C
authors.lastname: Kamp
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
authors.forename: Mitchell B
authors.initials: MB
authors.lastname: Max
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Schmader
mesh_terms: D000208:Acute Disease; D000368:Aged; D000588:Amines / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000008:administration & dosage; D002986:Clinical Trials as Topic / Q000639:trends*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D019317:Evidence-Based Medicine / Q000639:trends*; D005260:Female; D000077206:Gabapentin; D006562:Herpes Zoster / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D009518:New York / Q000453:epidemiology; D010098:Oxycodone / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy* / Q000453:epidemiology; D015990:Placebo Effect; D013781:Texas / Q000453:epidemiology; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000701:Analgesics, Opioid; D003509:Cyclohexanecarboxylic Acids; D003692:Delayed-Action Preparations; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D010098:Oxycodone