A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster

• Published in: Pain (Amsterdam) Vol. 142; no. 3; pp. 209 - 217
• Main Authors: Dworkin, Robert H., Barbano, Richard L., Tyring, Stephen K., Betts, Robert F., McDermott, Michael P., Pennella-Vaughan, Janet, Bennett, Gary J., Berber, Erhan, Gnann, John W., Irvine, Carrie, Kamp, Cornelia, Kieburtz, Karl, Max, Mitchell B., Schmader, Kenneth E.
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Elsevier B.V 01.04.2009; Lippincott Williams & Wilkins, Inc; Elsevier
• Subjects: Acute Disease; Acute pain; Aged; Amines - therapeutic use; Analgesics, Opioid - administration & dosage; Biological and medical sciences; Clinical Trials as Topic - trends; Cyclohexanecarboxylic Acids - therapeutic use; Delayed-Action Preparations - administration & dosage; Evidence-Based Medicine - trends; Female; Fundamental and applied biological sciences. Psychology; Gabapentin; gamma-Aminobutyric Acid - therapeutic use; Herpes zoster; Herpes Zoster - drug therapy; Herpes Zoster - epidemiology; Humans; Illness and personality; Illness, stress and coping; Male; New York - epidemiology; Oxycodone; Oxycodone - administration & dosage; Pain - drug therapy; Pain - epidemiology; Placebo Effect; Postherpetic neuralgia; Psychology and medicine; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Randomized clinical trial; Somesthesis and somesthetic pathways (proprioception, exteroception, nociception); interoception; electrolocation. Sensory receptors; Texas - epidemiology; Treatment Outcome; Vertebrates: nervous system and sense organs; Postherpetic neuralgia; Herpes zoster; Randomized clinical trial; Acute pain; Gabapentin; Oxycodone; Human; Skin disease; Nervous system diseases; Evaluation scale; Post-herpetic neuralgia; Quality of life; Infection; Treatment; Viral disease; Placebo; Clinical trial; Release
• ISSN: 0304-3959; 1872-6623; 1872-6623
• DOI: 10.1016/j.pain.2008.12.022

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 ⩾50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24 h ⩾ 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.