Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial

Trials. 2017 Jan 14;18(1):24. doi: 10.1186/s13063-016-1729-y.

Abstract

Background: Postherpetic neuralgia (PHN) is a chronic neuropathic pain that results from alterations of the peripheral nervous system in areas affected by the herpes zoster virus. The symptoms include pain, paresthesia, dysesthesia, hyperalgesia, and allodynia. Despite the availability of pharmacological treatments to control these symptoms, no treatments are available to control the underlying pathophysiology responsible for this disabling condition.

Methods/design: Patients with herpes zoster who are at least 50 years old and have a pain score of 4 or higher on a visual analogue scale (VAS) will be recruited. The aim is to recruit 134 patients from the practices of general physicians. Participants will be randomized to receive gabapentin to a maximum of 1800 mg/day for 5 weeks or placebo. Both arms will receive 1000-mg caplets of valacyclovir three times daily for 7 days (initiated within 72 h of the onset of symptoms) and analgesics as needed. The primary outcome measure is the percentage of patients with a VAS pain score of 0 at 12 weeks from rash onset. The secondary outcomes measures are changes in quality of life (measured by the SF-12 questionnaire), sleep disturbance (measured by the Medical Outcomes Study Sleep Scale), and percentage of patients with neuropathic pain (measured by the Douleur Neuropathique in 4 Questions).

Discussion: Gabapentin is an anticonvulsant type of analgesic that could prevent the onset of PHN by its antihypersensitivity action in dorsal horn neurons.

Trial registration: ISRCTN Registry identifier: ISRCTN79871784 . Registered on 2 May 2013.

Keywords: Gabapentin; Herpes zoster; Postherpetic neuralgia; Prevention; Primary health care.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acyclovir / adverse effects
  • Acyclovir / analogs & derivatives*
  • Acyclovir / therapeutic use
  • Amines / adverse effects
  • Amines / therapeutic use*
  • Analgesics / adverse effects
  • Analgesics / therapeutic use*
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Clinical Protocols
  • Cyclohexanecarboxylic Acids / adverse effects
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Double-Blind Method
  • Female
  • Gabapentin
  • Herpes Zoster / diagnosis
  • Herpes Zoster / drug therapy*
  • Herpes Zoster / virology
  • Humans
  • Male
  • Middle Aged
  • Neuralgia, Postherpetic / diagnosis
  • Neuralgia, Postherpetic / physiopathology
  • Neuralgia, Postherpetic / prevention & control*
  • Neuralgia, Postherpetic / virology
  • Pain Measurement
  • Quality of Life
  • Research Design
  • Sleep
  • Spain
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Valacyclovir
  • Valine / adverse effects
  • Valine / analogs & derivatives*
  • Valine / therapeutic use
  • gamma-Aminobutyric Acid / adverse effects
  • gamma-Aminobutyric Acid / therapeutic use*

Substances

  • Amines
  • Analgesics
  • Antiviral Agents
  • Cyclohexanecarboxylic Acids
  • gamma-Aminobutyric Acid
  • Gabapentin
  • Valine
  • Valacyclovir
  • Acyclovir

Associated data

  • ISRCTN/ISRCTN79871784