Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran

Pain. 2010 May;149(2):373-378. doi: 10.1016/j.pain.2010.02.043. Epub 2010 Mar 23.

Abstract

Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings. The present study examined relationships between changes in pain, depressed mood, physical functioning, vitality, sleep disturbance, cognitive complaints, and PGIC ratings among 1260 participants with fibromyalgia (FM) who completed one of two trials examining the safety and efficacy of milnacipran. Many of the relationships between change in clinical status and PGIC ratings were stronger among persons who rated themselves as improved (responders) versus those reporting no change or a worsening of their condition (non-responders). Among non-responders, simultaneous regression analysis revealed that greater degrees of depressed mood and pain, and poorer physical function were significantly associated with worse PGIC ratings. Among responders, improvements in pain were significantly associated with better PGIC ratings, along with improvements in vitality, sleep, physical function, and cognitive complaints. These findings underscore the complexity of global ratings in FM patients, and suggest the association between clinical status and PGIC ratings varies as a function of perceived treatment response. Several domains were associated with PGIC ratings, highlighting the need to assess multiple outcomes in clinical trials of treatments for FM.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living / psychology
  • Adult
  • Cognition Disorders / drug therapy
  • Cognition Disorders / etiology
  • Cognition Disorders / physiopathology
  • Cyclopropanes / administration & dosage*
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / etiology
  • Depressive Disorder / physiopathology
  • Drug Resistance / physiology
  • Female
  • Fibromyalgia / complications
  • Fibromyalgia / drug therapy*
  • Fibromyalgia / psychology*
  • Humans
  • Male
  • Middle Aged
  • Milnacipran
  • Outcome Assessment, Health Care / methods*
  • Pain Measurement / methods*
  • Patient Satisfaction
  • Quality of Life / psychology
  • Serotonin Uptake Inhibitors / administration & dosage
  • Sleep Wake Disorders / drug therapy
  • Sleep Wake Disorders / etiology
  • Sleep Wake Disorders / physiopathology
  • Treatment Outcome

Substances

  • Cyclopropanes
  • Serotonin Uptake Inhibitors
  • Milnacipran