Systematic review of the comparative effectiveness of antiepileptic drugs for fibromyalgia

J Pain. 2011 Apr;12(4):407-15. doi: 10.1016/j.jpain.2010.09.007. Epub 2010 Dec 13.


Fibromyalgia is a difficult-to-treat chronic pain syndrome that affects 2% of the US population. Pregabalin is an antiepileptic recently FDA approved for fibromyalgia treatment. Other antiepileptics have been suggested for treatment. This systematic review examines the relative benefits and harms of antiepileptic drugs in the treatment of fibromyalgia. A literature search was conducted and 8 studies matched criteria (7 studies of pregabalin, 1 of gabapentin). Both drugs reduced mean pain scores more than placebo at a modest rate (pregabalin, 38% to 50%; gabapentin, 51%). In a 6-month trial of pregabalin responders, 32% continued to have response at 6 months, with a mean time to loss of response of 34 days. Compared to placebo, the drugs had similarly high rates of adverse events and withdrawals. Without a head-to-head trial it is not possible to conclude if 1 antiepileptic is more effective or harmful than the other, although limited evidence suggests potential differences. Future studies must directly compare the drugs, include a more broadly defined population, examine long term benefits and harms, and include cointerventions. We conclude that pregabalin and gabapentin are modestly effective for the treatment of fibromyalgia but that their long-term safety and efficacy remain unknown.

Perspective: This systematic review evaluates the benefits and harms of using the antiepileptic drugs gabapentin and pregabalin for the treatment of fibromyalgia. Conclusions from this paper can help clinicians to more effectively treat the pain associated with fibromyalgia.

Publication types

  • Comparative Study
  • Review
  • Systematic Review

MeSH terms

  • Amines / therapeutic use*
  • Anticonvulsants / therapeutic use*
  • Clinical Trials as Topic
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Fibromyalgia / drug therapy*
  • Gabapentin
  • Humans
  • Pregabalin
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / therapeutic use


  • Amines
  • Anticonvulsants
  • Cyclohexanecarboxylic Acids
  • Pregabalin
  • gamma-Aminobutyric Acid
  • Gabapentin