Treatment of fibromyalgia syndrome with gabapentin and pregabalin – A meta-analysis of randomized controlled trials

Häuser, Winfried; Bernardy, Kathrin; Üçeyler, Nurcan; Sommer, Claudia

doi:10.1016/j.pain.2009.05.014

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Volume 145, Issue 1 , Pages 69-81, September 2009

Treatment of fibromyalgia syndrome with gabapentin and pregabalin – A meta-analysis of randomized controlled trials

Winfried Häuser
- Department of Internal Medicine I, Klinikum Saarbrücken gGmbH, Winterberg 1, D-66119 Saarbrücken, Germany
- Department of Psychosomatic Medicine, Technische Universität München, Langerstr. 3, D-81675 München, Germany
- Corresponding author. Address: Department of Psychosomatic Medicine, Technische Universität München, Langerstr. 3, D-81675 München, Germany. Tel.: +49 681 9632020; fax: +49 681 9632022.
Kathrin Bernardy
- Department of Psychosomatic Medicine, MediClin Bliestal Clinics, D-66440 Blieskastel, Germany
- Department of Anaesthesiology, Intensive Care and Pain Therapy, Saarland University Hospital, D-66421 Hamburg/Saar, Germany
Nurcan Üçeyler
- Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany
Claudia Sommer
- Department of Neurology, University of Würzburg, Josef-Schneider-Str. 11, D-97080 Würzburg, Germany

Received 21 November 2008; received in revised form 15 April 2009; accepted 12 May 2009. published online 18 June 2009.

Abstract

The efficacy of gabapentin (GPT) and pregabalin (PGB) in the treatment of fibromyalgia syndrome (FMS) was assessed. We screened MEDLINE, PsycINFO, SCOPUS, www.clinicaltrials.org, the Cochrane Library (through October 2008), and the reference sections of original studies on GPT/PGB in FMS. Randomized controlled trials (RCTs) on the treatment of FMS with GPT and PGB were analyzed. Six out of 127 RCTs studying 2422 subjects on treatment with GPT (one study) or PGB (five studies) and 1056 subjects on placebo with a median treatment duration of 11weeks were included into the systematic review. Five studies were suitable for meta-analysis. Effects were summarized using standardized mean differences (SMD). There was strong evidence for a reduction of pain (SMD -0.28, 95% CI −0.36, −0.20; p<0.001), improved sleep (SMD −0.39, 95% CI −0.48, −0.39; p<0.001), and improved health-related quality of life (HRQOL) (SMD −0.30, 95% CI −0.46, −0.15; p<0.001), but not for depressed mood (SMD −0.12, 95% CI −0.30, 0.06; p=0.18). There was strong evidence for a non-substantial reduction of fatigue (SMD −0.16, 95% CI −0.23, −0.09, p<0.001) and of anxiety (SMD −0.18, 95% CI −0.27, −0.10; p<0.001). The external validity of the studies was limited because patients with severe somatic and mental disorders were excluded.