Treatment of fibromyalgia syndrome with gabapentin and pregabalin – A meta-analysis of randomized controlled trials
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 11 weeks 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.
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RPT improves behavioural and physiological reactions, so its effects might indirectly affect cognitive reactions such as pain catastrophising.
“RPT improves behavioural and physiological reactions [59], thus their effects might indirectly affect cognitive reactions (that is, PC).”
From Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: A randomised controlled trial (2011) · cites this paper as [59]
Patients with severe somatic comorbidities including inflammatory rheumatic disorders were excluded by all trials.
“Patients with severe somatic comorbidities including inflammatory rheumatic disorders were excluded by all trials.”
From Comparative Efficacy and Harms of Duloxetine, Milnacipran, and Pregabalin in Fibromyalgia Syndrome (2010) · cites this paper as [32]
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- Authors
- Häuser, W., Bernardy, K., Üçeyler, N., & Sommer, C.
- Affiliations
- Klinikum Saarbrücken (DE)
- Saarland University (DE)
- University of Würzburg (DE)
- Corresponding author
- Häuser, Winfried
- Venue
- Pain
- Published
- 2009-09
- Volume
- 145
- Issue
- 1
- Pages
- 69-81
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W2023541450
- Cited by
- 243
- References
- 43
- Citations by year
- 2026: 8 · 2025: 6 · 2024: 4 · 2023: 5 · 2022: 8 · 2021: 13 · 2020: 9 · 2019: 7 · 2018: 10 · 2017: 13 · 2016: 16 · 2015: 14 · 2014: 15 · 2013: 23 · 2012: 24
- FWCI
- 3.87
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- fibromyalgia, gabapentin, pregabalin, analgesia, sleep quality, health-related quality of life, fatigue, anxiety, depressive mood, antiepileptic drugs
- MeSH terms
- Pregabalin, Gabapentin, Amines, Analgesics, Calcium Channel Blockers, Cyclohexanecarboxylic Acids, Fibromyalgia, gamma-Aminobutyric Acid, Humans, Reproducibility of Results, Randomized Controlled Trials as Topic, Databases, Bibliographic
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