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Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials
  1. Igho J Onakpoya1,
  2. Elizabeth T Thomas2,
  3. Joseph J Lee1,
  4. Ben Goldacre1,
  5. Carl J Heneghan1
  1. 1 Nuffield Department of Primary Care Health Sciences, Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK
  2. 2 Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia
  1. Correspondence to Dr Igho J Onakpoya; igho.onakpoya{at}


Objective To assess the benefits and harms of pregabalin in the management of neuropathic pain.

Design Rapid review and meta-analysis of phase III, randomised, placebo-controlled trials.

Participants Adults aged 18 years and above with neuropathic pain defined according to the International Association for the Study of Pain criteria.

Interventions Pregabalin or placebo.

Primary and secondary outcome measures Our primary outcomes were pain (as measured using validated scales) and adverse events. Our secondary outcomes were sleep disturbance, quality of life, Patient Global Impression of Change, Clinician Global Impression scale, anxiety and depression scores, overall discontinuations and discontinuations because of adverse events.

Results We included 28 trials comprising 6087 participants. The neuropathic pain conditions studied were diabetic peripheral neuropathy, postherpetic neuralgia, herpes zoster, sciatica (radicular pain), poststroke pain and spinal cord injury-related pain. Patients who took pregabalin reported significant reductions in pain (numerical rating scale (NRS)) compared with placebo (standardised mean difference (SMD) −0.49 (95% CI −0.66 to −0.32, p<0.00001), very low quality evidence). Pregabalin significantly reduced sleep interference scores (NRS) compared with placebo (SMD −0.38 (95% CI −0.50 to −0.26, p<0.00001), moderate quality evidence. Pregabalin significantly increased the risk of adverse events compared with placebo (RR 1.33 (95% CI 1.23 to 1.44, p<0.00001, low quality evidence)). The risks of experiencing weight gain, somnolence, dizziness, peripheral oedema, fatigue, visual disturbances, ataxia, non-peripheral oedema, vertigo and euphoria were significantly increased with pregabalin. Pregabalin was significantly more likely than placebo to lead to discontinuation of the drug because of adverse events (RR 1.91 (95% CI 1.54 to 2.37, p<0.00001), low quality evidence).

Conclusion Pregabalin has beneficial effects on some symptoms of neuropathic pain. However, its use significantly increases the risk of a number of adverse events and discontinuation due to adverse events. The quality of the evidence from journal publications is low.

  • Pregabalin
  • benefits
  • harms
  • systematic review
  • meta-analysis

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  • Patient consent for publication Not required.

  • Contributors IJO was involved with devising the review methods, conducting electronic searches, screening of abstracts, data extraction, data analysis and interpretation and codrafting of the review. ETT was involved with devising the review methods, screening of abstracts, data extraction, data analysis and interpretation and codrafting of the review. JJL was involved with data extraction, data analysis and interpretation and codrafting of the review. BG and CJH were involved with devising the review methods, data analysis and interpretation and codrafting of the review.

  • Funding IJO, BG and CJH are part of the Evidence Synthesis Working Group. The Evidence Synthesis Working Group is funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR) (ProjectNumber 390). JJL is supported by an NIHR In Practice Fellowship.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR, the NHS or the Department of Health.

  • Competing interests CJH has received expenses and fees for his media work. He has received expenses from the WHO and FDA and holds grant funding from the NIHR, the NIHR School of Primary Care Research, The Wellcome Trust and the WHO. He has received financial remuneration from an asbestos case. He has also received income from the publication of a series of toolkit books published by Blackwell’s. On occasion, he receives expenses for teaching EBM and is also paid for his general practitioner work in National Health Service out of hours. CEBM jointly runs the EvidenceLive Conference with the BMJ and the Overdiagnosis Conference with some international partners that are based on a non-profit making model. BG receives funding from the Laura and John Arnold Foundation and reports personal fees from intermittent additional personal income from speaking and writing for lay audiences on problems in science and medicine including regulatory shortcomings.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data available.