Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2019 Jan 21;9(1):e023600.
doi: 10.1136/bmjopen-2018-023600.

Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials

Igho J Onakpoya  1 , Elizabeth T Thomas  2 , Joseph J Lee  1 , Ben Goldacre  1 , Carl J Heneghan  1
Affiliations
Review

Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials

Igho J Onakpoya et al. BMJ Open. .

Abstract

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.

Keywords: Pregabalin; benefits; harms; meta-analysis; systematic review.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Flow chart showing the process for inclusion of RCTs assessing the effects of pregabalin in the management of neuropathic pain. RCTs, randomised clinical trials.
Figure 2
Figure 2
Graphical representation of the risk of bias in RCTs assessing the effects of pregabalin in the management of neuropathic pain.
Figure 3
Figure 3
Risk of bias summary for RCTs assessing the effects of pregabalin in the management of neuropathic pain.
Figure 4
Figure 4
Effect of pregabalin on pain scores in patients with neuropathic pain.
Figure 5
Figure 5
Effect of pregabalin on the risk of adverse events in patients with neuropathic pain.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Verma V, Singh N, Singh Jaggi A. Pregabalin in neuropathic pain: evidences and possible mechanisms. Curr Neuropharmacol 2014;12:44–56. 10.2174/1570159X1201140117162802 - DOI - PMC - PubMed
    1. Taylor CP, Angelotti T, Fauman E. Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta (alpha2-delta) subunit as a target for antiepileptic drug discovery. Epilepsy Res 2007;73:137–50. 10.1016/j.eplepsyres.2006.09.008 - DOI - PubMed
    1. Goodman CW, Brett AS. Gabapentin and Pregabalin for pain - is increased prescribing a cause for concern? N Engl J Med 2017;377:411–4. 10.1056/NEJMp1704633 - DOI - PubMed
    1. Spence D. Bad medicine: gabapentin and pregabalin. BMJ 2013;347:f6747 10.1136/bmj.f6747 - DOI - PubMed
    1. OpenPrescribing.net. High-level prescribing trends for Pregabalin (BNF code 0408010AE) across all GP practices in NHS England. 2010. https://openprescribing.net/chemical/0408010AE/ (accessed 8th Mar 2018).