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ABSTRACT
Introduction
Peripheral neuropathic pain is a highly disabling condition for patients and a challenge for neurologists and pain physicians. Although many drugs have been assessed in scientific studies, few have demonstrated a clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raised the question on the benefit-risk ratio when used in patients experiencing peripheral neuropathies.
Areas covered
The authors conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat neuropathic pain. This first review was focused on antidepressant and antiepileptic medications. The aim was to provide an overview of the treatment-emergent adverse events (≥10%) and the serious adverse effects described in clinical trials.
Expert opinion
Among antiepileptics and antidepressants, duloxetine appeared to have the most detailed safety for the treatment of peripheral neuropathic pain. Over all studies, the most commonly reported adverse effects were dizziness, drowsiness, nausea, and constipation. Only 20.0% of the included studies (N = 90) presented a good description of adverse effects that included a statistical comparison versusa placebo group. Important methodological improvements must be made to improve the assessment of medication safety in future clinical trials.
Article highlights
Review of double-blind, placebo-controlled, randomized clinical trials
Specific focus on adverse effects of antidepressant and antiepileptic medications used to treat peripheral neuropathic pain
Duloxetine presents the most detailed safety for the treatment of peripheral neuropathic pain
Adverse drug reactions are under-reported in most of the clinical trials
A detailed safety assessment of antidepressant and antiepileptic medications should be mandatory for clinical trials on peripheral neuropathic pain
This box summarizes key points contained in the article.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.