Efficacy and Safety of Melatonin on Pain Intensity and Sleep Quality in Adults with Neuropathic Pain: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
Abstract
Introduction: Neuropathic pain frequently coexists with sleep disturbance, and current pharmacotherapy is constrained by limited efficacy and adverse effects. Melatonin, a pleiotropic neurohormone with analgesic, antioxidant, anti-inflammatory and chronobiotic properties, has been proposed as an adjunctive treatment, but its magnitude of clinical benefit on pain and sleep across heterogeneous neuropathic-pain populations had not previously been quantitatively synthesised in a meta-analysis specific to neurology practice.
Methods: PubMed, Embase, Web of Science and the Cochrane Central Register of Controlled Trials were searched for randomised controlled trials of oral melatonin versus placebo or active control in adults with neuropathic pain, in accordance with PRISMA 2020. Two reviewers independently screened, extracted and assessed risk of bias using Cochrane RoB 2.0 with the crossover extension where applicable. The primary outcome was change in pain intensity (NRS or VAS); secondary outcomes were sleep quality (PSQI, ESS, sleep-interference NRS), responder rate (≥ 50 % pain reduction) and adverse events. Standardised mean differences (Hedges’ g) were pooled under a random-effects model with restricted maximum likelihood and Knapp–Hartung adjustment, with parallel raw mean differences on the NRS where instruments matched. Heterogeneity was quantified with I² and τ². Pre-specified subgroups examined etiology, dose and duration; sensitivity analyses used leave-one-out…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 491 participants or records.
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