Abstract
Our study aimed to investigate the effectiveness and safety of botulinum toxin type A in patients with restless legs syndrome. We searched electronic databases, including PubMed, Cochrane Library, and Web of Science, up to 12 June 2021, for published articles. We enrolled randomized controlled clinical trials and non-randomized controlled studies involving patients with restless legs syndrome who were treated with botulinum toxin. Quality assessment was performed using the Cochrane risk of bias tool and Joanna Briggs Institute Critical Appraisal Checklist for Quasi-Experimental Studies. As for the results, we included four articles comprising 62 participants, two studies were randomized controlled trials. Improvement in International Restless Legs Syndrome Study Group (IRLSSG) rating scale was observed in three studies. Adverse events were temporary and self-limited. Meta-analyses were performed, including the two randomized controlled trials with 27 participants. Compared with placebo, botulinum toxin injection significantly reduced scores of IRLSSG rating scale (SMD, −0.819, 95% confidence interval [CI], −1.377 to −0.262). A total of 11.8% (95% CI, 0.7–72.4%) of patients reported at least one adverse event. In conclusion, botulinum toxin injection may relieve restless legs syndrome related symptoms. However, decisive conclusions cannot be drawn because of the small number of patients included in our meta-analysis. Large-scale, randomized controlled trials are warranted to discover the optimal dose, safety, and long-term effect of intervention with botulinum toxin type A for patients with restless legs syndrome.
Highlights
Restless legs syndrome (RLS) is a sleep-related movement disorder characterized by an unpleasant urge to move the lower limbs
Inclusion criteria were studies with patients with RLS treated with botulinum toxin type A, and the follow-up time should be at least 4 weeks after injection
Botulinum toxin injection significantly reduced IRLSSG rating scale (IRLS) score at four weeks after injection (SMD, −0.819, 95% CI, −1.377 to −0.262, I2 = 0.0%, Figure 3)
Summary
Restless legs syndrome (RLS) is a sleep-related movement disorder characterized by an unpleasant urge to move the lower limbs. Criteria for the diagnosis of RLS include the International Restless Legs Syndrome Study Group (IRLSSG) and International Classification of Sleep Disorders, Third Edition (ICSD-3) [2,3]. The ICSD-3 criteria require distress and associated sleep disturbance, which is different from the IRLSSG consensus [2]. As for the measurement of disease severity for RLS, the IRLSSG rating scale (IRLS) was proposed. It assesses a range of RLS related symptoms and their impact on patients’ mood and daily life, and it has been proved reliable, valid, and responsive in clinical trials [4]
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