A Systematic Review and Meta-Analysis Protocol to Establish How Common Clinical Acupoint Stimulation-Related Therapies Should Be Used for Managing Insomnia

Background: Many studies have now investigated the effects of common clinical acupoint stimulation-related therapies (ASRTs) following the meridian theory of traditional Chinese medicine for the management of insomnia. However, ASRT choice is currently based on personal clinical experience or patient preference. This study will review the common ASRTs reported in clinical trials and analyze their efficacy and safety for managing insomnia with or without co-morbidities. Methods: English and Chinese databases will be thoroughly searched, and other potentially eligible trials will be obtained by reviewing reference lists of identified studies and previous reviews. Only randomized controlled trials (RCTs) of common clinical ASRTs to manage insomnia published in peer-reviewed journals will be considered. Sleep quality questionnaires or indices will be considered as the main outcome, while the secondary outcomes will include sleep parameters, daytime dysfunction, quality of life, and adverse effects. Two reviewers will independently investigate eligible RCTs, extract information, analyze their methodological quality, and employ Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria to evaluate the strength of the evidence. The treatment impact of various ASRTs will be calculated using meta-analysis techniques, and the degree of study heterogeneity will be assessed using Cochrane's Q and I-squared statistics. Subgroup and sensitivity analyses will be used to evaluate the reliability of the results. Results: Our systematic review and meta-analysis will present up-to-date evidence on: 1) which common clinical ASRTs are beneficial for the management of insomnia; and 2) whether the effects of common clinical ASRTs on insomnia vary depending on clinical, participant, and treatment characteristics. Conclusion: The results of our review should help decision-makers make educated choices regarding evidence-based non-pharmacological management options for insomnia. Study Registration: The International Platform of Registered Systematic Review and Meta-analysis (INPLASY), record INPLASY2021120137.