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Abstract
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.
Abbreviations
ASRTs, Acupoint Stimulation-Related Therapies; TCM, Traditional Chinese Medicine; RCTs, Randomized Controlled Trials; GRADE, Grading of Recommendations, Assessment, Development and Evaluation; INPLASY, International Platform of Registered Systematic Review and Meta-analysis; GABA, Gamma-aminobutyric Acid; CBT-I, Cognitive Behavioral Therapy for Insomnia; MA, Manual Acupuncture; EA, Electro-acupuncture; PRISMA-P, Preferred Reporting Items for Systematic Review and Meta-analysis Protocols; PRISMA, Preferred Reporting Items for Systematic Review and Meta-Analysis; PICOS, Participants, Intervention, Comparison, Outcome, and Study Design; PSQI, Pittsburgh Sleep Quality Index; AIS, Athens Insomnia Scale; DSM, Diagnostic and Statistical Manual of Mental Disorders; ICSD, International Classification of Sleep Disorders; ICD, International Classification of Diseases; CCMD, Chinese Classification of Mental Disorders; WASO, Wake After Sleep Onset; ISI, Insomnia Severity Index; LSEQ, Leeds Sleep Evaluation Questionnaire; HRQoL, Health-related quality of life; SF-36, Short Form-36; AEs, Adverse events; TESS, Treatment Emergent Symptom Scale; SERS, Side Effects Rating Scale; CNKI, Chinese National Knowledge Infrastructure; MeSH, Medical Subject Headings, RevMan, Review Manager; RoB, Risk of bias; WMD, Weighted Mean Difference; SMD, Standard Mean Difference; Cis, Confidence Intervals; RR, Risk Ratio.
Author Contributions
All authors made a significant contribution to this work, whether in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all of these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors have no conflicts of interest related to this work.