Efficacy and Safety of Acupuncture for Post-COVID-19 Insomnia: Protocol for a Systematic Review and Meta-Analysis

Background: The COVID-19 pandemic has had a profound global impact, leading to a range of persistent sequelae referred to as post-COVID-19 condition or"long COVID" that continueto affect patients worldwide. Among these sequelae, post-COVID-19 insomnia (PCI) has emerged as a significant issue. Conventional treatments, including cognitive behavioral therapy and pharmacological interventions, face limitations such as variable efficacy, potential side effects, and substantial costs. Recently, acupuncture has gained traction due to its efficacy, cost-effectiveness, and safety profile. Objective: This study aims to conduct a meta-analysis and systematic review evaluating the efficacy and safety of acupuncture for the treatment of PCI to delineate the optimal modality, intervention frequency, and duration for achieving the most beneficial outcomes, thereby providing a comprehensive understanding of acupuncture's role in managing PCI, contributing to evidence-based clinical practice, and informing clinical decision-making. Methods: Electronic searches will be performed in 12 databases from inception to October 2024 without language restrictions. This includes both English databases (PubMed, Cochrane Library, Web of Science, Embase, OVID and Scopus), as well as Chinese databases (China National Knowledge Infrastructure, Wan-Fang Data, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, DuxiuDatabase and the ChineseClinical Trial Registry Center). Randomized controlled trials on acupuncturefor PCI will be included. Primary outcomes will includethe response rateand insomnia severity; secondary outcomes will include the Traditional Chinese Medicine Symptom Scale (TCMSS) and adverse event rates. Data synthesis will use risk ratios for dichotomous data and mean differences for continuous data. Study selection, data extraction, and quality assessment will be conducted independently by 2 reviewers. Methodological quality of eligible studieswill be evaluated following the Cochrane Handbook for Systematic Reviews of Interventions (version 6.3). Meta-analysiswill be performed with RevMan 5.3. Results: Based on the data on response rate, insomnia severity, TCMSS score, and adverse event rates, this study will provide an evidence-based review of the efficacy and safety of acupuncture for PCI treatment. Conclusions:This systematic review will present the current evidence for acupuncture for PCI, aiming to inform clinical practices and decision-making and to enhancethe understanding of acupuncture's role in managing PCI. Furthermore, it will identify research gaps and suggest potential areas for future investigation. Trial Registration: PROSPERO CRD42024499284; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=499284 International Registered Report Identifier (IRRID): DERR1-10.2196/69417