The Efficacy and Safety of Acupuncture for Tinnitus-Associated Insomnia: A Protocol for a Systematic Review and Meta-Analysis.

BACKGROUND: Tinnitus accounts for a significant proportion of the factors that cause insomnia, and insomnia, in turn, aggravates tinnitus. Given that tinnitus and insomnia have a bidirectional relationship, tinnitus-associated insomnia is prevalent. Nonetheless, current treatments including medication and psychological therapies for tinnitus-associated insomnia do not yield satisfactory efficacy, thereby making it challenging to manage. Although acupuncture is a potentially effective treatment option, the current evidence on the efficacy and safety of acupuncture for tinnitus-associated insomnia remains inconclusive. Therefore, this systematic review and analysis protocol aims to investigate whether acupuncture is beneficial for tinnitus-associated insomnia with an acceptable safety profile.

METHODS: Nine mainstream English-language and Chinese-language databases will be searched to include qualified RCTs and meta-analyses will be conducted by combining extracted data using RevMan 5.3. The risk of bias 2.0 tool recommended by Cochrane will be adopted to evaluate the methodological quality of the included RCTs. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach will be utilized to appraise the strength and certainty of evidence. Where available, we will also perform sensitivity analyses, publication bias and subgroup analysis.

DISCUSSION: Expected results from our systematic review and meta-analysis will verify the efficacy and safety of acupuncture in tinnitus-associated insomnia. The evidence generated by this review will help patients and clinicians make informed treatment decisions.