Effect and safety of acupuncture for autism spectrum disorders A protocol for systematic review and meta-analysis

Background: Autism spectrum disorder (ASD) is a complex neurodevelopmental condition, which is characterized by impairment in social interaction or communication and lack of flexibility of imagination and behavior. Acupuncture is one of the most common modality of Traditional Chinese medicine (TCM) and has been used to treat various disease in clinical practice for more than 2000 years in China by correcting disharmony and dysregulation of body. It has sometimes been used as a treatment aimed at improving ASD symptoms and outcomes, but its clinical effectiveness and safety has not been rigorously reviewed. We will plan to conduct a systematic review and meta-analysis to summarize the current evidence on the effects and safety of acupuncture for ASD. Methods: The following databases will be searched: PubMed, the Cochrane Library, Embase, Wanfang Data, China National Knowledge Infrastructure, SinoMed, and VIP. Randomised controlled trials will be included to evaluate the effect and safety of acupuncture on patients with ASD. The primary outcome will be the core features of ASD. The risk of bias will be assessed by the Cochrane risk of bias tool. We will conduct a meta-analysis and sensitivity analysis, as well as a subgroup analysis if high heterogeneity is present, using Revman 5.3. We will use funnel plots to identify potential reporting biases. The Grading of Recommendations Assessment, Development and Evaluation will be used to evaluate the quality of evidence. Results: This study will be to assess the effect and safety of acupuncture for ASD. Conclusions: This study will assess the effect of acupuncture for ASD and provide reliable evidence for the choice of treatments. Ethics and dissemination: The protocol will not need ethical approval because no issues of participant privacy exist. The results of this systematic review will provide evidence about the effect and safety of acupuncture for ASD. The results will be disseminated through peer review.