Introduction: The purpose of this study is to evaluate the efficacy and safety of complementary and alternative medicine in the treatment of autism spectrum disorder.
Methods and analysis: We will electronically search Pubmed, Medline, Embase, Web of Science, the Cochrane Central Register of Controlled Trial, China National Knowledge Infrastructure, China Biomedical Literature Database, China Science Journal Database, and Wan-fang Database from their inception. Also, we will manually retrieve other resources, including reference lists of identified publications, conference articles, and gray literature. The clinical randomized controlled trials or quasi-randomized controlled trials related to complementary and alternative medicine treating autism spectrum disorder will be included in the study. The language is limited to Chinese and English. Research selection, data extraction, and research quality assessment will be independently completed by 2 researchers. Data were synthesized by using a fixed-effect model or random-effect model depend on the heterogeneity test. The Childhood Autism Rating Scale (CARS) and Autism Behavior Checklist (ABC) scores will be the primary outcomes. The scores of the Autism Treatment Evaluation Checklist and the Ritvo-Freeman Real Life Rating Scale will also be assessed as secondary outcomes. RevMan V.5.3 statistical software will be used for meta-analysis, and the level of evidence will be assessed by Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Continuous data will be expressed in the form of weighted mean difference or standardized mean difference with 95% confidence intervals (CIs), whereas dichotomous data will be expressed in the form of relative risk with 95% CIs.
Ethics and dissemination: The protocol of this systematic review does not require ethical approval because it does not involve humans. We will publish this article in peer-reviewed journals and presented at relevant conferences.
Systematic review registration: OSF Registries, DOI: 10.17605/OSF.IO/ HA97R (https://osf.io/ha97r).