Introduction: People use shiatsu for health maintenance and help with illness. Shiatsu is often considered safe, but there has been no published systematic review of its possible risks. The review aims to assess the evidence of safety and risk of harm for shiatsu.
Methods: All types of studies, independent of control and with any style of shiatsu are eligible. Reports in any language will be included. Peer-reviewed studies and non-peer-reviewed literature will be handled in separate parts of the review. Electronic databases (including among others MEDLINE, AMED, Alt HealthWatch, Web of Science, CiNii) will be searched for identification of peer-reviewed publications. Hand-search will be used for non-peer-reviewed literature. Risk of bias will be assessed using RoB 2.0 in conjunction with McHarm (randomised trials), ROBINS:I in conjunction with McHarm (non-randomised studies), a modified PHARMA checklist (adverse reports). When appropriate, reporting bias will be assessed using ORBIT. The relevance of the described intervention to shiatsu will be based on clinical experience, using CARE for massage and bodywork and TIDieR. Root cause analysis of adverse events will consider Bradford Hill's criteria in the light of clinical experience.
Results: Meta-analysis is not planned. Results for each study will be presented in tables. Relationships within and between studies will be explored. A theory about the safety profile of shiatsu will be developed. Identified incidents will be presented in a narrative way and tabular categories.
Discussion: The discussion will highlight the relevance to various stakeholders and will explore issues that occurred from the review.