In 2015, a review of shiatsu commissioned by NHMRC found no clear evidence demonstrating its efficacy in treating any clinical condition (1). The 2015 Overview was underpinned by an overview of systematic reviews (SRs) that focused solely on shiatsu and were published in the English language between 2008 and June 2014. Randomised controlled trials (RCTs) that were reported within included SRs and assessed shiatsu delivered to treat any clinical condition were eligible for inclusion; however, no evidence was found (4, 5). SRs that assessed acupressure as a sole intervention were not eligible for inclusion. The 2015 Overview informed the 2015 Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies, which resulted in shiatsu and 15 other natural therapies being excluded from private health insurance rebatesa . In this 2020 review, the evidence evaluation will build upon the 2015 Overview but will not be limited by publication date and a broader range of study types will be eligible for inclusion (inclusive of nonrandomised studies of interventions [NRSIs]). The updated review will also include studies that assess shiatsu for primary prevention. Evidence from eligible primary studies of shiatsu will be supplemented with evidence identified from an Overview of Reviews (a systematic review of systematic reviews) of acupressure, a core component of shiatsu. Similar to the 2015 review, eligible comparisons will be shiatsu versus control (but further delineated to shiatsu versus placebo and shiatsu versus no intervention) and shiatsu versus other interventions. Studies not published in the English language will not be translated, and databases in languages other than English will not be searched. The process for conducting the review is built upon the following framework: source the clinical evidence by performing a systematic literature search of the literature, identify eligible studies published in English and indexed in English language databases, incorporate additional literature identified through non-database sources received from the Department’s public call for evidence, NTREAP and NTWC, critically appraise and present the evidence, and determine the certainty in the evidence base for each question, using a structured assessment of the body of evidence in accordance with GRADE methodology (6). a https://www.health.gov.au/resources/publications/private-health-insurance-reforms-changing-coverage-for-somenatural-therapies Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 8 1.1 Description of condition and setting Shiatsu therapy has been practiced in Australia since the early 1970s and is used by people of all ages for a wide of range of reasons (7). A 2016 workforce survey of 121 shiatsu therapists working in Australia found the most common reasons for providing shiatsu therapy were to alleviate or treat a broad range of clinical and preclinical conditions including stress, mental health, pain, musculoskeletal problems, as well as rehabilitation and management of chronic health conditions including cancer care and disability care (7). Other conditions that practitioners report benefit from shiatsu therapy include headaches, migraine, sciatica, respiratory illnesses, fatigue, menstrual problems, circulatory problems, and rheumatic and arthritic complaints (8). The current review is not limited to any particular condition or setting (see 3.1.2 Types of participants) and therefore a concise description of each condition or problem, and the relevant setting, will be provided after conduct of the full text review. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 9 1.2 Description of intervention Shiatsu Shiatsu therapy is a complex, whole-system intervention that is based on the philosophy and theory of traditional Chinese (oriental) medicine (9). Shiatsu was popularised in the West following the legislation in Japan of “Anma-Shiatsu-Massage” in the mid-20th Century. The word ‘shiatsu’ originates from the Japanese word meaning ‘finger pressure’, through which the therapist applies pressure to the acupuncture (tsubo) points on the body. Practitioner or self-administered acupressure is believed to assist with alleviating a variety of symptoms associated with health conditions (10). In Australia, shiatsu therapists work in a range of settings: solo or group shiatsu clinics, multidisciplinary health clinics, at their home or in a mobile practice that allows for home or office visits (7). Shiatsu treatment is traditionally performed on a futon on the floor with the recipient fully clothed or covered by a sheet in a sitting or lying position (11). Shiatsu therapists working in Australia may have differing qualifications (including some that also receive training in acupuncture and other oriental therapies) and be registered as a shiatsu therapist and/or oriental massage therapist with one or more of the Australian natural therapy associations (7). The Shiatsu Therapy Association of Australia (STAA), a national peak body representing shiatsu