Background Tianma Gouteng Yin Formula (TGYF) is widely used to treat hypertension-related symptoms in clinical practice in East Asia. It has been shown to have a blood pressure lowering effect, reducing total cholesterol, improving clinical symptoms and quality of life, and preventing the occurrence of stroke in hypertensive patients. Understanding the effect of Tianma Gouteng Yin Formula on blood pressure, quality of life and cardiovascular risk factors could be valuable for the management of high blood pressure. Objectives To assess the efficacy and safety of Tianma Gouteng Yin Formula for treating primary hypertension compared to placebo or no treatment. S ear c h methods English databases including Cochrane Central (CCTR), MEDLINE, EMBASE, AMED, CINAHL, IPA, and the Hypertension Group Specialised Register were searched up to July 2011. Chinese databases including Chinese Biomedical Database, TCMonline, Chinese Dissertation Database, CMAC and the Index to Chinese Periodical Literature were searched up to April 2010. Selection criteria Randomised and quasi-randomised controlled trials that compared TGYF with no treatment or placebo for primary hypertension. Data collection and analysis No study was identified which met the inclusion criteria for this review. Main results No study was identified which met the inclusion criteria for this review. Authors' conclusions As no trials could be identified, no conclusions can be made about the role of TGYF in the treatment of primary hypertension. Well-designed randomized controlled studies need to be conducted and published.