Lih-Hwa Lin^{1, 2}, Jen-Huai Chiang^{1, 3}, Pei- Chi Chou¹, Po-Chi Liao⁴, San-Yuan Wu¹, Kao-Sung Tsai^{1, 5}, Huey-Yi Chen^{1, 3}, Yung-Hsiang Chen^{1, 6,}, Wen-Chi Chen^{1, 3,}

Safflower (Flos carthami; FC) has been used widely as a food additive, as a coloring and flavoring agent. It has also been used as a Chinese herbal medicine for improving blood flow and resolving thrombosis. This study investigated whether the risk of bleeding complications is increased among FC users. We conducted a retrospective study involving a test group that used FC and a control (non-FC users) group. The participants were aged 18 years and above, and were recruited from the 2000 – 2006. The participants were from beneficiaries of LHID2000. The FC cohort included participants who had been prescribed FC accumulated for more than 30 days, whereas the non-FC cohort included people who were not using FC prescriptions. The compared cohort individuals were randomly selected at a ratio of 1:4 and frequency matched by age, gender, and index year from FC user cohort group. The primary outcome was a new diagnosis of bleeding disorders including gastrointestinal (GI) bleeding (ICD-9-CM: 578.0, 578.1, 578.9), intracranial hemorrhage (ICD-9-CM: 432.0, 432.9), and blood transfusions (ICD-9-CM op-code: 99.0). The results showed that the proportions of participants with bleeding disorders were 2.6% and 2.3% in the FC and non-FC cohorts, respectively (P = 0.6675). In univariate and multivariate Cox’s proportional hazard regression models, the adjusted hazard ratio for bleeding disorders was 0.86 for the FC cohort relative to the non-FC cohort (P = 0.6094). In conclusion, the risk of bleeding complications was not increased among Chinese herbal medicine FC users.

bleeding disorder, chinese herbal medicine, safflower (Flos carthami), national health insurance database, population-based cohort study