We reexamined previous literature on Kampo-induced liver injury in Japan. These diagnoses were reviewed, independently of results on lymphocyte transformation test, by examining time to onset, course after cessation of the suspect Kampo medicine, concomitant drugs, search for non drug causes, and response to readministration. Among a total of 58 cases in the literature, 8 cases were assessed as insufficiently documented, and 4 cases were assessed as probably unrelated. Authors of the literature described that the 4 cases(probably unrelated in this study) were diagnosed with Kampo-induced liver injury based on positivity on lymphocyte transformation test. Since several experimental studies reported the mitogenic activity of Kampo medicine, lymphocyte transformation test is unsuitable as a diagnostic method of Kampo-induced liver injury. To examine the correct incidence and clinical features of Kampo-induced liver injury, reports on Kampo-induced liver injury that have been diagnosed accurately should be accumulated further.
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