2013 Volume 54 Issue 4 Pages 282-289
Collecting adverse case reports suspected to be due to health foods and evaluation of the causality are important to secure safety, even if the causal relationship between health foods and reported health problem is uncertain. Case reports are mainly collected at three sites: public health centers, practical living information online network system(PIO-NET), and individual companies. The case reports from the three sources are not dealt with consistently. In this study, we investigated and characterized those case reports from the viewpoint of evaluating causality, using the causality association rating methods, namely, the dendritic and pointed methods, which we reported previously. Information in public health centers comprised 20 reports per year; approximately 40% were from health care providers and contained detailed medical data. PIO-NET information comprised 366 reports per year; 80% were self-reports from users, and few medical details were included. Company information covered 1,323 cases from 13 companies; more than 90% were from users and most of them were complaints. Case reports from public health centers and PIO-NET showed that the largerst number of victims were female aged >60, with allergy and gastrointestinal symptoms. When these case reports from the letter two sources were examined using the causality association rating systems, most were rated as “possible” and only a few were rated as “probable”. As specific case reports from different information sources were examined in this study, we were able to identify several points that should be improved in our two rating methods. However, to ensure the safety of health foods, it will be necessary to collect a large number of high-quality case reports for evaluation by a suitable causality rating method, and to integrate those evaluated case reports into a single site.
