ABSTRACT
<b>Objective: </b>This study aimed to confirm whether the methods for assessing the reported causal relationship between dietary supplement intake and adverse events are reliable in the clinical setting.<br><b>Design: </b>The relationships between supplement intake and adverse events were assessed using two algorithms proposed in our previous report, and causal relationships were evaluated.<br><b>Methods: </b>Twelve raters with a high probability of handling adverse event information examined 200 records of dialogues with supplement users. Each rater independently assessed the causal relationship using the two algorithms. The relationships between supplement intake and adverse events were assessed for all 200 cases. Variability in the evaluation among raters was analyzed for each occupation and the whole group of raters. The distributions of evaluation were analyzed, and inter-rater reliability was evaluated using the intraclass correlation coefficient (ICC) and Fleiss’ kappa coefficient.<br><b>Results: </b>All events of 200 cases seemed to be slight and within the range of variation in daily life. Almost all cases were classified into two categories as “Possible” and “Lack of Information” by each rater. The ICC values for all raters, pharmacists, dieticians, and health care workers were 0.644, 0.573, 0.678, and 0.694, respectively, and the kappa coefficients using the two algorithms were 0.466, 0.426, 0.468, and 0.519 and 0.481, 0.478, 0.465, and 0.517, respectively. There were moderate levels of agreement based on the kappa coefficients and ICC values.<br><b>Conclusion: </b>The two algorithms proposed in our previous report may be reliable in the clinical setting. Their reliability could be enhanced by establishing a unified method of accumulation and recording adverse events for supplement intake, which should be evaluated by more raters using more cases of adverse events.
ABSTRACT
Recently, the number of cancer patients using complementary and alternative medicine (CAM) hasu been increasing world wide. Many hospitals in China have been using integrated traditional Chinese and western medicine (ITCWM, the use of both western and traditional Chinese medicine (TCM) together) for treatment or prevention of cancer, and considerable progress has been made. The present study investigated and systematically reviewed previous randomized controlled trials (RCTs) conducted to verify the effects of ITCWM on cancer in China, from a database of Chinese literature. Papers published in Chinese scientific journals were searched using the database provided by the National Science and Technology Library (NSTL, http://www.nstl.gov.cn), China. On the basis of a limited search strategy, 14 reports of RCTs were identified and reviewed. Almost all of these RCTs reported better results with the use of ITCWM than with western medicine alone. In order to promote evidence-based complementary and alternative medicine (EBCAM) in Japan, it will be necessary to collect and evaluate the scientific content of many clinical studies of CAM performed in China and other countries to establish a database. In the future, there will be a need to develop and establish methods such as meta-analysis for scientific evaluation of CAM.<br>