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KMID : 1234920180180010001
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Journal of Korean Oriental Association for Study of Obesity
2018 Volume.18 No. 1 p.1 ~ p.9
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Analysis of Adverse Events in Weight Loss Program in Combination with ‘Gamitaeeumjowee-Tang’ and Low-Calorie Diet
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Yoon Na-Ra
Yoo Young-Jae
Kim Min-Ji
Kim Seo-Young
Lim Young-Woo
Lim Hyung-Ho
Park Young-Bae
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Abstract
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Objectives: The objective of this study was to assess the safety of 'Gamitaeeumjowee-tang' by analyzing adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet.
Methods: A retrospective review of adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet from the electronic medical chart (n=124) between June 2015 and December 2016 was conducted. Three Korean Medicine Doctors (KMDs) reviewed adverse events for two times, during week 2 to 4 and at week 10, after starting weight loss program. Adverse events were evaluated in terms of causality, severity and system-organ classes. Also, agreement among the three KMDs was made through further discussion in case of disagreement after independent review.
Results: The overall rate of adverse events was 37.1% during week 2 to 4 and 16.9% at week 10. For causality of adverse events using the World Health Organization-Uppsala Monitoring Centre causality categories, 52.2% were evaluated 'possible' at week 2-4 and 57.1% were evaluated 'unlikely' at week 10. All symptoms were evaluated as 'mild' by LDS scale. Nausea (15, 12.1%) was the most frequent adverse event at week 2-4 and dizziness (6, 4.8%) was the most common at week 10.
Conclusions: Adverse events decreased over time. There were no serious adverse events and none of the subjects were dropped due to adverse events. Continuous study is needed to prove the safety of 'Gamitaeeumjowee-tang' for treating obesity.
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KEYWORD
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Gamitaeeumjowee-tang, Adverse drug event, Safety, Weight loss program, Low-calorie diet
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