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가미 태음조위탕과 저열량 식이를 병행한 체중 감량 프로그램에서 발생한 이상 반응 분석
Analysis of Adverse Events in Weight Loss Program in Combination with ‘Gamitaeeumjowee-Tang’ and Low-Calorie Diet
J Korean Med Obes Res 2018;18:1-9
Published online June 30, 2018;  https://doi.org/10.15429/jkomor.2018.18.1.1
Copyright © 2018 The Society of Korean Medicine for Obesity Research.

윤나라, 유영재, 김민지, 김서영, 임영우, 임형호1, 박영배2
Na-Ra Yoon, Young-Jae Yoo, Min-ji Kim, Seo-Young Kim, Young-Woo Lim, Hyung Ho Lim1, Young-Bae Park2

누베베 한의원, 1가천대학교 한의과대학, 2누베베 미병 의학 연구소

Nubebe Korean Medical Clinic, 1College of Korean Medicine, Gachon University, 2Nubebe Mybou Research Institute
Young-Bae Park
Nubebe Mybou Research Institute, Top Building 2F, 10 Seongnam-daero 926beon-gil, Bundang-gu, Seongnam 13506, Korea
Tel: +82-31-745-6400
Fax: +82-31-736-2252
E-mail: bmppark@khu.ac.kr
Received April 7, 2018; Revised May 18, 2018; Accepted May 31, 2018.
cc This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
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.
Keywords : Gamitaeeumjowee-tang, Adverse drug event, Safety, Weight loss program, Low-calorie diet


June 2018, 18 (1)
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