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Analysis of Adverse Events in Weight Loss Program in Combination with ‘Gamitaeeumjowee-Tang’ and Low-Calorie Diet

  • Journal of Korean Medicine for Obesity Research
  • Abbr : J Korean Med Obes Res
  • 2018, 18(1), pp.1-9
  • DOI : 10.15429/jkomor.2018.18.1.1
  • Publisher : The Society of Korean Medicine for Obesity Research
  • Research Area : Medicine and Pharmacy > Korean Medicine
  • Published : June 30, 2018

윤나라 1 Yeong-Jae Yoo 1 Min-Ji Kim 1 Seo-Young Kim 1 Young-Woo Lim 1 Lim Hyung Ho 2 Young-Bae Park 3

1누베베 한의원
2가천대학교
3누베베 미병 의학 연구소

Accredited

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.

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