AbstractObjectivesThe purpose of this study is to report weight changes and analyze adverse events in diabetic patients with Gamitaeeumjowee-Tang for weight loss.
MethodsA retrospective chart review of weight change and adverse events was performed during the 10-week weight loss program using Gamitaeeumjowee-tang with low-calorie diets for diabetics(n=61). Weight and BMI changes were compared before and after the program and calculated the percentage of people who lost more than 5% of their weight, also identified whether subjects felt satiated or not. Adverse events were evaluated in terms of causality, severity and system-organ classes.
ResultsAfter 10-week weight loss program, significant weight loss (5.9±2.32kg, 7.73% reduction from baseline) and BMI reduction (2.9±0.86) were reported (n=61). Those who lost more than 5 percent of their body weight accounted for 88.5%, and also 88.5% of the participants felt full to help control their appetite. In assessing the causality of adverse events, ‘Unlikely’ was the most common (66%) and in severity evaluations, almost all symptoms were mild. Insomnia was the most frequently reported during the first 8 weeks, and constipation was reported the most afterwards.
ConclusionsA combination of Gamitaeeumjowee-tang and low-calorie diets for 10 weeks appears to help weight reduction without serious adverse events in diabetic patients. Future well-designed prospective clinical studies testing the effectiveness and safety of this weight loss program are warranted.
참고문헌1. Korean Diabetes Association. Treatment Guideline for Diabetes. (2018). 13, 17.
2. Jang, HC, & Choi, SH. Characterization of Patients with Type 2 Diabetes according to Body Mass Index: Korea National Health and Nutrition Examination Survey from 2007 to 2011. Endocrinol Metab, (2015). 30, 514-21.
![]() 3. Korean Obesity Association. Treatment Guideline for Obesity. (2018). p. 17-18.
4. Korean Diabetes Association. Diabetes Fact Sheet. (2018.
5. Torgerson, JS, Hauptman, J, Boldrin, MN, & Sjostrom, L. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care, (2004). 27, 155-61.
![]() ![]() 6. Wing, RR, Lang, W, Wadden, TA, Safford, M, Knowler, WC, & Bertoni, AG, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care, (2011). 34, 1481-6.
![]() ![]() ![]() 7. Kim, DH, Park, SC, Lee, JH, Lee, HY, Cho, MK, & Cho, JYi, et al. Recent Research Trends in Korean Medicine Treatment of Diabetes Mellitus - Focusing on Domestic Articles from 2008 to 2013 -. Korean J Orient Int Med, (2013). 4(3), 240-55.
8. Hanefeld, M, Fischer, S, Schmechel, H, Rothe, G, Schulze, J, & Dude, H, et al. Diabetes Intervention Study, Multi-intervention trial in newly diagnosed NIDDM. Diabetes Care, (1991). 14, 308-17.
![]() ![]() 9. United Kingdom Prospective Diabetes Study (UK-PDS). 13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. BMJ, (1995). 310, 83-8.
![]() ![]() 10. Lee, MJ, & Kim, SS. Management of Obesity in Patients with Diabetes Mellitus. J Korean Diabetes, (2017). 18, 229-38.
![]() 11. Chon, S, Park, CY, Koh, GP, Oh, SJ, Woo, JT, & Kim, SW, et al. The Effect of Orlistat in Obese Patients with Type 2 Diabetes: Benefit on Abdominal Obesity and Glycemic Control. J Korean Med Obes Res, (2004). 13(4), 281-92.
12. Lee, EJ, & Kim, TN. Pharmacological Management of Obesity in Patients with Type 2 Diabetes: An Update. Korean J Obes, (2016). 25(3), 121-8.
![]() 13. O’Neil, PM, Smith, SR, Weissman, NJ, Fidler, MC, Sanchez, M, & Zhang, J, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity, (2012). 20, 1426-36.
![]() ![]() 14. Hollander, P, Gupta, AK, Plodkowski, R, Greenway, F, Bays, H, & Burns, C, et al. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care, (2013). 36, 4022-9.
![]() ![]() ![]() 15. Davies, MJ, Bergenstal, R, Bode, B, Kushner, RF, Lewin, A, & Skjøth, TV, et al. Efficacy of liraglutide for weight loss among patients with type 2 diabetes: The SCALE diabetes randomized clinical trial. JAMA, (2015). 314, 687-99.
![]() ![]() 16. Han, HJ, Kim, HJ, Park, EY, Jang, JA, An, TH, & Seo, HS, et al. The effect of oriental obesity therapy on Morbid obese patient with Type 2 Diabetes: Two Cases Report. J Korean Med, (2010). 10, 57-63.
17. Kim, HJ, & Kim, KS. Improvement of type 2 diabetes by very-low-calorie diet-A case report. J Korean Med, (2002). 2(1), 97-102.
18. Cha, YY. A case Study on the Treatment of Obese patient with diabetes. J Korean Med, (2004). 4(1), 193-9.
19. World Health Organization–Uppsala Monitoring Centre (WHO-UMC). Causality categories [Internet] Uppsala (Sweden): World Health Organization–Uppsala Monitoring Centre (WHO-UMC). (2018). [cited 2012 Oct 22]. Available from: https://who-umc.org/media/164200/who-umc-causality-assessment_new-logo.pdf
20. Korea Institute of Drug Safety & Risk Management. Adverse Drug Reaction Assessment Report. 1st ed.Seoul. Korea Institute of Drug Safety & Risk Management;(2013). p. 60-3.
21. National Cancer Institute National Institute of Health US DEPARTMENT OF HEALTH AND HUMAN SERVICES. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (2010.
22. Basch, E, Reeve, B, Mitchell, S, Clauser, S, Minasian, L, & Dueck, A, et al. Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). (2014). 106(9), 244.
23. Korea Institute of Drug Safety & Risk Management. Terminology Guide for Reporting Adverse Drug Reactions. Seoul. Korea Institute of Drug Safety & Risk Management;(2014). p. 1-6.
24. Lee JM. Longevity and life preservation in Eastern medicine. Seoul. Haklimsa;(1986). p. 333-8.
25. Lee, JE, Song, YK, & Lim, HH. Clinical trial of Taeeumjowui-tang (Taiyintiaowei-tang) on obese patients: randomized, double blind, placebo-controlled study. J Orient Rehab Med, (2010). 20(4), 197-213.
26. Lim, SY, Park, SW, Joo, JH, Kim, SR, Kim, DJ, & Choi, WS. The effects of Taeeumjowui-tang (Taiyintiaowei-tang) on obesity in Sasang constitution. J East-West Med, (2012). 37(4), 109-16.
27. Park, SJ, Nahmkoong, W, Cheon, CH, Park, JS, Jang, BH, & Shin, YC, et al. Efficacy and safety of Taeeumjowi-tang in obese Korean adults: a double-blind, randomized, and placebo-controlled pilot trial. Evid-Based Complement Altern Med, (2013). 2013, 498935.
![]() 28. Hwang, MJ, Shin, HD, & Song, MY. Literature review of herbal medicines on treatment of obesity since 2000; mainly about Ephedra Herba. J Korean Med Obes Res, (2007). 7(1), 39-54.
29. Jang, IS, & Hwang, EH. The Need for Clinical Practice Guidelines in Usage of Mahuang in Weight Loss. J Korean Med Obes Res, (2007). (1), 23-9.
30. Jo, GW, OK, , JM, , Kim, SY, & Lim, YW. Review on the efficacy and safety of Mahuang and ephedrine in the treatment of obesity-focused on RCT. J Korean Med, (2017). 38(3), 170-84.
![]() 31. Wing, RR, Marcus, MD, Epstein, LH, & Jawad, A. A “family-based” approach to the treatment of of obese Type II diabetic patients. J Consult Clin Psychol, (1991). 59, 156-62.
![]() ![]() 32. Yoon, NR, Yoo, YJ, Kim, MJ, Kim, SY, Lim, YW, & Lim, HH, et al. 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), 1-9.
![]() 33. Kim, HJ, & Kim, JY. Clinical report about the adverse reactions of Taeeumin·Soeumin·Soyangin by Taeeumjowi-tang. Korean J Oriental Physiology & Pathology, (2008). 22(6), 1600-5.
34. Luyster, FS, & Dunbar-Jacob, J. Sleep quality and quality of life in adults with type 2 diabetes. Diabetes Educ, (2011). 379, 347-55.
![]() 35. Jain, A, Sharmab, R, Yadavc, N, Chaudhary, P, Jainc, G, & Maanju, M. Quality of life and its association with insomnia and clinical variables in type 2 diabetes. J Egypt Public Health Assoc, (2017). 92(1), 52-9.
![]() ![]() 36. Attarian, H, Hachul, H, Guttuso, T, & Phillips, B. Treatment of chronic insomnia disorder in menopause: Evaluation of literature. Menopause, (2015). 22(6), 674-84.
![]() ![]() 37. Kim, Hwa. Diagnosis and Management of Diabetic Autonomic Neuropathy Chong. J Korean Diabetes, (2018). 19, 160-7.
![]() 38. Christensen, P, Bliddal, H, Riecke, BF, Leeds, AR, Astrup, A, & Christensen, R. Comparison of a low-energy diet and a very low-energy diet in sedentary obese individuals: a pragmatic randomized controlled trial. Clin Obes, (2011). 1(1), 31-4.
![]() ![]() 39. Kim, JS, & Yoon, SH. Effect of Naesosan gastric motility between normal intact and antral dilatated rats. J Korean Orient Int Med, (2008). 29(1), 117-129.
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