Gamitaeeumjowee-tang for Weight Loss in Post-Menopausal Obese Women: A Retrospective Chart Review

Article information

J Korean Med. 2024;45(1):64-78
Publication date (electronic) : 2024 March 1
doi : https://doi.org/10.13048/jkm.24004
1Nubebe Korean Medical Clinic Bundang Center
2Nubebe Obesity Research Institute
Correspondence to: Eunjoo Kim, Nubebe Korean Medical Clinic Bundang Center, 10 Seongnam-daero, 926beon-gil, Bundang-gu, Seongnam 13506, Korea, Tel: +82-31-702-0045, Fax: +82-31-701-8993, E-mail: boggil82@gmail.com
Received 2023 November 17; Revised 2023 December 22; Accepted 2024 February 16.

Abstract

Objectives

The purpose of this study is to evaluate weight change and analyze adverse events in post-menopausal obese women with Gamitaeeumjowee-tang for weight loss.

Methods

A retrospective chart review was conducted for medical records of 115 post-menopausal obese women (body mass index, BMI≥25 kg/m2) who were administered with Gamitaeeumjowee-tang for 12 weeks for the purpose of weight loss. Weight, skeletal muscle ratio and BMI changes were compared before and after the program. Adverse events were evaluated by causality, severity and system-organ classes.

Results

A total of 115 patients were included in this study. The average total weight loss in post-menopausal women was 5.72±2.04kg(p<0.001) and the average weight loss rate was 8.06±2.70%(p<0.001). After the 12-week program, the body fat rate was significantly decreased(3.76±2.20%)(p<0.001) and the skeletal muscle ratio was significantly increased(2.07±1.24%)(p<0.001). There were no significant differences in weight loss, skeletal muscle ratio change and body fat rate change depending on the number of hospital visits. Insomnia was frequently reported throughout the period, and no serious adverse events were reported.

Conclusions

This study showed the potential that weight management treatment with Gamitaeeumjowee-tang could be a good way to lose weight of post-menopausal obese women without serious adverse events. Continuous well designed clinical studies are needed.

Fig. 1

Flow chart of dataset for analysis

Composition of Gamitaeeumjowee-tang

Baseline Characteristics of Patients

Weight and Body Composition Change after Taking Gamitaeeumjowee-tang

Initial Characteristics according to Visit Interval

Comparison of Weight Change according to Visit Interval

Adverse Events Reported from 115 Patients using Gamitaeeumjowee-tang

Adverse Events According to System Organ Classes

References

1. Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation 2012;126(1):126–132. https://doi.org/10.1161/CIRCULATIONAHA.111.087213.
2. Park JH, Yoon SJ, Lee H, Jo HS, Lee SI, Kim Y, et al. Burden of disease attributable to obesity and overweight in korea. Int J Obes 2006;30(11):1661–1669. https://doi.org/10.1038/sj.ijo.0803321.
3. World Health Organization. The Asia-Pacific Perspective: Redefining obesity and its treatment 2000;
4. Haam JH, Kim BT, Kim EM, Kwon H, Kang JH, Park JH, et al. Diagnosis of obesity: 2022 update of clinical practice guidelines for obesity by the korean society for the study of obesity. J Obes Metab Syndr 2023;32(2):121. https://doi.org/10.7570/jomes23031.
5. Korean Society for the Study of Obesity. Prevalence and trends in obesity Seoul: Available from: URL: http://kosso.med1dev.net/html/?pmode=BBBS0001300004&smode=view&seq=1388.
6. Eckel RH. Obesity: Mechanisms and clinical management USA: Lippincott Williams & Wilkins; 2003. p. 3–102.
7. World Health Organization. Report of a WHO scientific group: Research on the menopause WHO Technical Report Series. 1981. 670p. 8–12.
8. Poehlman ET, Goran MI, Gardner AW, Ades PA, Arciero PJ, Katzman-Rooks SM, et al. Determinants of decline in resting metabolic rate in aging females. Am J Physiol 1993;264(3):E450–E455. https://doi.org/10.1152/ajpendo.1993.264.3.E450.
9. Yun YS. Obesity in women: Effect of pregnancy and menopause. J Korean Acad Fam Med 2002;23(5):553–564.
10. Kanai H, Matsuzawa Y, Kotani K, Keno Y, Kobatake T, Nagai Y, et al. Close correlation of intra-abdominal fat accumulation to hypertension in obese women. Hypertension 1990;16(5):484–490. https://doi.org/10.1161/01.HYP.16.5.484.
11. Barrett-Connor E. Epidemiology and the menopause: A global overview. Int J Fertile 1993;38:6–14.
12. Sotelo MM, Johnson SR. The effects of hormone replacement therapy on coronary heart disease. Endocr Metab Clin North Am 1997;26(2):313–328. https://doi.org/10.1016/S0889-8529(05)70249-8.
13. Dupuit M, Maillard F, Pereira B, Marquezi ML, Lancha AH Jr, Boisseau N. Effect of high intensity interval training on body composition in women before and after menopause: A meta-analysis. Exp Physiol 2020;105(9):1470–1490. https://doi.org/10.1113/EP088654.
14. Cho HS, Seo YH, Kim KW, Cho JH, Song MY. The retrospective analysis of effects of h gambitang (gb-001) on weight loss in pre-and post-menopausal obese woman. J Korean Med Obes Res 2020;20(1):20–30. https://doi.org/10.15429/jkomor.2020.20.1.20.
15. Wang ST, Lin YK, Weng SF, Huang CL, Huang HC, Chiu YC, et al. Skeletal Muscle Ratio: A Complete Mediator of Physical Activity and HbA1C in Type 2 Diabetes. Biol Res Nurs 2020;22(4):534–543. https://doi.org/10.1177/109980042094288.
16. Korean Obesity Association. Treatment Guideline for Obesity 2018;:17–18.
17. Korea Institute of Drug Safety & Risk Management. Adverse drug assessment report 1st edth ed. Seoul: Korea Institute of Drug Safety & Risk Management; 2013. p. 60–63.
18. National Cancer Institute. National Institute of Health, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 2010.
19. Korea Institute of Drug Safety & Risk Management. Terminology guide for reporting adverse drug reactions Seoul: Korea Institue of Drug Safety & Risk Management; 2014. p. 1–6.
20. Lee JM. Longevity and life preservation in Eastern medicine Seoul: Haklimsa; 1986. p. 333–338.
21. Lee HR, Oh HJ, Lee JY, Lee JH. A systematic review and meta-analysis on constitutional herbal medicine treatment for obesity. J Sasang Constitut Med 2022;34(2):36–47. https://doi.org/10.7730/JSCM.2022.34.2.36.
22. Kang EY, Park YB, Kim MY, Park YJ. A study on factors associated with weight loss by ‘ gamitaeeumjowee-tang’ . J Korean Med Obes Res 2017;17(2):68–76. https://doi.org/10.15429/jkomor.2017.17.2.68.
23. 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. https://doi.org/10.15429/jkomor.2018.18.1.1.
24. Jang IS, Yang CS, Hwang EH. The need for clinical practice guidelines in usage of mahuang in weight loss. J Korean Med Obes Res 2007;7(1):23–29.
25. Soh MG, Song YK, Lim HH. A literature review on obesity in elderly. J Korean Med Obes Res 2006;6(2):51–58.
26. Choi JK. Obesity defined by body mass index and metabolic status in the elderly. J Korean Geriatr Soc 2011;15(4):222–229.
27. Lee SS, Choi HJ. The relationship between perception of old age and social participation of older adults. J Soc Sci Res 2019;30(2):181–198. 10.16881/jss.2019.04.30.2.181.
28. Jeong H, Lee C, Han SY, Ko YJ, Kim KJ. Relationship between anemia with frailty and nutritional intake in persons age 65 and older: The 2016–2018 korea national health and nutrition examination survey. Korean J Fam Pract 2023;13(1):15–22. https://doi.org/10.21215/kjfp.2023.13.1.15.
29. Yang MS, Shin MS, An HL. A literature review on obesity in postmenopausal women. J Korean Med Obes Res 2008;8(2):1–13.
30. Fabricatore AN, Wadden TA, Moore RH, Butryn ML, Heymsfield SB, Nguyen AM. Predictors of attrition and weight loss success: Results from a randomized controlled trial. Behav Res Ther 2009;47(8):685–691. https://doi.org/10.1016/j.brat.2009.05.004.
31. Hadžiabdić MO, Mucalo I, Hrabač P, Matić T, Rahelić D, Božikov V. Factors predictive of drop-out and weight loss success in weight management of obese patients. J Hum Nutr Diet 2015;28(2):24–32. https://doi.org/10.1111/jhn.12270.
32. Batterham Marijka Tapsell L, Charlton K, O’shea J, Thorne R. Using data mining to predict success in a weight loss trial. J Hum Nutr Diet 2017;30(4):471–478. https://doi.org/10.1111/jhn.12448.
33. Han JY, Park YJ. Analysis of factors influencing obesity treatment according to initial condition and compliance with medication. J Korean Med Obes Res 2019;19(1):31–41. https://doi.org/10.15429/jkomor.2019.19.1.31.
34. Nam SH, Kim SY, Lim YW, Park YB. Review on predictors of weight loss in obesity treatment. J Korean Med Obes Res 2018;18(2):115–127. https://doi.org/10.15429/jkomor.2018.18.2.115.
35. Annesi JJ, Whitaker AC. Psychological factors associated with weight loss in obese and severely obese women in a behavioral physical activity intervention. Heal Educ Behav 2010;37(4):593–606. https://doi.org/10.1177/109019810933167.
36. Annesi JJ, Whitaker AC. Psychological factors discriminating between successful and unsuccessful weight loss in a behavioral exercise and nutrition education treatment. Int J Behav Med 2010;17(3):168–175. 10.1007/s12529-009-9056-2.
37. Lee EJ, Park YB, Lim YW, Kim SY. The association between sleep and weight loss among adult women with obesity administered with gamitaeeumjowee-tang . J Korean Med 2020;41(3):22–31. https://doi.org/10.13048/jkm.20023.
38. Lee AR, Lee DY, Kim MJ, Lee HS, Choi KH, Kim SY, et al. Gamitaeeumjowee-tang for weight loss in diabetic patients: A retrospective chart review. J Korean Med 2021;42(1):46–58. https://doi.org/10.13048/jkm.21004.
39. Park MJ, Kim EJ, Ok JM, Choi KH, Lim YW. Gamitaeeumjowee-tang for weight loss in overweight and obese women with polycystic ovary syndrome: A retrospective chart review. J Korean Med Obes Res 2022;22(2):136–146. https://doi.org/10.15429/jkomor.2022.22.2.136.
40. Proserpio P, Marra S, Campana C, Agostoni EC, Palagini L, Nobili L, et al. Insomnia and menopause: A narrative review on mechanisms and treatments. Climacteric 2020;23(6):539–549. https://doi.org/10.1080/13697137.2020.1799973.
41. Kim E, Park YB, Choi K, Lim YW, Ok JM, Noh EY, et al. Application of machine learning to predict weight loss in overweight, and obese patients on korean medicine weight management program. J Korean Med 2020;41(2):58–79. https://doi.org/10.13048/jkm.20015.

Article information Continued

Fig. 1

Flow chart of dataset for analysis

Table 1

Composition of Gamitaeeumjowee-tang

Ingredient Dose(g)/day
Ephedra Herba 16.0~24.0
Rehmanniae Radix Preparat 8.0
Coicis Semen 8.0
Zingiberis Rhizoma Recens 4.0
Acori Gramineri Rhizoma 3.3
Zizyphi Semen 3.3
Alismatis Rhizoma 2.6
Scutellariae Radix 1.3
Schizandrae Fructus 1.3
Puerariae Radix 1.3
Asparagi Tuber 1.3
Angelicae Tenuissimae Radix 1.3
Longanae Arillus 1.3
Castanea Moliissima 1.3
Liriopis Tuber 1.3
Total amount 55.6~59.6

Table 2

Baseline Characteristics of Patients

Characteristics N(%) Mean ± standard deviation
Mean age(year) 53.83 ± 3.28
40′s 13(11.3)
50′s 102(88.7)
Mean weight(kg) 70.94 ± 6.87
Mean body fat mass(kg) 29.43 ± 4.90
Mean skeletal muscle(kg) 22.53 ± 2.29
Mean BMI(kg/m2) 28.80 ± 2.48
25–30 85(73.9)
≥30 30(26.1)

BMI ; Body mass index

Table 3

Weight and Body Composition Change after Taking Gamitaeeumjowee-tang

Variables Mean ± standard deviation N(%)
Initial weight(kg) 70.94 ± 6.87
Final weight(kg) 65.22 ± 6.53
Weight loss(kg) 5.72 ± 2.04**
Body fat mass loss(kg) 4.78 ± 2.08**
BMI loss(kg/m2) 2.32 ± 0.82**
Skeletal muscle loss(kg) 0.49 ± 0.70**
Mean weight loss rate(%) 8.06 ± 2.70**
≥5% weight loss 102(88.7)
≥10% weight loss 27(23.5)
Mean skeletal muscle loss rate(%) −2.07 ± 1.24**
Mean body fat loss rate(%) 3.76 ± 2.20**

BMI ; Body mass index,

*

p<0.01

**

p<0.001

Table 4

Initial Characteristics according to Visit Interval

Variables Visits every 3–4 weeks (Mean ± standard deviation) Visits every 5–6 weeks (Mean ± standard deviation)
N 43 72
Mean age(year) 53.70 ± 3.22 53.91 ± 3.31
Initial weight(kg) 71.48 ± 5.63 70.62 ± 7.50
Initial body fat mass(kg) 29.88 ± 4.05 29.15 ± 5.32
Initial skeletal muscle(kg) 22.55 ± 2.36 22.52 ± 2.24
Initial BMI(kg/m2) 28.98 ± 2.04 28.69 ± 2.70

BMI ; Body mass index

Table 5

Comparison of Weight Change according to Visit Interval

Variables Visits every 3–4 weeks (Mean ± standard deviation) Visits every 5–6 weeks (Mean ± standard deviation)
Weight loss(kg) 5.69 ± 2.04** 5.74 ± 2.04**
Body fat mass loss(kg) 5.02 ± 2.02** 4.65 ± 2.11**
BMI loss(kg/m2) 2.31 ± 0.83** 2.33 ± 0.81**
Skeletal muscle loss(kg) 0.35 ± 0.71* 0.57 ± 0.68***
Comparison of weight loss between the two groups(kg) 0.04 ± 0.40
Comparison of skeletal muscle loss rate(%) −0.25 ± 0.24
Comparison of body fat loss rate(%) 0.49 ± 0.42

BMI : Body mass index,

*

p<0.01

**

p<0.001

Table 6

Adverse Events Reported from 115 Patients using Gamitaeeumjowee-tang

Variables Visit every 3–4 weeks (N= 72) Visit every 5–6 weeks (N= 43)

2–6 weeks, n(%) 6–12 weeks, n(%) 2–4 weeks, n(%) 4–8 weeks, n(%) 8–12 weeks, n(%)
Causality (WHO-UMC)
 Possible 37 (27.0) 9 (18.0) 23 (38.3) 5 (15.2) 5 (27.8)
 Unlikely 100 (73.0) 41 (82.0) 37 (61.7) 28 (84.8) 13 (72.2)
 Conditional/unclassified 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Total 137 (100) 50 (100) 60 (100) 33 (100) 18 (100)

Severity (CTCAE v4.0)
 Mild (Grade1) 137 (100) 49 (98.0) 59 (98.3) 29 (87.9) 17 (94.4)
 Moderate (Grade 2) 0 (0.0) 1 (2.0) 1 (1.7) 4 (12.1) 1 (5.6)
 Severe (Grade 3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Total 137 (100) 50 (100) 60 (100) 33 (100) 18 (100)

WHO-UMC; World Health Organization-Uppsala Monitoring Centre, CTCAE; Common Terminology Criteria for Adverse Events

Table 7

Adverse Events According to System Organ Classes

System-organ classes Symptom Visit every 3–4 weeks (N= 72) Visit every 5–6 weeks (N= 43)

2–6 weeks, n(%) 6–12 weeks, n(%) 2–4 weeks, n(%) 4–8 weeks, n(%) 8–12 weeks, n(%)
Gastro-intestinal system disorders Nausea 9 (6.6) 4 (8.0) 7 (11.7) 4 (12.1) 0 (0.0)
Dyspepsia 2 (1.5) 1 (2.0) 5 (8.3) 1 (3.0) 1 (5.6)
Constipation 19 (13.9) 13 (26.0) 4 (6.7) 6 (18.2) 2 (11.1)
Diarrhea 3 (2.2) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)
Vomiting 1 (0.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Abdominal pain 0 (0.0) 1 (2.0) 2 (3.3) 0 (0.0) 0 (0.0)
Glossitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6)
Enterocolitis 0 (0.0) 0 (0.0) 0 (0.0) 1 (3.0) 0 (0.0)
Subtotal 34 (24.8) 19 (38.0) 19 (31.7) 12 (36.4) 4 (22.2)

Central & peripheral nervous system disorders Dizziness 12 (8.8) 1 (2.0) 3 (5.0) 1 (3.0) 1 (5.6)
Headache 16 (11.7) 1 (2.0) 5 (8.3) 3 (9.1) 0 (0.0)
tremor 7 (5.1) 0 (0.0) 2 (3.3) 0 (0.0) 0 (0.0)
Paresthesia 4 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Subtotal 39 (28.5) 2 (4.0) 10 (16.7) 4 (12.1) 1 (5.6)

Psychiatric disorders Insomnia 33 (24.1) 12 (24.0) 16 (26.7) 9 (27.3) 9 (50.0)
Subtotal 33 (24.1) 12 (24.0) 16 (26.7) 9 (27.3) 9 (50.0)

Autonomic nervous system disorders Dry mouth 11 (8.0) 1 (2.0) 2 (3.3) 1 (3.0) 0 (0.0)
Palpitation 7 (5.1) 1 (2.0) 1 (1.7) 0 (0.0) 0 (0.0)
Sweating increased 5 (3.6) 2 (4.0) 1 (1.7) 0 (0.0) 1 (5.6)
Hot flashes 1 (0.7) 1 (2.0) 1 (1.7) 0 (0.0) 0 (0.0)
Lips dry 0 (0.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0)
Subtotal 24 (17.5) 6 (12.0) 5 (8.3) 1 (3.0) 1 (5.6)

Body as a whole - general disorders Malaise 1 (0.7) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)
Fatigue 1 (0.7) 4 (8.0) 5 (8.3) 2 (6.1) 0 (0.0)
Temperature changed sensation 1 (0.7) 2 (4.0) 0 (0.0) 0 (0.0) 1 (5.6)
Chills-general disorders and administration site conditions 0 (0.0) 0 (0.0) 0 (0.0) 1 (3.0) 0 (0.0)
Non-cardiac chest pain 0 (0.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0)
Subtotal 3 (2.2) 7 (14.0) 6 (10.0) 3 (9.1) 1 (5.6)

Skin and appendages disorders Rash 0 (0.0) 0 (0.0) 0 (0.0) 1 (3.0) 0 (0.0)
Pruritus 0 (0.0) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)
Bullous dermatitis 0 (0.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0)
Urticaria 0 (0.0) 0 (0.0) 0 (0.0) 2 (6.1) 0 (0.0)
Subtotal 0 (0.0) 1 (2.0) 1 (1.7) 3 (9.1) 0 (0.0)

Urinary system disorders Urinary frequency 0 (0.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0)
bladder infection-Infections and infestations 1 (0.7) 0 (0.0) 0 (0.0) 1 (3.0) 0 (0.0)
Subtotal 1 (0.7) 1 (2.0) 0 (0.0) 1 (3.0) 0 (0.0)

Hearing and vestibular disorders Tinnitus 1 (0.7) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)
Subtotal 1 (0.7) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)

Reproductive disorders, female vaginal hemorrhage 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6)
Subtotal 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6)

Musculo-skeletal system disorders Myalgia 0 (0.0) 1 (2.0) 0 (0.0) 0 (0.0) 0 (0.0)
Muscle cramp 1 (0.7) 1 (2.0) 1 (1.7) 0 (0.0) 0 (0.0)
Subtotal 1 (0.7) 2 (4.0) 1 (1.7) 0 (0.0) 0 (0.0)

Metabolic and nutritional disorders Thirst 1 (0.7) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)
Subtotal 1 (0.7) 0 (0.0) 1 (1.7) 0 (0.0) 0 (0.0)

Vision disorders Vision blurred 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6)
Subtotal 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.6)