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

Yun-Jin Lee; Jeong-In Kang; Yun-Ha Kim; Eun-Chae Min; Young-Woo Lim; Eunjoo Kim; Lee, Yun-Jin; Kang, Jeong-In; Kim, Yun-Ha; Min, Eun-Chae; Lim, Young-Woo; Kim, Eunjoo

doi:10.13048/jkm.24033.e1

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.

Keywords: Menopause, Obesity, Weight loss, Gamitaeeumjowee-tang

J Korean Med. 2024;45(1):64-78

http://dx.doi.org/10.13048/jkm.24004

Table 6.

Adverse Events Reported from 115 Patients using Gamitaeeumjowee-tang

Variables	Visit every 5-6 weeks (N= 72)		Visit every 3-4 weeks (N= 43)
Variables	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 5-6 weeks (N= 72)		Visit every 3-4 weeks (N= 43)
System-organ classes	Symptom	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)
Psychiatric disorders	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)
Hearing and vestibular disorders	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)
Reproductive disorders, female	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)
Metabolic and nutritional disorders	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)
Vision disorders	Subtotal	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (5.6)