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JKM > Volume 45(1); 2024 > Article
Lee, Kang, Kim, Min, Lim, and Kim: Gamitaeeumjowee-tang for Weight Loss in Post-Menopausal Obese Women: A Retrospective Chart Review

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
jkm-45-1-64f1.gif
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)

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