Gamitaeeumjowee-tang for Weight Loss in Post-Menopausal Obese Women: A Retrospective Chart Review
Article information
J Korean Med. 2024;45(2):169-173
1Nubebe Korean Medical Clinic Bundang Center
2Nubebe Obesity Research Institute
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.
J Korean Med. 2024;45(1):64-78
http://dx.doi.org/10.13048/jkm.24004
Adverse Events Reported from 115 Patients using Gamitaeeumjowee-tang
Adverse Events According to System Organ Classes
Article information Continued
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)
|
| 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) |
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)
|
| 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) |
