<i>Gamitaeeumjowee-Tang</i> for weight loss in diabetic patients: A retrospective chart review

A-Reum Lee; Da-Yeon Lee; Min-Ji Kim; Hyang-Sook Lee; Ka-Hye Choi; Seo-Young Kim; Young-Woo Lim; Young-Bae Park; Lee, A-Reum; Lee, Da-Yeon; Kim, Min-Ji; Lee, Hyang-Sook; Choi, Ka-Hye; Kim, Seo-Young; Lim, Young-Woo; Park, Young-Bae

doi:10.13048/jkm.21004

JKM > Volume 42(1); 2021 > Article

Lee, Lee, Kim, Lee, Choi, Kim, Lim, and Park: Gamitaeeumjowee-Tang for weight loss in diabetic patients: A retrospective chart review

Original Article

The Journal of Korean Medicine 2021; 42(1): 46-58.

Published online: March 01, 2021

DOI: https://doi.org/10.13048/jkm.21004

Gamitaeeumjowee-Tang for weight loss in diabetic patients: A retrospective chart review

A-Reum Lee¹

, Da-Yeon Lee²

, Min-Ji Kim²

, Hyang-Sook Lee¹

, Ka-Hye Choi²^{, 3}

, Seo-Young Kim²^{, 3}

, Young-Woo Lim²^{, 3}

, Young-Bae Park³

¹Department of Medical Science of Meridian, College of Korean Medicine, Graduate School, Kyung Hee University

²Nubebe Korean Medical Clinic

³Nubebe Mibyeong Research Institute

Correspondence to: A-Reum Lee, Nubebe Korean Medical Clinic, 2F, 284, Gilju-ro, Bucheon-si, Gyeonggi-do, Republic of Korea [14548], Tel: +82-032-719-4877, Fax: +82-032-326-3601, E-mail: rumy1205@naver.com

Received January 29, 2021 Revised February 16, 2021 Accepted February 18, 2021

Abstract

Objectives

The purpose of this study is to report weight changes and analyze adverse events in diabetic patients with Gamitaeeumjowee-Tang for weight loss.

Methods

A 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.

Results

After 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.

Conclusions

A 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.

Keywords: Diabetes, Weight loss, Gamitaeeumjowee-tang, Adverse events, BMI

Fig. 1

Study patients flowchart

Fig. 2

Weight change from baseline

Table 1

Exclusion Criteria for Prescription

Pregnant or breast feeding women
Heart disease (heart failure, arrhythmia, myocardial infarction, angina pectoris, congenital heart disease, etc), or past history of ischemic heart attack
Uncontrolled hypertension (systolic blood pressure higher more than 160mmHg or relaxation period blood pressure higher more than 100mmHg)
Cerebral disease (cerebrovascular disease, cerebral aneurysm, epilepsy, cerebral infarction, etc), past history of stroke
Severe liver disease (liver failure, liver infarction, active hepatitis, etc.), urination disorder (urinary failure, etc.)
Psychiatric disorder (schizophrenia, severe depression, obsessive compulsive disorder, etc.)
Patients taking Tuberculosis drugs, asthma drugs, sympathomimetic agent, anti-obesity drugs, monoamine oxidase inhibitors.
Closed angle glaucoma
Hyperthyroidism
Other chronic neurological or cardiovascular diseases

Table 2

Composition of Gamitaeeumjowee-Tang

Ingredient		Dose(g)/day
麻黃	Ephedra Herba	16.0~24.0
薏苡仁	Coicis Semen	16.0
乾栗	Castanea Moliissima	16.0
熟地黃	Rehmanniae Radix Preparat	8.0
五味子	Schizandrae Fructus	5.3
麥門冬	Liriopis Tuber	5.3
天門冬	Asparagi Tuber	5.3
生薑	Zingiberis Rhizoma Recens	4.0
石菖蒲	Acori Gramineri Rhizoma	3.3
酸棗仁	Zizyphi Semen	3.3
澤瀉	Alismatis Rhizoma	2.6
龍眼肉	Longanae Arillus	1.3
黃芩	Scutellariae Radix	1.3
葛根	Puerariae Radix	1.3
藁本	Angelicae Tenuissimae Radix	1.3

Total Amount		90.6~98.6

Table 3

Baseline Characteristics of 61 Subjects

Characteristic
Female, n(%)	58 (95.1)
male, n(%)	3 (4.9)

Age, n(%)
20’s	0
30’s	12 (19.7)
40’s	23 (37.7)
50’s	20 (32.8)
60’s	5 (8.2)
70’s	1 (1.6)

Body mass index, n(%)
< 23	1(1.64)
23~24.9	4(6.56)
> 25	56(91.80)

Mean age (SD^*), y	48.0 (8.7)
Weight, mean (SD), kg	76.3 (13.9)
Body mass index, mean (SD), kg/m²	29.9 (5.0)

Abbreviations: SD, standard deviation

Table 4

Medical Records and Medication of 61 Subjects

Present illness	n	Diagnosis (n)
1. Cardiovascular system	34	Hypertension (23), Hyperlipidemia (19)
2. Musculoskeletal system	4	Spinal stenosis (2), Lumbar disc herniation (1), Rheumatoid arthritis (1), Degenerative arthritis (1)
3. ENT system	8	Asthma (3), Allergic rhinitis (3), Vocal nodules (1), Cupulolithiasis (1)
4. Urogenital system	2	Uterine myoma (1), Urinary incontinence (1)
5. Hepatobiliary system	3	Abnormal liver somatic index (2), Non-alcoholic fatty liver (1)
6. Digestive system	11	Gastritis (8), Reflux esophagitis (4), Gastric ulcer (1), Duodenitis (1)
7. Endocrine system	61	Diabetes (61), Hypothyroidism (4), Thyroid nodule (1), Pituitary adenoma (1)
8. Integumentary system	2	Urticaria (1), Cutaneous allergy (1)
9. Etc	3	Hemorrhagic retinopathy (1), Anemia (1), Glaucoma (1)
10. Total, n(%)	61(100)

Past history	n	Diagnosis (n)

11. Musculoskeletal system	7	Lumbar discectomy (3), Lumbar disc herniation (1), Rheumatoid arthritis (1), Other musculoskeletal surgery (2)
12. ENT system	3	Tonsillectomy (2), Asthma (1)
13. Urogenital system	20	Hysterectomy (8), Caesarean section (8), Hysteromyoma (2), Incontinence surgery (1), Benign ovarian tumor removal (1), Ovariectomy (1)
14. Hepatobiliary system	2	Cholelithotomy (2)
15. Digestive system	4	Appendectomy (1), Gastritis (1), Reflux esophagitis (1), Hemorrhoid (1)
16. Nervous system	1	Encephalomeningitis (1)
17. Endocrine system	7	Breast cancer (2), Thyroid cancer (1), Gestational thyroiditis (1) Gestational diabetes (1), Breast cyst (1), Pancreatic cyst (1)
18. Integumentary system	1	Herpes zoster (1)
19. Etc	4	Hemorrhagic retinopathy (1), Cataract surgery (1), Increased intracranial pressure (1), Gastrectomy (1)
20. Total, n (%)	39(63.9)

Medication	n(%)

21. Prescription drugs	56(91.8)	Hypoglycemic agents (51), Antihypertensive agents (22), Anti-dyslipidemia agent (19), Thyroid hormone agent (2), Female hormone agent (2), Other prescription drugs (8)
22. Dietary supplements	20(32.8)
23. Total, n(%)	57(92.8)

Abbreviations: ENT, ear nose and throat

Note: Total, number of subjects.

Table 5

Change of Weight and Body Mass Index for 10 weeks for 61 subjects

	Before	After 10 weeks	Difference	P-value
Weight (kg)	76.30±13.97	70.40±13.10	5.9±2.32	p<0.001
Body mass index (kg/m²)	29.89±5.05	27.60±4.81	2.9±0.86	p<0.001

Note: Values are presented as mean ± standard deviation unless otherwise indicated.

Table 6

Adverse Events Reported from 61 Patients on Weight Loss Program using Gamitaeeumjowee-tang

	2–4 weeks, n(%)	6–8 weeks, n(%)	10–12 weeks, n(%)
Causality(WHO-UMC)
Possible	14 (29.8)	10 (27.0)	6 (20.7)
Unlikely	32 (68.1)	26 (70.3)	17 (58.6)
Conditional/unclassified	1 (2.1)	1 (2.7)	6 (20.7)
Total	47 (100)	37 (100)	29 (100)

Severity(CTCAE)
Mild (grade 1)	46 (97.9)	36 (97.3)	29 (100)
Moderate (grade 2)	1 (2.1)	0 (0)	0 (0)
Severe (grade 3)	0 (0)	1 (2.7)	0 (0)
Total	47 (100)	37 (100)	29 (100)

HO-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	2–4 weeks, n(%)	6–8 weeks, n%)	10–12 weeks, n%)
Gastro-intestinal system disorders	Constipation	6 (9.8)	5 (8.2)	9 (14.8)
	Heartburn	6 (9.8)	5 (8.2)	0 (0)
	Nausea	3 (4.9)	0 (0)	0 (0)
	Esophageal pain	1 (1.6)	1 (1.6)	0 (0)
	Diarrhea	2 (3.3)	1 (1.6)	0 (0)
	Dry mouth	1 (1.6)	3 (4.9)	1 (1.6)
	Abdominal pain	1 (1.6)	0 (0)	1 (1.6)
	Subtotal	14 (22.9)	12 (19.7)	11 (18.0)

Psychiatric disorders	Insomnia	10 (16.4)	8 (13.1)	7 (11.5)
	Hypersomnia	1 (1.6)	1 (1.6)	0 (0)
	Subtotal	11 (18.0)	9 (14.8)	7 (11.5)

Central & Peripheral nervous system Disorders	Shakiness	3 (4.9)	1 (1.6)	0 (0)
	Dizziness	3 (4.9)	2 (3.3)	3 (4.9)
	Headache	2 (3.3)	1 (1.6)	3 (4.9)
	Hyperhidrosis	1 (3.3)	3 (4.9)	0 (0)
	Paresthesia	0 (0)	2 (3.3)	1 (1.6)
	Subtotal	8 (12.1)	8 (13.1)	5 (8.2)

Body as a whole-general disorders	Fatigue	1 (1.6)	0 (0)	1 (1.6)
	Edema legs	1 (1.6)	0 (0)	0 (0)
	Chest discomfort	1 (1.6)	2 (3.3)	0 (0)
	Hot flushes	1 (1.6)	0 (0)	0 (0)
	Subtotal	3 (4.9)	2 (3.3)	1 (1.6)

Autonomic nervous system disorders	Palpitation	1 (1.6)	0 (0)	0 (1.6)

Musculo-skeletal system disorders	Muscle pain	1 (1.6)	1 (1.6)	0 (0)
	Muscle fatigue	0 (0)	0 (0)	1 (1.6)
	Subtotal	1 (1.6)	1 (1.6)	1 (1.6)

Skin and appendages disorders	Alopecia	1 (1.6)	0 (0)	0 (0)
	Urticaria	0 (0)	1 (1.6)	0 (0)
	Subtotal	1 (1.6)	1 (1.6)	0 (0)

Urinary system disorders	Urinary frequency	0 (0)	0 (0)	1 (1.6)
	Difficulty in Micturition	0 (0)	0 (0)	1 (1.6)
	Subtotal	0 (0)	0 (0)	2 (3.3)

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