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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

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.

Fig. 1
Study patients flowchart
jkm-42-1-46f1.gif
Fig. 2
Weight change from baseline
jkm-42-1-46f2.gif
Table 1
Exclusion Criteria for Prescription
  1. Pregnant or breast feeding women

  2. Heart disease (heart failure, arrhythmia, myocardial infarction, angina pectoris, congenital heart disease, etc), or past history of ischemic heart attack

  3. Uncontrolled hypertension (systolic blood pressure higher more than 160mmHg or relaxation period blood pressure higher more than 100mmHg)

  4. Cerebral disease (cerebrovascular disease, cerebral aneurysm, epilepsy, cerebral infarction, etc), past history of stroke

  5. Severe liver disease (liver failure, liver infarction, active hepatitis, etc.), urination disorder (urinary failure, etc.)

  6. Psychiatric disorder (schizophrenia, severe depression, obsessive compulsive disorder, etc.)

  7. Patients taking Tuberculosis drugs, asthma drugs, sympathomimetic agent, anti-obesity drugs, monoamine oxidase inhibitors.

  8. Closed angle glaucoma

  9. Hyperthyroidism

  10. 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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