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JKM > Volume 43(3); 2022 > Article
Kim, Lim, Ok, and Kim: Analysis of Weight Loss and Adverse Events in Overweight, and Obese Patients on Korean Medicine Weight Management Program with Face-to-Face Treatment and Non-Face-to-Face Treatment: A Retrospective Chart Review

Abstract

Objectives

The purpose of this study is to analyze the weight loss and the adverse events of overweight and obese adults on weight loss program with face-to-face treatment (FTF) and non-face-to-face treatment (NFTF) in 6 Korean Medicine obesity clinics.

Methods

From March 2nd to March 10th, 2021, we collected data with a retrospective way from overweight and obese adults (body mass index, BMI≥23 kg/m2) who registered for a 12-week Gamitaeeumjowi-tang prescription program. After matching initial information of the FTF group and the NFTF group using propensity matching score, weight loss and BMI change were analyzed, and adverse events were evaluated in terms of causality, severity and system-organ classes.

Results

Weight and BMI change from baseline to 12 weeks was −7.98±3.09kg (10.41±3.57%), −3.03±1.14kg/m2 and −7.30±3.11kg (9.59±3.45%), −2.76±1.15kg/m2 for FTF group and NFTF group, respectively. Body weight and BMI significantly decreased before and after treatment in both groups, and there was no significant difference in weight loss and BMI change between the two groups. No serious adverse events were reported.

Conclusions

This study showed the potential that NFTF weight management treatment could be a good alternative way to FTF weight management treatment without serious adverse events.

Fig. 1

Non-face-to-face treatment protocol

NFTFT: non-face-to-face treatment
jkm-43-3-65f1.gif
Fig. 2

Flowchart of dataset for analysis

FTFT: face-to-face treatment; NFTFT: non-face-to-face treatment; PSM: propensity score matching
jkm-43-3-65f2.gif
Fig. 3

Weight loss and BMI change with a general linear model

FTFT: face-to-face treatment; NFTFT: none face-to-face treatment
Weight and body mass index were significantly decreased before and after treatment in each group (p<0.001). There was no significant difference in weight and BMI between the two groups (p>0.05).
jkm-43-3-65f3.gif
Table 1
Exclusion Criteria for Prescription
  • Heart disease (heart failure, arrythmia, myocardial infarction, angina pectoris, etc.), uncontrolled hypertension, past history of stroke or ischemic heart attack

  • Hyperthyroidism

  • Glaucoma, serious neurological or psychological diseases (schizophrenia, epilepsy, alcoholics, drug addiction, anorexia, bulimia nervosa, etc.)

  • Malignant tumor, liver failure, renal failure

  • Children, adolescents

  • Pregnant women, breast feeding women

  • Patients taking Tuberculosis drugs, asthma drugs, drugs affecting the central nervous system

  • Or the other chronic neurological or cardiovascular disease

Table 2
Basal Characteristics of Subjects
Total (n=46) FTFT (n=23) NFTFT (n=23) p-value
Age (years) 38.09±8.24 37.70±10.48 38.48±5.36 p>0.05
Female (n, %) 42 (91.30) 21 (91.30) 21 (91.30) p>0.05
Initial weight (kg) 75.69±11.61 76.04±12.79 75.35±10.59 p>0.05
Initial BMI (kg/m2) 28.66±3.19 28.83±3.47 28.49±2.95 p>0.05

FTFT: face-to-face treatment; NFTFT: non-face-to-face treatment

Data are expressed as n(%) for categorical variables and mean±SD for continuous variables.

Table 3
Comparison of Changes in Weight and Body Mass Index
Total (n=46) FTFT (n=23) NFTFT (n=23) p-value
Initial weight (kg) 75.69±11.61 76.04±12.79 75.35±10.59 p>0.05
Second weight (kg) 70.93±10.96 71.00±11.97* 70.87±10.12* p>0.05
Final weight (kg) 68.06±10.46 68.07±11.57* 68.05±9.50* p>0.05
Weight loss (kg) 7.64±3.08 7.98±3.09 7.30±3.11 p>0.05
Initial BMI (kg/m2) 28.66±3.19 28.83±3.47 28.49±2.95 p>0.05
Second BMI (kg/m2) 26.86±3.00 26.91±3.20* 26.80±2.85* p>0.05
Final BMI (kg/m2) 25.77±2.81 25.80±3.05* 25.73±2.61* p>0.05
BMI change (kg/m2) −2.89±1.14 −3.03±1.14 −2.76±1.15 p>0.05

FTFT: face-to-face treatment; NFTFT: none face-to-face treatment

Second weight (kg): weight at 6 week; final weight (kg): weight at 12 week; weight loss (kg)=final weight-initial weight; BMI Change (kg/m2)

Data are expressed as n (%) for categorical variables and mean±SD for continuous variables

* p<0.001, Comparison before and after within-group treatment

Table 4
Adverse Events Reported from 46 subjects
6weeks, n(%) 12weeks, n(%)

FTFT NFTFT Total FTFT NFTFT Total
Casuality(WHO-UMC)
 Possible 5 (45.5) 5 (83.3) 10 (58.8) 2 (25.0) 3 (60.0) 5 (38.5)
 Unlikely 6 (54.5) 0 (0) 6 (35.3) 6 (75.0) 2 (40.0) 8 (61.5)
 Conditional/unclassified 0 (0) 1 (16.7) 1 (5.9) 0 (0) 0 (0) 0 (0)
 Total 11 (100) 6 (100) 17 (100) 8 (100) 5 (100) 13 (100)

Severity(CTCAE)
 Mild (grade 1) 11 (100) 6 (100) 17 (100) 8 (100) 5 (100) 13 (100)
 Moderate (grade 2) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Severe (grade 3) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Total 11 (100) 6 (100) 17 (100) 8 (100) 5 (100) 13 (100)
Table 5
Adverse Events According to System Organ Classes
6 w, n(%) 12w, n(%)

System-organ classes Symptom FTFT NFTFT FTFT NFTFT
Gastro-intestinal system disorders Constipation 5 (45.45) 3 (50.0) 2 (25.0) 0 (0)
Nausea 1 (9.09) 0 (0) 2 (25.0) 1 (20.0)
Dry mouth or Thirst 1 (9.09) 0 (0) 0 (0) 1 (20.0)
Subtotal 7 (63.63) 3 (50.0) 4 (50.0) 2 (40.0)

Psychiatric disorders Insomnia 0 (0) 0 (0) 1 (12.5) 1 (20.0)
Subtotal 0 (0) 0 (0) 1 (12.5) 1 (20.0)

Central & Peripheral nervous system Disorders Dizziness 2 (18.18) 0 (0) 1 (12.5) 0 (0)
Headache 1 (9.09) 1 (16.66) 2 (25.0) 1 (20.0)
Subtotal 3 (27.27) 1 (16.66) 3 (37.5) 1 (20.0)

Vascular disorders Peripheral coldness 1 (9.09) 0 (0) 0 (0) 0 (0)
Subtotal 1 (9.09) 0 (0) 0 (0) 0 (0)

Autonomic nervous system disorders Palpitation 0 (0) 1 (16.66) 0 (0) 1 (20.0)
Subtotal 0 (0) 1 (16.66) 0 (0) 1 (20.0)

Skin and appendages disorders Pruritus 0 (0) 1 (16.66) 0 (0) 0 (0)
Subtotal 0 (0) 1 (16.66) 0 (0) 0 (0)
Total 11 (100) 6 (100) 8 (100) 5 (100)

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