This study was conducted to collect and analyze real world data to evaluate the effectiveness and safety of comprehensive traditional Korean Medicine treatment on quality of life, anorexia and cachexia of cancer patients.

Methods

We analyzed medical records of 62 cancer patients admitted to O-I Dang Korean Medicine Hospital from February 2018 to February 2019. The primary outcome was a change score in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Trial Outcome Index(TOI) of FAACT, 11 point Pain Intensity Numeric Rating Score (11 PI-NRS) and Patient Global Impression of Change (PGIC) and adverse event.

Results

Cachexia and quality of life in cancer patients assessed by FAACT, increased by 5.59±14.83 (p=0.004) after treatment. PI-NRS was reduced by 2.10±1.81 (p<0.001) and TOI and FACT-G total scores were increased by 5.17 ±11.70 (p=0.001) and 3.59±10.94 (p=0.012), respectively. These results were also clinically meaningful assessed via minimal clinically important difference (MCID). There was no severe adverse event.

Conclusion

These findings suggest that comprehensive traditional Korean Medicine treatment might be effective and safe strategy for improving quality of life, anorexia, cachexia and pain of cancer patients. Further advanced studies with controlled group and more participants with rigorous design are needed to ensure these findings.

Keywords: Anorexia; Cachexia; Neoplasm; Quality of life; Medicine; Korean Traditional; Retrospective studies

Fig. 1

Data Extraction Flow Sheet

Fig. 2

Distribution of each Clinical Outcome (N=62)

The value is ‘after treatment – before treatment’. PI-NRS was not normally distributed.

A, Trial Outcome Index (TOI); B, Functional Assessment of Cancer Therapy-General (FACT-G); C, Functional Assessment of Anorexia/Cachexia Therapy (FAACT); D, Pain Intensity Numeric Rating Scale

Table 1

General Characteristics of Included patients (N=62)

Table 2

Detailed Information of Integrative Korean Medicine Treatment and Concomitant treatment (N=62)

Table 3

Change value of cancer related clinical outcome (N=62)

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Article information Continued

Fig. 2

Distribution of each Clinical Outcome (N=62)

The value is ‘after treatment – before treatment’. PI-NRS was not normally distributed.

A, Trial Outcome Index (TOI); B, Functional Assessment of Cancer Therapy-General (FACT-G); C, Functional Assessment of Anorexia/Cachexia Therapy (FAACT); D, Pain Intensity Numeric Rating Scale

Table 1

General Characteristics of Included patients (N=62)

Variables	Frequency n(%) or Mean ± SD
Sex	Female, 42 (67.7%); male, 20 (32.3%)
Age	52.23 ± 10.09 <30, 2 (3.2%); 30~39, 2 (3.2%); 40~49, 15 (24.2%); 50~59, 29 (46.8%); 60~69, 13 (21.0%); ≧70, 1 (1.6%)
Height	163.47 ± 8.18
Weight	61.44 ± 9.11
Smoking status	Smoking, 1 (1.6%); Non-smoking, 48 (77.4%); Ex-smoking, 13 (30%)
Drinking status	Non-drinking, 10 (16.1%); Ex-drinking, 52 (83.9%)
Job	Office workers, 37 (59.7%); House wife, 18 (29.0%); Service, manufacturing workers, 4 (6.5%); None, 3 (4.8%).
Past History	Diabetes Mellitus, 4 (6.5%); Hypertension, 7 (11.3%) ; Hyperlipidemia, 3 (4.8%); Tuberculosis, 0 (0%); Hepatitis, 4 (6.5.%); Cardiovascular Disease, 2 (3.2%)
ECOG Performance status	Grade 0, 52 (83.9%); Grade 1, 8 (12.9%); NR, 2 (3.2%)
Chief complaint on admission (allow repetition)	[Gastrointestinal disorder, 29 (46.8%)] Anorexia, 9 (14.5%); Nausea and vomiting, 7 (11.3%); Abdominal pain, 6 (9.7%); Dyspepsia, 2 (3.2%) [Pain, 34 (54.8%)] Surgical site pain, 20 (32.3%); Neck, back, shoulder pain, 5 (8.1%); Lumbago, 3 (4.8%); Headache, 2 (3.2%); Other pain, 4 (6.5%) [Respiratory disorder, 4 (6.5%)] Cough, 2 (3.2%); Dyspnea, 2 (3.2%) [Other side effects of chemotherapy, 28 (45.2%)] Post-operative condition improvement, 8 (12.9%) Other side effects, 20 (32.6%)
Primary cancer	Breast, 15 (24.2%); Stomach, 9 (14.5%); Lung, 9 (14.5%); Thyroid, 9 (14.5%); Colon and rectum, 6 (9.7%); Liver, 3 (4.8%); Prostate, 2 (3.2%); Bile duct, 1 (1.6%); Uterus, 1 (1.6%); Brain, 1 (1.6%); Ureter, 1 (1.6%); Small Bowel, 1 (1.6%); Ovary, 1 (1.6%); Fallopian Tube Ovary, 1 (1.6%); Tongue, 1 (1.6%); Lymphoma, 1 (1.6%)
Metastasis (allow repetition)	Number of metastatic patients, 26 (41.9%) Metastatic site: Lymph node, 15 (24.2%); Lung, 6 (9.7%); Liver, 4 (6.5%); Peritoneum, 2 (3.2%); Brain, 1 (1.6%); Colon and rectum, 1 (1.6%); Chest wall, 1 (1.6%); Diaphragm, 1 (1.6%); Adrenal gland, 1 (1.6%)
Recurrence	Number of recurrent patients, 5 (8.0%)
Stage of cancer	0, 1 (1.6%); I, 19 (30.6%); II, 10 (16.1%); III, 2 (3.2%); IV, 12 (19.4%); NR, 18 (29.0%)
Chemotherapy	Number of patients treated with chemotherapy, 16 (25.8%) Session of chemotherapy: 1, 4 (6.5%); 3, 3 (4.8%); 4, 1 (1.6%); 6, 2 (3.2%); 7, 1 (1.6%); NR, 5 (8.1%)
Radiotherapy	Number of patients treated with radiotherapy, 6(9.7%) Number of radiotherapy: 27, 1 (1.6%); 30, 3 (4.8%); 32, 1 (1.6%); NR, 1 (1.6%)
Operation	Number of patients who had an operation, 57(91.9%) Number of operations: Once, 55 (88.7%); Twice, 1 (1.6%); Third times, 1 (1.6%)
Admission duration	1~5days, 3 (4.8%); 6~10days, 16 (25.8%); 11~15days, 36 (58.1%); 16~20days, 7 (11.3%)

NR, Not reported

Table 2

Detailed Information of Integrative Korean Medicine Treatment and Concomitant treatment (N=62)

Treatment	Frequency n(%) or Mean ± SD
Herbal Medicine	8 (12.9%) Banhasasim-tang(半夏瀉心湯) 2d/3d Cheonwangbosim-dan(天王補心丹) 1d, Sogeonjung-tang(小建中湯) 7d, Hyangsapyeongwi-san(香砂平胃散) 2d, Samulijin-tang(四物二陳湯) 15d, Uchashinki-hwan(牛車腎氣丸) 7d, Oryeong-san(五令散) 4d, Sipjeondaebo-tanggami(十全大補湯加味) 7d
Acupuncture (allow repetition)	62 (100%) In order of most used Sa-am acupuncture therapy SP(脾) jeonggyeok, 24 (38.7%); ST(胃) jeonggyeok, 11 (17.7%); ST(胃) seunggyeok, 9 (14.5%); KI(腎) jeonggyeok, 7 (11.3%); LR(肝) hangyeok, 7 (11.3%); LU(肺) jeonggyeok, 5 (8.1%); GB(膽) jeonggyeok, 5 (8.1%); LR(肝) jeonggyeok, 4 (6.5%); LI(大腸) seunggyeok, 4 (6.5%); TE(三焦) seunggyeok, 4 (6.5%); SI(小腸) jeonggyeok, 3 (4.8%); TE(三焦) jeonggyeok, 2 (3.2%); SP(脾) seunggyeok, 1 (1.6%); BL(膀胱) jeonggyeok, 1 (1.6%); HT(心) jeonggyeok, 1 (1.6%); LI(大腸) jeonggyeok, 1 (1.6%) In order of most used Sa-am acupuncture point(more than 5 times) SP 2(大都), 25 (40.3%); GB 41(足臨泣), 20 (32.3%); ST 43(陷谷), 19 (30.6%); ST 36(足三里), 15 (24.2%); LR 2(行間), 9 (14.5%); KI 3(太谿), 8 (12.9%); KI 7(復溜), 8 (12.9%); TE 2(液門), 6 (9.7%); LI 5(陽谿), 6 (9.7%); SI 5(陽谷), 6 (9.7%); SP 3(太白), 5 (8.1%); LU 9(太淵), 5 (8.1%); LR 8(曲泉), 5 (8.1%); SI 3(後谿), 5 (8.1%)
Infra-red	62 (100%)
Moxibustion	43 (69.4%)
Cupping therapy	43 (69.4%)
Concomitant treatment	Sodium selenite 500μg (Selenase®), 31(50%); Radiofrequency ablation, 9(14.5%); Mistletoe, 4(6.5%); Thymosin-α1 (Thy-1), 53(85.5%)

D, Days

Jeonggyeok(正格), taking the acupuncture point in the relevant meridian of the Deficient organ and tonifying the organ; Seunggyeok(勝格), taking the acupuncture point in the relevant meridian of the Excessive organ and sedating the organ; Hangyeok(寒格), taking the acupuncture point in the relevant meridian of the hot organ and cooling the organ.

SP, Spleen; ST, Stomach; KI, Kidney; LR, Liver; LU, Lung; GB, Gall Bladder; LI, Large Intestine; TE, Triple Energizer; SI, Small Intestine; BL, Bladder; HT, Heart

Table 3

Change value of cancer related clinical outcome (N=62)

Outcome	Before treatment Mean (SD)	After treatment Mean (SD)	Change value Mean (SD)	p-value
Physical Well-Being (PWB)	18.77 (6.08)	21.76 (4.72)	2.99 (5.11)	<0.001†
Social/Family Well-Being (SWB)	18.95 (5.38)	18.79 (5.60)	−0.16 (4.43)	0.771
Emotional Well-Being (EWB)	17.54 (3.95)	18.13 (4.09)	0.58 (3.65)	0.212
Functional Well-Being (FWB)	15.67 (5.80)	15.85 (5.93)	0.18 (4.63)	0.760
Anorexia Cachexia Subscale (ACS)	31.55 (6.88)	33.55 (6.42)	2.00 (6.63)	0.035†
FAACT Trial Outcome Index (TOI)	66.00 (15.02)	71.17 (13.21)	5.17 (11.70)	0.001*
FACT-G total score	70.95 (14.49)	74.54 (15.27)	3.59 (10.94)	0.012*
FAACT total score (primary outcome)	102.50 (18.52)	108.09 (18.82)	5.59 (14.83)	0.004*

PI-NRS	3.90 (2.38)	1.81 (1.71)	−2.10 (1.78)	<0.001†

FAACT, Functional Assessment of Anorexia/Cachexia Therapy; FACT, Functional Assessment of Cancer Therapy; PI-NRS, Pain intensity numeric rating score; SD, Standard Deviation

According to Normality test, Paired t-test or Wilcoxon signed rank test was conducted comparing before and after treatment value. Change value of PI-NRS, PWB and ACS was not normally distributed.

^{* or †}

p<0.05 was statistically significant (*, paired t-test; ^†, Wilcoxon signed rank test)

Except for PI-NRS, higher score means higher cancer related quality of life.