In South Korea, the political and social status of Traditional Korean Medicine (TKM) almost equals that of Western medicine. This is due to a strong preference for TKM in Korean people. When 1,000 people living in Seoul were asked to choose between Western medicine doctors and TKM doctors if they had developed a stroke, 25% of the subjects chose TKM doctors, and 45% of the subjects responded that they were willing to receive TKM treatments [
Considering the large role in the treatment of stroke, significant amount of effort was put into accumulating scientific evidence of the efficacy and safety of TKM. As a result, questionnaire for the pattern identification and guidelines for assessing the clinical indicators were developed over the years [
In this study, to verify the necessity and usefulness of pattern identification, we compared the two groups of the patients diagnosed as fire-heat pattern. The group who took the herbal prescriptions in accordance with the pattern identification and the group of people who did not take the herbal prescriptions accordingly were compared to demonstrate if the corresponding prescription taking group shows better outcome. Also, we performed a correlation study between the changes in clinical indicators and the improvement in dysfunctions to identify if the changes in symptoms are relevant to recovery of poststroke dysfunctions.
We enrolled ischemic stroke patients within 30 days after their ictus from Kyung Hee Korean Medical Center and Kyung Hee East-West Neo Medical Center. Imaging diagnosis such as computerized tomography (CT) or magnetic resonance imaging (MRI) was checked to confirm the ischemic stroke. We excluded traumatic strokes such as subarachnoid, subdural, and epidural hemorrhage. Also, we excluded patients with brain tumor, Alzheimer’s disease, multiple sclerosis, or any other neurodegenerative diseases. Informed consent of all the participants was obtained after a thorough explanation of the details. Over a 3-year period from May 2011 to January 2014, 300 patients were included in the study. The Institutional Review Board of the Kyung Hee Korean Medical Center and Kyung Hee East-West Neo Medical Center approved the present study (KOMCIRB-2011-02, KOMCIRB-2012-04, KHNMCOHIRB-2011-002, and KHNMCOHIRB-2012-003).
After the admission, two different TKM doctors identified the pattern of each patient based on the clinical indicators they show, and we confirmed the pattern only if the two TKM doctors had the same opinion. We used the Case Report Form (CRF) and the Standard Operation Procedures (SOP) developed by the Korean Institute of Oriental Medicine [
Clinical indicators related to pattern identification.
Overweight | Body Mass Index >23 (kg/m2) |
Insomnia | Inability to sleep or abnormal wakefulness |
Fatigue | Lack of strength |
Pale complexion | A white complexion with a hint of blue or gray, often caused by yang collapse or exuberance of cold |
Yellow complexion | Yellow discoloration of the face, generally suggesting accumulation of dampness |
Reddened complexion | A complexion redder than normal, indicating the presence of heat |
Darkish complexion | Dark discoloration of the face, often occurring in cold syndrome, water retention, or blood stasis |
Flushed cheeks | Localized flush in the cheeks, indicating yin deficiency |
Headache | Pain in the head |
Eye congestion | Congestion in eyeballs indicating presence of heat |
Eyeball dryness | Subjective feeling of dryness in the eyeballs |
Phlegm rale | An abnormal breathing sound by phlegm in the airways |
Faint low voice | A voice that is faint and low, scarcely audible |
Tongue sore | Ulceration in the oral cavity or tongue |
Halitosis | Bad smell from the mouth |
Thirst | Feeling of dryness of the mouth with a desire to drink |
Bitter taste in the mouth | A subjective bitter sensation in the mouth |
Night sweating | Sweating during sleep that ceases on awakening |
Chest discomfort | Unwell feeling of stuffiness and fullness in the chest |
Nausea | An unpleasant sensation with an urge to vomit |
Aversion to heat | Strong dislike of heat, also known as heat intolerance |
Afternoon tidal fever | Fever more marked in the afternoon |
Heat in the palms and soles | Subjective feverish feeling in the palms and soles |
Vexing heat in the extremities | Uncomfortable heat sensation in the extremities |
Reversal cold of the extremities | Pronounced cold in the extremities up to the knees and elbows, also the same as cold extremities |
Reddish yellow urine | Dark yellow or even reddish urine, indicating heat |
Pale tongue | A tongue less red than normal, indicating Qi and blood deficiency |
Red tongue | A tongue redder than normal, indicating the presence of heat |
White fur | A tongue coating white in color |
Yellow fur | A tongue coating yellow in color |
Thick fur | A tongue coating where the underlying tongue surface is not visible |
Dry fur | A tongue coating that looks dry and feels dry to the touch |
Teeth marked tongue | A tongue with dental indentations on its margin |
Enlarged tongue | A tongue that is larger than normal, pale in color, and delicate |
Mirror tongue | A completely smooth tongue free of coating, like a mirror |
Floating pulse | A superficially located pulse which can be felt by light touch and grows faint on hard pressure |
Deep pulse | A deeply located pulse which can only be felt when pressing hard |
Slow pulse | Bradycardia |
Rapid pulse | Tachycardia |
Strong pulse | A general term for strongly beating pulse |
Vacuous pulse | A general term for a feeble and void pulse |
Thin pulse | A pulse as thin as a silk thread, straight and soft, and feeble yet always perceptible upon hard pressure |
Slippery pulse | A pulse coming and going smoothly like beads rolling on a plate |
Flooding pulse | A pulse beating like dashing waves with forceful rising and gradual decline |
All subjects were studied twice, 2 weeks apart. During the 2-week period, all participants received conventional Western medicine treatment such as antiplatelet agent, risk factor control (e.g., hypertension, diabetes mellitus, dyslipidemia, and cardiac disease), and rehabilitation exercise. TKM treatment was also administered to all of the patients, which includes herbal prescription, acupuncture, and electroacupuncture. The contents of acupuncture and electroacupuncture treatment are shown in Table
Traditional Korean Medicine treatments applied in the study.
Treatment | Contents |
---|---|
Acupuncture (once a day) | LI4, LI11, ST36, LR3, GB20 (both sides), TE5, LI10, ST37, GB39, GB34, SP3, SP4 (debilitated side), GV20, GV26, and CV24 |
Electroacupuncture (once a day) | LI4, TE5, LI10, LI11, ST36, ST37, GB39, and LR3 (debilitated side) |
Classification of prescriptions used in this study by Korean Institute of Oriental Medicine.
Fire-heat pattern | Yin Deficiency Pattern | Phlegm Dampness Pattern | Qi Deficiency Pattern |
---|---|---|---|
Yangkyuksanwha-tang | Hyungbangjihwang-tang | Bosimgunbi-tang | Sunghyangjunggi-san |
Chungpyesagan-tang | Dokhwaljihwang-tang | Banhabaekchulchunma-tang | Bojungikgi-tang |
Yeoldahanso-tang | Jaumganghwa-tang | Sunkidodam-tang | Ssanghwa-tang |
Chungsim-tang | Yukmijihwang-tang | Gami-ondam-tang | Boyanghwano-tang |
Jihwangbakho-tang | Saryuk-tang | Yikgeebohyul-tang |
Baseline characteristics such as age, sex, Body Mass Index (BMI), period from onset to admission, medical history, alcohol and smoking habits, and Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification [
To assess the changes in the clinical indicators, we used the logistic equations for calculating the probability of each pattern suggested by Kim et al. [
Discriminant validity of probability of four patterns.
Probability of FHP | Probability of YDP | Probability of PDP | Probability of QDP |
|
|
---|---|---|---|---|---|
FHP group ( |
58.7 (38.8) | 14.0 (32.0) | 10.9 (25.7) | 1.4 (8.6) | <0.0001 |
YDP group ( |
17.8 (33.0) | 31.2 (42.0) | 16.5 (32.1) | 4.8 (13.9) | <0.0001 |
PDP group ( |
16.6 (33.9) | 0.8 (2.3) | 59.9 (42.7) | 4.5 (16.2) | <0.0001 |
QDP group ( |
0.1 (0.3) | 4.2 (11.8) | 19.6 (35.7) | 38.2 (43.7) | <0.0001 |
FHP, fire-heat pattern; YDP, Yin Deficiency Pattern; PDP, Phlegm Dampness Pattern; QDP, Qi Deficiency Pattern.
Statistical analysis was performed by using the Statistical Package for the Social Sciences version 12.0 for Windows (SPSS, Chicago, IL). Chi-square test was used for the categorical variables, and Mann-Whitney test was used for the continuous variables when comparing the two groups. Wilcoxon signed rank test was used for statistical comparisons between the values before and after the treatment. We correlated the changes in the probability of fire-heat pattern with the changes of SSS score and MI score, respectively, using Spearman’s rank correlation. A
Of the 300 patients enrolled in the study, 68 patients were discharged before the second checkup, and 44 patients with perfect MI and SSS score were excluded as they could not expect further improvement. 40 patients were unable to determine the pattern because the diagnosis of the two TKM doctors differed. 11 patients were dropped out due to missing data. Also, many patients diagnosed as Yin Deficiency Pattern, Phlegm Dampness Pattern, and Qi Deficiency Pattern received different types of herbal prescriptions during the treatment period. Only two patients in the Yin Deficiency Pattern, three patients in the Phlegm Dampness Pattern, and two patients in the Qi Deficiency Pattern received pattern corresponding herbal prescription for the whole 2-week period, so we were unable to secure a sufficient sample size for statistical analysis for those three patterns. Among the remaining 57 patients who were diagnosed as fire-heat pattern, we considered 40 patients who received herbal prescriptions targeting fire-heat pattern related symptoms into correspondence group and the other 17 patients who received herbal prescriptions focusing on clinical indicators of other patterns into noncorrespondence group (Figure
Flowchart of patients enrolled in this study. MI, Motricity Index; SSS, Scandinavian Stroke Scale; YDP, Yin Deficiency Pattern; PDP, Phlegm Dampness Pattern; QDP, Qi Deficiency Pattern.
General characteristics, period from onset to admission, medical history, alcohol and smoking experience, and proportion of ischemic stroke type according to TOAST classification showed no significant difference between the two groups (Table
Comparisons of baseline characteristics between the correspondence group and the noncorrespondence group.
Correspondence group ( |
Noncorrespondence group ( |
|
|
---|---|---|---|
Gender, male (%) | 24 (60.0) | 8 (47.1) | 0.397 |
Age, yr (SD) | 69.2 (10.0) | 68.4 (10.0) | 0.524 |
BMI, kg/m2 (SD) | 24.1 (3.0) | 24.5 (3.4) | 0.848 |
Treatment period from onset, day (SD) | 9.5 (6.2) | 12.7 (8.7) | 0.142 |
Past history | |||
Hypertension (%) | 32 (80.0) | 12 (70.6) | 0.499 |
Dyslipidemia (%) | 15 (37.5) | 7 (41.2) | 1.000 |
Diabetes mellitus (%) | 15 (37.5) | 6 (35.3) | 1.000 |
Heart disease (%) | 4 (10.0) | 2 (11.8) | 1.000 |
Stroke type | |||
LAA (%) | 11 (27.5) | 4 (23.5) | 1.000 |
CE (%) | 3 (7.5) | 1 (5.9) | 1.000 |
SVO (%) | 25 (62.5) | 11 (64.7) | 1.000 |
SUE (%) | 1 (2.5) | 1 (5.9) | 0.511 |
Life style | |||
Smoking (%) | 18 (45.0) | 7 (41.2) | 1.000 |
Alcohol (%) | 19 (47.5) | 5 (29.4) | 0.251 |
BMI, Body Mass Index; LAA, large artery arteriosclerosis; CE, cardiogenic embolism; SVO, small vessel occlusion; SUE, stroke of undetermined etiology.
Both groups showed increase in the MI score and the SSS score, but the increments of the MI score and the SSS score in the correspondence group were significantly greater than those of the noncorrespondence group (
Comparisons of MI score and SSS score between the correspondence group and the noncorrespondence group.
Correspondence group ( |
Noncorrespondence group ( |
|
|
---|---|---|---|
Visit 1 MI score | 54.8 ± 25.7 | 45.9 ± 31.7 | 0.382 |
|
14.3 ± 11.3 | 6.3 ± 9.3 | 0.003 |
Visit 1 SSS score | 39.9 ± 10.4 | 38.1 ± 11.8 | 0.662 |
|
6.9 ± 4.0 | 3.5 ± 3.2 | 0.001 |
MI, Motricity Index; SSS, Scandinavian Stroke Scale.
The probability of fire-heat pattern was significantly higher than the probability of other patterns in both groups (
Changes of the pattern probabilities in the correspondence group and the noncorrespondence group before and after the treatment.
Before | After |
|
|
---|---|---|---|
Correspondence group ( |
|||
Probability of fire-heat pattern | 62.6 ± 39.3† | 51.1 ± 40.4 | 0.013 |
Probability of Yin Deficiency Pattern | 9.8 ± 27.5 | 5.3 ± 17.9 | 0.337 |
Probability of Phlegm Dampness Pattern | 6.2 ± 17.8 | 8.8 ± 16.9 | 0.149 |
Probability of Qi Deficiency Pattern | 2.0 ± 10.3 | 3.6 ± 11.1 | 0.432 |
Noncorrespondence group ( |
|||
Probability of fire-heat pattern | 49.5 ± 37.0† | 43.8 ± 35.7 | 0.374 |
Probability of Yin Deficiency Pattern | 23.9 ± 40.1 | 32.5 ± 45.4 | 0.646 |
Probability of Phlegm Dampness Pattern | 22.0 ± 36.7 | 12.8 ± 31.3 | 0.182 |
Probability of Qi Deficiency Pattern | 0.0 ± 0.1 | 11.0 ± 26.0 | 0.050 |
†
In the correlation study, the decrease in the probability of fire-heat pattern showed significant correlation with the increase in the SSS score (
Correlation analysis between the changes of SSS score and the probability of fire-heat pattern in the correspondence group (
Correlation analysis between the changes of MI score and the probability of fire-heat pattern in the correspondence group (
The aim of this study was to verify the usefulness of the pattern identification. To achieve this goal, we compared the outcome of the treatments in pattern-prescription correspondence group and the noncorrespondence group. While the baseline scores did not differ significantly between the two groups, increments of MI score and SSS score after the treatment were significantly higher in the correspondence group than the noncorrespondence group (
A type of herbal prescription is selected based on the clinical indicators a patient is showing, and when used, the herbal prescriptions are expected to alleviate the clinical symptoms. We used the probability of fire-heat pattern as a scale to evaluate the changes in the clinical symptoms of patients diagnosed as fire-heat pattern. As expected, the probability of fire-heat pattern decreased significantly in the correspondence group (
Usage of herbal prescriptions on acute ischemic stroke patients has been studied over the years [
We could not verify the effectiveness of pattern identification in patients diagnosed as Yin Deficiency Pattern, Phlegm Dampness Pattern, and Qi Deficiency Pattern, because they were not consistent in consuming the herbal prescriptions corresponding with their pattern and therefore were not suitable for the subjects of this study. This was not expected when we designed the study, but due to this outcome, the application of the results in the present study should be limited only in the patients diagnosed as fire-heat pattern. Another limitation is that the probability of pattern does not properly evaluate the severity of the clinical symptoms related to each pattern since the scale was made to determine the pattern not to assess the clinical indicators. We used the probability of patterns in this study because this scale was created based on the data collected using the same CRF and SOP used in the present study. There is no widely accepted scale assessing the severity of the symptoms related to pattern identification, and it should be developed in the future for more researches concerning pattern identification.
In the present study, correspondence group displayed better outcome than the noncorrespondence group, and in the correspondence group, patients with lesser clinical indicators related to fire-heat pattern after the treatment showed better improvement in the recovery of functional impairment. These results imply that herbal prescriptions in accordance with the diagnosed pattern alleviate the clinical symptoms in relation with the diagnosed pattern and are more effective in restoring the dysfunctions caused by the disease than the noncorresponding prescriptions. The results provide evidence for the necessity and usefulness of pattern identification in TKM, but further research is needed to confirm the effectiveness of pattern identification for the other pattern groups.
The authors declare that there is no conflict of interests regarding the publication of this paper.
The authors sincerely thank the Korean Institute of Oriental Medicine for their help throughout the study.