Efficacy of mecasin for treatment of amyotrophic lateral sclerosis: A phase IIa multicenter randomized double-blinded placebo-controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Amyotrophic lateral sclerosis (ALS) is a lethal neurodegenerative disorder characterized by progressive paralysis of voluntary muscles. Mecasin, the extract of modified jakyakgamchobuja-tang-a herbal preparation comprising of Radix Paeoniae Alba, Radix Glycyrrhizae, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Gastrodiae, Radix Polygalae, Curcuma Root, Fructus Chaenomelis, and Rhizoma Atractylodis Japonicae-shows neuroprotective and anti-neuroinflammatory effects and alleviates the symptoms in patients with ALS. AIM OF THE STUDY: This trial aimed to evaluate the efficacy and safety of mecasin in these patients. MATERIAL AND METHODS: Patients were randomized to receive mecasin 1.6 g daily, mecasin 2.4 g daily, or placebo for 12 weeks. The primary endpoint was the Korean version of ALS Functional Rating Scale-Revised (K-ALSFRS-R) score. The secondary endpoints were muscular atrophy measurements, pulmonary function test results, creatine kinase levels, body weight, safety, and scores of the Medical Research Council (MRC) scale for muscle strength; Visual Analog Scale for pain (VAS pain); Hamilton Rating Scale for Depression; and Fatigue Severity Scale. RESULTS: Among the 30 patients randomized, 24 completed the follow-up. Significant between-group differences were detected in the primary endpoint using the omnibus F-test. The changes in the K-ALSFRS-R score between 12 weeks and baseline were -0·25, -1·32, and -2·78 in the mecasin 1.6 g, mecasin 2.4 g, and placebo groups, respectively. The difference in the K-ALSFRS-R score between the mecasin 1.6 g and placebo groups was 2·53 points (95% confidence interval [CI]: 0·61-4·45), and that between the 2.4 g and placebo groups was 1·46 points (95% CI: 0·48-3·40). However, no significant differences were detected in the secondary endpoints (MRC: dyspnea, p = 0·139; VAS pain, p = 0·916; forced vital capacity, p = 0·373). The incidence of adverse events was similar and low in all groups. CONCLUSIONS: Mecasin may retard symptomatic progression without major adverse effects. A phase IIb study to evaluate its long-term effects in ALS is ongoing.

Evidence Map of Cupping Therapy.

This study aimed to describe and assess the current evidence in systematic reviews on cupping therapy for various conditions. We searched PubMed, EMBASE, Cochrane Database of Systematic Reviews, China National Knowledge Infrastructure, and six Korean databases for systematic reviews of trials on cupping treatments for any condition published prior to March 2021. We used a bubble plot to graphically display the clinical topics, the number of articles, the number of participants in the total population, confidence, and effectiveness. Thirteen systematic reviews that met the inclusion criteria were included in the evidence map, and 16 bubbles were created. The findings from six reviews showed potential benefits of cupping for conditions such as low back pain, ankylosing spondylitis, knee osteoarthritis, neck pain, herpes zoster, migraine, plaque psoriasis, and chronic urticaria. Cupping has been applied in a variety of clinical areas, and systematic reviews in a few of these areas have demonstrated statistically significant benefits. The evidence map provides a visual overview of cupping research volume and findings. Evidence mapping can facilitate the transfer of knowledge from researchers to policymakers and promote research on musculoskeletal pain (such as low back pain, neck pain, and knee osteoarthritis) and skin disease (plaque psoriasis).

Psycho-Electrophysiological Benefits of Forest Therapies Focused on Qigong and Walking with Elderly Individuals.

We developed two distinct forest therapy programs (FTPs) and compared their effects on dementia prevention and related health problems for older adults. One was focused on Qigong practice in the forest (QP) and the other involved active walking in the forest (WP). Both FTPs consisted of twelve 2-h sessions over six weeks and were conducted in an urban forest. We obtained data from 25, 18, and 26 participants aged 65 years or above for the QP, WP, and control groups, respectively. Neuropsychological scores via cognition (MoCA), geriatric depression (GDS) and quality of life (EQ-5D), and electrophysiological variables (electroencephalography, bioimpedance, and heart rate variability) were measured. We analyzed the intervention effects with a generalized linear model. Compared to the control group, the WP group showed benefits in terms of neurocognition (increases in the MoCA score, and alpha and beta band power values in the electroencephalogram), sympathetic nervous activity, and bioimpedance in the lower body. On the other hand, the QP group showed alleviated depression and an increased bioimpedance phase angle in the upper body. In conclusion, both active walking and Qigong in the forest were shown to have distinctive neuropsychological and electrophysiological benefits, and both had beneficial effects in terms of preventing dementia and relieving related health problems for elderly individuals.

Radial Pulse and Electrocardiography Modulation by Mild Thermal Stresses Applied to Feet: An Exploratory Study with Randomized, Crossover Design.

OBJECTIVE: To investigate the changes in radial pulse induced by thermal stresses (TSs). METHODS: Sixty subjects were enrolled. Using an open-label, 2×2 crossover randomization design, both feet of each subject were immersed in 15 °C water for cold stress (CS) and in 40 °C water for heat stress (HS) for 5 min each. Radial pulse, respiration and electrocardiogram (ECG) signals were recorded before, during and immediately after the TSs. RESULTS: The analysis of heart rate variability revealed that CS increased the low-frequency (LF) and high-frequency (HF) components (P <0.05) and that HS reduced the LF and HF components (P <0.01). Both TSs reduced the normalized LF, increased the normalized HF, and reduced the LF/HF ratio. The differences in the ECG signals were more dominant during the TS sessions, but those in the radial pulse signals became more dominant immediately after the TS sessions. CS decreased the pulse depth (P <0.01) and increased the radial augmentation index (P <0.1), and HS increased the pulse pressure (P <0.1) and subendocardial viability ratio (P <0.01). There were no significant differences in pulse rate during the three time sequences of each TS. The respiration rate was increased (P <0.1), and the pulse rate per respiration (P/R ratio) was significantly decreased (P <0.05) with CS. The HF region (10-30 Hz) of the pulse spectral density was suppressed during both TSs. CONCLUSIONS: CS induced vasoconstriction and sympathetic reactions, and HS induced vasodilation and parasympathetic reactions. Based on definitions used in pulse diagnosis, we made the novel discoveries that the pulse became slower (decreased P/R ratio), more floating and tenser under CS and that the HF region of the spectral power decreased significantly under both TSs.

Traditional Korean Medicine-Based Forest Therapy Programs Providing Electrophysiological Benefits for Elderly Individuals.

We aimed to develop forest therapy programs (FTPs) to prevent dementia and related health problems in the elderly population, with the assumption that health benefits are FTP-type specific and depend on the participant's psychophysiological traits. For this purpose, we developed two distinct FTPs, namely, a guided-breathing meditation program (BP) and a walking program (WP); we adopted the approach of Sasang constitutional (SC) medicine, which categorizes individuals into one of three SC types (SC1, SC2, or SC3) for medical care. The FTPs ran 11 sessions over 11 weeks. We recruited 29/31/28 participants who were 65 years of age or older for the BP/WP/control groups, respectively; obtained electrophysiological measurements via electroencephalogram (EEG), heart rate variability (HRV), and bioimpedance; and analyzed the intervention effects with analysis of covariance. Compared with the control, the BP and WP resulted in benefits for neural activity and parasympathetic nervous activity (PNA), respectively, and both FTPs yielded distinct beneficial effects on bioimpedance. Constitution-specific effects were also present. The SC1- and SC2-type participants gained positive effects in neural activity from the BP and WP, respectively. The SC3-type participants showed improvements in PNA from the WP. In conclusion, for older individuals, both programs conferred health benefits that would help prevent dementia, and the benefits were program-specific and constitution-specific.

Short-Term Efficacy of Pulsed Radiofrequency Thermal Stimulation on Acupoints for Chronic Low Back Pain: A Preliminary Study of a Randomized, Single-Blinded, Placebo-Controlled Trial.

BACKGROUND: The objective of this study was to evaluate the pain-relief efficacy of thermal stimulation induced by a pulsed radiofrequency (PRF) thermal stimulation applied to acupoints (APs) in patients with low back pain (LBP). The study was designed as a randomized, single-blinded, placebo-controlled trial. Methods. Fifty-six LBP patients whose minimum pain intensity score on a visual analogue scale (VAS, 0-100 mm) was more than 30 mm were randomly allocated to either the placebo-controlled or the treatment group at a 1:1 ratio. The treatment and placebo-controlled groups received PRF thermal stimulation plus cupping therapy and cupping therapy only, respectively. Each patient was scheduled to receive a total of three treatment sessions over one week with allowing a window up to 4 days. Six of the 13 predefined APs were selected differently for each session depending on the change in patient's symptoms and intensity of pain. The primary outcome was the mean difference between the placebo-controlled and treatment group of VAS changes from the baseline to the end of the follow-up period. RESULTS: The patients' reported VAS scores from baseline to the end of follow-up (average: 9.8 days) were significantly decreased by 8.036 points (two-sided 95% CI, -11.841 to -4.231) and 13.393 points (two-sided 95% CI: 17.198 to -9.588) in the treatment and the placebo-controlled groups, respectively. However, the change in VAS scores between the treatment group and the placebo-controlled group was not significantly different (2.015 mm, two-sided 95% CI: -5.288 to 9.317). CONCLUSION: The trial results indicated that treatment with either PRF thermal stimulation with cupping therapy or cupping therapy alone effectively relieved LBP. The efficacy of PRF thermal stimulation combined with cupping therapy was not superior to that of cupping therapy alone. Trial registration number: Clinical Research Information Service (KCT0002137). The trial was registered retrospectively on 10 November, 2016.

An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

Introduction:Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration (p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels (p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire (p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" (p = 0.02). Five participants experienced minor adverse events, but no adverse events were specific to the GJD administration period. Conclusions: This trial produced the first clinical evidence that GJD might have anti-fatigue properties, especially under sleep deprivation; however, the investigation of cortisol-mediated mechanisms requires further larger-scale studies in the future. TRIAL REGISTRATION: World Health Organization International Clinical Trials Registry Platform KCT0001681 (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=KCT0001681).

Hemodynamic changes caused by acupuncture in healthy volunteers: a prospective, single-arm exploratory clinical study.

BACKGROUND: Radial pressure pulse wave (RPPW) examination has been a key diagnostic component of traditional Chinese medicine. The objective of this study was to investigate the changes in RPPW along with various hemodynamic variables after acupuncture stimulation and to examine the validity of pulse diagnosis as a modern diagnostic tool. METHODS: We conducted acupuncture stimulation at both ST36 acupuncture points in 25 healthy volunteers. We simultaneously assessed the RPPW by pulse tonometry; heart rate variability (HRV) by electrocardiogram; photoplethysmogram (PPG) signals, respiration rate, peripheral blood flow velocity and arterial depth by ultrasonography; and cardiac output by impedance cardiography, before, during and after a session of acupuncture stimulation. RESULTS: We observed consistent patterns of increased spectral energy at low frequency (<10 Hz) and pulse power using RPPW examination and in the amplitude and systolic area of the PPG signal during the entire acupuncture session. The low- and high-frequency domains of HRV increased and decreased, respectively, during the acupuncture session. The peripheral blood velocity rose shortly after needle insertion, reached a maximum in the middle of the session and decreased afterwards. The augmentation index (AIX) and pulse transit time (PTT) obtained from RPPW did not change significantly. CONCLUSION: Acupuncture stimulation at ST36 in healthy subjects increased the peripheral pulse amplitudes (pressure pulse wave (PPW) and PPG), blood flow velocity (ultrasonography) and sympathetic nerve activity (HRV). The lack of changes in the AIX and PTT suggests that the increased pulse amplitudes and blood flow velocity may result from increased cardiac output. TRIAL REGISTRATION: Clinical Research Information Service ( KCT0001663 ).

Effects of Acupuncture Stimulation on the Radial artery's Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study.

INTRODUCTION: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. METHODS AND ANALYSIS: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. DISCUSSION: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

A Systematic Review on Sasang Constitutional Type-Associated Susceptibility to Disorders in Korea.

BACKGROUND/OBJECTIVE: Sasang constitutional medicine is a component of traditional Korean medicine that classifies individuals into four Sasang constitutional types (SCTs) by their physical and psychological traits. Each SCT is known to show different susceptibilities to disorders. This systematic review investigated the effect of SCT as a risk factor for various disorders. METHODS: A systematic literature survey was conducted by searching seven databases for all articles on the prevalence rates of disorders according to SCT and sex. RESULTS: From 14,272 relevant articles, 15 studies (13 disorders) were ultimately identified to verify different prevalence rates by SCT. Of the 13 disorders, 6 (prehypertension, general obesity, abdominal obesity, metabolic syndrome, diabetes mellitus, and irritable bowel syndrome [IBS]) had a significantly different prevalence by SCT. Metabolic syndrome and its associated disorders showed the highest prevalence in Taeumin-type individuals, whereas IBS was most prevalent in Soeumin-type individuals. In general, these findings were consistent with the results obtained in an analysis of male and female participants. CONCLUSIONS: This study revealed that susceptibility to disorders was affected by SCT to some extent. Further studies are needed to determine the concrete features of SCT-related susceptibility, which may be helpful in preventive medicine with Sasang constitutional practice.

Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: study protocol for a randomised controlled trial.

BACKGROUND: Many herbal medicines are traditionally used as anti-fatigue agents in east Asian countries; however, there is a dearth of clinical evidence supporting the anti-fatigue effects of such medicines and their mechanisms. This study is a feasibility trial to assess the clinical efficacy of Gongjin-dan (GJD) and verify its mechanisms by exploring fatigue outcomes, including endocrine and immunological biomarkers in humans. METHODS/DESIGN: To investigate the anti-fatigue effects of GJD and the mechanism underlying these effects, a randomised, double-blind, placebo-controlled crossover clinical trial was designed. Participants (24 healthy male volunteers) will be hospitalised for 4 days (3 nights), during which acute fatigue and stress conditions will be induced by sleep deprivation, and GJD or a placebo will be administered (twice daily). The primary outcome will be changes in serum cortisol levels, measured in the morning, as an objective biomarker of sleep deprivation-induced fatigue and stress. The secondary outcomes will include: the Fatigue Severity Scale; the Brief Fatigue Inventory, and the Leeds Sleep Evaluation Questionnaire scores; levels of salivary cortisol, epinephrine, norepinephrine, oxidative stress-related biomarkers, homocysteine, and immunological factors; and heart rate variability. After a washout period of more than 4 weeks, a second treatment phase will commence in which participants who were previously administered the placebo will receive the drug and vice versa, following the same treatment regime as in the first phase. DISCUSSION: This study protocol provides a unique opportunity to enhance our understanding of fatigue and the effects of GJD on fatigue in terms of endocrine and immunological mechanisms by validating the study design and determining feasibility. Findings from this trial will help researchers to design a pilot or definitive clinical trial of traditional herbal medicine for chronic fatigue. TRIAL REGISTRATION: Korean National Clinical Trial Registry CRIS; KCT0001681 , registered on 29 October 2015.

Validation of the qi blood yin yang deficiency questionnaire on chronic fatigue.

BACKGROUND: Chronic fatigue (CF) reflects an imbalance of inter-organ functions or of the four essential physiological components qi, blood (xue), yin, and yang. CF can be subdivided into different patterns. However, there are no diagnostic methods for CF. This study aimed to clinically validate a pattern identification method by identifying correlations between CF and responses to the qi blood yin yang deficiency questionnaire (QBYY-Q). METHODS: Participants were recruited between May and June 2014 through the Kyung Hee University Korean Medicine hospital website and via posters and comprised 129 CF patients diagnosed with the United States Centers for Disease Control and Prevention (1994) criteria. Participants who had organic diseases that explained the CF were excluded. A total of 159 participants were asked to complete the QBYY-Q, the fatigue severity scale, and the Chalder fatigue scale. The latter two questionnaires were used to assess convergent validity with the QBYY-Q. Among the 129 CF participants, 70 and 59 had chronic fatigue syndrome and idiopathic chronic fatigue, respectively. Two Korean medical doctors independently assessed participants' qi, blood, yin, and yang deficiency patterns using QBYY deficiency pattern identification guidelines. Based on the results of a preliminary study of the QBYY-Q, we selected 32 reliable items for symptoms corresponding to each deficiency pattern. The items were used to estimate internal consistency and construct validity. Multinomial logistic regression analysis was performed for scores on each deficiency pattern. RESULTS: The data were means and standard deviations or numbers of participants and proportions for continuous and categorical variables, respectively. A statistical significance level of P < 0.05 was assumed. The QBYY-Q showed satisfactory internal consistency. Explanatory factor analysis extracted two factors for each deficiency pattern. The percentages of explained variance for qi, blood, yin, and yang deficiency were 45.1, 58.0, 52.2, and 63.4 %, respectively. Each QBYY-Q deficiency score was positively associated with each corresponding deficiency pattern. Qi deficiency was used as a reference category. Odds ratios of blood, yin, and yang deficiency were 10.97, 10.69, and 14.64, respectively. CONCLUSION: The QBYY-Q was suitable for estimating the influences of qi, blood, yin, and yang deficiencies in CF. Trial registration This trial was registered with the Korean Clinical Trial Register (KCT0001199).

Confirmatory and Exploratory Factor Analysis for Validating the Phlegm Pattern Questionnaire for Healthy Subjects.

Background. Phlegm pattern questionnaire (PPQ) was developed to evaluate and diagnose phlegm pattern in Korean Medicine and Traditional Chinese Medicine, but it was based on a dataset from patients who visited the hospital to consult with a clinician regarding their health without any strict exclusion or inclusion. In this study, we reinvestigated the construct validity of PPQ with a new dataset and confirmed the feasibility of applying it to a healthy population. Methods. 286 healthy subjects were finally included and their responses to PPQ were acquired. Confirmatory factor analysis (CFA) was conducted and the model fit was discussed. We extracted a new factor structure by exploratory factor analysis (EFA) and compared the two factor structures. Results. In CFA results, the model fit indices are acceptable (RMSEA = 0.074) or slightly less than the good fit values (CFI = 0.839, TLI = 0.860). Many average variances extracted were smaller than the correlation coefficients of the factors, which shows the somewhat insufficient discriminant validity. Conclusions. Through the results from CFA and EFA, this study shows clinically acceptable model fits and suggests the feasibility of applying PPQ to a healthy population with relatively good construct validity and internal consistency.

Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial.

Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n = 28) or the sham laser acupuncture group (n = 28). Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version) were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

Thermoregulatory Responses to Graded Exercise Differ among Sasang Types.

We compared sweat rate and variables such as workload (W e ), metabolic heat production (H prod), and temperature increment load (T inc) across Sasang types. 304 apparently healthy participants aged 20-49 years with their Sasang type determined were enrolled. Local sweat rates on the chest (LSRchest) and back (LSRback) were measured using a perspiration meter during a maximum treadmill exercise test. Oxygen uptake was measured continuously using a breath-by-breath mode indirect calorimeter. The TaeEum (TE) type had a larger body size, a higher percent body fat, and a lower body area surface area (BSA) to body mass compared with the other Sasang types, particularly the SoEum (SE) type. The TE type tended to have a shorter exercise time to exhaustion and lower maximal oxygen uptake (mL·kg(-1)·min(-1)) than the other types. LSRchest in TE types was greater than that of the SE and SoYang (SY) types in men, whereas LSRback was higher in the TE type than that of the other types in women. After normalizing LSR for W e , H prod, T inc, and BSA, this tendency still remained. Our findings suggest that the thermoregulatory response to graded exercise may differ across Sasang types such that the TE type was the most susceptible to heat stress.

Association of hypertension with physical factors of wrist pulse waves using a computational approach: a pilot study.

BACKGROUND: The objectives of this pilot study were to examine the association between hypertension and physical factors of wrist pulse waves to avoid subjective diagnoses in Traditional Chinese Medicine (TCM) and Traditional Korean Medicine (TKM). An additional objective was to assess the predictive power of individual and combined physical factors in order to identify the degree of agreement between diagnosis accuracies using physical factors and using a sphygmomanometer in the prediction of hypertension. METHODS: In total, 393 women aged 46 to 73 years participated in this study. Logistic regression (LR) and a naïve Bayes algorithm (NB) were used to assess statistically significant differences and the predictive power of hypertension, and a wrapper-based machine learning method was used to evaluate the predictive power of combinations of physical factors. RESULTS: In both wrists, L-PPI and R-PPI (maximum pulse amplitudes in the left Gwan and right Gwan) were the factors most strongly associated with hypertension after adjusting for age and body mass index (p = <0.001, odds ratio (OR) = 2.006 on the left and p = <0.001, OR = 2.504 on the right), and the best predictors (NB-AUC = 0.692, LR-AUC = 0.7 on the left and NB-AUC = 0.759, LR-AUC = 0.763 on the right). Analyses of both individual and combined physical factors revealed that the predictive power of the physical factors in the right wrist was higher than for the left wrist. The predictive powers of the combined physical factors were higher than those of the best single predictors in both the left and right wrists. CONCLUSION: We suggested new physical factors related to the sum of the area on the particular region of pulse waves in both wrists. L-PPI and R-PPI among all variables used in this study were good indicators of hypertension. Our findings support the quantification and objectification of pulse patterns and disease in TCM and TKM for complementary and alternative medicine.

Herbal medicines for treating tic disorders: a systematic review of randomised controlled trials.

BACKGROUND: It was reported that 64% of tic disorder patients used complementary and alternative medicine. This review aims to evaluate the efficacy of herbal medicines in treating tic disorders. METHODS: We searched eight databases including MEDLINE and CINAHL from their respective inceptions up to September 2013. The search terms were related to the concept of "herbal medicine" AND "tic disorder OR Tourette's syndrome". We included randomised controlled trials (RCTs) of any type of herbal medicines. We assessed the methodological quality of the trials according to the Cochrane risk of bias criteria. RESULTS: Sixty one studies were identified, and four RCTs met the inclusion criteria. Two types of herbal medicines, Qufeng Zhidong Recipe (QZR) decoction and Ningdong (ND) granules, were used in the included RCTs. All four RCTs had a high risk of bias. Two RCTs tested the effects of QZR on the Yale Global Tic Severity Scale (YGTSS) score and response rate compared with conventional medicine. The meta-analysis showed significant effects of QZR on the YGTSS score with high statistical heterogeneity (n = 142; weighted mean difference: -18.34; 95% confidence interval (CI): -23.07 to -13.60; I2 = 97%) and the response rate (n = 142; risk ratio: 1.69; 95% CI: 1.39 to 2.06; I2 = 0%). One RCT compared ND granules with placebo and showed significant effects on the YGTSS score and response rate. The other RCT show significant effects of ND granules plus conventional medicine on the response rate compared with conventional medicine only. CONCLUSION: This systematic review provided first piece of limited meta-analytic evidence for the effectiveness of herbal medicines in improving the symptoms of tic disorders.

Constitution-specific features of perspiration and skin visco-elasticity in SCM.

BACKGROUND: Human skin properties have been used as an important diagnostic component in traditional medicine as they change with health conditions. Sasang constitutional medicine (SCM) puts emphasis on the recognition of the constitution-specific skin features prior to the diagnostic decision of health. In this work, in search of skin-characteristics effectively reflecting SCM features, we compared several skin properties such as perspiration, visco-elasticity, elasticity, and elasticity hysteresis, in several candidate body parts. METHODS: We conducted a clinical study in which a total of 111 healthy females aged 50 - 70 years participated with their Sasang constitution (SC) types determined objectively by the Sasang constitutional analytic tool. Perspiration on the skin surface was estimated by using a capacitance sensor to measure the amount of moisture on the palm, forehead, and philtrum before and after a heating stimulus. We acquired the visco-elasticity, elasticity, and elasticity hysteresis at the forearm by Dermalab's elasticity sensing device. An analysis of covariance (ANCOVA) was conducted to evaluate the effect of SC on the nine skin features acquired. RESULTS: The visco-elasticity of the forearm of the Soeum-in (SE) group was significantly lower than that of the Taeeum-in (TE) group (F = 68.867, p < 0.001), whereas the elasticity hysteresis of the SE group was higher than that of the TE group (F = 10.364, p < 0.01). The TE group had more perspiration on the forehead than the SE group (F = 9.050, p < 0.01). The SE group had a large perspiration difference between the philtrum and the forehead compared with the TE group (F = 7.892, p < 0.01). CONCLUSIONS: We found four significant skin features that reflect the inherent constitutional attributes of the TE and SE groups in accordance with SCM literature; the visco-elasticity, elasticity hysteresis, perspiration on the forehead and philtrum. Our findings are based on a novel interpretation of the SCM literature and will contribute to developing the constitutional health status evaluation system in SCM.

A practical approach to Sasang constitutional diagnosis using vocal features.

BACKGROUND: Sasang constitutional medicine (SCM) is a type of tailored medicine that divides human beings into four Sasang constitutional (SC) types. Diagnosis of SC types is crucial to proper treatment in SCM. Voice characteristics have been used as an essential clue for diagnosing SC types. In the past, many studies tried to extract quantitative vocal features to make diagnosis models; however, these studies were flawed by limited data collected from one or a few sites, long recording time, and low accuracy. We propose a practical diagnosis model having only a few variables, which decreases model complexity. This in turn, makes our model appropriate for clinical applications. METHODS: A total of 2,341 participants' voice recordings were used in making a SC classification model and to test the generalization ability of the model. Although the voice data consisted of five vowels and two repeated sentences per participant, we used only the sentence part for our study. A total of 21 features were extracted, and an advanced feature selection method-the least absolute shrinkage and selection operator (LASSO)-was applied to reduce the number of variables for classifier learning. A SC classification model was developed using multinomial logistic regression via LASSO. RESULTS: We compared the proposed classification model to the previous study, which used both sentences and five vowels from the same patient's group. The classification accuracies for the test set were 47.9% and 40.4% for male and female, respectively. Our result showed that the proposed method was superior to the previous study in that it required shorter voice recordings, is more applicable to practical use, and had better generalization performance. CONCLUSIONS: We proposed a practical SC classification method and showed that our model having fewer variables outperformed the model having many variables in the generalization test. We attempted to reduce the number of variables in two ways: 1) the initial number of candidate features was decreased by considering shorter voice recording, and 2) LASSO was introduced for reducing model complexity. The proposed method is suitable for an actual clinical environment. Moreover, we expect it to yield more stable results because of the model's simplicity.

Recent progress in voice-based sasang constitutional medicine: improving stability of diagnosis.

Sasang constitutional medicine is a unique form of tailored medicine in traditional Korean medicine. Voice features have been regarded as an important cue to diagnose Sasang constitution types. Many studies tried to extract quantitative voice features and standardize diagnosis methods; however, they had flaws, such as unstable voice features which vary a lot for the same individual, limited data collected from only few sites, and low diagnosis accuracy. In this paper, we propose a stable diagnosis model that has a good repeatability for the same individual. None of the past studies evaluated the repeatability of their diagnosis models. Although many previous studies used voice features calculated by averaging feature values from all valid frames in monotonic utterance like vowels, we analyse every single feature value from each frame of a sentence voice signal. Gaussian mixture model is employed to deal with a lot of voice features from each frame. Total 15 Gaussian models are used to represent voice characteristics for each constitution. To evaluate repeatability of the proposed diagnosis model, we introduce a test dataset consisting of 10 individuals' voice recordings with 50 recordings per each individual. Our result shows that the proposed method has better repeatability than the previous study which used averaged features from vowels and the sentence.