Safety and efficacy of East Asian herbal medicine for iron deficiency anemia in children and adolescents: a systematic review and meta-analysis.

Background: This systematic review and meta-analysis aimed to evaluate the efficacy and safety of East Asian herbal medicine (HM) for iron deficiency anemia (IDA) in children and adolescents. Methods: Twelve electronic databases were searched in 28 May 2023 for randomized controlled trials (RCTs) evaluating the efficacy of HM in children with IDA. The primary outcome measures for treatment included blood hemoglobin and serum ferritin levels, whereas the secondary outcomes included the total effective rate (TER), incidence of adverse events (AEs), average healing time, and hematologic indicators related to IDA. Meta-analysis was performed using Review Manager 5.4 and R studio 4.3 software, and subgroup analyses were performed according to the different groups (type of intervention and duration of treatment). The effect size measures used were the risk ratio, mean difference, and standardized mean difference with 95% confidence intervals. The risk of bias was assessed using a revised Cochrane risk of bias tool for randomized trials, and the quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation tools. Results: The meta-analysis included 28 studies. Five studies compared the efficacy of HM alone with that of oral iron alone, whereas 23 compared the efficacy of a combination of HM and oral iron with that of oral iron alone. The meta-analysis revealed that the HM treatment group showed significant improvements in all outcome measures compared to those observed in the oral iron group. Moreover, HM significantly reduced the incidence of gastrointestinal AE, compared to that associated with oral iron. Among the 28 studies, the most commonly used HM prescription was Xingpi Yanger Granules, and the most commonly used botanical drug was Astragali Radix, followed by Atractylodis Rhizoma Alba and Angelicae Sinensis Radix. Conclusion: This meta-analysis identified evidence of the efficacy and safety of HM in children with IDA. Compared to conventional oral iron therapy, HM improved IDA-related blood markers and TER, with fewer AEs and shorter mean healing times. However, further well-designed, large-scale clinical trials are necessary to strengthen the evidence of the efficacy and safety of botanical drugs. Systematic Review Registration: PROSPERO 2022 CRD42022334670. (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022334670).

Integrative Korean Medicine Treatment for Obesity and Overweight in Children and Adolescents: A Multicenter Retrospective Chart Review Study.

Introduction: Integrative Korean medicine treatment (IKM), including herbal medicine (HM) and acupuncture, has been widely used for obesity and overweight in children and adolescents in South Korea. We investigated the real-world usage status and the potential effect of the IKM for obesity and overweight in children and adolescents. Methods: Multicenter medical charts were retrospectively reviewed of obese and overweight children and adolescents who visited Korean medicine institutions with the goal of weight control for the first time and received IKM, to analyze the usage status and effect of IKM. We defined IKM responders as those with an improved obesity grade on the body mass index (BMI) percentile and analyzed their characteristics. Results: Medical charts of 209 patients (183 obese and 26 overweight) with a mean age of 11.45 years were examined. Patients visited the institution a mean of 5.95 times, and HM alone and HM plus acupuncture were frequently used IKM. HM was prescribed to 205 patients, 167 of whom received an HM prescription containing Ephedrae Herba. An HM of the decoction type was prescribed to 189 patients, and the average treatment duration was 76.54 days. After IKM, the percentile and z-score of BMI and weight significantly declined and height percentile and z-score were significantly enhanced, without serious adverse events. In the IKM responders, age, and the proportion of girls and overweight were significantly higher, and the percentile and z-score of height, weight, and BMI were significantly lower. Conclusion: This is the first study to examine the real-world usage of IKM for obesity and overweight in children and adolescents. A significant improvement in obesity-related outcome measures after IKM, illustrated the potential effect of IKM.

Cost-effectiveness analysis of herbal medicines in children with idiopathic short stature.

BACKGROUND: Herbal medicines have been used for a long time to treat idiopathic short stature (ISS) in children in East Asian countries. The aim of this study was to analyze the cost-effectiveness of 5 herbal medicines frequently used in clinical settings for children with ISS based on medical records. METHODS: Patients with ISS who had been prescribed a 60-day supply of herbal medicines in 1 Korean medicine hospital were included in this analysis. Their height and height percentile were measured before and after treatment within 6-months. The average cost-effectiveness ratios (ACERs) of 5 herbal medicines for height (cm) and height percentile were calculated for boys and girls, respectively. RESULTS: The ACERs per 1 cm height growth were USD 56.2 (Naesohwajung-Tang), USD 74.8 (Ogapi-Growth decoction), USD 86.6 (Gamcho-Growth decoction), USD 94.6 (Gwakhyangjeonggi-San plus Yukmijihwang-Tang), and USD 113.8 (Boyang-Growth decoction). The ACERs per 1 percentile height growth were USD 205 (Naesohwajung-Tang), USD 293 (Ogapi-Growth decoction), USD 470 (Gamcho-Growth decoction), USD 949 (Boyang-Growth decoction), and USD 1051 (Gwakhyangjeonggi-San plus Yukmijihwang-Tang). CONCLUSION: Herbal medicine might be a potential economical alternative treatment for ISS.

Chuna manual therapy for the treatment of anorexia in children: A PRISMA-compliant systematic review and meta-analysis.

BACKGROUND: Anorexia in children can cause malnutrition, low immunity, growth retardation, and various secondary infections, resulting in a huge burden on society. In East Asia, Chuna manual therapy has been widely used for the treatment of childhood anorexia. We aimed to comprehensively evaluate the effects of Chuna manual therapy for treating childhood anorexia. METHODS: Twelve databases were comprehensively searched from their inception to September 13, 2022. Only randomized controlled trials assessing Chuna manual therapy for the treatment of childhood anorexia were included. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias tool. The quality of evidence for each main outcome was evaluated using the grading of recommendations assessment, development, and evaluation approach. A meta-analysis was performed, and the pooled data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes. RESULTS: Twenty-five RCTs involving 2230 participants were included. The meta-analysis showed that Chuna manual therapy had a higher total effective rate (TER) based on anorexia symptoms than that of lysine inositol and vitamin B12 (RR: 1.53, 95% CI: 1.28-1.84), multi-enzyme and multi-vitamin (RR: 1.21, 95% CI: 1.11-1.33), and zinc calcium gluconate (RR: 1.22, 95% CI: 1.06-1.39). There was no significant difference in total effective rate between Chuna manual therapy and zinc gluconate plus lysine. No adverse events associated with Chuna manual therapy were reported. Overall, the included studies had an unclear risk of bias, and the quality of evidence was generally moderate to low. CONCLUSION: Current evidence showed that Chuna manual therapy may be effective and safe for improving anorexia symptoms, especially compared with lysine inositol and vitamin B12, multi-enzyme plus multi-vitamin, and zinc calcium gluconate. However, owing to the low methodological quality of the included studies, more rigorous, high-quality RCTs are required on this topic.

Acupuncture for the treatment of childhood anorexia: A systematic review and meta-analysis.

OBJECTIVES: Childhood anorexia, among the commonest symptoms of children, involved long-term loss of appetite/decreased food intake and refusal to try or eat certain foods. Acupuncture is increasingly popular in childhood anorexia due to the side effects and dissatisfaction of conventional treatment, but, the efficacy and safety of acupuncture for childhood anorexia have not been reviewed systematically. METHODS: From 12 electronic databases, randomized controlled trials (RCTs) assessing acupuncture for childhood anorexia were identified in June 2021, with posttreatment improvement in clinical symptoms of anorexia as the primary outcome. A meta-analysis was conducted if two or more studies used the same interventions or same outcome measures. The risk of bias and quality of evidence were evaluated. RESULTS: A total of 32 RCTs with 3518 participants were included. When acupuncture was used as monotherapy or adjunctive therapy, the total effectiveness rate based on anorexia symptoms, hemoglobin levels, abdominal subcutaneous fat, and body weight significantly improved. However, results in nutritional indices were inconsistent. The recurrence rate of anorexia was significantly lower in the acupuncture group. No serious adverse events in relation to acupuncture were reported. in general, the risk of bias of the included studies was unclear and the quality of evidence for the main findings was low to moderate. CONCLUSIONS: Acupuncture may improve symptoms of childhood anorexia without serious adverse events. However, because of the low methodological quality and quality of evidence in existing reports, further high-quality clinical trials are needed to conclusively establish the efficacy and safety of this treatment.

Survey of Clinical Practice Patterns of Korean Medicine Doctors for Anorexia in Children: A Preliminary Study for Clinical Practice Guidelines.

Parents often have concerns regarding anorexia in their children and visiting medical institutions for the intervention of it. This study aimed to investigate the clinical practice patterns of Korean medicine doctors (KMDs) for anorexia in children using a web-based survey. A link to the questionnaire was sent via email to all KMDs that were affiliated with the Association of Korean Medicine. The questionnaire covered items on the sociodemographic characteristics and clinical characteristics related to Korean medicine (KM), such as diagnosis, treatment, awareness, safety, and effectiveness. Of 23,910 KMDs, 384 agreed to participate and complete the questionnaire. Anorexia in children was diagnosed mainly by clinical features (36.4%) and the pattern identification (PI) theory of 'Qi, Blood, Fluid, Humor, and Organ system diagnoses' (32.8%). The most frequently used PIs was 'spleen-stomach qi deficiency' (38.6%), which was followed by 'spleen failure in transportation' (23.3%), 'stomach yin deficiency' (15.5%), and 'liver depression' (14.2%). Herbal medicine (38.1%) was the primary KM treatment for anorexia, and the names of the most frequently prescribed herbal decoctions were Sogunjung-tang (16.5%), Hyangsayukgunja-tang (15.9%), and Bojungikgi-tang (13.9%). This study provides information on the existing clinical practice patterns of KMDs for anorexia in children. Based on this survey, the clinical practice guidelines will be developed.

A survey of the clinical practice followed by Korean medicine doctors for scoliosis: Preliminary data for clinical practice guidelines.

Scoliosis is a spinal disease in which the Cobb angle is >10°. Scoliosis treatment can be surgical or conservative, and clinical practice guidelines (CPGs) for conservative treatments have been updated since 2006. There have been several articles regarding the efficacy and safety of Korean medicine (KM) in treating scoliosis, but there are no CPGs. Our study investigated the current clinical practice using a survey for the future establishment of KM-CPGs. The survey mainly comprised clinical practice status, diagnosis, treatment, progress and prognosis, and perception of KM on scoliosis, with reference to existing surveys of other musculoskeletal disorders and scoliosis-related articles. A web-based survey was conducted from February 16, 2021 to February 28, 2021. We found that 60% of KM doctors (KMDs) respondents treated patients with scoliosis, and they valued radiographical measurements and scoliosis-related factors in the diagnosis. KMDs used multiple KM treatments, including acupuncture, Chuna, cupping, pharmacopuncture, and herbal medicine, and they emphasized the importance of KM more in nonstructural scoliosis than in structural scoliosis. Although the perception of the prognosis of scoliosis was in agreement with that suggested by previous guidelines, KMDs showed outstanding focus on reduction of symptoms of scoliosis and improvement of quality of life. Despite some limitations, including low participation and the need for consulting other medical practitioners, our study may be helpful for the development of KM-CPGs because it is the first to analyze the perceptions of KMDs on scoliosis and to collect preliminary data that are of significance for preparing clinical guidelines.

Integrative traditional Korean medicine treatment for children with idiopathic short stature: A STROBE-compliant case series.

Integrative traditional Korean medicine (TKM) treatment including herbal medicine and acupuncture has been used frequently by parents in South Korea for the treatment of children with idiopathic short stature (ISS). We aimed to report the TKM treatments currently being used for children with ISS and explore their therapeutic effects. The medical records of children who met the criteria for ISS and who had been treated with TKM for the management of ISS were retrospectively reviewed. In total, 116 patients (mean [standard deviation] age, 8.07 [3.08] years; 52.6% girls) enrolled in the study. Their mean height percentile was 1.45 and body mass index was 16.19 kg/m2. During the study period of 5 years, participants visited the outpatient clinic an average of 2.93 times; the mean number of days to the next visit was 101 days. All patients received herbal medicine treatment, and the formulation was mainly decoction type. Additional treatments including ear acupuncture and moxibustion were also used. After treatment with TKM, the height percentile and standard deviation scores increased in both girls and boys (P < .001 and P < .01, respectively). Additionally, the predicted adult height, estimated based on bone age, increased in girls (P < .05). This study provided preliminary data for future research in TKM use in children with ISS.

Herbal Medicine for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis.

Background: Anorexia is a common obstacle to adequate nutrition in childhood, a critical period for physical growth. East Asian traditional medicine treatment modalities including herbal medicine (HM) a re considered an attractive therapeutic option, especially in East Asian countries. The purpose of this systematic review was to comprehensively examine the efficacy and safety of HM for anorexia in children. Methods: A total of 12 electronic databases from their inception date to June 2021 were searched for randomized controlled trials (RCTs) assessing the efficacy of HM for the treatment of anorexia in children. The primary outcome was an improvement in anorexia clinical symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data are presented as the mean difference or standardized mean difference and risk ratio (RR) with their 95% confidence intervals (CIs). The risk of bias and quality of evidence were assessed using the Cochrane Collaboration's risk of bias tool and Grading of Recommendations, Assessment, Development, and Evaluations tool. Results: A total of 205 RCTs were included. A comparison of HM with placebo revealed that the total effective rate based on anorexia symptom improvement was significantly higher in the HM group (RR 1.58, 95% CI 1.34, 1.85). In comparison with controls, HM as monotherapy or adjunctive therapy to dietary supplements or conventional medications led to significant improvements in anorexia symptoms, body measurements, levels of blood biomarkers related to gastrointestinal function, and nutrition indices, with a lower recurrence rate of anorexia. No serious adverse events related to HM were reported. The risk of bias of the included studies was generally unclear, and the quality of evidence was generally low to moderate. Conclusion: Our study showed that HM could improve clinical symptoms, some anthropometric outcomes, and some biological markers related to appetite and growth in children with anorexia. However, considering the high risk of bias of the included studies and the heterogeneity of the HMs used, future research should focus on the use of standardized HMs and the implementation of methodologically robust clinical trials. Systematic Review Registration: https://www.crd.york.ac.uk/prosperodisplay_record.php?ID=CRD42021274376, identifier CRD42021274376.

Protective effects of Banhasasim-tang, a herbal medicine, against cold restraint stress-induced gastric ulcers.

Banhasasim-tang (BST), a herbal medicine, has been used for nausea and fever from cold damage. This study aimed to investigate the protective effects of BST in cold restraint stress-induced gastric ulcers. Male Sprague Dawley rats were orally treated with various doses of BST including 0.25, 0.5, 1, 3, 6, 9, 12 and 18g/kg based on the human daily intake dose. After treatment once per day for 3 days, rats were restrained into the cold stress chamber for 12h at 4°C to induce gastric ulcers. Gastric hemorrhagic ulcer area was evaluated and serum adrenocorticotropic hormone (ACTH), corticosterone, epinephrine and dopamine levels were determined. Compared to cold stress-induced gastric ulcer rats, hemorrhage ulcer areas were reduced in BST-treated stomach tissues at all concentrations. Increased serum ACTH, corticosterone and epinephrine levels were significantly decreased by BST treatment in cold stress-induced gastric ulcer rats. Moreover, there were increments of serum dopamine levels in 3 and 6g/kg of BST-treated groups. Taken together, BST positively ameliorated cold restraint stress-induced gastric hemorrhage with decrease in serum stress-related biomarkers such as ACTH, corticosterone, epinephrine and dopamine. The 3-6-fold of human daily intake dose of BST exhibited protective effects as a herbal medicine for gastric ulcers.

The effectiveness and safety of Chuna manual therapy on scoliosis: A protocol for systematic review and meta-analysis.

BACKGROUND: Scoliosis is a spinal deformity and is diagnosed as Cobb angle being greater than 10°. Because it is accompanied with structural dysfunction, it can cause pain, worsen the patient's general health and quality of life. The prevalence of scoliosis has been increasing and many treatments, including surgical treatment and conservative treatment, such as observation, bracing, physiotherapy, and Chuna manual therapy (CMT), have been suggested. CMT is a manual therapy in Korean medicine that provides effective stimulation to the patient's body structure to treat structural dysfunction. After Korean national health insurance's coverage of CMT in 2019, the application of CMT for scoliosis has increased, and many studies have been reported. There have been attempts to elucidate the effectiveness of CMT on scoliosis; however, its effectiveness still remains unconfirmed. Therefore, the aim of this study is to evaluate the effectiveness and safety of CMT on scoliosis. METHODS: The published randomized controlled trials that evaluated the effectiveness and safety of CMT for scoliosis will be searched for in multiple electronic databases without the limitation of country and language. Data on characteristics of studies, interventions, comparators, outcome measures, results, and information for assessment of study quality will be extracted. The primary outcome will be the Cobb angle and the secondary outcomes will be the scales of pain, function, quality of life and disability, and adverse events. Data synthesis and analysis will be conducted using the Review Manager software for Windows (RevMan ver. 5.3.; Copenhagen; The Nordic Cochrane Center, The Cochrane Collaboration, 2014). Subgroup analysis to identify the differences between different CMT maneuvers will also be performed. For risk of bias assessment, the "risk of bias" tool from Cochrane Collaboration will be used. RESULTS: This study will present the clinical evidence on the effectiveness and safety of CMT on scoliosis. CONCLUSION: This study will propose useful evidence for treatment, further research, and health policies in the future.

Longitudinal Bone Growth Stimulating Effect of Allium macrostemon in Adolescent Female Rats.

Allium macrostemon (AM) may affect bone growth by regulating bone formation and resorption. To examine the effect of AM on bone growth, 48 rats were divided into four administration groups in which either distilled water, AM (100 and 300 mg/kg), or recombinant human growth hormone (rhGH; 20 µg/kg) was administered for 10 days. On day 9, all animals were intraperitoneally injected with tetracycline hydrochloride (20 mg/kg), and 48 h after the injection, the rats were sacrificed. Their tibial sections were photographed to measure bone growth. Antigen-specific immunohistochemistry was performed to detect insulin-like growth factor-1 (IGF-1) and bone morphogenetic protein-2 (BMP-2). The food intake of the AM 100 mg/kg group was higher; however, the food intake of the AM 300 mg/kg group was less than that of the control group. The rhGH and AM 100 mg/kg groups showed greater rates of bone growth (359.0 ± 23.7 and 373.1 ± 28.0 µm/day, respectively) compared with the control group. IGF-1 and BMP-2 in the AM and rhGH groups were highly expressed. Indigestion at higher doses of AM led to nonsignificant bone growth in spite of increased IGF-1 and BMP-2 expression. Therefore, a suitable amount of AM could increase bone growth.

Herbal Medicine Treatment for Influenza: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

The aim of this research is to evaluate the clinical evidence of an herbal medicine (HM) treatment on influenza and describe the potential benefits and adverse events by reviewing all relevant randomized controlled trials. All papers published from 2010 to 2019 in all languages in six databases were searched, including all randomized controlled trials on adults and children, testing herbal medicine for treatment of influenza, alone or in combination with conventional antiviral therapy. The main outcome parameters of interest were total effective rate, time to resolution of fever, adverse events, complications, and duration of viral shedding. 25 trials of 3044 patients were included. Herbal medicine compared to placebo significantly reduced time to fever resolution by 4.96[Formula: see text]h (mean difference, [Formula: see text]4.96; 95% CI, [Formula: see text]7.11 to [Formula: see text]2.80; [Formula: see text]), herbal medicine compared to oseltamivir showed no significant difference (mean difference, [Formula: see text]1.82; 95% CI, [Formula: see text]6.08 to 2.44; [Formula: see text]), and herbal medicine plus oseltamivir combined treatment significantly reduced duration of fever by 7.84[Formula: see text]h compared to a single treatment with oseltamivir (mean difference, [Formula: see text]7.84; 95% CI, [Formula: see text]12.51 to [Formula: see text]3.17; [Formula: see text]). Herbal medicine compared to placebo showed a significantly better total effective rate (risk ratio, 1.90; 95% CI, 1.18 to 3.07; [Formula: see text]), herbal medicine compared to oseltamivir indicated significantly better effective rate (risk ratio, 1.15; 95% CI, 1.03 to 1.29; [Formula: see text]), and combined treatment showed a significantly better total effective rate compared to a single treatment with oseltamivir (risk ratio, 1.20; 95% CI, 1.06 to 1.36; [Formula: see text]). Regarding safety, no serious adverse events were reported in HM treatment. HM presented fewer adverse events compared to oseltamivir, but the difference was not significant (risk difference, [Formula: see text]0.04; 95% CI, [Formula: see text]0.09 to 0.00; [Formula: see text]), and the combined treatment did not increase adverse events compared to oseltamivir (risk difference, [Formula: see text]0.02; 95% CI, [Formula: see text]0.06 to 0.02; [Formula: see text]). Research findings show that herbal medicine treatments have beneficial therapeutic effects on influenza and could decrease duration of fever and improve total effective rate. In addition, herbal medicine plus oseltamivir combined therapy could increase the therapeutic effect compared to a single treatment with oseltamivir.

Herbal medicine in women undergoing in vitro fertilization/ intracytoplasmic sperm injection: A systematic review and meta-analysis.

A combination of in vitro fertilization (IVF) and herbal medicine (HM) has been widely used in Asian countries. We conducted a systematic review of randomized controlled trials (RCTs) that evaluated the effects of HM as an adjunct to IVF and reported the pregnancy outcomes, including the live birth rate (LBR) and clinical pregnancy rate (CPR). HM was consistently more likely to increase the LBR (RR 1.34, 95 % CI 1.05-1.72) and CPR (RR 1.38, 95 % CI 1.29-1.49) than those not receiving adjunctive treatment. The CPR in the HM treatment group was also improved compared to the placebo group (RR 1.85, 95 % CI 1.42-2.42). The adverse events were not significantly different between the HM and control groups. These findings indicate that HM may have beneficial effects on pregnancy outcomes in females undergoing IVF. Large-scale, long-term RCTs with robust methodological inputs are needed to clarify the role of HM.

Ameliorative and Synergic Effects of Derma-H, a New Herbal Formula, on Allergic Contact Dermatitis.

Allergic contact dermatitis (ACD) is characterized by itching, skin inflammation, and allergic responses caused by release of immunoglobulin E and T helper 2-specific cytokines. The aim of this study is to investigate the ameliorative and synergic effects of herbal formula, Derma-H, containing Astragalus membranaceus Fisch. ex Bunge (AM) and Nepeta tenuifolia Benth (NT) which have been used as traditional medicinal herbs for the cure of dryness, edema, and pruritus. 2,4-Dinitrochlorobenzene (DNCB) was applied for ACD induction. AM, NT, and a mixture of AM and NT was topically applied to skin lesions for 11 days. Dermatitis score and number of scratches were significantly diminished in AM, NT, and AM + NT (Derma-H)-treated groups. Especially, Derma-H was more effective than single treatment of AM and NT on skin hyperplasia and mast cell infiltration. Also, NGF expression decreased by NT and a mixture of AM and NT. Additionally, series of TrkA, Raf-1, MEK, and ERK were significantly inhibited by topical AM and NT application. Those findings suggested AM and NT treatment has a synergic effect on DNCB-induced ACD in mice.

Analysis of the bio-psychological characteristics of Sasang typology in Korean preschool children using the ponderal index and the temperament and character inventory.

OBJECTIVES: The aim of this study was to identify different physical and mental characteristics among three common Sasang types, Tae-eum, So-yang, and So-eum (except scarce type, Tae-Yang) in preschoolers, to improve constitutional diagnoses. METHODS: Our study included 65 boys and 67 girls from six kindergartens in South Korea. The number of children who were categorized as Tae-Yang, Tae-Eum, So-Yang, and So-Eum types were 1, 56, 40, and 35, respectively. We measured height, weight, mid-parental height, predicted adult height, ponderal index (PI), and findings from the junior temperament and character inventory 3 to 6. RESULTS: The Tae-eum type exhibited higher weight percentiles and PIs than the other types (p < 0.001), and the So-eum type displayed higher harm avoidance (HA) scores than the Tae-eum type (p = 0.033). CONCLUSIONS: Children with high PIs and low HA scores have a higher probability of being classified as the Tae-eum type than as the So-eum type.

Anti-inflammatory effects of Samsoeum, a Korean medicine for health insurance, on chronic bronchitis caused by lipopolysaccharide in rats.

BACKGROUND: Samsoeum (SSE), a Korean medicine, has been used to treat upper respiratory infection including residual coughs after catching a cold, and colds in patients with gastrointestinal disorder. In this study, we investigated the inhibitory effect of SSE against lipopolysaccharide (LPS)-induced bronchitis and characterized its optimal dosing range based on the improvement of SSE concentrations. MATERIALS AND METHODS: Male Sprague Dawley rats were intra-nasally administered LPS on day 0, 3 and 6. 2 g kg-1 dose of SSE for rat was determined by the human equivalent dose formula and orally administered once a day from day 3 to day 6. To clarify the optimal administration dose of SSE, various doses including 0.5 (1/4 fold), 1 (1/2 fold), 6 (3 fold), 12 (6 fold), 24 (12 fold) and 36 g kg-1 (18 fold) were also orally administered. In addition, the molecular mechanism of SSE in mucin hyperproduction was investigated in LPS-sensitized A549 cells. RESULTS: Oral administration of SSE ameliorated alveolar wall thickening and inflammatory cell infiltration of lung tissues in LPS-induced bronchitis at doses of 1/4 fold, 1/2 fold and 1 fold. The total cell and neutrophil numbers in bronchoalveolar lavage fluid (BALF) were reduced in the SSE-treated groups compared with the LPS group. In addition, 0.5, 1 and 2 g kg-1 of SSE suppressed LPS-induced mucin glycoprotein 5AC (MUC5AC) production in BALF. Furthermore, SSE treatment significantly inhibited the pro-inflammatory cytokines, resulting in the decrease of MUC5AC production by the JAK1/STAT6 signaling pathway. CONCLUSIONS: 1, 2 and 6 g kg-1 of SSE ameliorated chronic bronchitis by inhibiting LPS-induced neutrophil infiltration and MUC5AC release in BALF. These findings suggested that SSE with 0.5-3-fold of general daily intake dose would be a therapeutic agent for chronic bronchitis.

Improvement of a massage chair (BEG-100) on height growth in children with average: Human subjects research.

BACKGROUND: Studies that examine the growth effects of massage at ages beyond infancy are rare. A recently developed massage chair (BEG-100) targets teenagers who want to increase their growth. The chair can stretch areas around the knee after fixating the knee and ankle areas. METHODS: This is a clinical study that included 38 children aged 11 years whose heights ranged from 145.0 to 155.0 cm. We aim to observe the potential of a 24-week massage for growth promotion. We will also evaluate the changes in height percentile, height, height standard deviation score, bone age, height standard deviation score for bone age, growth rate, predicted height estimated from bone age, seated height-to-standing height ratio, weight, and body mass index. To confirm safety, the associated adverse events will be investigated. OBJECTIVE: The aim of this study was to investigate the growth-promoting effect of BEG-100 in children with average height. TRIAL REGISTRATION: KCT0004673 (Clinical Research Information Service).

Exploratory analysis of cold, heat, deficiency, or excess pattern distribution in women with dysmenorrhea.

OBJECTIVE: To understand the impact and implications of cold, heat, deficiency, or excess pattern identification in relation to dysmenorrhea, comparing the prevalence of these patterns between women with and without dysmenorrhea is needed. METHODS: We gathered data from the Korea Constitutional Multicenter Bank. A total of 508 patients were recruited and provided with cold, heat, deficiency, or excess pattern and dysmenorrhea questionnaires. On the basis of their responses, they were divided into the dysmenorrhea group (moderate or severe dysmenorrheic pain; n = 90) and non-dysmenorrhea group (no dysmenorrheic pain; n = 155). We analyzed the characteristics of the groups and compared the cold, heat, deficiency, or excess pattern scores. Comparisons were performed using the independent t-test. We also performed multiple comparisons of each individual symptom between the groups to explore which symptoms appear with dysmenorrhea using the Bonferroni adjustment method. RESULTS: There was a high positive correlation between deficiency pattern scores and excess pattern scores (p < 0.001). The cold, deficiency, and excess pattern scores were significantly higher in the dysmenorrhea group than in the non-dysmenorrhea group (p < 0.001). Twenty among the 76 pattern items showed significant differences between the groups (p < 0.001). Among all items, there was a large effect size only in sleep quality (mean difference 1.07, 95% confidence interval 0.75-1.39, p < 0.001). CONCLUSIONS: Women with dysmenorrhea have higher cold, deficiency, and excess pattern scores than those without dysmenorrhea. The longitudinal observation of these symptoms needs to be evaluated using a clinical prospective study design in accordance with pattern differentiation in the future.

Safety, effectiveness, and economic evaluation of an herbal medicine, Ukgansangajinpibanha granule, in children with autism spectrum disorder: a study protocol for a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial.

BACKGROUND: Autism spectrum disorder (ASD) is characterized by continuous impairment in communication and social interaction and by limited and repetitive behaviors, interests, or activities. Behavioral, educational, and pharmaceutical interventions have been shown to reduce behavioral disabilities, improve verbal/non-verbal communication, and help patients acquire self-reliance skills. However, there has been a lack of systematic verification and consensus regarding the treatment of the core symptoms of ASD because of its unclear etiology. Ukgansangajinpibanha (UGSJB), a legitimately prescribed herbal medicine for nervousness, insomnia, night crying, and malnutrition in South Korea and Japan, has been used for angry, sensitive, nervous, and unsettled children with ASD. METHODS/DESIGN: This trial is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial. The 4- to 6-year-old children with ASD will be randomly assigned to following groups: 1. A UGSJB granule with acupuncture, twice daily (n = 120) 2. A placebo group with acupuncture, twice daily (n = 120). The following outcome measures will be used: behavior by the Childhood Autism Rating Scale, Autism Behavior Checklist, and Aberrant Behavior Checklist; social maturity by the Social Maturity Scale; quality of life by the Child Health Questionnaire and EuroQoL Five-dimension Five-level Youth; and parental stress by the Parenting Stress Index at baseline and at 6, 12, and 24 weeks after the beginning of treatment. In addition, to evaluate safety, we will investigate the adverse reactions that may be caused by UGSJB granule. Finally, we will make an economic evaluation of UGSJB for the treatment of ASD. DISCUSSION: We prepared a well-designed clinical trial to investigate the safety and effectiveness of UGSJB on ASD symptoms compared with placebo treatment. The results from this study will provide clinical evidence on the safety, effectiveness, and economic value of UGSJB combined with acupuncture in children with ASD. TRIAL REGISTRATION: Clinical Research Information Service: KCT0003007 (registered on April 5, 2018).