A Randomized Clinical Efficacy Trial of Red Yeast Rice (Monascus pilosus) Against Hyperlipidemia.

Red yeast rice (RYR) has been used as an alternative treatment for hyperlipidemia. According to the previous studies, other compounds, besides monacolin K in RYR, may also reduce the serum lipid level. This study aims at examining the efficacy of monacolin K-rich and Gamma-Aminobutyric Acid (GABA)-rich RYR (Monascus pilosus) with regards to treating hyperlipidemia in a randomized control, double-blind clinical trial. In the research, we assigned 50 eligible subjects to monacolin K-rich RYR, GABA-rich RYR and placebo groups ( n=16 , 17, 17, respectively). The concentrations of TC, LDL-C, HDL, TG and blood biochemical data were evaluated at different phases: before applying (visit 1), after 1-month (visit 2), 2-month (visit 3), 3-month (visit 4) of providing the intervention and 1-month after ending the test food (visit 5) among three groups. During the 3-month intervention, the serum TC and LDL-C levels decreased significantly in the monacolin K group compared to the baseline and the other two groups. The Serum TG level declined steadily but was not statistically significant. Meanwhile, no marked differences in the serum HDL level were revealed among the three groups. Most safety assessment data had minor variation except two subjects (in monacolin K and GABA group separately) reported elevated liver enzymes. Monacolin K-rich RYR can reduce cholesterol as expected, while the GABA-rich RYR performed non-significant reduction on serum triglyceride. The research results demonstrate that using different concentrations and ratios between monacolin K and GABA could be beneficial for antihyperlipidemia.

A Systematic Review and Meta-Analysis of the Effect of Lifestyle Modification on Metabolic Control in Overweight Children.

Childhood obesity is associated with type 2 diabetes mellitus. We aimed to determine the effects of lifestyle modification programs on fasting plasma glucose (FPG) levels in overweight children. We queried six relevant electronic databases and manually searched for studies published before December 2016. Overweight/obese children who underwent a lifestyle modification for more than 6 months were included. A total of 3923 children from eight randomized controlled trials (RCTs) were included. Compared with the control group, the lifestyle modification group had significantly lower FPG levels by 1.3 mg/dL. The mean differences were significantly decreased for both secondary outcomes; BMI z-score decreased by 0.16 units and insulin levels decreased by 2.4 mU/L. The metaregression showed that the follow-up duration was associated with FPG levels and BMI and insulin levels and half year is a suitable follow-up duration for this population. This study showed that lifestyle modification programs may be effective in reducing the FPG levels of overweight/obese children. Further high-quality RCTs with longer follow-up periods are needed to evaluate the long-term effect of this complementary approach for diabetes mellitus prevention on overweight/obese children.

Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus.

ETHNOPHARMACOLOGICAL RELEVANCE: Life-long insulin is the standard treatment for type 1 diabetes mellitus (T1DM). The role of traditional Chinese medicine (TCM) in T1DM is still not clear. The aim of this study is to explore the prescription pattern of TCM and its impact on the risk of diabetic ketoacidosis (DKA) in patients with T1DM. MATERIALS AND METHODS: We retrieved samples from the registry for catastrophic illness patients from the National Health Insurance Research Database (NHIRD). Based on a frequency (1:4) matched case-control design, patients with T1DM in 2000-2011 were designated as cases (TCM users) and controls (non-TCM users). TCM treatment for patients with T1DM was analyzed. The incidence of DKA and the annual costs of emergency visits and hospitalizations were evaluated for all causes. RESULTS: Overall, 416 subjects were TCM users, whereas a total of 1608 matched subjects were classified as non-TCM users. The most common Chinese herbal formula and single herb is Liu-wei-di-huang-wan (Six-ingredient pill of Rehmannia) and Huang-qi (Radix Astragali; Astragalus membranaceus (Fisch.) Bunge, Astragalus membranaceus var. mongholicus (Bunge) P.K.Hsiao), respectively. Compared with non-TCM users, we found a 33% reduction in DKA incidence for all TCM users (aHR 0.67, 95% CI 0.56-0.81, p <0.000) and a 40% reduction for users receiving TCM treatment for more than 180 days (aHR 0.58, 95% CI 0.41-0.82, p <0.01). There were no significant differences between TCM users and non-users in the frequency and medical costs of emergency visits and hospitalizations. CONCLUSIONS: Integrative TCM use may reduce the risk of DKA in patients with T1DM. Our results suggest that TCM may have a substantial positive impact on the management of TIDM.

A nationwide population-based study of traditional Chinese medicine usage in children in Taiwan.

OBJECTIVES: To characterize the application of traditional Chinese medicine (TCM) among pediatric patients. DESIGN AND SETTING: This study examined data sets from the National Health Insurance Research Database in Taiwan. Two cohorts, each with one million patients who were randomly sampled from the beneficiaries of the National Health Insurance Program from January 1 to December 31 in 2005 or 2010, were chosen for analysis. Children had at least one TCM outpatient clinical record were defined as TCM users, whereas children who had no TCM outpatient records were defined as non-TCM users. MAIN OUTCOME MEASURES: The demographic data, treatment modalities and the disease distributions of the pediatric TCM users were analyzed from two randomly sampled cohorts. RESULTS: Overall, 22% and 22.5% of the children used TCM in 2005 and 2010, respectively. The utilization rate of TCM increased with age. Herbal remedies were the most commonly used therapeutic approach, followed by manipulative therapy and acupuncture. There was an increasing trend of using herbal remedies (increased from 65.6% to 74.4%) and acupuncture (increase from 7.5% to 11.4%), but there was a markedly decreased use of manipulative therapies from 25.6% to 12.3% from 2005 to 2010. There is an obvious increasing use of TCM due to diseases of the digestive system, skin/subcutaneous tissue and genitourinary system from 2005 to 2010. A further comparison of the prevalence rates between TCM and non-TCM visits indicated that allergic rhinitis, dyspepsia, injury and musculoskeletal diseases, as well as menstrual disorders, were the main diseases that children tended to visit TCM clinics in Taiwan. CONCLUSIONS: Our nationwide population-based study revealed the high prevalence and specific usage patterns of TCM in the pediatric population in Taiwan. The results of this study should provide valuable information for physicians, parents and the government concerning pediatric healthcare.

Traditional Chinese medicine for idiopathic precocious puberty: A hospital-based retrospective observational study.

OBJECTIVES: To characterize the application of traditional Chinese medicine (TCM) among children with idiopathic precocious puberty (IPP). DESIGN AND SETTING: This study examined data sets from patients diagnosed with IPP at Chang Gung Memorial Hospital between 2010 and 2012. The patients were allocated into three groups according their voluntary choice of treatment modalities: TCM users (received TCM treatment only), Western medicine (WM) users (received WM treatment only), and "no treatment" group (received no medical treatment at all). MAIN OUTCOME MEASURES: The demographic data of children with IPP were characterized. The prescription patterns and frequencies of TCM for IPP patients were analyzed. The patients' bone maturation rates and the change of predicted height after different approaches were measured as outcomes. RESULTS: There were 3390 patients enrolled in the study. Zhi-Bai-Di-Huang-Wan (70.62%) was the most common herbal formula and Mai-Ya (Hordei Fructus Germinatus) (51.58%) was the most common single herb prescribed for IPP in all of the 2784 prescriptions. The bone maturation rates of TCM users (0.95±0.20) and WM users (0.69±0.05) were both decelerated but the "no treatment" group had an accelerated bone maturation rate of 1.33±0.04. TCM and WM users also had higher predicted height after treatment (1.15±1.19cm versus 1.73±0.29cm), while the "no treatment" group had a decreased predicted height (-0.52±0.23cm). CONCLUSIONS: Our study revealed a comprehensive list of TCM prescriptions for IPP patients. Future well-designed, randomized, double-blinded, and placebo-controlled clinical trials are warranted to evaluate the efficacy and safety of TCM for precocity.

Characteristics and prescription patterns of traditional Chinese medicine in atopic dermatitis patients: ten-year experiences at a medical center in Taiwan.

OBJECTIVES: Complementary and alternative therapies in treating atopic dermatitis are not uncommon. However, substantial evidence and consensus on treating atopic dermatitis is lacking. The aim of this study is to investigate the characteristics and utilization of traditional Chinese medicine in patients with atopic dermatitis. DESIGN: We retrospectively collected patients with atopic dermatitis at the Chang Gung Memorial Hospital in Taiwan between 2002 and 2011. Patients' demographic data, duration and frequency of treatment, serum total immunoglobulin E levels, and traditional Chinese medicine treatment principles and prescription were analyzed. RESULTS: There were 4145 patients (8.8%) received traditional Chinese medicine therapy between 2002 and 2011. Among them, 2841 (68.54%) chose TCM only and 1304 (31.46%) chose to combine TCM and WM therapies. Those who chose combination therapy were younger, and needed more times of visit and longer duration of treatment. The most frequent comorbid conditions accompany atopic dermatitis were allergic rhinitis (46.06%) and asthma (21.46%). Among the 87,573 prescriptions written for Chinese medicine, the most frequently prescribed herbal formula and single herb were Xiao-Feng-San (Eliminate Wind Powder) (16.98%) and Bai-Xian-Pi (Cortex Dictamni) (12.68%), respectively. The most commonly used therapeutic principles of herbal formulas and single herbs were releasing exterior (20.23%) and clearing heat (41.93%), respectively. CONCLUSION: Our hospital-based study characterized the utilization patterns of traditional Chinese medicine in atopic dermatitis patients. This information could be used as references for clinical application and provide valuable information for future clinical trials.