No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.

OBJECTIVE: To observe the effect of combining red yeast rice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies. METHODS: A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeast rice + L. casei) or the control group (red yeast rice + placebo). One red yeast rice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8. RESULTS: At week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeast rice can signifificantly reduce LDL-C, total cholesterol and triglyceride. CONCLUSION: The combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.

Evaluation of the potential inhibitory activity of a combination of L. acidophilus, L. rhamnosus and L. sporogenes on Helicobacter pylori: A randomized double-blind placebo-controlled clinical trial.

OBJECTIVES: To investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had signifificant inhibitive effects on Helicobacter pylori (H. pylori). METHODS: This is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test (△UBT) result > 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1:1. These subjects took one capsule of probiotics or placebo twice daily. The primary measurement was the change in △UBT values. RESULTS: The △UBT values during the 4-week treatment period and the 2-week follow-up period were not signifificantly different between the treatment group and the placebo group, indicating that the inhibitive effects on H. pylori were comparable between both groups. The monocyte count (%) was 5.77±1.11 in the treatment group versus 5.09±1.12 in the placebo group (P=0.044), and the basophile count was 0.55±0.32 in the treatment group versus 0.36±0.23 in the placebo group (P=0.024) at week 2 of the treatment period, both of which reached statistical signifificance. The monocyte count was 5.75±1.26 in the treatment group and 4.72±0.99 in the placebo group at the end of the follow-up period (P=0.003). CONCLUSION: There was no signifificant inhibitive effects of the three probiotic strains (L. acidophilus, L. rhamnosus, and L. sporogenes) on H. pylori. Probiotics can not play the same role as antibiotics in the eradication of H. pylori, the role of probiotics is likely to be important as adjuvant to the triple or quadruple therapy for H. pylori, especially in resistance cases.

Efficacy and safety of herbal medicine yun-cai tea in the treatment of hyperlipidemia: A double-blind placebo-controlled clinical trial.

OBJECTIVE: Animal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial. METHODS: This was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group (30 patients) and the placebo group (30 patients), for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol (LDL-C) at 8 weeks. The secondary endpoints included total cholesterol (TC) and triglycerides (TG). RESULTS: Our results revealed no statistically signifificant differences in LDL-C and TC between the two groups. Despite the lack of a statistically signifificant difference in the level of TG between the two groups, a declining trend was noted. A signifificant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline (P=0.048). The incidence of stomach discomfort, gastroesophageal reflfl ux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other signifificant adverse events were found. CONCLUSION: It is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary.

Protective effect of wogonin on proinflammatory cytokine generation via Jak1/3-STAT1/3 pathway in lipopolysaccharide stimulated BV2 microglial cells.

Wogonin is a flavonoid compound which exhibits antioxidation, anti-inflammation, neuroprotection, and antitumorgenesis functions. However, the mechanism of how wogonin reduces proinflammatory cytokine generation in activated microglia is unclear. At present, we found wogonin inhibited lipopolysaccharide (LPS)-/interferon-γ (INF-γ)-induced generation of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α). Wogonin exhibited parallel inhibition on LPS-/INF-γ-induced expression of IL-6 and TNF-α messenger RNA at the same concentration range. LPS-/INF-γ-induced phosphorylation of signal transduction and transcription 1 and 3 (STAT1/3) were also inhibited by wogonin. Although wogonin expressed only weak inhibitory effect on LPS-/INF-γ-induced phosphorylation of Janus kinase-2 (Jak-2) and tyrosine kinase (Tyk)-2, it significantly attenuated the phosphorylation of Jak-1 and Jak-3. These results indicated that the blockade of IL-6 and TNF-α production by wogonin in LPS-/INF-γ-stimulated BV2 microglial cells was attributed mainly to the interference in Jak-1/-3-STAT1/3 signaling pathway.

Ocimum gratissimum is effective in prevention against liver fibrosis in vivo and in vitro.

Ocimum gratissimum is a traditional herb commonly found in tropical regions, which prevents free radical damage and protects the liver from oxidative stress. In this study, we tested in vivo and in vitro the effectiveness of O. gratissimum extracts (OGEs) in anti-hepatic fibrosis in rats. Male Wistar rats were administered with carbon tetrachloride (CCl4) by intraperitoneal injection and varying amounts of oral injection of OGE doses (0-40 mg/kg body weight) for 8 weeks. Our experiments showed that OGE significantly reduced liver damage, including steatosis and fibrosis, in a dose-dependent manner, as well as significantly decreased the elevation in plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT). It also inhibited the formation of lipid peroxidative products during CCl4 treatment. Moreover, OGE-inhibited CCl4-induced liver collagen accumulation and promoted the expression of catalase, an anti-oxidative enzyme. The inhibition of fibrosis factors α-SMA expression was also observed. In primary cultures, OGE significantly inhibited the serum-induced activation of hepatic stellate cells (HSCs), and the expression of α-SMA and collagen α (I). These data suggest that O. gratissimum possesses anti-hepatic fibrosis properties via its anti-oxidative components.

Relationship between adiponectin and leptin, and blood lipids in hyperlipidemia patients treated with red yeast rice.

BACKGROUND: This study aimed to investigate the possible relationships between adiponectin and leptin, blood lipids such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG) as well as other clinical biomarkers in hyperlipidemia patients treated with red yeast rice. METHODS: 30 patients with primary hyperlipidemia were recruited, treated with red rice yeast capsules 600 mg twice a day for 8 weeks, and followed up for 4 weeks. The primary endpoint was the mean difference in LDL-C from baseline to week 8, while the secondary endpoints were the mean percentage changes from baseline of total cholesterol, TG, HDL-C, adiponectin, and leptin. RESULTS: At week 8, the decrease in LDL-C and total cholesterol was -38.11 ± 30.90 mg/dl (p < 0.0001) and -44.54 ± 27.46 mg/dl (p < 0.0001), respectively, and the increase in adiponectin was 35.83 ± 67.85 µg/ml (p = 0.017) as compared to baseline. Adiponectin also correlated positively with HDL-C (r2 = 0.39; p = 0.001). Serum leptin correlated negatively with TG (r2 = 0.19; p = 0.035), and there was a trend of correlation between leptin and HDL-C, but this was not statistically significant (r2 = 0.16; p = 0.052). CONCLUSION: Red yeast rice can significantly increase adiponectin and can significantly lower LDL-C and total cholesterol levels. Adiponectin correlates positively with HDL-C while serum leptin correlates negatively with TG. Red yeast rice has a potentially protective effect in obesity-related and cardiovascular diseases.

Evaluation on the Pharmacological Effect of Traditional Chinese Medicine SiJunZiTang on Stress-Induced Peptic Ulcers.

Purpose. To explore the effects of SiJunZiTang (SJZT) on central neurotransmitters and the inhibition of HCl hypersecretion, along with the role of the vagus nerve. From this, the effects of SJZT and its constituent ingredients on inhibiting stress-induced peptic ulcers will be determined. Methods. Methods used to determine SJZT's effectiveness included (1) measuring the antipeptic ulcer effects of varying combinations of the constituents of SJZT; (2) evaluations of monoamine (MA) level in the brain; and (3) measuring the effects of longer-term SJZT treatment. Results. Comparing the control and experimental groups where the rats' vagus nerves were not cut after taking SJZT orally (500 mg/kg and 1000 mg/kg), the volume of enterogastric juice, free HCl and total acidity all reduce dose-dependently. The group administered SJZT at 1000 mg/kg showed significant reductions (P < 0.05). For the experimental groups where the vagus nerves were cut, a comparison with the control group suggests that the group receiving SJZT (500 mg/kg) orally for 21 days demonstrated a cure rate of 34.53%. Conclusion. The results display a correlation between the therapeutic effects of SJZT on stress-induced peptic ulcers and central neurotransmitter levels. Further to this, SJZT can inhibit the hypersecretion of HCl in the stomach, thus inhibiting stress-induced peptic ulcers.

Factors influencing antihypertensive medication compliance in Taiwan: a nationwide population-based study.

BACKGROUND: Poor medication compliance with antihypertensive drugs may have a significant impact on clinical outcomes, hospitalisation and healthcare expenditure. This study aims to assess medication compliance and its underlying factors in patients receiving antihypertensive drugs in Taiwan. METHODS: This retrospective population-based study was based on data from Taiwan's Longitudinal Health Insurance Database (LHID). All patients (n = 78,558) were aged 30 years or more and had received at least one antihypertensive prescription between January 2004 and December 2007. We used the medication possession ratio (MPR) as an index to measure the level of medication compliance. RESULTS: Approximately 53% of the patients had high compliance with antihypertensive medication. Factors that were positively associated with medication compliance included patients being aged 30-44 years, higher comorbidity scores (odds ratio (OR): 1.18; 95% confidence interval (CI): 1.08-1.28), the same prescribing physician being visited and a single-drug therapy being prescribed. Female sex (OR: 0.92; 95% CI: 0.89-0.95) and higher socioeconomic status (OR: 0.91; 95% CI: 0.86-0.96) were negatively associated with drug compliance. In addition, high-compliance patients were less likely to be treated at medical centres, corporations (OR: 0.89; 95% CI: 0.84-0.93) or rural (OR: 0.88; 95% CI: 0.83-0.94) institutions. CONCLUSION: Several patient- and institution-related factors may influence medication compliance. Therefore, for optimal outcomes, patients' awareness of the need for compliance with antihypertensive therapy must be enhanced, and effective intervention strategies should be developed.

A neutral risk on the development of new-onset diabetes mellitus (NODM) in Taiwanese patients with dyslipidaemia treated with fibrates.

There are no data on the incidence of new-onset diabetes mellitus (NODM ) in nondiabetic dyslipidaemia patients treated with fibrates. The aim of our study was to clarify these issues, to investigate the relationship between NODM and fibrate and whether the fibrates lead to increased risk for developing NODM. A retrospective cohort study was conducted by analyzing the Longitudinal Health Insurance Database (LHID 2005) of the National Health Insurance Research Database (NHIRD) from 2005 to 2010 to investigate all fibrate prescriptions for patients with dyslipidaemia. We estimated the hazard ratios (HRs) of NODM associated with fibrate use. We identified 145 NODM patients among 3,815 dyslipidaemic patients in the database for the study period. The risk estimates for NODM for users of fenofibrate (HR 1.30; 95% CI 0.82, 2.05) and gemfibrozil (HR 0.771; 95% CI 0.49, 1.22) were not associated with an increased risk of developing NODM (P > 0.05). Our results revealed that patients with dyslipidaemia who took fenofibrate and gemfibrozil had a neutral risk of NODM. The reasons may be associated with the fibrates have the properties that activate PPARα and in some cases also activated PPARγ, leading to showing a neutral risk of NODM.

Cardioprotective effects of luteolin during ischemia-reperfusion injury in rats.

BACKGROUND: Antioxidants effectively reduce ischemia-reperfusion (IR) injury. The cardioprotective effects of luteolin, a flavonoid that exhibits antioxidant properties and is widely available in many fruits and vegetables, were examined in rats subjected to myocardial IR injury. METHODS AND RESULTS: Rats were subjected to myocardial ischemia or reperfusion injury to evaluate the antiarrhythmic effects of luteolin. Myocardial infarct size was determined histochemically with triphenyltetrazolium chloride staining of the left ventricle. Luteolin was administered intravenously 15min before occlusion of the coronary artery. The incidence and duration of ventricular tachycardia and ventricular fibrillation and mortality during myocardial ischemia were significantly reduced by luteolin (10µg/kg). Similarly, luteolin (1µg/kg) reduced ventricular arrhythmias and mortality during the reperfusion phase. Pretreatment with luteolin decreased plasma lactate dehydrogenase and nitric oxide (NO) levels. Luteolin (10µg/kg) significantly reduced the myocardial infarct size, as well as malondialdehyde production in tissue samples of myocardial IR injury. Luteolin also downregulated inducible NO synthase protein and mRNA expression, but did not significantly alter neuronal NO synthase or endothelial NO synthase expression. CONCLUSIONS: Luteolin is capable of protecting the myocardium against IR injury. The actions of luteolin are at least partly mediated through downregulation of NO production and its own antioxidant properties.

In vitro anti-microbial and in vivo cytokine modulating effects of different prepared Chinese herbal medicines.

The toxicity, antimicrobial and cytokine modulating effects of herbal medicines in treating periodontal diseases were evaluated in this study. Using the broth dilution method and disc agar diffusion test, in individual and combined decocted preparations, different concentrations of Ching-Wei-San and its individual herbal components, Coptidis rhizoma, Angelicae sinensis radix, Rehmanniae radixet rhizom, Moutan radicis cortex, and Cimicifuga foetida, were tested for in vitro inhibitory effects on three well-known plaque-causing bacteria, Porphyromonas gingivialis, Streptococcus sanguis, and Streptococcus mutans, and two common pathogens, Staphylococcus aureus and Escherichia coli. The cytokine modulating effects were evaluated in Balb/c mice. The results suggested that one milliliter Ching-Wei-San at the 25,000 mg/mL concentration daily for the mice had significantly high levels in the liver function indexes in the 3-day acute toxicity test and in both the liver and kidney function indexes in the 28-day subacute toxicity test (P<0.01). The 250 mg/mL Ching-Wei-San is comparable to 250 mg/mL of tetracycline, and had similar inhibitory effects on the tested bacteria. Coptidis rhizoma (62.5 mg/mL) was the only individual herbal component to show 100% inhibitory effects. The mean cytokine ratios of IL-2, IL-4, IFN-gamma, and TNF-alpha in Balb/c mice treated with individual herbal components were shown to be different from each other. Ching-Wei-San modulated the immunity of mice, up-regulated IL-2, IL-4 and TNF-alpha, but down-regulated IFN-gamma. The effects of none of the individual herbal components alone can substitute for the cumulative effect of Ching-Wei-San.

Anti-hypertension effects of traditional Chinese medicine ju-ling-tang on renal hypertensive rats.

This research investigated the anti-hypertension effect of the traditional Chinese medicine (TCM) ju-ling-tang (JLT) on an animal model of hypertension induced by unilateral renal artery ligation. In the study of anti-hypertension effects, 60 minutes after oral administration with NG tube feeding of 240 mg/kg JLT, a significant decrease in blood pressure (p < 0.05) was observed and sustained till 120 minutes. In the group given 50 mg/kg alpha-methyldopa orally, the effect was obvious 90 minutes after medication (p < 0.01), and lasted until 240 minutes. In terms of organ pathology, a significant reduction in the extent of induced glomerular sclerosis was observed in rats given 240 mg/kg JLT compared with the control. From these results, we infer that JLT has a beneficial anti-hypertensive effect on renal hypertension.

Induction of apoptosis in human oral cancer cell lines, OC2 and TSCCa, by chingwaysan.

Chingwaysan, a Chinese herbal formula, contains Cimicfugae Rhizoma, Rehmanniae Radixet Rhizoma, Moutan Radicis Cortex, Coptidis Rhizoma and Angelicae Sinensis Radix. This medicine is well-known for its curing power for ulcerated gums, toothaches, cheek boils and bleeding gingiva. However, no reports can be found on its application in the treatment of oral cancers. We are therefore interested in whether Chingwaysan is capable of causing abnormal apoptosis processes, and whether this condition can be rectified through Chingwaysan herb treatment. We used aqueous extract to treat OC2 and TSCCa cells (both are human oral cancer cell lines) with different Chingwaysan concentrations (0, 10, 25, 50, 75 and 100 microl/ml). The MTT (3, (4, 5-dimethyl-thiazol) 2, 5-diphenyl-tetraxolium bromide) reduction assay was employed to quantify the differences in cell activity and viability. DNA ladder formation on agarose electrophoresis was also performed. The bax expression level was monitored using immunoblotting techniques. The patterns of the changes in expression were scanned and analyzed by NIH image 1.56 software. Taken together, drastic morphological changes, reduced cell viability and the presence of inter-nucleosomal DNA fragmentation all indicated that Chingwaysan is capable of inducing apoptosis in OC2 and TSCCa cell lines. Furthermore, the accumulation of wild type bax protein significantly increased in a dose-dependent manner upon treatment with Chingwaysan. In conclusion, Chingwaysan can induce apoptosis via a bax-dependent pathway in cells from these two particular oral cancer cell lines.