Traditional Chinese medicine in the treatment of patients with hyperuricemia: A randomized placebo-controlled double-blinded clinical trial.

BACKGROUND: Studies have demonstrated the association of hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease, and chronic renal disease. Although Western medicine presents promising effects for treating hyperuricemia and gout, identifying a safe and effective alternative to traditional Chinese medicine (TCM) for treating hyperuricemia is essential. OBJECTIVE: To evaluate the efficacy and safety of TCM formulas, "Wu-Ling San" and "Yin Chen Wu-Ling San," in patients with hyperuricemia. METHODS: A randomized, double-blinded, placebo-controlled clinical trial in adults with hyperuricemia was conducted. Sixty patients with serum urate level higher than 8 mg/dL were enrolled in the study. Patients were then randomized into three arms: "Wu-Ling San," "Yin Chen Wu-Ling San," and placebo for 4 weeks. Efficacy and safety were evaluated at weeks 2, 4, and 8. Primary and secondary endpoints were set to evaluate the serum urate concentration and related indicators at weeks 2, 4, and 8. RESULTS: No significant differences were observed among the three arms in terms of the serum urate level (<6 mg/dL) at week 4. The serum urate level was lower in the "Yin Chen Wi-Ling" arm at week 8 (8.1 mg/dL vs. 9.1 mg/dL, p = .034). The serum urate levels were significantly different in both the "Wu-Ling San" and "Yin Chen Wu-Ling San" arms from those at the baseline (p < .05). CONCLUSIONS: Two TCM formulas were found to be relatively safe for the short-term treatment of the patients with hyperuricemia. No statistically significant difference was observed in reaching the target-serum urate level <6 mg/dL.

Traditional Chinese medicine use is associated with lower risk of pneumonia in patients with systemic lupus erythematosus: a population-based retrospective cohort study.

Objectives: To investigate the association between traditional Chinese medicine (TCM) therapy and the risk of pneumonia in patients with systemic lupus erythematosus (SLE). Methods: This population-based control study analyzed the data retrieved from the National Health Insurance Research database in Taiwan. From a cohort of 2 million records of the 2000-2018 period, 9,714 newly diagnosed patients with SLE were initially included. 532 patients with pneumonia and 532 patients without pneumonia were matched 1:1 based on age, sex, and year of SLE diagnosis using propensity score matching. The use of TCM therapy was considered from the SLE diagnosis date to the index date and the cumulative days of TCM therapy were used to calculate the dose effect. Conditional logistic regression was used to investigate the risk of pneumonia infection. Furthermore, to explore the severity of pneumonia in SLE, sensitivity analyses were performed after stratification using the parameters of emergency room visit, admission time, and antibiotic use. Results: TCM therapy for >60 days could significantly reduce the risk of pneumonia in patients with SLE (95% CI = 0.46-0.91; p = 0.012). Stratified analysis showed that TCM use also reduced the risk of pneumonia in younger and female patients with SLE by 34% and 35%, respectively. TCM for >60 days significantly reduced the risk of pneumonia in the follow-up periods of >2, >3, >7, and >8 years. In addition, the exposure of TCM for >60 days reduced the risk of pneumonia in patients with SLE who were treated with antibiotics for moderate or severe pneumonia. Finally, the study found that using formulae to tonify the kidney for more than 90 days and formulae to activate blood circulation for less than 30 days could significantly reduce the risk of pneumonia infection in patients with SLE. Conclusion: TCM use is associated with a lower risk of pneumonia among patients with SLE.

Traditional Chinese Medicine in Patients With Primary Sjogren's Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Background: Sjogren's syndrome (SS) is a chronic inflammatory autoimmune disease mainly characterized by dryness, fatigue, and pain. Current therapies for SS in Western medicine are limited. The purpose of this clinical study was to explore the efficacy and safety of using a traditional Chinese medicine (TCM) formula on patients with primary SS. Methods: We performed a 12-week, randomized, double-blinded, placebo-controlled clinical trial at Chung Shan Medical University Hospital. We included 42 patients with SS between the ages of 20 and 80 years who met the classification criteria of the American and European Consensus Group (AECG). Patients who had other severe systemic manifestations or diseases were excluded from this trial. After screening, patients were randomly assigned to the TCM treatment group or placebo group (ratio of 2:1). We treated the TCM group with 6 g of Gan-Lu-Yin granules after breakfast and 6 g of Jia-Wei-Xiao-Yao-San combined with 1 g of Suan-Zao-Ren-Tang and 1 g of Ye-Jiao-Teng every night after dinner. Patients in the control group were treated with a placebo with the same appearance and flavor but only one-tenth the dosage of that received by the treatment group. The European League Against Rheumatism Sjogren's Syndrome Patient-Reported Index (ESSPRI) was used as the primary endpoint at week 12. Secondary endpoints were the Sjogren's Syndrome Disease Activity Index (SSDAI), physician global assessment (PGA), visual analogue scale (VAS), Multidimensional Fatigue Inventory, Medical Outcomes Survey Short Form-36, and the Pittsburgh Sleep Quality Score (PSQI). Adverse events were also recorded. Results: Of the 42 randomized patients, 28 patients were assigned to the TCM treatment group and 14 patients were assigned to the controlled group. During the study period, 5 patients withdrew from the TCM group and 7 withdrew from the control group. At week 12, the ESSPRI scores of both groups had improved. The ESSPRI score of the treatment group decreased by 0.62 (95% CI P = 0.557) and that of the placebo group decreased by 0.91 (P = 0.557). However, no significant difference was observed between the two groups. Sleep duration in the PSQI was -0.61, which exhibited an improvement of more than the -0.21 compared with the placebo group (P = 0.914). Conclusion: At week 12, the ESSPRI scores did not reveal that the use of the TCM formula was efficacious for treating patients with Sjogren's syndrome. However, the PSQI scores indicated that this formula could prolong patient sleep duration. We also found that this formula could decrease the blood pressure of patients.

Chinese herbal medicine might be associated with a lower rate of joint replacement in patients with osteoarthritis: A 12-year population-based matched cohort analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: To determine whether adjuvant Chinese herbal medicine (CHM) treatment is associated with the risk of joint replacement in osteoarthritis (OA) patients. MATERIALS AND METHODS: This retrospective study used a population-based national health insurance (NHI) database from 2000 to 2012 in Taiwan. A total of 125,023 newly diagnosed OA patients were selected from one million beneficiaries of longitudinal health insurance database. Based on applying ten selected frequently used CHM formulas for OA, patients were divided into CHM user and non-CHM user. One-CHM to four-non-CHM user were propensity score matched with age, gender, monthly income, urbanization, comorbidities, Nonsteroidal anti-inflammatory drugs (NSAIDs) and index year were adjusted to reduce selection bias and confounding. Cox regression model was used for comparing the hazard ratios (HR) for the risk of joint replacement and Kaplan-Meier curve for the proportion of joint replacement. RESULTS: OA patients who were female, younger (20-60 years), higher income and lived in urbanization location were found to preferred using CHM. Younger CHM users had a lower adjusted HR (0.63) of the risk of joint replacement (95% confidence interval (CI) = 0.42-0.94). Compared to non-CHM user, HR among CHM users (≥225 days annually) is 0.48 (95% CI = 0.31-0.76). The proportion of joint replacement in younger non-CHM user began to rise notably with time (log-rank test, p = 0.026). However, this benefit by CHM did not apply to older (over 60 years) OA patients. CONCLUSION: This study suggested that adjuvant CHM might be associated with a lower rate of joint replacement in OA patients. CHM therapy might be considered in OA patients to reduce the need of joint replacement.

Association Between Chinese Herbal Medicine Therapy and the Risk of Chronic Kidney Disease in Gout Patients.

Background: Chinese herbal medicine (CHM) has been nationally and globally used in treating gout for over a millennium. The potential relationship between the incidence of chronic kidney disease (CKD) in gout patients and CHM therapy is unclear. Thus, this study aimed to provide some evidence regarding the relationship between CHM therapy and the occurrence of CKD in gout patients. Methods: We used data from the National Health Insurance Research database (NHIRD) in Taiwan. In this population-based nested case-control study, all participants were identified by International Classification of Diseases, Ninth Revision (ICD-9). Conditional logistic regression was used to calculate the odds ratio (OR) of the risk of CKD in gout patients treated with CHM therapy. Results: Data on 1718 gout patients with CKD and 1:1 matched 1718 gout patients without CKD were collected for analysis. The results showed that CHM therapy in gout patients did not increase the risk of developing CKD (adjusted OR = 1.01; 95% confidence interval [CI]: 0.86-1.18; p > 0.05). Moreover, CHM therapy in gout patients for >365 days did not increase the incidence of CKD (adjusted OR = 1.30; 95% CI: 0.90-1.88; p = 0.162). Conclusion: Traditional CHM therapy does not increase the incidence of CKD in gout patients.

Associations of Chinese Herbal Medicine Usage with Risk of Dementia in Patients with Parkinson's Disease: A Population-Based, Nested Case-Control Study.

Background: Patients who have Parkinson's disease (PD) comorbid with dementia is common. With the prolonged life expectancy, dementia is gradually becoming prevalent and affects most patients' life qualities. However, the efficacy of current treatments in dementia of PD is limited. Previous studies indicated the potential roles of Chinese herbal medicine (CHM) in treating dementia, yet the correlation between CHM usage and risk of dementia in PD patients is unclear. Methods: This case-control study was nested within a National Health Insurance database of patients over 50 years with newly diagnosed PD from year 2000 to 2010. Among these PD patients, dementia and nondementia groups were discussed, respectively, in terms of the duration of taking CHM (≥90 vs. <90 days), age (50-64 vs. ≥65 years) and gender. Results: The risk of dementia in patients with PD is lower in CHM users compared with non-CHM users, especially in those taking CHM for more than 90 days (adjusted odds ratio [aOR] 0.58; 95% confidence interval [95% CI] 0.39-0.87). The use of CHM was significantly related to the lower risk of dementia in the subgroups of patients with age ≥65 years for CHM usage <90 days (aOR 0.68; 95% CI 0.53-0.88), patients with age ≥65 years for CHM usage ≥90 days (aOR 0.63; 95% CI 0.42-0.94), female patients using CHM for ≥90 days (aOR 0.43; 95% CI 0.22-0.84), and male patients using CHM for <90 days (aOR 0.62; 95% CI 0.43-0.88). Conclusions: The authors demonstrated the association of CHM usage with lower risk of dementia in patients with PD, especially in women with the usage of CHM for more than 90 days. Since no arbitrary causal conclusions could be drawn from retrospective cohort studies, the finding in this study could be used to generate a hypothesis for a subsequent design of prospective longitudinal study.

Hydroxychloroquine Does Not Increase the Risk of Cardiac Arrhythmia in Common Rheumatic Diseases: A Nationwide Population-Based Cohort Study.

Objectives: Hydroxychloroquine (HCQ) is widely used to treat rheumatic diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and Sjögren's syndrome (SS). Cardiac arrhythmia has been concerned as important safety issue for HCQ. The aim of this study was to investigate whether hydroxychloroquine increases new-onset arrhythmia among patients with RA, SLE or SS. Methods: This was a retrospective cohort study that conducted from the longitudinal health insurance database of Taiwan. Patients with newly diagnosed RA, SLE or SS with age ≥20 years old were selected from 2000 to 2012. Patients who received HCQ and without HCQ treatment groups were matched by propensity score to minimize the effect of selection bias and confounders. The Cox proportional hazard model was used to analyze the risk of arrhythmia between the two groups after controlling for related variables. Results: A total of 15892 patients were selected to participate and finally 3575 patients were enrolled in each group after matching. There was no different risk of all arrhythmia in patients using HCQ than without HCQ (adjusted hazards ratio 0.81, 95% CI 0.61-1.07) and ventricular arrhythmia as well. The incidence of arrhythmia did not increase when HCQ co-administrated with macrolides. The arrhythmia risk was also not different regardless of daily HCQ dose <400mg or ≥400mg or follow-up duration of ≦4 months or >4 months. Conclusion: The administration of HCQ did not increase the risk of all cardiac arrhythmia and ventricular arrhythmia regardless of different duration of treatment (≦4 months or >4 months) or cumulative dose (<400mg or ≥400mg) in patients with common autoimmune diseases such as RA, SLE and SS.

Adenine Inhibits the Growth of Colon Cancer Cells via AMP-Activated Protein Kinase Mediated Autophagy.

BACKGROUND: Adenine is involved in a variety of cell biological processes and has been explored for pharmacological uses. Its therapeutic use for managing cancer is of great interest. In the present study, we investigated the anticancer effects of adenine and the underlying mechanism in colon cancer cells. METHODS: Cell viability was measured using the MTT assay. Levels of phosphorylation and protein expression were determined using western blotting. qPCR was carried out to determine the changes in mRNA expression of genes of interest. RESULTS: Adenine significantly inhibited the viability of colon cancer cells, HT29 and Caco-2 cells, in a dose-dependent manner. Adenine induced significant apoptosis in HT29 cells, whereas Caco-2 cells exhibited less apoptotic responses. The data showed that adenine activated AMP-activated protein kinase (AMPK) signaling contributing to autophagic cell death through mTOR in both colon cancer cell lines. CONCLUSIONS: Our findings suggest that adenine inhibits the growth of colon cancer cells. Anticancer activity of adenine in colon cancer cells is attributable to the activation of apoptotic signaling and in turn the AMPK/mTOR pathway. Adenine represents a natural compound with anticancer potency.

Characterization of T-Cell Receptor Repertoire in Patients with Rheumatoid Arthritis Receiving Biologic Therapies.

Rheumatoid arthritis (RA) is a systematic autoimmune disease, predominantly causing chronic polyarticular inflammation and joint injury of patients. For the treatment of RA, biologic disease-modifying antirheumatic drugs (bDMARDs) have been used to reduce inflammation and to interfere with disease progression through targeting and mediating the immune system. Although the therapeutic effects of bDMARDs in RA patients have been widely reported, whether these drugs also play important roles in T-cell repertoire status is still unclear. We therefore designed the study to identify the role of T-cell repertoire profiles in RA patients with different types of bDMARD treatments. A high-throughput sequencing approach was applied to profile the T-cell receptor beta chain (TCRB) repertoire of circulating T lymphocytes in eight patients given adalimumab (anti-TNF-α) with/without the following use of either rituximab (anti-CD20) or tocilizumab (anti-IL6R). We subsequently analyzed discrepancies in the clonal diversity and CDR3 length distribution as well as usages of the V and J genes of TCRB repertoire and interrogated the association between repertoire diversity and disease activities followed by the treatment of bDMARDs in these RA patients. All groups of patients showed well-controlled DAS28 scores (<2.6) after different treatment regimens of drugs and displayed no significant statistical differences in repertoire diversity, distribution of CDR3 lengths, and usage of V and J genes of TCRB. Nonetheless, a trend between overall TCRB repertoire diversity and disease activity scores in all bDMARD-treated RA patients was observed. Additionally, age was found to be associated with repertoire diversity in RA patients treated with bDMARDs. Through the profiling of the TCR repertoire in RA patients receiving different biologic medications, our study indicated an inverse tendency between TCR repertoire diversity and disease activity after biologic treatment in RA patients.

Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis.

BACKGROUND: Ixekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis. METHODS: Data from SPIRIT-P1 and SPIRIT-P2 were integrated. Patients with PsA were randomized to 80-mg ixekizumab every 4 weeks (IXEQ4W) or 2 weeks (IXEQ2W), after a 160-mg starting dose, or to placebo. Inadequate responders at week 16 received rescue therapy. Among patients with baseline enthesitis (Leeds Enthesitis Index [LEI] > 0) or dactylitis (Leeds Dactylitis Index-Basic [LDI-B] > 0), baseline characteristics and disease burden were reported. At week 24, LEI and LDI-B (percentage of patients with resolution [LEI = 0, LDI-B = 0]) were assessed. In pooled treatment groups, the impact of enthesitis or dactylitis resolution on health-related quality of life (HRQoL) (EuroQol-5 Dimensions Visual Analogue Scale [EQ-5D VAS]), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and pain was assessed. RESULTS: The integrated analysis set comprised 679 patients; of these, 60% (n = 403 of 675) had baseline enthesitis (LEI > 0) and 23% (n = 155 of 676) had baseline dactylitis (LDI > 0). At week 24, ixekizumab-treated patients experienced significantly more resolution than placebo of enthesitis (39% IXEQ4W, 35% IXEQ2W, 21% placebo) and dactylitis (78% IXEQ4W, 65% IXEQ2W, 24% placebo). Furthermore, at entheseal points measured by the LEI, ixekizumab-treated patients had significantly higher resolution of enthesitis compared to placebo. At week 24, among all placebo- and ixekizumab-treated patients, resolution of enthesitis was associated with improvements in function and HRQoL whereas dactylitis resolution was associated with more limited improvements. The least squares mean HAQ-DI improvements from baseline were - 0.44 and - 0.25 for patients who did/did not resolve enthesitis, and - 0.41 and - 0.31 for patients who did/did not resolve dactylitis. EQ-5D VAS improvements were 12.3 and 5.8 for patients who did/did not resolve enthesitis, and 10.8 and 9.8 for patients who did/did not resolve dactylitis. CONCLUSIONS: Among patients with pre-existing enthesitis or dactylitis, IXEQ2W- and IXEQ4W-treatment resulted in significant improvements in enthesitis and dactylitis. Enthesitis resolution was associated with improvements in patients' function, pain, and HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01695239 , registered on September 25, 2012, and NCT02349295 , registered on October 10, 2014.

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.

Adjunctive Treatment with Rhodiola Crenulata in Patients with Chronic Obstructive Pulmonary Disease--A Randomized Placebo Controlled Double Blind Clinical Trial.

UNLABELLED: Chronic obstructive pulmonary disease (COPD) is a low grade systemic inflammatory disease characterized by dyspnea and exercise intolerance even under standard therapy. Rhodiola crenulata (RC) has been shown to exert anti-inflammatory effects and to enhance exercise endurance, thereby having the potential to treat COPD. In this 12-week, randomized, double-blind, placebo-controlled clinical trial, 57 patients with stable moderate-to-severe COPD aged 70±8.8 years were given RC (250 mg twice/day) (n=38) or a placebo (250 mg twice/day) (n=19) in addition to their standard regimen. There were no significant differences in anthropometrics, quality of life, lung function, six-minute walk and incremental exercise tests between the two groups at enrollment. Over the 12 weeks, RC was well tolerated, significantly reduced triceps skin thickness (Δ=-1 mm, p=.04), change of FEV1 (4.5%, p=.03), and improved workload (Δ=10%, p=.01); although there were no significant differences in these factors between the two groups. However, there were significant between-group differences in tidal volume and ventilation-CO2-output ratio at peak exercise (both p=.05), which were significantly related to peak work rate (both p<.0001). RC tended to protect against acute exacerbation of COPD (p=.1) but not other measurements. RC did not improve the six-minute walk test distance but significantly improved tidal breathing and ventilation efficiency, most likely through improvements in work rate. Further studies with a larger patient population are needed in order to confirm these findings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT02242461.

Complementary usage of Rhodiola crenulata (L.) in chronic obstructive pulmonary disease patients: the effects on cytokines and T cells.

Although chronic obstructive pulmonary disease (COPD) is an inflammatory disease predominantly involving T cells, no study of Rhodiola as an immunomodulator in COPD patients has been reported. In this study, COPD patients took Rhodiola crenulata 500 mg (n = 38) or placebo (starch/phosphate buffered saline) (n = 19) daily for 12 weeks and were compared with untreated, age-matched, and sex-matched non-COPD control subjects. Our results showed that serum levels of IL-2, IL-10, and IFN-γ in COPD patients before treatment are significantly higher than levels in non-COPD controls (p < 0.05). A significant decrease in IFN-γ was seen in the Rhodiola treatment group (p < 0.05) but not in the placebo group (p > 0.05). The results suggested that Rhodiola treatment had beneficial antiinflammation effects, lower COPD assessment test score and decreased high-sensitivity C-reactive protein, on COPD patients (p < 0.05). The effects of Rhodiola treatment on COPD patients were shown to decrease the IFN-γ concentration and CD8(+) count but increase the expressions of CD4(+) CD25(+) FOXP3(+) and CD4(+) CD25(+) CD45(+) FOXP3(+) in the blood significantly (p < 0.05). This is the first trial using Rhodiola as a complementary therapy for COPD patients. T cells play an important role in the pathogenesis of COPD through the increased expression of CD8(+) T cells and IFN-γ and may be a viable target for potential therapy.

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.

The traditional Chinese medicine prescription patterns of Sjögren׳s patients in Taiwan: a population-based study.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese medicines (TCM), when given for symptom relief, have gained widespread popularity among Sjögren׳s patients. The aim of this study was to analyze the utilization of TCM among Sjögren׳s patients in Taiwan. MATERIALS AND METHODS: The usage, frequency of service, and the Chinese herbal products prescribed among Sjögren׳s patients were evaluated in a cohort of 1,000,000 beneficiaries recruited from the National Health Insurance Research Database. The logistic regression method was employed to estimate the odds ratios (ORs) for utilization of a TCM. RESULTS: More than 90% of Sjögren׳s patients received TCM out-patient services at least once during the study period. Patients with secondary Sjögren׳s syndrome were more likely to seek TCM treatment than those with primary Sjögren׳s syndrome. The aOR for those suffering from at least one rheumatologic disease was 1.56 (95% CI: 1.26-1.93), those with two rheumatologic diseases was 1.98 (95% CI: 1.29-3.04), while those with three or more rheumatologic diseases was 7.86 (95% CI: 1.09-56.58). Compared to Sjögren׳s patients who used no medical treatment, the aOR for those who took one type of conventional medication was 1.55 (95% CI: 1.25-1.92), those who took two types was 1.98 (95% CI: 1.60-2.47) while those who took three or more types was 2.91 (95% CI: 2.20-3.84). Qi-Ju-Di-Huang-Wan (Lycium Berry, Chrysanthemum, and Rehmannia Pill) was the most frequently prescribed formula among Sjögren׳s patients. CONCLUSION: Qi-Ju-Di-Huang-Wan is the most commonly prescribed Chinese herbal formula for Sjögren׳s syndrome and its effects should be taken into account by healthcare providers.

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.

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of Fufang Danshen (Salvia miltiorrhiza) as add-on antihypertensive therapy in Taiwanese patients with uncontrolled hypertension.

Hypertension generally requires the use of a combination therapy to achieve the satisfactory control of blood pressure. A traditional Chinese herb, Danshen (Salvia miltiorrhiza), has been shown to have cardioprotective effects in animals and humans. The study investigated the add-on effect of Fufang Danshen extract capsule in Taiwanese hypertensive patients with uncontrolled blood pressure. This was a double-blind, placebo-controlled, randomized, single-center study clinical trial. Fifty-five patients with uncontrolled mild to moderate hypertension were enrolled under current conventional antihypertensive treatment, randomized equally to receive a Fufang Danshen capsule (formula mixture) 1000 mg twice-daily or a placebo capsule for 12 weeks. Primary endpoints were the control rate and the response rate. By ITT analysis at week 12, the control rates were 25.5% in the Fufang Danshen group and 7.3% in the control group (p = 0.016). The response rates were 45.6% in the Fufang Danshen group and 38.2% in the placebo group (p = 0.946). A significant reduction of systolic blood pressure at week 12 was noted in the Fufang Danshen group compared with the placebo group (13.8 vs 4.2 mmHg, p = 0.005). A decrease of pulse rate was also noted in the Fufang Danshen group (- 3.2 vs +2.7/min, p = 0.027). Adverse events were not statistically different between the two groups. It was concluded that Fufang Danshen (Salvia miltiorrhiza) extract reduced systolic blood pressure and pulse rate, and was well tolerated in patients with hypertension.