Herbal Formula SS-1 Increases Tear Secretion for Sjögren's Syndrome.

Background: Sjögren's syndrome (SS) is an autoimmune inflammatory disease that primarily affects the exocrine glands, leading to glandular dysfunction. The hallmark symptoms of SS are dry eyes and mouth, compromising the quality of life of patients and decreasing their capacity to perform their daily activities. Objective: This study aims to evaluate the efficacy of the herbal formula SS-1 for its potential therapeutic benefits for patients with Sjögren's syndrome. Materials and Methods: The bioactivity profile of SS-1 was determined using four different SS-1 concentrations across 12 human primary cell systems of the BioMAP profile. After that, a randomized, double-blind, crossover, placebo-controlled trial was performed including 57 patients treated with SS-1 for 28 weeks. Results: Biologically multiplexed activity profiling in cell-based models indicated that SS-1 exerted anti-proliferative activity in B cells and promoted anti-inflammatory and immunomodulatory activity. In the clinical trial, Schirmer's test results revealed significant improvements in both eyes, with increases of 3.42 mm (95% CI, 2.44-4.41 mm) and 3.45 mm (95% CI, 2.32-4.59 mm), respectively, and a significant reduction in artificial tear use, which was -1.38 times/day, 95% CI, -1.95 to -0.81 times/day. Moreover, the increases in B-cell activating factor (BAFF) and B-cell maturation antigen (BCMA) levels were dampened by 53.20% (295.29 versus 555.02 pg/ml) and 58.33% (99.16 versus 169.99 pg/ml), respectively. Conclusion: SS-1 treatment significantly inhibited B-cell maturation antigen. No serious drug-related adverse effects were observed. Oral SS-1 administration may be a complementary treatment for Sjögren's syndrome.

The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes. METHODS: Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation. RESULTS: At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of ß cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial. CONCLUSIONS: This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and ß-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.

Prostate resected weight and postoperative prostate cancer incidence after transurethral resection of the prostate: A population-based study.

To analyze whether different volumes of tissue resected during transurethral resection of the prostate (TURP) would associate with the subsequent development of prostate cancer.This population-based retrospective cohort study recruited 49,206 patients with benign prostate hyperplasia (BPH) undergoing TURP between 2005 and 2012. Patients were recruited from the Taiwan National Health Insurance Research Database. Patients were separated into three groups, based on different volumes of tissue resected during TURP (5-15 g, 15-50 g, >50 g).Of the 49,206 patients, 633 patients were diagnosed with new onset of prostate cancer following TURP. Older age was a risk factor contributing to the onset of prostate cancer (P = .0196) and different volumes of tissue resected were significantly related to the incidence of postoperative prostate cancer (P = .0399). The group of patients with a smaller volume of prostate resected had a higher risk of prostate cancer with a hazard ratio (HR) of 1.221 (95% confidence interval [CI]: 1.035, 1.440; P = .0179). However, the risk in the group of patients with a larger volume of prostrate resected was not significantly different, with an HR of 1.277 (95% CI: 0.981, 1662; P = .0690). The incidence of prostate cancer in Taiwanese males over 30 years of age has previously been reported to be 0.0560%; the mean incidence was 0.2282% in our present study.This study shows that BPH patients who had a smaller volume of tissue resected during TURP show a higher incidence of prostate cancer postoperatively. Currently, no clear mechanism is shown to demonstrate the relationship between resected prostate weight and the incidence of tumors. Patients with a larger prostate volume might have lower urinary tract symptoms earlier and then seek professional help. It is possible that surgical procedures might remove the potentially carcinogenic prostate tissue and thus reduce the risk of an aggressive tumor developing in the future.

One-year survival rate and healthcare costs after cardiac arrest in Taiwan, 2006-2012.

OBJECTIVES: The annual increase in costs and the quality of life of survivors of cardiac arrest are major concerns. This study used National Health Insurance Research Database (NHIRD) of Taiwan to evaluate the 1-year survival rate and the annual healthcare costs of survivors after cardiac arrest. METHODS: This retrospective, fixed-cohort study conducted from 2006 to 2012, involved 2 million individuals randomly selected from the NHIRD of Taiwan. Adult patients at least 18 years old who were diagnosed with cardiac arrest were enrolled. Survival was followed up for 1 year. RESULTS: In total, 2,256 patients were enrolled. The survivor cohort accounted for 4% (89/2256) of the study population. There were no significant differences in the demographic characteristics of the survival and non-survival cohorts, with the exceptions of gender (male: survival vs. non-survival, 50.6% vs. 64.5%, p = 0.007), diabetes mellitus (49.4% vs. 35.8%, p = 0.009), and acute coronary syndrome (44.9% vs. 31.9%, p = 0.010). Only 38 (1.7%) patients survived for > 1 year. The mean re-admission to hospital during the 1-year follow up was 73.5 (SD: 110.2) days. The mean healthcare cost during the 1-year follow up was $12,953. Factors associated with total healthcare costs during the 1-year follow up were as follows: city or county of residence, being widowed, and Chronic Obstructive Pulmonary Disease (city or county of residence, ß: -23,604, p < 0.001; being widowed, ß: 25,588, p = 0.049; COPD, ß: 14,438, p = 0.024). CONCLUSIONS: There was a great burden of the annual healthcare costs of survivors of cardiac arrest. Socioeconomic status and comorbidity were major confounders of costs. The outcome measures of cardiac arrest should extend beyond the death, and encompass destitution. These findings add to our knowledge of the health economics and indicate future research about healthcare of cardiac arrest survivors.

The Efficacy and Safety of a Fixed Combination of Chinese Herbal Medicine in Chronic Urticaria: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.

Background: Chronic urticaria is a bothersome skin disease, and Chinese herbal medicine (CHM) is commonly used as adjuvant therapy. This study aimed to evaluate the effectiveness and safety of the mixture of two CHM formula, Xiao-Feng-San (XFS) and Qing-Shang-Fang-Feng-Tang (QSFFT), in treating urticaria through a randomized, double-blind, placebo-controlled clinical trial. Methods: 78 participants entered the screening phase between November 2012 and August 2015. Participants were randomly and equally allocated in either CHM group (2 gm XFS and 2 gm QSFFT four times a day and 5 mg levocetirizine once daily for 28 days followed by 5 mg levocetirizine once daily alone for 28 days) or control group (placebo and 5 mg levocetirizine daily followed by 5 mg levocetirizine once daily for 28 days alone). Symptom improvement was set as the primary outcome, and the influence on sleep quality and changes in serum markers were used as secondary outcomes. Per protocol design was applied to the final analysis. Results: A total of 56 participants entered the final analysis stage. Participants in the CHM group had more prominent symptom relief on day 56 (the weekly urticaria activity score, UAS7, as 9.9 ± 9.2 vs. 15.6 ± 10.8, p = 0.038). In the CHM group, participants' symptom severity reduced progressively (trend analysis, p < 0.001) while the decreasing trend was less favored in the control group (trend analysis, p = 0.056). The life quality improved gradually in both groups, while the differences between CHM and control groups were statistically insignificant. For urticaria-related cytokines, interferon-γ seemed to decrease positively in the CHM group (about 30.8% reduction from baseline, trend analysis p = 0.013). For safety issue, the CHM prescription was well-tolerated with no noticeable long-term side effects when compared to the control group. At 6-month follow-up of symptom changes after the end of the trial, the CHM group participants reported positive results in no recurrence or ≥50% improvement (36.3% in CHM group vs. 20% in Control group, p = 0.103). Conclusions: The combination of XFS and QSFFT tended to be feasible and tolerable adjuvant therapy for urticaria in addition to standard therapy. However, larger study population with longer follow-up duration may be still needed. Trial registration: NCT01715740 (ClinicalTrials.gov).

Cognitive effects of weight-shifting controlled exergames in patients with chronic stroke: a pilot randomized comparison trial.

BACKGROUND: The exergaming training involves motor as well as cognitive stimulation. Although exergame studies have been reported to have benefits in motor function, the effects of exergames on improving cognitive function remain inconclusive. Moreover, no study has been reported in stroke patients. AIM: The objective of this study was to compare the cognitive effects of 2 weight-shifting controlled exergaming systems and conventional weight- shifting training in patients with chronic stroke. DESIGN: This was a single-blind randomized controlled trial. SETTING: All participants were recruited from a rehabilitation department of a tertiary hospital. POPULATION: Patients (N.=37) with chronic hemiplegic stroke. METHODS: Patients were randomly allocated to one of the Wii Fit, Tetrax biofeedback, or conventional weight-shifting training groups. All interventions were administered 30 minutes per session, twice a week for 12 weeks. We used total score and the 9 domain scores of Cognitive Abilities Screening Instrument Chinese version (CASI C-2.0), and Berg Balance Scale (BBS) as the outcome measures. The outcome measures were assessed before and after training, and at 3 months follow-up. RESULTS: There were no significant differences among the 3 groups in the percentage of change in CASI total score and BBS, either post intervention or at the 3-month follow-up. At assessing the percentage of change in each domain of CASI, we found significant differences among the 3 groups in the abstraction/judgment domain after intervention (Wii Fit 16.25 [9.77, 37.50]% vs. Tetrax 0.00 [-10.00, 0.00]% vs. weight-shift 11.00 [0.00, 14.38]%, P=0.01], and at the 3-month follow-up (Wii Fit 20.00 [10.83, 31.25]% vs. Tetrax -10.00 [-11.11, 10.00]% vs. weight-shifting 0.00 [-2.27, 11.46]%, P=0.01). The differences came from the differences between Wii Fit and Tetrax mainly. There were significant differences among the 3 groups in language domain after intervention (Wii Fit 0.00 [0.00, 5.54]% vs. Tetrax 0.00 [-3.00, 0.00]% vs. weight-shift 0.00 [0.00, 0.00]%, P=0.045), but not at the 3-month follow-up (P=0.13). There was no correlation between the percentage of change in BBS and CASI total score postintervention ( r=-0.15 P=0.38). CONCLUSIONS: Wii Fit games training might be beneficial in some cognitive functions, such as abstraction/judgment, language in patients with chronic stroke. Wii Fit games, the commercial entertainment exergames, had superior effect in abstract/judgment and language domains as compared to the rehabilitation exergame (Tetrax balance system). Hence, Wii Fit games might be considered as a tool in post-stroke cognitive rehabilitation programs.

Efficacy of Traditional Chinese Medicine in Xerostomia and Quality of Life during Radiotherapy for Head and Neck Cancer: A Prospective Pilot Study.

Xerostomia is one of the most common acute and late complications of radiotherapy for head and neck cancer, and it affects quality of life. We conducted a prospective study to evaluate the efficacy of traditional Chinese medicine (TCM) in toxicities and quality of life during radiotherapy. Head and neck cancer patients who were scheduled for radiotherapy were checked for inclusion/exclusion criteria before enrollment. Patients in the study group (inpatients) were hospitalized in a Chinese medicine ward and received concomitant TCM intervention during radiotherapy, while those in the control group (outpatients) received only conventional cancer treatments at the Western outpatient department. The primary end point was amelioration of postradiotherapy side effects. The secondary end points were quality of life during the cancer therapy and occurrence of adverse events following the TCM treatments. Thirty inpatients and 50 outpatients completed the study. Compared to the control group, those in the TCM group had decreased severity of xerostomia. There was no treatment-related impairment of renal or hepatic function among TCM group. Although better outcomes of social contact, dyspnea, physical and emotional function, and financial problems were found in the TCM group, we need further confirmation about the impact of hospitalization itself on these results.

Neuroprotective mechanism of BNG-1 against focal cerebral ischemia: a neuroimaging and neurotrophin study.

BNG-1 is a herb complex used in traditional Chinese medicine to treat stroke. In this study, we attempted to identify the neuroprotective mechanism of BNG-1 by using neuroimaging and neurotrophin analyses of a stroke animal model. Rats were treated with either saline or BNG-1 for 7 d after 60-min middle cerebral artery occlusion by filament model. The temporal change of magnetic resonance (MR) imaging of brain was studied using a 7 Tesla MR imaging (MRI) system and the temporal expressions of neurotrophin-3 (NT-3), brain-derived neurotrophic factor (BDNF), and nerve growth factor (NGF) in brain were analyzed before operation and at 4 h, 2 d, and 7 d after operation. Compared with the saline group, the BNG-1 group exhibited a smaller infarction volume in the cerebral cortex in T2 image from as early as 4 h to 7 d, less edema in the cortex in diffusion weighted image from 2 to 7 d, earlier reduction of postischemic hyperperfusion in both the cortex and striatum in perfusion image at 4 h, and earlier normalization of the ischemic pattern in the striatum in susceptibility weighted image at 2 d. NT-3 and BDNF levels were higher in the BNG-1 group than the saline group at 7 d. We concluded that the protective effect of BNG-1 against cerebral ischemic injury might act through improving cerebral hemodynamics and recovering neurotrophin generation.

The use of complementary and alternative medicine by patients with chronic hepatitis C.

BACKGROUND: The use of complementary and alternative medicine (CAM) is expanding globally. However, prevalence of its use by patients with chronic hepatitis C (CHC) remains unclear. METHODS: An exploratory, descriptive study was conducted using a questionnaire and interview to describe the use of CAM by patients with CHC attending a liver clinic in the United States. RESULTS: Eighty percent (n = 120) had used CAM in the last 12 months, most often prayer for health reasons (63%), multivitamins (56%) and herbal medicine (25%). A higher level of education (p < 0.005), poorer health status (p < 0.002) and prior use of anti-viral therapy (p < 0.02) were predictors of CAM use. Participants used CAM to promote general health, but herbal medicine was used to treat CHC symptoms and prevent liver disease. CONCLUSION: Use of CAM is common among patients with CHC. Failure to acknowledge the use of CAM as a management strategy may restrict the health provider's ability to provide optimal care.