A randomized, double-blind, placebo-controlled, parallel-group 12-week pilot phase II trial of SaiLuoTong (SLT) for cognitive function in older adults with mild cognitive impairment.

INTRODUCTION: This study primarily aimed to evaluate the efficacy and safety of SaiLuoTong (SLT) on cognition in mild cognitive impairment (MCI). METHODS: Community-dwelling people with MCI aged ≥60 years were randomly assigned to 180 mg/day SLT or placebo for 12 weeks. RESULTS: Thirty-nine participants were randomized to each group (N = 78); 65 were included in the final analysis. After 12 weeks, the between-groups difference in Logical Memory delayed recall scores was 1.40 (95% confidence interval [CI]: 0.22 to 2.58; P = 0.010); Delis-Kaplan Executive Function System Trail Making Test Condition 4 switching and contrast scaled scores were 1.42 (95% CI: -0.15 to 2.99; P = 0.038) and 1.56 (95% CI: -0.09 to 3.20; P = 0.032), respectively; Rey Auditory Verbal Learning Test delayed recall was 1.37 (95% CI: -0.10 to 2.84; P = 0.034); and Functional Activities Questionnaire was 1.21 (95% CI: -0.21 to 2.63; P = 0.047; P < 0.001 after controlling for baseline scores). DISCUSSION: SLT is well tolerated and may be useful in supporting aspects of memory retrieval and executive function in people with MCI. Highlights: SaiLuoTong (SLT) improves delayed memory retrieval and executive function in people with mild cognitive impairment (MCI).SLT is well tolerated in people ≥ 60 years.The sample of community dwellers with MCI was well characterized and homogeneous.

Study protocol for a phase III randomised controlled trial of Sailuotong (SLT) for vascular dementia and Alzheimer's disease with cerebrovascular disease.

Vascular dementia (VaD) accounts for 15-20% of all dementia cases. It is a syndrome of acquired cognitive impairment with a complex pathophysiological basis. A novel herbal formulation (Sailuotong; SLT) consisting of Panax ginseng C.A Mey, Ginkgo biloba L and Crocus sativus L extracts was developed to treat VaD. Preclinical animal studies found significant improvements in memory and in pathogenic biochemical parameters. Appropriate safety of SLT was shown in acute and chronic toxicity studies, and early clinical trials of SLT demonstrated enhancements in cognition in VaD patients. A fully powered study with a long intervention period is needed to confirm the efficacy and safety of this novel intervention. A rigorous phase III clinical trial was developed with the aim of recruiting 238 patients diagnosed with mild to moderate probable VaD, or VaD mixed with Alzheimer's disease (where cerebrovascular disease is the clinical dominant contributor to dementia, abbreviated as CVD+AD). Using a permuted block strategy, participants will be randomly allocated to receive SLT (120 mg bd) or placebo capsules for an intervention period of 52 weeks and will be followed-up for an additional 13 weeks. The primary outcome measures are the Vascular Dementia Assessment Scale-cognitive subscale and Alzheimer's Disease Cooperative Study-Activities of Daily Living scale. Secondary outcome measures include the Clinician's Interview Based Impression of Change-Plus, CLOX, EXIT-25, Neuropsychiatric Inventory-Clinician rating scale, and Dementia Quality of Life questionnaire. Safety is assessed through adverse event reports and liver, renal, and coagulation studies. Primary and secondary outcome measures will be compared between treatment and placebo groups, using intention to treat and per protocol analyses. We hypothesise that a 52-week treatment of SLT will be clinically effective and well tolerated in participants with VaD or AD+CVD. This project will provide vital efficacy and safety data for this novel treatment approach to VaD.

Perceptions of Participants on Trial Participation and Adherence to Tai Chi: A Qualitative Study.

Purpose: Trial participation and adherence to interventions can directly influence the evaluation of outcomes in clinical trials for real world applications. The factors that influence trial participation and adherence to Tai Chi interventions in people with cardiovascular diseases remains unknown. This study aimed to explore participants' perceptions of influential factors on their trial participation and adherence to a Tai Chi intervention within a trial setting. Patients and Methods: Participants had coronary heart disease and/or hypertension in a randomized controlled trial comparing Tai Chi with a waitlist control. Data were collected via face-to-face, semi-structured interviews and analyzed using thematic analysis. Results: Thirty-four participants from the Tai Chi group who completed the randomized trial were interviewed. Six dominating themes and four sub-themes are discussed under the facilitators of internal and external motivation, positive feelings, benefits of Tai Chi and future practice with an overall internal motivation to improve health. Positive feelings had three sub-themes: positive feelings toward Tai Chi, the project, and the learning experience. The Tai Chi instructor(s) was found to be a crucial element in motivating participants' adherence to Tai Chi. Conclusion: From the perception of participants, the facilitators to their trial participation and adherence to a Tai Chi intervention included internal and external motivation, positive feelings towards Tai Chi, the project and the learning experience, and perceived benefits of Tai Chi. Perceived barriers included concerns about the safety and complexity of Tai Chi practice, lack of group atmosphere outside of class, and scheduling conflicts. Future researchers can address these factors to improve trial recruitment and implementation of Tai Chi and other mind-body interventions in research and for real world applications.

Does tai chi improve psychological well-being and quality of life in patients with cardiovascular disease and/or cardiovascular risk factors? A systematic review.

BACKGROUND: Psychological risk factors have been recognised as potential, modifiable risk factors in the development and progression of cardiovascular disease (CVD). Tai Chi, a mind-body exercise, has the potential to improve psychological well-being and quality of life. We aim to assess the effects and safety of Tai Chi on psychological well-being and quality of life in people with CVD and/or cardiovascular risk factors. METHODS: We searched for randomised controlled trials evaluating Tai Chi for psychological well-being and quality of life in people with CVD and cardiovascular risk factors, from major English and Chinese databases until 30 July 2021. Two authors independently conducted study selection and data extraction. Methodological quality was evaluated using the Cochrane Risk of Bias tool. Review Manager software was used for meta-analysis. RESULTS: We included 37 studies (38 reports) involving 3525 participants in this review. The methodological quality of the included studies was generally poor. Positive effects of Tai Chi on stress, self-efficacy, and mood were found in several individual studies. Meta-analyses demonstrated favourable effects of Tai Chi plus usual care in reducing anxiety (SMD - 2.13, 95% confidence interval (CI): - 2.55, - 1.70, 3 studies, I2 = 60%) and depression (SMD -0.86, 95% CI: - 1.35, - 0.37, 6 studies, I2 = 88%), and improving mental health (MD 7.86, 95% CI: 5.20, 10.52, 11 studies, I2 = 71%) and bodily pain (MD 6.76, 95% CI: 4.13, 9.39, 11 studies, I2 = 75%) domains of the 36-Item Short Form Survey (scale from 0 to 100), compared with usual care alone. Tai Chi did not increase adverse events (RR 0.50, 95% CI: 0.21, 1.20, 5 RCTs, I2 = 0%), compared with control group. However, less than 30% of included studies reported safety information. CONCLUSIONS: Tai Chi seems to be beneficial in the management of anxiety, depression, and quality of life, and safe to practice in people with CVD and/or cardiovascular risk factors. Monitoring and reporting of safety information are highly recommended for future research. More well-designed studies are warranted to determine the effects and safety of Tai Chi on psychological well-being and quality of life in this population. SYSTEMATIC REVIEW REGISTRATION: International Prospective Register for Systematic Reviews (PROSPERO), CRD42016042905. Registered on 26 August 2016.

A pilot randomized controlled trial of WeiNaoKang (SaiLuoTong) in treating vascular dementia.

Objective: WeiNaoKang (or SaiLuoTong) is an herbal formula consisting of ginkgo, ginseng, and saffron. Our objective was to investigate if WeiNaoKang could improve cognitive function and cerebral perfusion in patients suffering from vascular dementia. Methods: A 16-week randomized double-blind, placebo-controlled trial was carried out in the setting of a memory disorder clinic at a single center. Patients with vascular dementia diagnosed clinically but supported by imaging and other investigations were invited to participate. The diagnoses were based on the National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria. An independent blinded assessor evaluated the effects of the formula. Intervention group was compared to the control group. A subgroup of participants was randomly chosen for further evaluation of cerebral perfusion by single photon emission computed tomography scans post-treatment. Results: Both groups were comparable in age (mean = 74 ± 7.2 years in the placebo group and 75 ± 7.4 in the intervention group) and in other demographics. Sixty-two participants were included in final analysis. Alzheimer's Disease Assessment Scale - Cognitive Portion (ADAS-cog) was the primary outcome. By week 16, the mean ADAS-cog reduced from 24.48 to 20.30 (mean reduction = 4.18) for those in the treatment group, and from 18.98 to 17.81 (mean reduction = 1.18) for those in the placebo group. The difference in mean reduction of ADAS-cog was -3.00 (95% confidence interval [CI] = -4.910 to -1.100) in favor of the treatment group. Secondary outcomes of activities of daily living and quality of life measures also showed significant difference. In the perfusion scan analysis, the difference in the change in cerebral blood flow (t-scores) pre- and post-treatment between the intervention group (n = 7) and the placebo group (n = 11) was statistically significant (P < 0.001). Conclusion: In this randomized, double-blind placebo-controlled trial, we demonstrated significant differences in improvement in cognitive function and activities of daily living. The clinical improvement is corroborated with improvement in cerebral perfusion in a subset of participants.

Zao Ren An Shen capsule for insomnia: a double-blind, randomized, placebo-controlled trial.

STUDY OBJECTIVES: The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. METHODS: We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for 4 weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events (AEs). Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. RESULTS: A nonsignificant (p > .05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with AEs was not significantly different (p > .05) between the two groups. Except for subjective sleep onset latency, which had a nonsignificant (p > .05) medium effect (Cohen's d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen's d < .4) and nonsignificant (p > .05). The acceptability and tolerability were high in the active group. CONCLUSIONS: ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.Registration: This clinical trial was registered in Australia New Zealand Clinical Trial Registry (registration number ACTRN12619000140156) under the name "Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial" (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376730&isReview=true).

Use of complementary medicines and lifestyle approaches by people living with dementia: Exploring experiences, motivations and attitudes.

BACKGROUND: Lack of effective treatments for chronic conditions is associated with high rates of complementary medicine (CM) use. However, little is known about CM use for dementia. AIMS AND OBJECTIVES: The aim of this study was to explore the experiences, motivations, and attitudes towards CM use by people living with dementia in an Australian setting. DESIGN: This study had a qualitative research design; quantitative demographic information was also collected. METHODS: In-depth interviews were conducted with people living with dementia and their caregivers (N = 18). A thematic (inductive) analysis approach was taken to interpret data. RESULTS: Three in four participants used CM for dementia, spending ~AUD$100/month (USD$70/month). Within three overarching themes, a range of sub-themes was identified: (1) CM knowledge and use: people living with dementia and caregivers understanding of CM, types of CM used, and CM usage patterns; (2) Self-determined reasons for use/non-use: maintain or improve quality of life, hope, management of dementia symptoms, level of awareness, willingness and evidence, perceptions on efficacy and safety of CM, experiences of conventional medicine, and holistic approach to wellness; (3) External determinants of use: information on CM, relationship influences on CM use, and experiences with General Practitioners (GPs) and CM. CONCLUSION: Findings highlight that CM use is widespread and positively viewed by people living with dementia and their caregivers. Decisions regarding CM use were based on personal opinions. Findings have important implications for conversations with health professionals regarding CM use by people living with dementia to improve communication, health literacy, and reduce the risk of adverse effects through polypharmacy. IMPLICATIONS FOR PRACTICE: This study showed that CM is a valued approach for dementia management by people living with dementia, their families, and healthcare providers. Future international research is required to evaluate the efficacy and safety of these approaches and promote accurate advice in nursing care.

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020.

The objective of this bibliometric review was to identify the volume, breadth, and characteristics of clinical studies evaluating Tai Chi published between January 2010 and January 2020. Five English and four Chinese language databases were searched. Following independent screening, 1018 eligible publications representing 987 studies were identified, which was a three-fold increase from the previous decade. Most common were randomized controlled trials (548/987, 55.5 %), followed by systematic reviews (157/987, 15.9 %), non-randomized controlled clinical studies (152/987, 15.4 %), case series (127/987, 12.9 %) and case reports (3/987, 0.3 %) that were conducted in China (730/987, 74.0 %), followed by the United States of America (123/987, 12.5 %) and South Korea (20/987, 2.0 %). Study participants were mostly in the adult (55.2 %) and/or older adult (72.0 %) age groups. The top ten diseases/conditions were hypertension, chronic obstructive pulmonary disease, diabetes, knee osteoarthritis, heart failure, depression, osteoporosis/osteopenia, breast cancer, coronary heart disease and insomnia. A quarter of the studies enrolled healthy participants to evaluate the effects of Tai Chi on health promotion/preservation, balance/falls, and physiological/biomechanical outcomes. Yang style Tai Chi was the most popular, followed by Chen and Sun style. Tai Chi was mostly commonly delivered face-to-face by a Tai Chi instructor in group settings for 60 min, three times a week, for 12 weeks. Most studies (93.8 %) reported at least one outcome in favor of Tai Chi. Adverse events were underreported (7.2 %). Over half fell short of expected intervention reporting standards, signalling the need for Tai Chi extensions to existing guidelines.

Perceptions and experiences of lifestyle interventions in women with polycystic ovary syndrome (PCOS), as a management strategy for symptoms of PCOS.

BACKGROUND: The international clinical practice guidelines for PCOS emphasize diet and exercise as first-line management of clinical signs and symptoms. This study aimed to describe the patterns, perceptions and experiences of lifestyle interventions for women in the community with PCOS. METHOD: An electronic survey of 493 members of two PCOS consumer support groups, collected by cloud-based Survey Monkey, described women's types and patterns of diet and exercise, experiences and perceptions of effectiveness. Women were recruited from the Polycystic Ovary Association of Australia (POSAA) and from the Facebook group, PCOS University Research Group. Associations between participants perceptions of effectiveness, and diet types and exercise patterns were assessed using logistic regression. Response bias for the POSAA group was assessed with a continuum of resistance model. RESULTS: 91% of POSAA members and 311 Facebook group members aged 16-50 years responded to the survey. Nearly all women reported adjusting their dietary and exercise practices with the aim to improve their health and/or PCOS (82% and 73% respectively), however less than 13% reported achievement of health goals (12.2% and 8.1% respectively). Low carbohydrate, high protein diets, and vigorous activity were associated with self-perceived effectiveness (r.0.16, p < 0.01; r.0.15 p < 0.01 and r.0.2 p < 0.01 respectively). Barriers for lifestyle interventions included psychosocial factors. Response bias was not assessed for the Facebook group, however self-reported PCOS aligned with prevalence of clinical phenotypes and suggests results are generalizable to clinical populations of women with PCOS, who are responsible for self-directing and administering lifestyle interventions to manage their PCOS. CONCLUSIONS: Perceptions of effectiveness for lifestyle interventions by women with PCOS may be complicated by a lack of rigorous evidence. The strength of recommendations in clinical practice guidelines may be enhanced by clinical trials investigating flexible and feasible lifestyle interventions for women in the community with PCOS.

Effects of Nonpharmacological Interventions in Chemotherapy-Induced Peripheral Neuropathy: An Overview of Systematic Reviews and Meta-Analyses.

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the prevalent and disabling side effects of cancer treatment. However, management strategies for CIPN currently remain elusive, with treatment restricted to neuropathic pain medications, supportive care, and chemotherapy dosing adjustments. This overview explores evidence on the potential benefits and safety of nonpharmacological interventions in preventing and treating CIPN in cancer patients. METHODS: Seven databases were searched for systematic reviews of randomized controlled trials (RCTs). The methodological quality of the selected reviews was assessed by AMSTAR 2, and the quality of evidence was judged by GRADE. Twenty-eight systematic reviews were considered eligible for this review. RESULTS: It was found that nonpharmacological interventions (acupuncture, exercise, herbal medicine, nutritional supplements) provided potential benefits for patients with CIPN. Furthermore, Chinese herbal medicine, administered orally or externally, significantly prevented and/or relieved the incidence and severity of CIPN in comparison to control groups (no additional treatment, placebo, and conventional western medicine). However, the quality of evidence and strength of recommendations were compromised by the inconsistencies and imprecision of included studies. The main concerns regarding the quality of systematic reviews included the lack of sufficiently rigorous a priori protocols, and the lack of protocol registration adopted in the included studies. CONCLUSIONS: Though looking across reviews, Chinese herbal medicine appear generally effective in CIPN, uncertainty remains about the effects of many other nonpharmacological interventions. The evidence on what works was particularly compromised by reporting and methodological limitations, which requires further investigation to be more certain of their effects.

Zao Ren An Shen for insomnia: a systematic review with meta-analysis.

OBJECTIVE: To assess the effectiveness and safety of Zao Ren An Shen (ZRAS), a Chinese herbal medicine formula, for the treatment of insomnia. METHODS: Seven databases (ie, EMBASE, PubMed, the Cochrane library, and PsycINFO, Chinese National Knowledge Infrastructure, Wanfang and Chongqing VIP) were searched from their inception to 6 November 2018. Controlled trials comparing the effectiveness or safety of ZRAS to conventional treatments, a placebo or no-treatment in an insomnia population were selected. Primary outcomes were: sleep quality (assessed with the Pittsburgh Sleep Quality Index, PSQI), and the number of adverse events at post-treatment. The risk of bias was assessed with the Cochrane Collaboration's tool and meta-analyses were performed using RevMan 5.3. RESULTS: A total of 19 studies (1780 participants) were included. The effect of ZRAS on sleep quality (mean difference) was found to be superior compared to placebo in the sole placebo-controlled study located [-0.90 (-1.56, -0.24; 95% CI), p = 0.007] and similar to Benzodiazepine Receptor Agonists (BzRAs) [0.17 (-0.29, 0.64); 95% CI, p = 0.46]. The number of adverse events (relative risk) was lower for ZRAS than BzRAs [0.16 (0.12, 0.23; 95% CI), p < 0.001]. An overall high risk of bias was found in the selected studies. CONCLUSIONS: The results favor ZRAS against BzRAs and placebo for the treatment of insomnia. However, the poor methodology of the studies prevents strong recommendations for ZRAS. Clinical trials with higher quality designs are required.

Is insomnia disorder associated with time in bed extension?

OBJECTIVE: There is a lack of evidence for extension of time in bed behaviors (i.e., getting to bed earlier, going out of bed later, staying in bed while awake and napping) as perpetuating factors of insomnia. The aim of this study is to assess if insomnia disorder is associated with extension of time in bed behaviors. METHODS: 150 good sleepers and 173 insomniacs were recruited between December 2017 and June 2018. A cross-sectional survey was performed using the Wang Insomnia Integrated Questionnaire. RESULTS: Bedtime, rising time and time in bed were not different between good sleepers and insomniacs (Cohen's d, <0.01, 0.07, 0.07, respectively; all p>0.05) and were not correlated with insomnia severity (all p>0.05). Staying in bed while awake during the night and in the morning where both different between good sleepers and insomniacs (Cohen's d, 1.33 and 0.85, respectively; all p<0.001) and were positively correlated with insomnia severity (all p<0.001). Napping was more frequent (p<0.01) among good sleepers (63.3%) than insomniacs (48.6%) and a predictor of good sleep (p<0.01). CONCLUSION: Going to bed earlier and getting out of bed later do not seem to be associated with insomnia. Staying in bed while awake during the night and in the morning are associated with insomnia but could be only signs of insomnia symptoms. Limiting time in bed to prevent insomnia might and suppressing insomniacs' napping behavior to treat insomnia might not be effective.

Sailuotong Capsule Prevents the Cerebral Ischaemia-Induced Neuroinflammation and Impairment of Recognition Memory through Inhibition of LCN2 Expression.

BACKGROUND: Astrogliosis can result in astrocytes with hypertrophic morphology after injury, indicated by extended processes and swollen cell bodies. Lipocalin-2 (LCN2), a secreted glycoprotein belonging to the lipocalin superfamily, has been reported to play a detrimental role in ischaemic brains and neurodegenerative diseases. Sailuotong (SLT) capsule is a standardized three-herb preparation composed of ginseng, ginkgo, and saffron for the treatment of vascular dementia. Although recent clinical trials have demonstrated the beneficial effect of SLT on vascular dementia, its potential cellular mechanism has not been fully explored. METHODS: Male adult Sprague-Dawley (SD) rats were subjected to microsphere-embolized cerebral ischaemia. Immunostaining and Western blotting were performed to assess astrocytic reaction. Human astrocytes exposed to oxygen-glucose deprivation (OGD) were used to elucidate the effects of SLT-induced inflammation and astrocytic reaction. RESULTS: A memory recovery effect was found to be associated with the cerebral ischaemia-induced expression of inflammatory proteins and the suppression of LCN2 expression in the brain. Additionally, SLT reduced the astrocytic reaction, LCN2 expression, and the phosphorylation of STAT3 and JAK2. For in vitro experiments, OGD-induced expression of inflammation and LCN2 was also decreased in human astrocyte by the SLT treatment. Moreover, LCN2 overexpression significantly enhanced the above effects. SLT downregulated these effects that were enhanced by LCN2 overexpression. CONCLUSIONS: SLT mediates neuroinflammation, thereby protecting against ischaemic brain injury by inhibiting astrogliosis and suppressing neuroinflammation via the LCN2-JAK2/STAT3 pathway, providing a new idea for the treatment strategy of ischaemic stroke.

Zao Ren An Shen capsule for chronic insomnia: Study protocol for a randomized, placebo-controlled trial.

BACKGROUND: Zao Ren An Shen (ZRAS), a Chinese Herbal Medicine product, has been proposed as an alternative to recommended treatments for chronic insomnia. There is a lack of strong evidence supporting this proposition. AIMS: To assess the efficacy and safety of ZRAS capsule for chronic insomnia compared to placebo. METHODS: A parallel-group, double-blind, randomized-controlled trial will be performed in Western Sydney University, Australia. After a 1-week placebo run-in, adults with chronic insomnia (n = 90) will be randomized in a 1:1 ratio to receive either ZRAS capsule or placebo for 4 weeks. Insomnia severity (Insomnia Severity Scale score), sleep parameters (measured with the Consensus Sleep Diary and actigraphy), fatigue levels (Fatigue Severity Scale score), psychological status (Depression Anxiety Stress Scale score), quality of life (Assessment of Quality of Life score), and adverse events will be assessed at baseline, mid-treatment, post-treatment and at a 1-month follow-up. EXPECTED OUTCOMES: We hypothesize that ZRAS capsule will improve insomnia severity, sleep parameters, fatigue levels, psychological status, and quality of life better than placebo at mid-treatment, post-treatment, and follow-up. We also hypothesize that the number of adverse events provoked by ZRAS capsule will be similar to placebo at these time-points. TRIAL REGISTRATION: Australia New-Zealand Clinical Trial Registry (Registration number ACTRN12619000140156).

Chromatographic Analysis and Anti-Oxidative Property of Naoxinqing Tablet, a Proprietary Preparation of Diospyros Kaki Leaves.

The Naoxinqing (NXQ) tablet is a standardised proprietary herbal product containing an extract of persimmon leaves (Diospyros kaki) for the management of cardio- and cerebrovascular diseases. Although previous reports suggested that the efficacy of NXQ is at least partly mediated by its anti-oxidative property, the anti-oxidative effect of the major components of NXQ has not been studied systematically. For quality control purposes, only analytical methods limited to 3 marker analytes have been reported, the extent to which the other components affect efficacy has not been explored. In this study, we developed an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC MS/MS) method for the identification of seven analytes (kaempferol-3-O-glucoside (astragalin), quercetin-3-O-galactoside (hypericin), quercetin-3-O-glucoside (isoquercitin), kaempferol, 3,4-dihydroxybenzoic acid (protocatechuic acid), and furan-2-carboxylic acid (pyromucic acid) and quercetin) in the NXQ. This is the first method reported and validated for the quantification of the seven major secondary metabolites in NXQ. The results for the quantified analytes were then compared in 15 different batches of NXQ. The variation observed in the seven components highlights the need to quantify key bioactive components to ensure product consistency. Radical scavenging activity and abundance was used to rank the analytes. The anti-oxidative effects of NXQ were examined using cultured human vascular endothelial cells (EA.hy926). Corrected 2,2-di(4-tert-octylphenyl)-1-picrylhydrazyl (DPPH) activity results revealed that quercetin and kaempferol have the strongest anti-oxidant capacity in the extract. Both quercetin and kaempferol significantly inhibited the hydrogen peroxide (H2O2)-induced EA.hy926 cell injury and intracellular reactive oxygen species (ROS) generation. In conclusion, we established and validated an UPLC-MS/MC method for the analysis of major bioactive components in the NXQ and demonstrated that its anti-oxidative property may play a critical role in cerebrovascular protection.

Synergistic study of a Danshen (Salvia Miltiorrhizae Radix et Rhizoma) and Sanqi (Notoginseng Radix et Rhizoma) combination on cell survival in EA.hy926 cells.

BACKGROUND: This study investigated the protective effects of the Danshen (DS) and Sanqi (SQ) herb pair on cell survival in the human cardiovascular endothelial (EA.hy926) cell line exposed to injury. METHODS: Nine combination ratios of Danshen-Sanqi extracts (DS-SQ) were screened for their protective effects in the EA.hy926 cell line against two different cellular impairments induced by DL-homocysteine (Hcy) - adenosine (Ado) - tumour necrosis factors (TNF) and oxidative stress (H2O2), respectively. The type of interaction (synergistic, antagonistic, additive) between DS and SQ was analysed using a combination index (CI) model. The effects of key bioactive compounds from DS and SQ were tested using the same models. The compound from each herb that demonstrated the most potent activity in cell viability was combined to evaluate their synergistic/antagonistic interaction using CI. RESULTS: DS-SQ ratios of 6:4 (50-300 µg/mL) produced synergistic effects (CI < 1) in restoring cell viability, reducing lactate dehydrogenase (LDH) leakage and caspase-3 expressions against Hcy-Ado-TNF. Additionally, DS-SQ 6:4 (50-150 µg/mL) was found to synergistically protect endothelial cells from impaired cellular injury induced by oxidative damage (H2O2) by restoring reduced cell viability and inhibiting excessive expression of reactive oxygen species (ROS). In particular, the combination of salvianolic acid A (SA) and ginsenoside Rb1 (Rb1) at 4:6 (1-150 µM) showed synergistic effects in preventing cytotoxic effects caused by Hcy-Ado-TNF (CI < 1). This simplified combination also demonstrated synergistic effects on H2O2-induced oxidative damage on EA.hy926 cells. CONCLUSIONS: This study provides scientific evidence to support the traditional use of the DS-SQ combination on protecting endothelial cells through their synergistic interactions.

Current Status and Major Challenges to the Safety and Efficacy Presented by Chinese Herbal Medicine.

Traditional Chinese medicine (TCM) is not only used prevalently in Asian countries but has also gained a stable market globally. As a principal form of TCM, Chinese herbal medicine (CHM) is comprised of treatments using multiple Chinese herbs which have complex chemical profiles. Due to a lack of understanding of its modality and a lack of standardization, there are significant challenges associated with regulating CHM's safety for practice and understanding its mechanisms of efficacy. Currently, there are many issues that need to be overcome in regard to the safety and efficacy of CHM for the further development of evidence-based practices. There is a need to better understand the mechanisms behind the efficacy of CHM, and develop proper quality standards and regulations to ensure a similar safety standard as Western drugs. This paper outlines the status of CHM in terms of its safety and efficacy and attempts to provide approaches to address these issues.

Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment.

BACKGROUND: Mild cognitive impairment (MCI) is a syndrome characterised by a decline in cognition but relatively intact activities of daily living. People with MCI have an increased risk of developing dementia, and MCI is often referred to as a transitional stage between healthy ageing and dementia. Currently, there are no pharmaceutical therapies approved by the US Federal Drug Administration for MCI. Randomised controlled trials on the two major classes of anti-dementia pharmaceuticals, cholinesterase inhibitors and glutamate receptor antagonists, have produced poor results in MCI cohorts. There is a need to test and evaluate new and promising treatments for MCI that target multiple aspects of the syndrome's multi-faceted pathophysiology. The primary aim of this study is to evaluate the efficacy of 12 weeks of treatment with a standardised herbal formula, Sailuotong (SLT), compared to placebo, on cognition in older adults with MCI. Secondary aims are to assess SLT's mechanisms of action via electroencephalography (EEG), autonomic function, brain blood flow, and inflammation, as well as its safety in this cohort. METHODS/DESIGN: The target cohort for this trial is community-dwelling older adults over the age of 60 years who meet the National Institute of Aging-Alzheimer's Association working group core clinical criteria for MCI due to Alzheimer's disease. Eighty participants will be recruited and randomly allocated via a permuted block strategy at a 1:1 ratio to either the treatment or placebo group. The co-primary cognitive outcome measures are Logical Memory Story A delayed recall (episodic memory), Letter Number Sequencing (perceptual processing speed), and both the Trail Making Test and Rey Complex Figure Test (executive function). Secondary outcome measures are EEG activity, autonomic function (via electrocardiogram, skin conductance, and peripheral pulse pressure), brain blood flow (via common carotid artery ultrasound), and serum concentrations of inflammatory cytokines. Analyses will be performed blind to group allocation. DISCUSSION: This study is a 12-week, randomised, double-blind, placebo-controlled trial. Primary and secondary outcome measures will be compared between treatment and placebo groups at baseline and endpoint. Data from this pilot study will inform a larger, more highly powered clinical trial if the findings are positive. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000371392 Registered on 10 March 2017.

Corrigendum to "Prior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial".

[This corrects the article DOI: 10.1155/2016/3587569.].

Chinese Herbal Medicine as a Potential Treatment of Abdominal Aortic Aneurysm.

Abdominal aortic aneurysm (AAA) is an irreversible condition where the abdominal aorta is dilated leading to potentially fatal consequence of aortic rupture. Multiple mechanisms are involved in the development and progression of AAA, including chronic inflammation, oxidative stress, vascular smooth muscle (VSMC) apoptosis, immune cell infiltration and extracellular matrix (ECM) degradation. Currently surgical therapies, including minimally invasive endovascular aneurysm repair (EVAR), are the only viable interventions for AAAs. However, these treatments are not appropriate for the majority of AAAs, which measure <50 mm. Substantial effort has been invested to identify and develop pharmaceutical treatments such as statins and doxycycline for this potentially lethal condition but these interventions failed to offer a cure or to retard the progression of AAA. Chinese herbal medicine (CHM) has been used for the management of cardiovascular diseases for thousands of years in China and other Asian countries. The unique multi-component and multi-target property of CHMs makes it a potentially ideal therapy for multifactorial diseases such as AAA. In this review, we review the current scientific evidence to support the use of CHMs for the treatment of AAA. Mechanisms of action underlying the effects of CHMs on AAA are also discussed.