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.

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.

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.

Guidance for establishing an integrative oncology service in the Australian healthcare setting-a discussion paper.

There is an obvious mismatch between the high reported rates of use of traditional and complementary medicines (T&CM) by Australian cancer patients and cancer survivors and the low numbers of Australian cancer services integrating T&CM. An estimated 65% of Australian cancer patients use at least one form of T&CM. Over half use T&CM in conjunction with conventional cancer therapy. Yet, less than 20% of Australian hospital cancer care facilities provide access to T&CM. This compares to around 70% of UK cancer care facilities offering at least one T&CM therapy. Barriers to developing integrative oncology services include determining an appropriate service model and revenue structure; concerns with ethical and legal issues such as regulations and credentialing; and inadequate high-quality scientific evidence demonstrating safety and effectiveness, including concerns about the possibility of adversely affecting chemotherapy or radiotherapy treatment. This paper aims to provide general guidance and practical strategies for those seeking to develop integrative oncology services in Australian cancer care facilities.

High-performance liquid chromatography coupled with tandem mass spectrometry technology in the analysis of Chinese Medicine Formulas: A bibliometric analysis (1997-2015).

There is a recognized challenge in analyzing traditional Chinese medicine formulas because of their complex chemical compositions. The application of modern analytical techniques such as high-performance liquid chromatography coupled with a tandem mass spectrometry has improved the characterization of various compounds from traditional Chinese medicine formulas significantly. This study aims to conduct a bibliometric analysis to recognize the overall trend of high-performance liquid chromatography coupled with tandem mass spectrometry approaches in the analysis of traditional Chinese medicine formulas, its significance and possible underlying interactions between individual herbs in these formulas. Electronic databases were searched systematically, and the identified studies were collected and analyzed using Microsoft Access 2010, Graph Pad 5.0 software and Ucinet software package. 338 publications between 1997 and 2015 were identified, and analyzed in terms of annual growth and accumulated publications, top journals, forms of traditional Chinese medicine preparations and highly studied formulas and single herbs, as well as social network analysis of single herbs. There is a significant increase trend in using high-performance liquid chromatography coupled with tandem mass spectrometry related techniques in analysis of commonly used forms of traditional Chinese medicine formulas in the last 3 years. Stringent quality control is of great significance for the modernization and globalization of traditional Chinese medicine, and this bibliometric analysis provided the first and comprehensive summary within this field.

Nutritional supplements and herbal medicines for women with polycystic ovary syndrome; a systematic review and meta-analysis.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common, reproductive endocrinopathy associated with serious short and long term health risks. Many women with PCOS use ingestible complementary medicines. This systematic review examined the effect on menstrual regulation and adverse effects from randomised controlled trials. METHODS: Randomised controlled trials (RCTs) that compared herbal or nutritional supplements to placebo or active controls in women with PCOS were eligible for inclusion. Electronic databases were searched to July 2017. Study selection and assessment of quality were conducted independently by two review authors. RESULTS: Twenty four studies (1406 women) investigating seven nutritional supplements and four herbal medicines were included. No one study was assessed as having a low risk of bias. Four trials reported on the primary endpoint menstrual regulation. There was no evidence on improved menstrual regularity for calcium plus vitamin D compared to Metformin (RR: 0.66, 95% CI 0.35 to 1.23, p = 0.19), reduced amenorrhoea for Camellia sinensis compared to placebo (RR: 0.17, 95% CI 0.02 to 1.72, p = 0.13) and no difference in the number of menses per month for Cinnamomum sp. against placebo (MD 0.05, 95% CI -0.36 to 1.36, p = 0.26). Adverse effects were investigated in seven studies (164 women). Mild adverse effects were found for Cinnamomum sp. compared to placebo (17 women, RR: 0.36, 95% CI 0.03 to 0.70, p = 0.03). No difference was found for adverse effects between inositol, B complex vitamins, vitamin D, chromium and placebo. Improved reproduction, metabolic hormones and hyperandrogenism was found for inositol and improved cholesterol for omega three fish oils. CONCLUSION: There is no high quality evidence to support the effectiveness of nutritional supplements and herbal medicine for women with PCOS and evidence of safety is lacking. High quality trials of nutritional supplements and herbal medicines examining menstrual regulation and adverse effects in women with PCOS are needed.

An interpretive review of consensus statements on clinical guideline development and their application in the field of traditional and complementary medicine.

BACKGROUND: Despite ongoing consumer demand and an emerging scientific evidence-base for traditional and complementary medicine (T&CM), there remains a paucity of reliable information in standard clinical guidelines about their use. Often T&CM interventions are not mentioned, or the recommendations arising from these guidelines are unhelpful to end-users (i.e. patients, practitioners and policy makers). Insufficient evidence of efficacy may be a contributing factor; however, often informative recommendations could still be made by drawing on relevant information from other avenues. In light of this, the aim of this research was to review national and internationally endorsed consensus statements for clinical guideline developers, and to interpret how to apply these methods when making recommendations regarding the use of T&CM. METHOD: The critical interpretive review method was used to identify and appraise relevant consensus statements published between 1995 and 2015. The statements were identified using a purposive sampling technique until data saturation was reached. The most recent edition of a statement was included in the analysis. The content, scope and themes of the statements were compared and interpreted within the context of the T&CM setting; including history, regulation, use, emerging scientific evidence-base and existing guidelines. RESULTS: Eight consensus statements were included in the interpretive review. Searching stopped at this stage as no new major themes were identified. The five themes relevant to the challenges of developing T&CM guidelines were: (1) framing the question; (2) the limitations of using an evidence hierarchy; (3) strategies for dealing with insufficient, high quality evidence; (4) the importance of qualifying a recommendation; and (5) the need for structured consensus development. CONCLUSION: Evidence regarding safety, efficacy and cost effectiveness are not the only information required to make recommendations for clinical guidelines. Modifying factors such as burden of disease, magnitude of effect, current use, demand, equity and ease of integration should also be considered. Uptake of the recommendations arising from this review are expected to result in the development of higher quality clinical guidelines that offer greater assistance to those seeking answers about the appropriate use of T&CM.

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp2  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

Sailuotong Prevents Hydrogen Peroxide (H2O2)-Induced Injury in EA.hy926 Cells.

Sailuotong (SLT) is a standardised three-herb formulation consisting of Panax ginseng, Ginkgo biloba, and Crocus sativus designed for the management of vascular dementia. While the latest clinical trials have demonstrated beneficial effects of SLT in vascular dementia, the underlying cellular mechanisms have not been fully explored. The aim of this study was to assess the ability and mechanisms of SLT to act against hydrogen peroxide (H2O2)-induced oxidative damage in cultured human vascular endothelial cells (EAhy926). SLT (1-50 µg/mL) significantly suppressed the H2O2-induced cell death and abolished the H2O2-induced reactive oxygen species (ROS) generation in a concentration-dependent manner. Similarly, H2O2 (0.5 mM; 24 h) caused a ~2-fold increase in lactate dehydrogenase (LDH) release from the EA.hy926 cells which were significantly suppressed by SLT (1-50 µg/mL) in a concentration-dependent manner. Incubation of SLT (50 µg/mL) increased superoxide dismutase (SOD) activity and suppressed the H2O2-enhanced Bax/Bcl-2 ratio and cleaved caspase-3 expression. In conclusion, our results suggest that SLT protects EA.hy916 cells against H2O2-mediated injury via direct reduction of intracellular ROS generation and an increase in SOD activity. These protective effects are closely associated with the inhibition of the apoptotic death cascade via the suppression of caspase-3 activation and reduction of Bax/Bcl-2 ratio, thereby indicating a potential mechanism of action for the clinical effects observed.

INDIVIDUALIZED YOGA FOR REDUCING DEPRESSION AND ANXIETY, AND IMPROVING WELL-BEING: A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: Depression and anxiety are leading causes of disability worldwide. Current treatments are primarily pharmaceutical and psychological. Questions remain about effectiveness and suitability for different people. Previous research suggests potential benefits of yoga for reducing depression and anxiety. The aim of this study is to investigate the effects of an individualized yoga intervention. METHODS: A sample of 101 people with symptoms of depression and/or anxiety participated in a randomized controlled trial comparing a 6-week yoga intervention with waitlist control. Yoga was additional to usual treatment. The control group was offered the yoga following the waitlist period. Measures included Depression Anxiety Stress Scale (DASS-21), Kessler Psychological Distress Scale (K10), Short-Form Health Survey (SF12), Scale of Positive and Negative Experience (SPANE), Flourishing Scale (FS), and Connor-Davidson Resilience Scale (CD-RISC2). RESULTS: There were statistically significant differences between yoga and control groups on reduction of depression scores (-4.30; 95% CI: -7.70, -0.01; P = .01; ES -.44). Differences in reduced anxiety scores were not statistically significant (-1.91; 95% CI: -4.58, 0.76; P = .16). Statistically significant differences in favor of yoga were also found on total DASS (P = .03), K10, SF12 mental health, SPANE, FS, and resilience scores (P < .01 for each). Differences in stress and SF12 physical health scores were not statistically significant. Benefits were maintained at 6-week follow-up. CONCLUSION: Yoga plus regular care was effective in reducing symptoms of depression compared with regular care alone. Further investigation is warranted regarding potential benefits in anxiety. Individualized yoga may be particularly beneficial in mental health care in the broader community.

Ginsenoside Rg1 protects starving H9c2 cells by dissociation of Bcl-2-Beclin1 complex.

BACKGROUND: Autophagy can result in cellular adaptation, as well as cell survival or cell death. We investigated how ginsenoside Rg1(G-Rg1) regulates the relationship between autophagy and apoptosis induced by continuous starvation. METHODS: H9c2 cells under continuous starvation were treated with or without ginsenoside Rg1, and autophagy and apoptosis related proteins were assessed over a continuous time course by Western blot. Dynamic fluorescence intensity of green fluorescent protein (GFP)-LC3 was used to assess autophagosome formation by live cell imaging. Cyan fluorescent protein (CFP) -Beclin1(BECN1) and yellow fluorescent protein (YFP) -Bcl-2 were co-transfected into cells to observe ginsenoside Rg1 regulation of BECN1/Bcl-2 interaction using Fluorescence Resonance Energy Transfer (FRET). Immunoprecipitation was also used to assess BECN1/Bcl-2 interaction over a continuous time course. RESULTS: In H9c2 cells, starvation induced both apoptosis and autophagy. Cell apoptosis was significantly attenuated in ginsenoside Rg1-treated conditions, while autophagy was promoted. Ginsenoside Rg1 weakened the interaction between Beclin1 and Bcl-2, inhibiting apoptosis while promoting autophagy. Our results suggest that autophagy is beneficial to starved cardiac cells over a period of time. Furthermore, we describe the effect of ginsenoside Rg1 on the relationship between autophagy and apoptosis during starvation. CONCLUSIONS: Our findings provide valuable evidence for employing ginsenoside Rg1 as a specific promoter of autophagy and inhibitor of apoptosis.

Analytical Method Validation and Quality Control of a Seven-Herb Chinese Medicine Formulation Used for the Treatment of Irritable Bowel Syndrome with Constipation.

There is a need for increased QC of complex herbal medicine formulations to ensure product consistency, efficacy, and safety. This study reports an HPLC with photodiode array and electrospray ionization-tandem MS method for quantifying selected analytes in a seven-herb formulation. Fourteen analytes were selected for quantification based on the criteria available from the Herbal Chemical Marker Ranking System, which takes into account the bioavailability, reported bioactivity, and physiological action related to its intended use, as well as commercial availability of the standard. After optimizing the columns and chromatographic conditions, 13 of the 14 analytes were able to be determined in one run, with the remaining analyte analyzed on its own. The method was successfully applied to two different extracts of the formulation, demonstrating an application for the QC of a complex herbal mixture with respect to their chemical characteristics.

Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C. METHODS: We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16. RESULTS: There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated. CONCLUSIONS: In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo. Clinical trial registration no: ACTRN12609000558224.

Berberine alleviates ox-LDL induced inflammatory factors by up-regulation of autophagy via AMPK/mTOR signaling pathway.

BACKGROUND: Inflammation induced by oxidized low-density lipoprotein (ox-LDL) plays an important role in the pathogenesis of atherosclerosis. Recently, roles of autophagy against inflammation in the process of atherosclerosis have drawn increasing attention. Here, we tested the possible molecular mechanisms by which berberine confers an anti-inflammatory effect in macrophages by upregulation of autophagy. METHODS: J774A.1 macrophages were incubated with various doses of ox-LDL for various times. We evaluated the inflammatory factors and autophagy proteins (LC3II/LC3I, and SQSTM1/p62) to ascertain the optimal dose and time. Ox-LDL-induced inflammatory factors and autophagy in J774A.1 cells were tested by the AimPlex multiplex assay, Western blotting, confocal microscopy, and transmission electron microscopy in the presence of berberine or chloroquine (CQ). Adenosine 5'-monophosphate-activated protein kinase (AMPK) inhibitor compound C was used to evaluate the AMPK/mTOR signaling pathway. RESULTS: Berberine dose- and time-dependently reduced ox-LDL-induced inflammation and increased the ratio of LC3II/LC3I, and SQSTM1/p62 in J774A.1 cells. CQ significantly attenuated the berberine-induced autophagy and anti-inflammation. In addition, berberine increased the ratio of p-AMPK/AMPK and decreased the ratio of p-mTOR/mTOR. AMPK inhibitor compound C abolished berberine-induced autophagy and promoted p-mTOR/mTOR expression in J774A.1 cells. CONCLUSION: Berberine treatment inhibits inflammation in J774A.1 cells by inducing autophagy, which is mediated through activation of the AMPK/mTOR signaling pathway. Importantly, this study provides new insight into berberine's molecular mechanism and its therapeutic potential in the treatment of atherosclerosis.

Ganoderma lucidum mushroom for the treatment of cardiovascular risk factors.

BACKGROUND: Ganoderma lucidum (also known as lingzhi or reishi) is a mushroom that has been consumed for its broad medicinal properties in Asia for over 2000 years. G lucidum is becoming increasingly popular in western countries as a complementary medicine for cardiovascular health. OBJECTIVES: To evaluate the effectiveness of G lucidum for the treatment of pharmacologically modifiable risk factors of cardiovascular disease in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL Issue 6 of 12, 2014) on The Cochrane Library, MEDLINE (OVID, 1946 to June week 3 2014), EMBASE (OVID, 1980 to 2014 week 26), Science Direct (1823 to 2013), Current Controlled Trials (1990 to 2013), Australian New Zealand Clinical Trials Registry (2005 to 2013), Chinese Biomedical Literature Database (2007 to 2013), Chinese Medical Current Contents (2007 to 2013) and other databases. We checked reference lists of included studies, contacted content experts and handsearched The International Journal of Medicinal Mushrooms. We applied no language or publication restrictions. SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials of G lucidum for the treatment of cardiovascular risk factors. Primary outcomes were blood glucose level, blood pressure and lipid profile. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed risk of bias and cross checked data extraction and analysis. A third author arbitrated in the event of disagreement. MAIN RESULTS: Five trials with a total of 398 participants were eligible for inclusion. Of these, one study was published in Chinese and translated to English; one study was published but study authors provided the additional data used in this review; one study was unpublished and the study authors provided data; and two studies did not provide comparison group data suitable for statistical analyses. The three studies from which data were used for statistical analyses compared G lucidum (1.4 g to 3 g per day) to placebo over 12 to 16 weeks of intervention. Although inclusion criteria varied, all participants of these three studies had type 2 diabetes mellitus. Of the five included studies, risk of bias was low for one study and unclear for the remaining four.Results from two studies showed that G lucidum was not associated with statistically or clinically significant reduction in HbA1c (WMD -0.10%; 95% CI -1.05% to 0.85%; 130 participants), total cholesterol (WMD -0.07mmol/L; 95% CI -0.57 mmol/L to 0.42 mmol/L; 107 participants ), low-density lipoprotein cholesterol (WMD 0.02 mmol/L; 95% CI -0.41 mmol/L to 0.45 mmol/L; 107 participants), or body-mass index (WMD -0.32 kg/m(2); 95% CI -2.67 kg/m(2) to 2.03 kg/m(2;) 107 participants). All other analyses were from a single study of 84 participants. We found no improvement for fasting plasma glucose (WMD 0.30 mmol/L; 95% CI -0.95 mmol/L to 1.55 mmol/L). Measures of post-prandial blood glucose level found inconsistent results, being in favour of placebo for '2-hour post-prandial blood glucose' (WMD 0.7 mmol/L; 95% CI 0.29 mmol/L to 1.11 mmol/L) and in favour of G lucidum for 'plasma glucose under the curve at 4th hour' (WMD -49.4mg/dL/h; 95% CI -77.21 mg/dL/h to -21.59 mg/dL/h). As the Minimal Clinical Important Differences are unknown, the clinical significance of this effect is unclear. There were no statistically significant differences between groups for blood pressure or triglycerides. Participants who took G lucidum for four months were 1.67 times (RR 1.67 95% CI 0.86 to 3.24) more likely to experience an adverse event than those who took placebo but these were not serious side effects. AUTHORS' CONCLUSIONS: Evidence from a small number of randomised controlled trials does not support the use of G lucidum for treatment of cardiovascular risk factors in people with type 2 diabetes mellitus. Future research into the efficacy of G lucidum should be placebo-controlled and adhere to clinical trial reporting standards.

Process of care in outpatient Integrative healthcare facilities: a systematic review of clinical trials.

BACKGROUND: Patients currently integrate complementary medicine (CM) and allopathic, choosing a combination of therapies rather than a single therapy in isolation. Understanding integrative healthcare (IHC) extends beyond evaluation of specific therapies to encompass evaluations of multidisciplinary complex interventions. IHC is defined as a therapeutic strategy integrating conventional and complementary medical practices and practitioners in a shared care setting to administer an individualized treatment plan. We sought to review the outcomes of recent clinical trials, explore the design of the interventions and to discuss the methodological approaches and issues that arise when investigating a complex mix of interventions in order to guide future research. METHOD: Five databases were searched from inception to 30 March 2013. We included randomized and quasi-experimental clinical trials of IHC. Data elements covering process of care (initial assessment, treatment planning and review, means for integration) were extracted. RESULTS: Six thousand two hundred fifty six papers were screened, 5772 were excluded and 484 full text articles retrieved. Five studies met the inclusion criteria. There are few experimental studies of IHC. Of the five studies conducted, four were in people with lower back pain. The positive findings of these studies indicate that it is feasible to conduct a rigorous clinical trial of an integrative intervention involving allopathic and CM treatment. Further, such interventions may improve patient outcomes. CONCLUSIONS: The trials in our review provide a small yet critical base from which to refine and develop larger studies. Future studies need to be adequately powered to address efficacy, safety and include data on cost effectiveness.

Establishing key components of yoga interventions for reducing depression and anxiety, and improving well-being: a Delphi method study.

BACKGROUND: Previous research suggests benefits of yoga in reducing depression and anxiety. However, common concerns in reviews of the research include lack of detail, rationale and consistency of approach of interventions used. Issues related to heterogeneity include amount, types and delivery of yoga interventions. This study aims to document consensus-based recommendations for consistency of yoga interventions for reducing depression and anxiety. METHODS: The Delphi method was used to establish consensus from experienced yoga teachers. Thirty-three eligible teachers were invited to participate, from four different countries. Two rounds of an online survey were sent to participants. The first round sought initial views. The second round sought consensus on a summary of those views. Survey questions related to frequency and duration (dosage) of the yoga, approaches and techniques to be included or avoided, and training and experience for yoga teachers. RESULTS: Twenty-four teachers agreed to participate. Eighteen completed the second round (n = 18). General consensus (>75% of participants in agreement) was achieved on parameters of practice (dosage): an average of 30 to 40 minutes, to be done 5 times per week, over a period of 6 weeks. Numerous recommendations for yoga techniques to include or avoid were collected in the first round. The second round produced a consensus statement on those recommendations. Breath regulation and postures were considered very important or essential for people with depression; and relaxation, breath regulation and meditation being very important or essential for people with anxiety. Other recommended components also achieved consensus. There was also general consensus that it is very important or essential for teachers to have a minimum of 500 training hours over 2 years, at least 2 years teaching experience, training in developing personalised yoga practices, training in yoga for mental health, and professional supervision or mentoring. CONCLUSIONS: The Delphi process has achieved a consensus statement on the application of yoga for reducing anxiety and depression. This consensus provides a checklist for identification of commonalities and evaluation of past research. Future research can proceed to develop and evaluate consensus-based yoga intervention protocols for the reduction of anxiety and depression, and improvements in well-being.

The process of care in integrative health care settings - a qualitative study of US practices.

BACKGROUND: There is a lack of research on the organisational operations of integrative healthcare (IHC) practices. IHC is a therapeutic strategy integrating conventional and complementary medicine in a shared context to administer individualized treatment. To better understand the process of care in IHC - the way in which patients are triaged and treatment plans are constructed, interviews were conducted with integrative health care leaders and practitioners in the US. METHODS: Semi-structured interviews were conducted with a pragmatic group of fourteen leaders and practitioners from nine different IHC settings. All interviews were conducted face-to-face with the exception of one phone interview. Questions focussed on understanding the "process of care" in an integrative healthcare setting. Deductive categories were formed from the aims of the study, focusing on: organisational structure, processes of care (subcategories: patient intake, treatment and charting, use of guidelines or protocols), prevalent diseases or conditions treated, and the role of research in the organisation. The similarities and differences of the ITH entities emerged from this process. RESULTS: On an organisational level, conventional and CM services and therapies were co-located in all nine settings. For patients, this means there is more opportunity for 'seamless care'. Shared information systems enabled easy communication using internal messaging or email systems, and shared patient intake information. But beyond this infrastructure alignment for integrative health care was less supported. There were no use of protocols or guidelines within any centre, no patient monitoring mechanism beyond that which occurred within one-on-one appointments. Joint planning for a patient treatment was typically ad hoc through informal mechanisms. Additional duties typically come at a direct financial cost to fee-for-service practitioners. In contrast, service delivery and the process of care within hospital inpatient services followed a more formalised structure. CONCLUSIONS: IHC is a complex, emerging field with divergent meanings and interpretations. The structures and processes of the IHC entities reported provide insight to the variable ways in which IHC manifests whilst commonly holding a similar vision. This report contributes to understanding IHC, providing evidence for future planning, implementation and evaluation to meet patient needs and demands in this area.

A survey of the use of complementary medicine by a self-selected community group of Australian women with polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a complex reproductive endocrinopathy affecting up to 20% of reproductive aged women. Whilst there are effective pharmaceutical treatment options, women with PCOS have expressed a strong desire for alternatives. This study investigates the use and attitudes of women with PCOS towards complementary medicine (CM). METHODS: Women as members of PCOS support groups responded to an anonymous on-line survey which examined rates and patterns of use for CM's, areas of health for use, perceptions of effectiveness, safety and demographic features. Data collection targeted women with PCOS using two consumer support groups. The first group self-selected following direct email to members of a land based consumer support group, the Polycystic Ovary Syndrome Association of Australia (POSAA). The second sample was generated through the electronic social network Facebook, using a snowball technique. Two surveys, identical in content, were collected by cloud based Survey Monkey. Data were described and associations between the variables, 'reasons for use' and 'perceptions of effectiveness' were explored. Non-response bias was assessed using a continuum of resistance model. RESULTS: 493 women participated in the study; 91.1% response rate from the POSAA group. Over 70% reported use of complementary medicine, usually nutritional and herbal supplements and 76.6% of CM users reported consultation with a complementary practitioner. Many participants were using CM to treat PCOS however most were using it to concurrently treat a range of health conditions, describing women's desire for more than single symptom management. Disadvantages for CM use were cited by 71% of respondents. Women using complementary medicine with specific treatment goals in mind reported greater self-perceived effectiveness, suggesting that informed use may improve women's satisfaction with CM. Adverse reactions were reported by 12.2% of women and the need for further research into adverse reactions for CM's was identified. Demographic and PCOS characteristics were similar to clinical populations of PCOS and non-response bias was shown as not significant. CONCLUSION: This study describes the prevalence of use for complementary medicine by women with PCOS as over 70% and adds to our understanding of women's experiences with CM and their motivations for use of CM.

Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a prevalent, complex endocrine disorder characterised by polycystic ovaries, chronic anovulation and hyperandrogenism leading to symptoms of irregular menstrual cycles, hirsutism, acne and infertility. Evidence based medical management emphasises a multidisciplinary approach for PCOS, as conventional pharmaceutical treatment addresses single symptoms, may be contra-indicated, is often associated with side effects and not effective in some cases. In addition women with PCOS have expressed a strong desire for alternative treatments. This review examines the reproductive endocrine effects in PCOS for an alternative treatment, herbal medicine. The aim of this review was to identify consistent evidence from both pre-clinical and clinical research, to add to the evidence base for herbal medicine in PCOS (and associated oligo/amenorrhoea and hyperandrogenism) and to inform herbal selection in the provision clinical care for these common conditions. METHODS: We undertook two searches of the scientific literature. The first search sought pre-clinical studies which explained the reproductive endocrine effects of whole herbal extracts in oligo/amenorrhoea, hyperandrogenism and PCOS. Herbal medicines from the first search informed key words for the second search. The second search sought clinical studies, which corroborated laboratory findings. Subjects included women with PCOS, menstrual irregularities and hyperandrogenism. RESULTS: A total of 33 studies were included in this review. Eighteen pre-clinical studies reported mechanisms of effect and fifteen clinical studies corroborated pre-clinical findings, including eight randomised controlled trials, and 762 women with menstrual irregularities, hyperandrogenism and/or PCOS. Interventions included herbal extracts of Vitex agnus-castus, Cimicifuga racemosa, Tribulus terrestris, Glycyrrhiza spp., Paeonia lactiflora and Cinnamomum cassia. Endocrine outcomes included reduced luteinising hormone (LH), prolactin, fasting insulin and testosterone. There was evidence for the regulation of ovulation, improved metabolic hormone profile and improved fertility outcomes in PCOS. There was evidence for an equivalent effect of two herbal medicines and the pharmaceutical agents bromocriptine (and Vitex agnus-castus) and clomiphene citrate (and Cimicifuga racemosa). There was less robust evidence for the complementary combination of spirinolactone and Glycyrrhiza spp. for hyperandrogenism. CONCLUSIONS: Preclinical and clinical studies provide evidence that six herbal medicines may have beneficial effects for women with oligo/amenorrhea, hyperandrogenism and PCOS. However the quantity of pre-clinical data was limited, and the quality of clinical evidence was variable. Further pre-clinical studies are needed to explain the effects of herbal medicines not included in this review with current clinical evidence but an absence of pre-clinical data.