The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

Despite the growth of traditional Chinese medicine (TCM) and western herbal medicine (WHM) research in Australia, little is known about how ethics committees (HRECs) assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management

Can external use of Chinese herbal medicine prevent cumulative peripheral neuropathy induced oxaliplatin? : a systematic literature review with meta-analysis

Background. Peripheral neurotoxicity caused by oxaliplatin (OXA) chemotherapy is the main limitation preventing continuation of chemotherapy in patients with gastrointestinal cancer. The purpose of this study was to determine the efficacy of external use of Chinese herbal medicine (CHM) on the incidence of cumulative OXA-induced peripheral neurotoxicity (OIPN). Method. Scientific literature databases were searched to identify controlled clinical trials analyzing CHM in OIPN. Clinical studies that included at least 1 relevant primary outcome were analyzed by 2 independent reviewers. Meta-analysis was performed on the software RevMan 5.3. Results. 700 cancer patients of 9 studies were reported, of whom 352 received external CHM and 348 received warm water baths, conventional medicine, or no intervention as controls. Neurotoxicity incidence (Levi grade ≥ 1) was significantly decreased in CHM group, compared with no intervention (P .05). Conclusion. External use of CHM may be beneficial in preventing the OXA-induced cumulative neurotoxicity. However, given the low quality of the evidence, the results should be interpreted with caution

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

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

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

Social and Cultural Factors Affecting Complementary and Alternative Medicine (CAM) Use during Menopause in Sydney and Bologna

Background. Previous surveys found CAM use during menopause to be popular. This paper compares the results from two surveys (Sydney and Bologna) to examine factors that determine the extent and pattern of CAM use to alleviate menopausal symptoms. Methods. Women, aged 45–65 years, who were symptomatic when transitioning through menopause or asymptomatic but taking menopause-specific treatments, were recruited in Sydney (n=1,296) and Bologna (n=1,106) to complete the same voluntary, anonymous, and self-administered questionnaire. The results were reanalysed using stratified analyses to determine similarities and differences. Results. Demographics of the two cohorts differed significantly. CAM was more popular in Sydney. The most significant determinants of CAM use were the use of CAM for other conditions besides menopause and the severity of vasomotor symptoms. Occupational status was a determinant of CAM use amongst Bologna respondents only. In order to relieve symptoms, Australian and Italian women used different CAM modalities whose effectiveness was generally perceived as good. Conclusion. CAM use is popular amongst menopausal women from Sydney and Bologna. Differences in the patterns of CAM use seem to depend on CAM availability and on the educational level and professional status of users. The complex interaction between market, social, and cultural factors of CAM use seems to be more influential on women’s choice of CAM than the available evidence of their effectiveness

The practice and regulatory requirements of naturopathy and western herbal medicine in Australia

Australian health workforce regulation is premised on the need to protect public health and safety. Specific criteria are set out by governments to ascertain the degree of risk and the need for government intervention. A study was undertaken to understand the current state of usage and the practice of naturopathy and western herbal medicine, and to ascertain whether statutory regulation was warranted. We found increased use of these complementary therapies in the community, with risks arising from both the specific practices as well as consumers negotiating a parallel primary health care system. We also found highly variable standards of training, a myriad of professional associations, and a general failure of current systems of self-regulation to protect public health and safety. Statutory regulation was the preferred policy response for consumers, insurers, general practitioners, and most of the complementary therapists. While we found a case for statutory registration, we also argue that a minimalist regulatory response needs to be accompanied by other measures to educate the public, to improve the standards of practice, and to enhance our understanding of the interaction between complementary and mainstream health care

Diabetes Mellitus, cognitive impairment, and traditional Chinese medicine

Diabetes mellitus (DM) is a metabolic disorder affecting a large number of people worldwide. Numerous studies have demonstrated that DM can cause damage to multiple systems, leading to complications such as heart disease, cancer, and cerebrovascular disorders. Numerous epidemiological studies have shown that DM is closely associated with dementia and cognition dysfunction, with recent research focusing on the role of DM-mediated cerebrovascular damage in dementia. Despite the therapeutic benefits of antidiabetic agents for the treatment of DM-mediated cognitive dysfunction, most of these pharmaceutical agents are associated with various undesirable side-effects and their long-term benefits are therefore in doubt. Early evidence exists to support the use of traditional Chinese medicine (TCM) interventions, which tend to have minimal toxicity and side-effects. More importantly, these TCM interventions appear to offer significant effects in reducing DM-related complications beyond blood glucose control. However, more research is needed to further validate these claims and to explore their relevant mechanisms of action. The aims of this paper are (1) to provide an updated overview on the association between DM and cognitive dysfunction and (2) to review the scientific evidence underpinning the use of TCM interventions for the treatment and prevention of DM-induced cognitive dysfunction and dementia

TCM Zheng Classification and Clinical Trials

According to the traditional Chinese medicine (TCM) theory, TCM Zheng (or pattern, syndrome) is an analysis on disease presentation by TCM practitioners. Zheng classification (Bian Zheng) is a traditional diagnostic method to categorize patients’ syndromes based on their presented conditions. Currently, combination of Zheng classification and biomedical diagnosis becomes a common model in TCMdiagnostics in clinical practice. Clinical treatments of a patient rely on the classification of a specificTCMZheng. This special issue collects articles describing the clinical trials with TCMZheng classification, Zheng classification methodology from clinical data, systematic reviews on clinical studies using Zheng classification, and the clinical pharmacological evaluation on TCM interventions using the omics platforms as well as bioinformatics

A Chinese Herbal Preparation Containing Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum Reduces Circulating Adhesion Molecules

Circulating adhesion molecules (CAMs), surface proteins expressed in the vascular endothelium, have emerged as risk factors for cardiovascular disease (CVD). CAMs are involved in intercellular communication that are believed to play a role in atherosclerosis. A Chinese medicine, the “Dantonic Pill” (DP) (also known as the “Cardiotonic Pill”), containing three Chinese herbal material medica, Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, has been used in China for the prevention and management of CVD. Previous laboratory and animal studies have suggested that this preparation reduces both atherogenesis and adhesion molecule expression. A parallel double blind randomized placebo-controlled study was conducted to assess the effects of the DP on three species of CAM (intercellular cell adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 and endothelial cell selectin (E-selectin)) in participants with mild-moderate hypercholesterolemia. Secondary endpoints included biochemical and hematological variables and clinical effects. Forty participants were randomized to either treatment or control for 12 weeks. Treatment with DP was associated with a statistically significant decrease in ICAM-1 (9% decrease, P = .03) and E-Selectin (15% decrease, P = .004). There was no significant change in renal function tests, liver function tests, glucose, lipids or C-reactive protein levels and clinical adverse effects did not differ between the active and the control groups. There were no relevant changes in participants receiving placebo. These results suggest that this herbal medicine may contribute to the development of a novel approach to cardiovascular risk reduction

Does Tai Chi improve psychological well-being and quality of life in patients with cardiovascular disease and/or cardiovascular risk factors? : a systematic review protocol

Introduction: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide. Psychological risk factors such as stress, anxiety and depression are known to play a significant and independent role in the development and progression of CVD and its risk factors. Tai Chi has been reported to be potentially effective for health and well-being. It is of value to assess the effectiveness and safety of Tai Chi on psychological well-being and quality of life in people with CVD and/or cardiovascular risk factors. Methods and analysis: We will include all relevant randomised controlled trials on Tai Chi for stress, anxiety, depression, psychological well-being and quality of life in people with CVD and cardiovascular risk factors. Literature searching will be conducted until 31 December 2016 from major English and Chinese databases. Two authors will conduct data selection and extraction independently. Quality assessment will be conducted using the risk of bias tool recommended by the Cochrane Collaboration. We will conduct data analysis using Cochrane’s RevMan software. Forest plots and summary of findings tables will illustrate the results from a meta-analysis if sufficient studies are identified. Ethics and dissemination: Ethics approval is not required as this study will not involve patients. The results of this study will be submitted to a peer-reviewed journal for publication, to inform both clinical practice and further research on Tai Chi and CVDs. Discussion: This review will summarise the evidence on Tai Chi for psychological well-being and quality of life in people with CVD and their risk factors. We anticipate that the results of this review would be useful for healthcare professionals and researchers on Tai Chi and CVDs