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

Does syndrome differentiation matter? A meta-analysis of randomized controlled trials in Cochrane Reviews of Acupuncture

Background: One of the basic and important principles of Traditional Chinese Medicine theory is syndrome differentiation, which is widely utilized for individual diagnosis and in the application of acupuncture treatment. However, the impact of syndrome differentiation on therapeutic effect is unclear because of insufficient supportive clinical evidence. Objective: The aim of this study was to analyze current Cochrane Database systematic reviews of acupuncture and to evaluate differences in therapeutic effects of acupuncture treatment when syndrome differentiation is utilized, compared to when this approach is not utilized. Methods: Cochrane Database systematic reviews of acupuncture were included if the reviews had sufficient data to perform subgroup analyses by syndrome differentiation applied during acupoints' selection. Searching was conducted across all available articles of the Cochrane Library, and the search concluded in July 2011. Results: Forty-four trials from five Cochrane reviews were included in 10 subgroup meta-analyses. Seven meta-analyses showed that there were no differences between trials using fixed acupoints prescriptions and trials using individualized treatment based on relevant symptom improvements in cases of acute stroke, depression, epilepsy, migraine, and peripheral joint osteoarthritis (OA). The remaining 3 meta-analyses showed that acupuncture with fixed prescriptions was superior to individualized acupuncture for pain relief of peripheral joint OA, compared to sham control. Conclusions: The available evidence showed no significant difference between acupuncture treatment with or without syndrome differentiation. Large, well-designed trials are warranted to address the use of syndrome differentiation for specific diseases or conditions in order to confirm if there are any advantages of using syndrome differentiation to achieve better therapeutic effects with acupuncture

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 sever-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 analysed 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

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

Efficacy of a Chinese herbal medicine in providing adequate relief of constipation-predominant irritable bowel syndrome : a randomized controlled trial

Background and 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), 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 an IBS Symptom Severity Scale (IBS-SSS) and the Bristol Stool Form Scale (BSFS), 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 the CHM reported adequate relief (P=.010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS-SSS 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, based on the BSFS (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

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

Choosing chemical markers for quality assurance of complex herbal medicines : development and application of the Herb MaRS criteria

With increasing use of herbal medicines for chronic or serious illness, relevant quality assurance methods are essential for making claims of therapeutic benefit. Adequate demonstration of safety and efficacy based on chemical composition and ensuring consistency between manufactured batches is critical. To date, there has been no uniform standard approach or detailed framework provided to industry for selecting relevant chemical markers used to standardize herbal products. We developed the Herbal Marker Ranking System(Herb MaRS) providing guidance on prioritizing the selection of chemical markers for quality control of complex multi-herb mixtures, while also taking into account the bioactivity in relation to the symptoms of the disease and its concentration in the formula. We apply the Herb MaRS evaluation criteria to a seven-herb formulation for the treatment of irritable bowel syndrome with constipation. Our ranking scale accommodates the clinical and pharmacological use of the formulation and its claimed indications