Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.

INTRODUCTION: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme. METHODS AND ANALYSIS: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them. ETHICS AND DISSEMINATION: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000584730.

Knowledge and attitudes towards medicinal cannabis and complementary and integrative medicine (CIM): a survey of healthcare professionals working in a cancer hospital in Australia.

PURPOSE: We investigated attitudes and practices of healthcare professionals (HCPs) to medicinal cannabis (MC) and complementary and integrative medicine (CIM), including individual therapies, such as acupuncture, massage, herbs, dietary supplements, nutrition and exercise. We explored whether healthcare occupation influenced attitudes to CIM and MC; referral pathways for advice on CIM; and interest in a pharmacy service to evaluate herbs and supplements. METHODS: Cross-sectional survey. All clinical staff at a comprehensive cancer hospital were invited to complete an anonymous questionnaire about CIM and MC. We used descriptive analysis to describe the respondent's knowledge and attitudes, and Fisher's exact test to test for differences by occupation, length of time at the hospital and age. RESULTS: Most of the 116 HCPs respondents supported integrating CIM into cancer care (94.8%) and wanted to learn more (90%) and to understand benefits and contraindications. Most respondents believed that CIM (87.9%) could benefit patients with cancer, and MC could benefit those with advanced cancer (49-51%). Whilst just over half (52.6%) felt confident discussing CIM with patients, only 10% felt they had sufficient knowledge to discuss MC. Most felt they did not have sufficient knowledge to specifically discuss mind and body practices (63.8%) or herbs and supplements (79%). HCPs (63%) would be more inclined to allow use of herbs and supplements with cancer treatment if a pharmacy service was available to evaluate interactions. Occupation, length of time at hospital and age influenced confidence and knowledge about CIM. CONCLUSIONS: The integration of evidence-based CIM and MC into cancer care is hampered by a lack of knowledge of benefits and contraindications, and gaps in education. Effective and safe integration may require targeted development of services such as pharmacy to evaluate the safety of herbs and supplements, and inclusion of cancer specialists who have received training in individual CIM therapies and MC.

Acupuncture and Reflexology for Patients Undergoing Chemotherapy: A Cohort Study.

PURPOSE: Around three quarters of individuals undergoing chemotherapy self-report multiple symptoms. There is clinical trial evidence of effectiveness for acupuncture for commonly experienced symptoms, and emerging evidence for reflexology, but little is known about the effects of these therapies on multiple symptoms when implemented in a real world setting during active chemotherapy treatment. METHODS: This was a cohort study of participants receiving reflexology and/or acupuncture while attending chemotherapy. Participants received a 20 minute reflexology treatment or a 20 minute acupuncture treatment or a combination of both. Patient reported outcome measures were administered before and after the treatment using the Edmonton Symptom Assessment Scale (ESAS). RESULTS: During the study period, 330 unique patients received a total of 809 acupuncture and/or reflexology treatments. Participants had, on average, 5.3 symptoms each which they reported as moderate to severe (≥4/10) using the ESAS at baseline. Following treatment, participants reported 3.2 symptoms as moderate to severe. The symptom change for all participant encounters receiving any therapy was statistically significant for all symptoms, and clinically significant (a reduction of more than 1) for all symptoms except financial distress, appetite, and memory. Clinically significant levels of global distress (<3) were reduced in 72% of all participants receiving either therapy. No adverse events were recorded. CONCLUSIONS: The results indicate that acupuncture and reflexology administered alongside chemotherapy may reduce patient reported symptom burden and patient global symptom related distress. Future research would include an active control group, and consider confounding factors such as chemotherapy stage and medication.

Characteristics and Symptom Burden of Patients Accessing Acupuncture Services at a Cancer Hospital.

BACKGROUND: Patients with cancer are often impacted by a significant symptom burden. Cancer hospitals increasingly recognize the value of complementary and integrative therapies to support the management of cancer related symptoms. The aim of this study is to provide a better understanding of the demographic characteristics and symptoms experienced by cancer patients who access acupuncture services in a tertiary hospital in Australia. METHODS: A retrospective audit was conducted of patients that presented to the acupuncture service at Chris O'Brien Lifehouse between July 2017 and December 2018. Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Wellbeing (MYCaW) outcome measures were used. The quantitative data was analyzed using descriptive statistics and Principal Component Analysis. RESULTS: A total of 127 inpatients and outpatients (mean age 55, range 19-85) were included with 441 individual surveys completed (264 ESAS, 177 MYCaW). Patients were predominantly female (76.8%) and breast cancer was the most prevalent primary diagnosis (48%). The most prevalent symptoms in the ESAS were sleep problems (88.6%), fatigue (88.3%), lack of wellbeing (88.1%), and memory difficulty (82.6%). Similarly, symptoms with the highest mean scores were numbness, fatigue, sleep problems and hot flushes, whilst neuropathy, and hot flashes were scored as the most severe (score ≥7) by patients. Cluster analysis yielded 3 symptom clusters, 2 included "physical symptoms" (pain, sleep problems, fatigue and numbness/neuropathy), and (nausea, appetite, general well-being), whilst the third included "psychological" symptoms (anxiety, depression, spiritual pain, financial distress). The most frequent concerns expressed by patients (MyCaW) seeking acupuncture were side effects of chemotherapy (24.6%) and pain (20.8%). CONCLUSION: This audit highlights the most prevalent symptoms, the symptoms with the greatest burden and the types of patients that receive acupuncture services at an Australian tertiary hospital setting. The findings of this audit provide direction for future acupuncture practices and research in hospital settings.

Integrative Oncology: International Perspectives.

Interest in integrative oncology (IO) is growing globally. Patients with cancer are actively using traditional complementary and integrative medicine (TCIM) as part of their cancer and survivorship care. Published studies from around the world report increasing use of TCIM by people living with cancer. This article summarizes the presentations that took place during a symposium titled, "Integrative Oncology: International Perspectives" at the International Research Congress on Integrative Medicine and Health in Baltimore, 2018. The purpose of the presentations was to examine whether cancer services across a variety of geographical regions, including Australia, Canada, the United States, and the European Union, were actively responding to cancer survivors' demand for TCIM. The presenters highlighted utilization rates and both facilitators and barriers to the provision of IO services in their respective countries and regions. The audience discussion following the presentations drew out many noteworthy perspectives.

Establishing an integrative oncology service in the Australian healthcare setting-the Chris O'Brien Lifehouse Hospital experience.

Comprehensive cancer centres are on the rise as patients seek a more holistic approach to maintaining their wellbeing when living with a cancer diagnosis. Many cancer centres worldwide now incorporate a selection of evidence-based complementary therapies and qualified therapists into their offerings. The Chris O'Brien Lifehouse, a comprehensive cancer centre in Sydney, Australia, provides integrative oncology services including acupuncture, massage, reflexology, dietetics and exercise physiology for individual patients, along with group programmes, and an integrative and supportive care medical specialist. The purpose of this paper is to reflect on one model of integrative oncology service and approach to integration and team and service development.

Single herbal medicine for diabetic retinopathy.

BACKGROUND: Diabetic retinopathy is one of the major causes of blindness and the number of cases has risen in recent years. Herbal medicine has been used to treat diabetes and its complications including diabetic retinopathy for thousands of years around the world. However, common practice is not always evidence-based. Evidence is needed to help people with diabetic retinopathy or doctors to make judicious judgements about using herbal medicine as treatment. OBJECTIVES: To evaluate the effectiveness and harm of single herbal medicine for diabetic retinopathy. SEARCH METHODS: We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register, MEDLINE, Embase, OpenGrey, the ISRCTN registry, ClinicalTrials.gov and the ICTRP. The date of the search was 12 June 2018. We also searched the following Chinese databases in June 2013: Chinese BioMedical Literature Database (CBM), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), Wanfang China Dissertation Database (CDDB), Wanfang China Conference Paper Database (CCPD) and the Index to Chinese Periodical Literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of any single herb (or extracts from a single herb) as a treatment for people with diabetic retinopathy. We considered the following comparators: placebo, no treatment, non-herbal (conventional) medicine or surgical treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias in the studies. Our prespecified outcomes were: progression of diabetic retinopathy, visual acuity, microaneurysms and haemorrhages in the retina, blood glycated haemoglobin A1c (HbA1c) (%) and adverse effects. We performed meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 10 studies involving 754 participants, of which nine were conducted in China and one in Poland. In all studies, participants in both groups received conventional treatment for diabetic retinopathy which included maintaining blood glucose and lipids using medicines and keeping a stable diabetic diet. In three studies, the comparator group also received an additional potentially active comparator in the form of a vasoprotective drug. The single herbs or extracts included Ruscus extract tablet, Sanqi Tongshu capsule, tetramethylpyrazine injection, Xueshuantong injection, Puerarin injection and Xuesaitong injection. The Sanqi Tongshu capsule, Xueshuantong injection and Xuesaitong injection were all made from the extract of Radix Notoginseng (San qi) and the main ingredient was sanchinoside. The risk of bias was high in all included studies mainly due to lack of masking (blinding). None of the studies reported the primary outcome of this review, progression of retinopathy.Combined analysis of herbal interventions suggested that people who took these herbs in combination with conventional treatment may have been more likely to gain 2 or more lines of visual acuity compared to people who did not take these herbs when compared to conventional intervention alone at the end of treatment (RR 1.26, 95% CI 1.08 to 1.48; 5 trials, 541 participants; low-certainty evidence). Subgroup analyses based on the different single herbs found no evidence for different effects of different herbs, but the power of this analysis was low. One study reported Sanqi Tongshu capsule might be associated with a greater reduction in microaneurysms and haemorrhages in the retina (very low-certainty evidence). The pooled analysis of two studies on tetramethylpyrazine or Xueshuantong injection showed such herbs may have had little effect on lowering HbA1c (MD 0.00, 95% CI -0.58 to 0.58; 215 participants; low-certainty evidence).There was very low-certainty evidence on adverse events. Two studies reported minor adverse events such as uncomfortable stomach, urticaria, dizziness and headache. There was no report of observation on adverse events in the other studies. AUTHORS' CONCLUSIONS: No conclusions could be drawn about the effect of any single herb or herbal extract on diabetic retinopathy from the current available evidence. It was difficult to exclude the placebo effect as a possible explanation for observed differences due to the lack of placebo control in the included studies. Further adequately designed trials are needed to establish the evidence.

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.

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.

Defining the quality of acupuncture: the case of acupuncture for cancer-related fatigue.

BACKGROUND: The quality and dose of acupuncture used in a clinical trial affects the outcome, as with the quality and dose of any intervention. The dose of acupuncture treatment may be characterized by the frequency of treatment, needle type and depth, length of needle retention, point selection, and combination. The dose in trials of acupuncture has at times been described as low or inappropriate but is seldom assessed in systematic reviews of acupuncture trials. This article examines the research evaluating acupuncture for cancer-related fatigue to determine what characteristics of treatment may contribute to a quality acupuncture intervention. METHODOLOGY: English and Chinese language databases were searched from inception to December 2013 for randomized controlled trials of acupuncture for the treatment of cancer-related fatigue. Assessment of the quality of the acupuncture intervention was undertaken using the domains and items from the NICMAN framework. RESULTS: Seven studies with a total of 690 patients were included. Four of the studies were designed as feasibility or pilot studies, and the other 3 studies were described as "effectiveness" trials. The treatment paradigm for the active intervention was based on traditional Chinese medicine in all studies, yet few of the studies were explicit as to how the active intervention was justified within a traditional Chinese medicine paradigm. Acupuncture point prescriptions were developed by a small consensus panel or based on typical points and/or "clinical experience." No discussion of traditional Chinese medicine theory or literature review was reported in any studies. Acupuncture point location was adequately described in 4 of the 7 studies. Frequency of treatment was twice per week in 2 studies; all others were once per week. Two studies did not apply needle manipulation or stimulation, and no justification was given. CONCLUSION: The 7 trials reviewed meet some criteria for a quality acupuncture intervention. However, frequently elements of the intervention were not addressed, and it is possible that the dosage trialed was suboptimal. Systematic reviews of acupuncture are likely to continue to be inconclusive while comparisons are conducted of heterogeneous interventions without providing.

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.

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.

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

OBJECTIVES: To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. METHODS: We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. RESULTS: A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. CONCLUSIONS: The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted.

Cost-effectiveness of Acupuncture for Chronic Nonspecific Low Back Pain.

Cost-effectiveness is a major criterion underpinning decisions in mainstream health care. Acupuncture is increasingly used in patients with chronic lower back pain (LBP), but there is a lack of evidence on cost-effectiveness. The objective of this study was to assess the cost-effectiveness of acupuncture in alleviating chronic LBP either alone or in conjunction with standard care compared with patients receiving routine care, and/or sham. To determine effectiveness, we undertook meta-analyses which found a significant improvement in pain in those receiving acupuncture and standard care compared with those receiving standard care alone. For acupuncture and standard care vs. standard care and sham, a weak positive effect was found for weeks 12 to 16, but this was not significant. For acupuncture alone vs. standard care alone, a significant positive effect was found at week 8, but not at weeks 26 or 52. The main outcome parameters for our cost-effectiveness analysis were the incremental cost-effectiveness ratio (ICER) of acupuncture treatment presented as cost (A$) per disability-adjusted life-year (DALY) saved. The WHO benchmark for a very highly cost-effective intervention is one that costs less than gross domestic product per capita per quality-adjusted life-year (QALY) gained or DALY averted, or less than around $A52,000 in 2009 (the base year for the analysis). According to this threshold, acupuncture as a complement to standard care for relief of chronic LBP is highly cost-effective, costing around $48,562 per DALY avoided. When comorbid depression is alleviated at the same rate as pain, cost is around $18,960 per DALY avoided. Acupuncture as a substitute for standard care was not found to be cost-effective unless comorbid depression was included. According to the WHO cost-effectiveness threshold values, acupuncture is a cost-effective treatment strategy in patients with chronic LBP.

Acupuncture for induction of labour.

BACKGROUND: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. The use of complementary therapies is increasing and some women look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. The limited observational studies to date suggest acupuncture for induction of labour appears safe, has no known adverse effects to the fetus, and may be effective. However, the evidence regarding the clinical effectiveness of this technique is limited. OBJECTIVES: To determine the effectiveness and safety of acupuncture for third trimester cervical ripening or induction of labour. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 November 2012), PubMed (1966 to 23 November 2012), Embase (1980 to 23 November 2012), Dissertation Abstracts (1861 to 23 November 2012), CINAHL (1982 to 23 November 2012), the WHO International Clinical Trials Registry Portal (ICTRP) (23 November 2012) and bibliographies of relevant papers. SELECTION CRITERIA: Clinical trials comparing acupuncture used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, evaluated methodological quality and extracted data. MAIN RESULTS: The original review included three trials and seven trials were excluded. This updated review includes 14 trials, and excludes eight trials. Three trials previously excluded due to no clinically relevant outcomes are now included. Eight new trials were included, and four new trials were excluded. We included 14 trials with data reporting on 2220 women.Trials reported on three primary outcomes only caesarean section, serious neonatal morbidity and maternal mortality. No trial reported on vaginal delivery not achieved within 24 hours; and uterine hyperstimulation with fetal heart rate (FHR) changes. There was no difference in caesarean deliveries between acupuncture and the sham control (average risk ratio (RR) 0.95, 95% confidence interval (CI) 0.69 to 1.30, six trials, 654 women), and acupuncture versus usual care (average RR 0.69, 95% CI 0.40, 1.20, six trials, 361 women). There was no difference in neonatal seizures between acupuncture and the sham group (RR 1.01, 95% CI 0.06 to 16.04, one trial, 364 women).There was some evidence of a change in cervical maturation for women receiving acupuncture compared with the sham control, (mean difference (MD) 0.40. 95%CI 0.11 to 0.69, one trial, 125 women), and when compared with usual care (MD 1.30, 95% CI 0.11 to 2.49, one trial, 67 women). The length of labour was shorter in the usual care group compared with acupuncture (average standardised mean difference (SMD) 0.67, 95% CI 0.18 to 1.17, one trial 68 women). There were no other statistically significant differences between groups. Few studies reported on many clinically relevant outcomes. One trial was at a low risk of bias on all domains. AUTHORS' CONCLUSIONS: Overall, there have been few studies assessing the role of acupuncture for induction of labour. Before implications for clinical practice can be made there is a need for well-designed randomised controlled trials to evaluate the role of acupuncture to induce labour and for trials to assess clinically meaningful outcomes.

Herbal medicines for fatty liver diseases.

BACKGROUND: Fatty liver disease is potentially a reversible condition that may lead to end-stage liver disease. Since herbal medicines such as Crataegus pinnatifida and Salvia miltiorrhiza have increasingly been used in the management of fatty liver disease, a systematic review on herbal medicine for fatty liver disease is needed. OBJECTIVES: To assess the beneficial and harmful effects of herbal medicines for people with alcoholic or non-alcoholic fatty liver disease. SEARCH METHODS: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 3, 2012), MEDLINE, EMBASE, and Science Citation Index Expanded to 1 March 2012. We also searched the Chinese BioMedical Database, Traditional Chinese Medical Literature Analysis and Retrieval System, China National Knowledge Infrastructure, Chinese VIP Information, Chinese Academic Conference Papers Database and Chinese Dissertation Database, and the Allied and Complementary Medicine Database to 2 March 2012. SELECTION CRITERIA: We included randomised clinical trials comparing herbal medicines with placebo, no treatment, a pharmacological intervention, or a non-pharmacological intervention such as diet or lifestyle, or Western interventions in participants with fatty liver disease. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently. We used the 'risk of bias' tool to assess the risk of bias of the included trials. We assessed the following domains: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. We presented the effects estimates as risk ratios (RR) with 95% confidence intervals (CI) or as mean differences (MD) with 95% CI, depending on the variables of the outcome measures. MAIN RESULTS: We included 77 randomised clinical trials, which included 6753 participants with fatty liver disease. The risks of bias (overestimation of benefits and underestimation of harms) was high in all trials. The mean sample size was 88 participants (ranging from 40 to 200 participants) per trial. Seventy-five different herbal medicine products were tested. Herbal medicines tested in the randomised trials included single-herb products (Gynostemma pentaphyllum, Panax notoginseng, and Prunus armeniaca), proprietary herbal medicines commercially available, and combination formulas prescribed by practitioners. The most commonly used herbs were Crataegus pinnatifida,Salvia miltiorrhiza,Alisma orientalis,Bupleurum Chinense,Cassia obtusifolia, Astragalus membranaceous, and Rheum palmatum. None of the trials reported death, hepatic-related morbidity, quality of life, or costs. A large number of trials reported positive effects on putative surrogate outcomes such as serum aspartate aminotransferase, alanine aminotransferase, glutamyltransferase, alkaline phosphatases, ultrasound, and computed tomography scan. Twenty-seven trials reported adverse effects and found no significant difference between herbal medicines versus control. However, the risk of bias of the included trials was high.The outcomes were ultrasound findings in 22 trials, liver computed tomography findings in eight trials, aspartate aminotransferase levels in 64 trials, alanine aminotransferase activity in 77 trials, and glutamyltransferase activities in 44 trials. Six herbal medicines showed statistically significant beneficial effects on ultrasound, four on liver computed tomography, 42 on aspartate aminotransferase activity, 49 on alanine aminotransferase activity, three on alkaline phosphatases activity, and 32 on glutamyltransferase activity compared with control interventions. AUTHORS' CONCLUSIONS: Some herbal medicines seemed to have positive effects on aspartate aminotransferase, alanine aminotransferase, ultrasound, and computed tomography. We found no significant difference on adverse effects between herbal medicine and control groups. The findings are not conclusive due to the high risk of bias of the included trials and the limited number of trials testing individual herbal medicines. Accordingly, there is also high risk of random errors.

Interrater reliability of chinese medicine diagnosis in people with prediabetes.

Background. Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. We hypothesise that the use of a validated instrument may improve consistency. Biochemical biomarkers may also be used enhance reliability. Methods. Twenty-seven participants with prediabetes were assessed by two TCM practitioners using a validated instrument (TEAMSI-TCM). Inter-rater reliability was summarised using percentage agreement and the kappa coefficient. One-way ANOVA and Tukey's post hoc test were used to test links between TCM diagnosis and biomarkers. Results. The two practitioners agreed on primary diagnosis of 70% of participants. kappa = 0.56 (P < 0.001). The three predominant TCM diagnostic patterns for people with prediabetes were Yin deficiency, Qi and Yin deficiency and Spleen qi deficiency. The Spleen Qi deficiency with Damp cohort had statistically significant higher fasting glucose, higher insulin, higher insulin resistance, higher HbA1c and lower HDL than those with Qi and Yin deficiency. Conclusions. Using the TEAMSI-TCM resulted in moderate interrater reliability between TCM practitioners. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability.

Chinese herbal medicine for impaired glucose tolerance: a randomized placebo controlled trial.

BACKGROUND: Diabetes remains a major health problem worldwide. Low-risk low-cost alternatives to pharmaceutical interventions are needed where lifestyle modifications have failed. We conducted a double-blind randomised placebo controlled trial to investigate the efficacy of a Chinese herbal formula, Jiangtang Xiaozhi, in treating impaired glucose control and insulin resistance in persons with prediabetes and controlled diabetes. METHODS: Seventy-one patients with prediabetes or 'controlled' diabetes were randomised to receive 3 capsules of Jiangtang Xiaozhi (n = 39) or placebo (n = 32) three times daily for 16 weeks with a follow up eight weeks later (week 24). The primary outcome was change in glycaemic control as evidenced by fasting blood glucose (FBG), post-prandial plasma glucose and glycosylated haemoglobin (HbA1c). Other measures included change in fasting insulin, insulin resistance and sensitivity, lipids, C-reactive protein (CRP), body mass index (BMI), waist girth, blood pressure (BP), health related quality of life (HRQoL) and safety. Analysis of covariance (ANCOVA) was used to model outcomes at 16 weeks, by treatment group corrected for baseline level of the outcome variable. RESULTS: In patients receiving Jiangtang Xiaozhi, FBG was not significantly different (p = 0.73) compared to placebo after 16 weeks of treatment (6.3 ± 1.1 mmol/L vs 6.7 ± 1.3 mmol/L). There was a significant difference (p = 0.04) in the mean levels of fasting insulin between the treatment group (11.6 ± 5.5 mmol/L) and the placebo group (22.1 ± 25.9 mmol/L). Insulin resistance slightly decreased in the treatment group (1.58 ± 0.74) compared to that of the placebo group (2.43 ± 1.59) but this change did not reach statistical significance (p = 0.06). Patients taking Jiangtang Xiaozhi had a significant improvement in high-density lipoprotein (HDL) level compared to the placebo group at week 16 (p = 0.03). Mean levels of cholesterol, triglycerides, BMI, waist-girth, HRQoL, BP, CRP and insulin sensitivity were not significantly different between the two groups. The herbal medicine was well tolerated. CONCLUSIONS: In the current study, the 16 week Jiangtang Xiaozhi treatment did not lower fasting blood glucose, but it improved serum insulin and HDL cholesterol in a Western population with prediabetes or controlled diabetes. Our trial may have been underpowered. Dosage needs to be considered before commencing a longer adequately powered trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000128897; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362005.

The use of complementary and alternative medicine by people with cardiovascular disease: a systematic review.

BACKGROUND: Complementary and alternative medicine (CAM) may offer benefits as well as risks to people with cardiovascular disease. Understanding the prevalence and the nature of CAM use will encourage beneficial CAM therapies, prevent potential herb-drug interactions and foster communication between patients and physicians. METHODS: A systematic search of eight bibliographic databases was conducted for studies that investigated CAM use in patients with cardiovascular diseases. Two independent reviewers selected relevant abstracts and evaluated the quality of included studies. RESULTS: Twenty-seven studies were included. Prevalence of CAM use in cardiac patients ranged from 4% - 61%. Biologically-based therapies usage ranged from 22% to 68%. Herbal medicines were used by between 2% and 46%. A large proportion of patients did not inform medical practitioners about their CAM use and up to 90% of treating physicians did not discuss CAM use with their patients. CONCLUSIONS: CAM use in patients with cardiovascular disease appears common. The findings suggest that the effects of CAM on medical management of cardiovascular disease may be overlooked and that patient-physician communication need to be strengthened.

Chinese herbal medicines for people with impaired glucose tolerance or impaired fasting blood glucose.

BACKGROUND: Around 308 million people worldwide are estimated to have impaired glucose tolerance (IGT); 25% to 75% of these will develop diabetes within a decade of initial diagnosis. At diagnosis, half will have tissue-related damage and all have an increased risk for coronary heart disease. OBJECTIVES: The objective of this review was to assess the effects and safety of Chinese herbal medicines for the treatment of people with impaired glucose tolerance or impaired fasting glucose (IFG). SEARCH STRATEGY: We searched the following databases: The Cochrane Library, PubMed, EMBASE, AMED, a range of Chinese language databases, SIGLE and databases of ongoing trials. SELECTION CRITERIA: Randomised clinical trials comparing Chinese herbal medicines with placebo, no treatment, pharmacological or non-pharmacological interventions in people with IGT or IFG were considered. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. Trials were assessed for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, outcome assessors and intervention providers, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS: This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta-analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels. AUTHORS' CONCLUSIONS: The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co-interventions, unclear methods of randomisation, poor reporting and other risks of bias.