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

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

Complementary medicines and therapies in clinical guidelines on pregnancy care: A systematic review.

BACKGROUND: There is a need for evidence-based guidance on complementary medicines and therapies (CMT) use during pregnancy due to high prevalence of use and lack of guidance on the balance of benefit and harms. AIM: Evaluate the extent to which current clinical practice guidelines relevant to Australian healthcare professionals make clear and unambiguous recommendations about CMT use in pregnancy, and synthesise these recommendations. METHODS: The search included EMBASE, PubMed, the National Health and Medical Research Council's Clinical Practice Guidelines Portal, and websites of Australian maternity hospitals and professional/not-for-profit organisations for published guidelines on pregnancy care. Data were synthesised narratively. Guidelines were appraised by two independent reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. FINDINGS: A total of 48 guidelines were found, of which 41% provided recommendations that were not limited to routine vitamin and mineral supplementation. There were wide variations in recommendations, particularly for vitamin D and calcium. There was some consensus on recommending ginger and vitamin B6 for nausea and vomiting, and additional supplementation for women with obesity. Guidelines generally scored poorly in the domains of editorial independence and rigour of development. DISCUSSION: There is a lack of guidance with regard to appropriate CMT use during pregnancy, which may result in less-than-optimal care. Inconsistency between guidelines may lead to variations in care. CONCLUSION: Guidelines should include clear and unambiguous guidance on appropriate CMT use during pregnancy, be based on a structured search of the evidence and informed by stakeholder engagement.

Shared Medical Appointments and Mindfulness for Type 2 Diabetes-A Mixed-Methods Feasibility Study.

Introduction: Type 2 diabetes (T2DM) is a major health concern with significant personal and healthcare system costs. There is growing interest in using shared medical appointments (SMAs) for management of T2DM. We hypothesize that adding mindfulness to SMAs may be beneficial. This study aimed to assess the feasibility and acceptability of SMAs with mindfulness for T2DM within primary care in Australia. Materials and Methods: We conducted a single-blind randomized controlled feasibility study of SMAs within primary care for people with T2DM living in Western Sydney, Australia. People with T2DM, age 21 years and over, with HbA1c > 6.5% or fasting glucose >7.00 mmol/L within the past 3 months were eligible to enroll. The intervention group attended six 2-h programmed SMAs (pSMAs) which were held fortnightly. pSMAs included a structured education program and mindfulness component. The control group received usual care from their healthcare providers. We collected quantitative and qualitative data on acceptability as well as glycemic control (glycated hemoglobin and continuous glucose monitoring), lipids, anthropometric measures, blood pressure, self-reported psychological outcomes, quality of life, diet, and physical activity using an ActiGraph accelerometer. Results: Over a 2-month period, we enrolled 18 participants (10 females, 8 males) with a mean age of 58 years (standard deviation 9.8). We had 94.4% retention. All participants in the intervention group completed at least four pSMAs. Participants reported that attending pSMAs had been a positive experience that allowed them to accept their diagnosis and empowered them to make changes, which led to beneficial effects including weight loss and better glycemic control. Four pSMA participants found the mindfulness component helpful while two did not. All of the seven participants who contributed to qualitative evaluation reported improved psychosocial wellbeing and found the group setting beneficial. There was a significant difference in total cholesterol levels at 12 weeks between groups (3.86 mmol/L in intervention group vs. 4.15 mmol/L in the control group; p = 0.025) as well as pain intensity levels as measured by the PROMIS-29 (2.11 vs. 2.38; p = 0.034). Conclusion: pSMAs are feasible and acceptable to people with T2DM and may result in clinical improvement. A follow-up fully-powered randomized controlled trial is warranted. Clinical Trial Registration: Australia and New Zealand Clinical Trial Registry, identifier ACTRN12619000892112.

Informing the Model of Care for an Academic Integrative Health Care Center: A Qualitative Study of Primary Care Stakeholder Views.

Objectives: To engage with local primary care stakeholders to inform the model of care for a proposed academic integrative health care center incorporating evidence-informed traditional, complementary, and integrative medicine (TCIM) in Sydney, Australia. Design: In-depth semistructured interviews, informed by community-based participatory research principles, were conducted to explore primary care stakeholder preferences and service requirements regarding the proposed Western Sydney Integrative Health (WSIH) center in their local district. Setting: Telephone and face-to-face interviews at primary care clinics in Sydney. Subjects: Thirteen participants took part in the study: eight general practitioners (GPs) and five primary care practice managers (PMs). Methods: GPs were recruited through local GP newsletters, closed GP Facebook groups, and snowballing. PMs were recruited through a national PM newsletter. The semistructured interviews were audiorecorded and transcribed verbatim before conducting a thematic analysis. Results: Three main themes emerged: (1) the rationale for "why" the WSIH center should be established, (2) "what" was most important to provide, and (3) "how" the center could achieve these goals. Participants were willing to refer to the service, acknowledging the demand for TCIM, current gaps in chronic disease care, and negligible Government funding for TCIM. They endorsed a model of care that minimizes out-of-pocket costs for the underserved, incorporates medical oversight, integrates evidence-informed TCIM with conventional health care, builds trust through interprofessional communication and education, and provides sound clinical governance with a strong focus on credentialing and risk management. It was proposed that safety and quality standards are best met by a GP-led approach and evidence-based practice. Conclusions: Our findings demonstrate that participants acknowledged the need for a model of care that fits into the local landscape through integrating conventional health care with TCIM in a team-based environment, with medical/GP oversight to ensure sound clinical governance. Findings will be used with input from other stakeholder groups to refine the WSIH model of care.

Informing the model of care for an academic integrative healthcare centre: a qualitative study exploring healthcare consumer perspectives.

BACKGROUND: In response to high demand and the growing body of evidence for traditional and complementary therapies, the practice of integrative medicine and integrative healthcare has emerged where these therapies are blended with conventional healthcare. While there are a number of academic integrative healthcare centres worldwide, there are none in Australia. Western Sydney University will soon establish an academic integrative healthcare centre offering evidence-informed traditional and complementary therapies integrated with conventional healthcare in a research-based culture. The aim of this study was to explore healthcare consumers' views about the perceived need, advantages, and disadvantages of the proposed centre and its relevance to community-defined problems and health and service needs. METHODS: Qualitative methods, informed by community-based participatory research, were used during 2017. Focus groups supplemented with semi-structured interviews were conducted with healthcare consumers. Participants were recruited through paid advertisements on Facebook. Thematic coding, informed by an integrative healthcare continuum, was used to analyse and organise the data. Analysis was augmented with descriptive statistics of participant demographic details. RESULTS: Three main themes emerged: (i) the integrative approach, (i) person-centred care, and (iii) safety and quality. Participants proposed a coordinated healthcare model, with perspectives falling along a continuum from parallel and consultative to fully integrative models of healthcare. The importance of multidisciplinary collaboration and culturally appropriate, team-based care within a supportive healing environment was emphasised. A priority of providing broad and holistic healthcare that was person centred and treated the whole person was valued. It was proposed that safety and quality standards be met by medical oversight, evidence-informed practice, practitioner competency, and interprofessional communication. CONCLUSIONS: Our findings demonstrate that participants desired greater integration of conventional healthcare with traditional and complementary therapies within a team-based, person-centred environment with assurances of safety and quality. Findings will be used to refine the model of care for an academic integrative healthcare centre in Western Sydney.

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

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