Ayurveda for managing noncommunicable diseases in organisation for economic co-operation and development: A qualitative systematic review protocol on experiences, perceptions, and perspectives of ayurvedic practitioners and patients.

Background and Aims: Ayurveda is a traditional medicine that originated in the Indian subcontinent, and its use remains widespread in the Indian subcontinent, especially for managing noncommunicable diseases (NCDs). It is also becoming increasingly popular in the Organization for Economic Co-operation and Development (OECD) countries as complementary and alternative medicine. Qualitative research studies have been conducted in various OECD countries to explore the experiences, perceptions, and perspectives of Ayurvedic practitioners and patients with NCDs regarding the usage of Ayurveda for managing these conditions. However, to date, no systematic review on this topic has been published. Therefore, this systematic review aims to synthesize the experiences, perceptions, and perspectives of Ayurvedic practitioners and patients with NCDs on the usage of Ayurveda for managing these conditions in OECD countries. Methods: The systematic review will be conducted in accordance with the joanna briggs institute systematic review guideline on qualitative evidence. We will include qualitative research studies conducted among Ayurvedic practitioners or adult patients with NCDs in any OECD member country to explore experiences, perceptions, or perspectives regarding the usage of Ayurveda for managing NCDs. MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), AMED, and Web of Science will be searched to identify published studies. EthOS and ProQuest Dissertations and Theses will be searched to identify unpublished studies. No date or language restrictions will be applied. Initially, a narrative synthesis will be conducted. Where possible, study findings will be pooled using the meta-aggregation approach.

Development process of a clinical guideline to manage type 2 diabetes in adults by Ayurvedic practitioners.

Background: Type 2 diabetes mellitus (T2DM), a common chronic health condition, has major health and socioeconomic consequences. In the Indian subcontinent, it is a health condition for which individuals commonly consult Ayurvedic (traditional medical system) practitioners and use their medicines. However, to date, a good quality T2DM clinical guideline for Ayurvedic practitioners, grounded on the best available scientific evidence, is not available. Therefore, the study aimed to systematically develop a clinical guideline for Ayurvedic practitioners to manage T2DM in adults. Methods: The development work was guided by the UK's National Institute for Health and Care Excellence (NICE) manual for developing guidelines, the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. First, a comprehensive systematic review was conducted which evaluated Ayurvedic medicines' effectiveness and safety in managing T2DM. In addition, the GRADE approach was used for assessing the certainty of the findings. Next, using the GRADE approach, the Evidence-to-Decision framework was developed, and we focused on glycemic control and adverse events. Subsequently, based on the Evidence-to-Decision framework, a Guideline Development Group of 17 international members made recommendations on Ayurvedic medicines' effectiveness and safety in T2DM. These recommendations formed the basis of the clinical guideline, and additional generic content and recommendations were adapted from the T2DM Clinical Knowledge Summaries of the Clarity Informatics (UK). The feedback given by the Guideline Development Group on the draft version was used to amend and finalize the clinical guideline. Results: A clinical guideline for managing T2DM in adults by Ayurvedic practitioners was developed, which focuses on how practitioners can provide appropriate care, education, and support for people with T2DM (and their carers and family). The clinical guideline provides information on T2DM, such as its definition, risk factors, prevalence, prognosis, and complications; how it should be diagnosed and managed through lifestyle changes like diet and physical activity and Ayurvedic medicines; how the acute and chronic complications of T2DM should be detected and managed (including referral to specialists); and advice on topics like driving, work, and fasting including during religious/socio-cultural festivals. Conclusion: We systematically developed a clinical guideline for Ayurvedic practitioners to manage T2DM in adults.

Content and quality of clinical practice guidelines for the management of type 2 diabetes in India: A systematic review.

INTRODUCTION: Over the last few decades, India has witnessed an increase in the number of people with type 2 diabetes mellitus (T2DM). Consequently, several clinical practice guidelines (CPGs) have been developed to assist western and traditional Indian medicine practitioners in managing this disease. This systematic review aimed to evaluate and synthesize the content and quality of these CPGs. METHODS: Several databases and sources were searched from inception to May 2022, to identify CPGs for managing adults with T2DM in India. The screening of titles and abstracts and full texts, data extraction and quality assessment were conducted by two independent reviewers. Any disagreements were resolved through discussion or by involving a third reviewer. A data extraction tool from a previous study was adapted to extract the content of the included CPGs, and the Appraisal of Guidelines for Research and Evaluation II tool was used to assess the quality of the included CPGs. A narrative synthesis was conducted. RESULTS: Of 3350 records identified, 11 were retrieved for full-text screening and five CPGs were included in this systematic review-three focused on traditional Indian medicine (Ayurveda) and two focused on western medicine. These two western medicine CPGs contained comprehensive recommendations for managing T2DM but only one of these, the Research Society for the Study of Diabetes in India/Endocrine Society of India (RSSDI/ESI) CPG, was of high quality. CONCLUSIONS: Only one CPG can be recommended for managing T2DM by western medicine practitioners in India. Future CPGs, especially for traditional Indian medicine practitioners, should be developed and updated using the standard CPG manuals and quality appraisal tools. REGISTRATION: PROSPERO (CRD42021279499).

A clinical guideline-based management of type 2 diabetes by ayurvedic practitioners in Nepal: A feasibility cluster randomized controlled trial protocol.

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a common chronic condition with significant health and socioeconomic consequences. In Nepal, T2DM is a common disease for which people consult ayurvedic (traditional medical system) practitioners and use ayurvedic medicines. Strong concerns remain about the suboptimal T2DM management of many patients by ayurvedic practitioners, and therefore, based on the best available scientific evidence, we have developed a clinical guideline for managing T2DM by ayurvedic practitioners. The research question to be addressed by a definitive cluster randomized controlled trial (RCT) is whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners in Nepal as compared to usual ayurvedic management (i.e., without any clinical guideline). In preparation for this future work, this current study aims to determine the feasibility of undertaking the definitive cluster RCT. METHODS: This is a 2-arm, feasibility cluster RCT with a blinded outcome assessment and a qualitative evaluation. The study is conducted in 12 public and private ayurveda centers in and outside the Kathmandu Valley in Nepal (1:1 intervention:control). Eligible participants should be new T2DM adult patients (i.e., treatment naïve) - the glycated hemoglobin level should be 6.5% or above but less than 9%. At least 120 participants (60/group) will be recruited and followed up for 6 months. Important parameters, needed to design the definitive trial, will be estimated, such as the standard deviation of the outcome measure (i.e., glycated hemoglobin level at 6-month follow-up), intraclass correlation coefficient, cluster size, recruitment, the time needed to recruit participants, follow-up, and adherence to the recommended ayurvedic medicine. Semi-structured qualitative interviews will be conducted with around 20 to 30 participants and all the participating ayurvedic practitioners to explore their experiences and perspectives of taking part in the study and of the intervention and a sample of eligible people declining to participate in the study to explore the reasons behind nonparticipation. DISCUSSION: We are now conducting a feasibility cluster RCT in Nepal to determine the feasibility of undertaking the definitive cluster trial. The first participant was recruited on 17 July 2022. If the feasibility is promising (such as recruitment, follow-up, and adherence to the recommended ayurvedic medicine), then the parameters estimated will be used to design the definitive cluster trial. Decisions over whether to modify the protocol will mainly be informed by the qualitative data.

Risk factors for falls among older adults in India: A systematic review and meta-analysis.

Background and Aim: Falls are common among older adults in India. Several primary studies on its risk factors have been conducted in India. However, no systematic review has been conducted on this topic. Thus, the objective of this systematic review was to synthesize the existing evidence on the risk factors for falls among older adults in India. Methods: JBI and Preferred Reporting Items for Systematic Reviews and Meta-Analyse guidelines were followed, and two independent reviewers were involved in the process. This review included observational studies conducted among older adults (aged ≥ 60 years) residing in India, reporting any risk factor for falls as exposure and unintentional fall as the outcome. MEDLINE, EMBASE, PsycInfo, CINAHL, and ProQuest Dissertations and Theses were searched until September 24, 2020. Where possible, data were synthesized using random-effects meta-analysis. Results: The literature search yielded 3445 records. Twenty-two studies met the inclusion criteria of this systematic review, and 19 studies were included in the meta-analysis. Out of the 22 included studies in the systematic review, 12 (out of 18) cross-sectional studies, two case-control studies, and two cohort studies met more than 70% criteria in the respective Joanna Briggs Institute (JBI) checklists. Risk factors for falls among older adults in India included sociodemographic factors, environmental factors, lifestyle factors, physical and/or mental health conditions, and medical interventions. Conclusions: This systematic review and meta-analysis provided a holistic picture of the problem in India by considering a range of risk factors such as sociodemographic, environmental, lifestyle, physical and/or mental health conditions and medical intervention. These findings could be used to develop falls prevention interventions for older adults in India. Systematic Review and Meta­Analysis Registration: The systematic review and meta-analysis protocol was registered with PROSPERO (registration number-CRD42020204818).

Effectiveness and Safety of Ayurvedic Medicines in Type 2 Diabetes Mellitus Management: A Systematic Review and Meta-Analysis.

Introduction: Many Ayurvedic medicines have the potential for managing type 2 diabetes mellitus (T2DM), with previous systematic reviews demonstrating effectiveness and safety for specific Ayurvedic medicines. However, many of the reviews need updating and none provide a comprehensive summary of all the Ayurvedic medicines evaluated for managing T2DM. Objective: The objective of this systematic review was to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing T2DM. Inclusion criteria: Published and unpublished RCTs assessing the effectiveness and safety of Ayurvedic medicines for managing T2DM in adults. Methods: The JBI systematic review methodology was followed. A comprehensive search of sources (including 18 electronic databases) from inception to 16 January 2021 was made. No language restrictions were applied. Data synthesis was conducted using narrative synthesis and random effects meta-analyses, where appropriate. Pooled results are reported as mean differences (MD) with 95% confidence intervals (CI). Results: Out of 32,519 records identified from the searches, 219 articles were included in the systematic review representing 199 RCTs (21,191 participants) of 98 Ayurvedic medicines. Overall, in the studies reviewed the methodology was not adequately reported, resulting in poorer methodological quality scoring. Glycated hemoglobin (HbA1c) was reduced using Aegle marmelos (L.) Corrêa (MD -1.6%; 95% CI -3 to -0.3), Boswellia serrata Roxb. (-0.5; -0.7 to -0.4), Gynostemma pentaphyllum (Thunb.) Makino (-1; -1.5 to -0.6), Momordica charantia L. (-0.3; -0.4 to -0.1), Nigella sativa L. (-0.4; -0.6 to -0.1), Plantago ovata Forssk. (-0.9; -1.4 to -0.3), Tinospora cordifolia (Willd.) Hook.f. and Thomson (-0.5; -0.6 to -0.5), Trigonella foenum-graecum L. (-0.6; -0.9 to -0.4), and Urtica dioica L. (-1.3; -2.4 to -0.2) compared to control. Similarly, fasting blood glucose (FBG) was reduced by 4-56 mg/dl for a range of Ayurvedic medicines. Very few studies assessed health-related quality of life (HRQoL). Adverse events were not reported in many studies, and if reported, these were mostly none to mild and predominately related to the gastrointestinal tract. Conclusion: The current evidence suggests the benefit of a range of Ayurvedic medicines in improving glycemic control in T2DM patients. Given the limitations of the available evidence and to strengthen the evidence base, high-quality RCTs should be conducted and reported.

Feasibility Trial of Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) among High-Risk People in India: A Qualitative Study to Explore Participants' Trial- and Intervention-Related Barriers and Facilitators.

Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga programme for T2DM prevention (YOGA-DP) and conducted a feasibility randomised controlled trial (RCT) among high-risk people in India. This qualitative study's objective was to identify and explore participants' trial- and intervention-related barriers and facilitators. The feasibility trial was conducted at two Yoga centres in New Delhi and Bengaluru, India. In this qualitative study, 25 trial participants (13 intervention group, 12 control group) were recruited for semi-structured interviews. Data were analysed using deductive logic and an interpretative phenomenological approach. Amongst intervention and control participants, key barriers to trial participation were inadequate information about recruitment and randomisation processes and the negative influence of non-participants. Free blood tests to aid T2DM prevention, site staff's friendly behaviour and friends' positive influence facilitated trial participation. Amongst intervention participants, readability and understanding of the programme booklets, dislike of the Yoga diary, poor quality Yoga mats, difficulty in using the programme video, household commitment during home sessions, unplanned travel, difficulty in practising Yoga poses, hesitation in attending programme sessions with the YOGA-DP instructor of the opposite sex and mixed-sex group programme sessions were key barriers to intervention participation. Adequate information was provided on T2DM prevention and self-care, good venue and other support provided for programme sessions, YOGA-DP instructors' positive behaviour and improvements in physical and mental well-being facilitated intervention participation. In conclusion, we identified and explored participants' trial- and intervention-related barriers and facilitators. We identified an almost equal number of barriers (n = 12) and facilitators (n = 13); however, intervention-related barriers and facilitators were greater than for participating in the trial. These findings will inform the design of the planned definitive RCT design and intervention and can also be used to design other Yoga interventions and RCTs.

Content, Structure and Delivery Characteristics of Yoga Interventions for the Management of Osteoarthritis: A Systematic Review Protocol.

The global burden of osteoarthritis among adults is rising. Yoga might be a potential solution for the management of osteoarthritis. This systematic review aims to synthesise the content, structure and delivery characteristics of effective yoga interventions for the management of osteoarthritis. The JBI methodology for systematic reviews of effectiveness and the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines will be followed. Randomised controlled trials (RCTs) assessing the effectiveness of yoga interventions for the management of osteoarthritis in adults will be included in this review. We aim to search the following databases to find published and unpublished studies: MEDLINE, EMBASE, CINAHL, PsycInfo, SPORTDiscus, AMED, Web of Science, CENTRAL, TRIP, AYUSH Research Portal, ABIM, CAM-QUEST, PeDro, OpenGrey, EthOS, ProQuest Dissertations and Theses and DART-Europe-e-theses portal. No date or language restrictions will be applied. A narrative synthesis will be conducted with the help of tables. A meta-regression will be conducted to explore the statistical evidence for which the components (content, structure and delivery characteristics) of yoga interventions are effective.

Content, Structure and Delivery Characteristics of Yoga Interventions for Managing Rheumatoid Arthritis: A Systematic Review Protocol.

The global burden of rheumatoid arthritis among adults is rising. Yoga might be a potential solution for managing rheumatoid arthritis. This systematic review aims to synthesise the content, structure and delivery characteristics of effective yoga interventions for managing rheumatoid arthritis. The JBI methodology for systematic reviews of effectiveness and the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines will be followed. PRISMA for systematic review protocols (PRISMA-P) was used to write the protocol. Randomised controlled trials assessing the effectiveness of yoga interventions for managing rheumatoid arthritis in adults will be included in this review. We aim to search the following databases to find published and unpublished studies: ABIM, AMED, AYUSH Research Portal, CAM-QUEST, CINAHL, CENTRAL, EMBASE, MEDLINE, PeDro, PsycInfo, SPORTDiscus, TRIP, Web of Science, DART-Europe-e-theses portal, EthOS, OpenGrey and ProQuest Dissertations and Theses. No date or language restrictions will be applied. A narrative synthesis will be conducted. Meta-regression will be conducted to explore the statistical evidence for which components (content, structure and delivery characteristics) of yoga interventions are effective.

Content, Structure, and Delivery Characteristics of Yoga Interventions for Managing Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Objectives: This systematic review aimed to synthesize the content, structure, and delivery characteristics of effective yoga interventions used for managing hypertension and to compare these characteristics with ineffective interventions. Design and Method: The JBI and the PRISMA guidelines were followed in this systematic review. RCTs conducted among hypertensive adults were included. RCTs reporting at least one of the major components of yoga (i.e., asana, pranayama, and dhyana and relaxation practices) and comparing them with no intervention or any intervention were eligible. Sixteen databases were searched for published and unpublished studies without any date and language restrictions till March 15, 2021. Results: The literature search yielded 13,130 records. 34 RCTs (evaluating 38 yoga interventions) met the inclusion criteria. Overall, included studies had low methodological quality mostly due to inadequate reporting. Yoga reduced SBP and DBP compared to a control intervention (MD -6.49 and -2.78; 95CI% -8.94- -4.04 and -4.11- -1.45, respectively). Eighteen, 14 and 20 interventions were effective in improving SBP, DBP, or either, respectively. 13 out of 20 effective interventions incorporated all the 3 major components of yoga and allocated similar durations to each component whereas ineffective interventions were more focused on the asana and duration of asana practice was longer. The most common duration and frequency of effective interventions were 45 min/session (in 5 interventions), 7 days/week (in 5 interventions), and 12 weeks (in 11 interventions) whereas the most common session frequency was 2 days a week (in 7 interventions) in ineffective interventions. Effective interventions were mostly center-based (in 15 interventions) and supervised (in 16 interventions) and this was similar with ineffective interventions. Conclusion: Despite the low quality and heterogeneity of included studies, our findings suggest yoga interventions may effectively manage hypertension. The differences between the effective and ineffective interventions suggest that effective yoga interventions mostly incorporated asana, pranayama, and dhyana and relaxation practices and they had a balance between these three components and included regular practice. They were mostly delivered in a center and under supervision. Future studies should consider developing and evaluating an intervention for managing hypertension using the synthesized findings of the effective interventions in this review. Systematic Review Registration: [PROSPERO], identifier [CRD42019139404].

Characteristics of Yoga Providers and Their Sessions and Attendees in the UK: A Cross-Sectional Survey.

Yoga is an ancient Indian philosophy and way of life that is being used as a method of improving health and wellbeing. Evidence shows that yoga has several health benefits, such as managing many noncommunicable diseases, such as hypertension, and improving mental health. The popularity of yoga is growing in the UK, but it is mostly unregulated with little information available about yoga providers and their sessions and attendees. This study aimed to explore who is providing yoga; what sessions are available, where, and at what cost; and who attends these sessions in the UK and whether yoga providers were aware of health conditions in their sessions. A cross-sectional survey was undertaken among yoga providers in the UK. They were approached through four major UK yoga associations. In total, 407 yoga providers participated. Most providers were aged 45-64 years (69%), female (93%), and white (93%). The median number of group sessions and one-to-one sessions delivered per week was four and two, respectively. The most common styles were Hatha (28%), Iyengar (26%), and Vinyasa (15%). Sessions had a varying emphasis on different yogic practices, but 59% of providers allocated most time to yogic poses (asana), 18% to breathing practices (pranayama), and 12% to meditation (dhyana) and relaxation practices. Most (73%) reported that their attendees disclosed their health conditions to them, most commonly mental health issues (41%), hypertension (25%), and heart diseases (9%). This study showed that yoga sessions are widely available in the UK, often provided and practiced by women, and concentrate on yogic poses. Sessions concentrate on the asana and tend not to include many of the more holistic aspects of yoga that are practiced in South Asian countries. Yoga providers are often aware of health conditions but may benefit from training to deliver sessions suitable for specific health conditions.

Yoga Program for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People: Qualitative Study to Explore Reasons for Non-participation in a Feasibility Randomized Controlled Trial in India.

Background: Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga program for T2DM prevention (YOGA-DP) among high-risk people and conducted a feasibility randomized controlled trial (RCT) in India. The objective of this study was to identify and explore why potential participants declined to participate in the feasibility RCT. Methods: An exploratory qualitative study, using semi-structured interviews, was conducted at a Yoga center in New Delhi, India. Fourteen people (10 women and four men) who declined to participate in the feasibility RCT were interviewed, and 13 of them completed the non-participant questionnaire, which captured their socio-demographics, diets, physical activities, and reasons for declining. Results: Three types of barriers were identified and explored which prevented participation in the feasibility RCT: (1) personal barriers, such as lack of time, perceived sufficiency of knowledge, preferences about self-management of health, and trust in other traditional and alternative therapies; (2) contextual barriers, such as social influences and lack of awareness about preventive care; and (3) study-related barriers, such as lack of study information, poor accessibility to the Yoga site, and lack of trust in the study methods and intervention. Conclusions: We identified and explored personal, contextual, and study-related barriers to participation in a feasibility RCT in India. The findings will help to address recruitment challenges in future Yoga and other RCTs. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: CTRI/2019/05/018893.

Development of a Yoga Program for Type-2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India.

Introduction: Many Indians are at high-risk of type-2 diabetes mellitus (T2DM). Yoga is an ancient Indian mind-body discipline, that has been associated with improved glucose levels and can help to prevent T2DM. The study aimed to systematically develop a Yoga program for T2DM prevention (YOGA-DP) among high-risk people in India using a complex intervention development approach. Materials and Methods: As part of the intervention, we developed a booklet and a high-definition video for participants and a manual for YOGA-DP instructors. A systematic iterative process was followed to develop the intervention and included five steps: (i) a systematic review of the literature to generate a list of Yogic practices that improves blood glucose levels among adults at high-risk of or with T2DM, (ii) validation of identified Yogic practices by Yoga experts, (iii) development of the intervention, (iv) consultation with Yoga, exercise, physical activity, diet, behavior change, and/or diabetes experts about the intervention, and (v) pretest the intervention among Yoga practitioners and lay people (those at risk of T2DM and had not practiced Yoga before) in India. Results: YOGA-DP is a structured lifestyle education and exercise program, provided over a period of 24 weeks. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices), and Dhyana (meditation) and relaxation practices. Once participants complete the program, they are strongly encouraged to maintain a healthy lifestyle in the long-term. Conclusions: We systematically developed a novel Yoga program for T2DM prevention (YOGA-DP) among high-risk people in India. A multi-center feasibility randomized controlled trial is in progress in India.

Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol.

INTRODUCTION: A huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT. INTERVENTION: YOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices. METHODS AND ANALYSIS: This is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20-30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues. TRIAL REGISTRATION NUMBER: CTRI/2019/05/018893.

Effectiveness and safety of Ayurvedic medicines in type 2 diabetes mellitus management: a systematic review protocol.

OBJECTIVE: The objective of this review is to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes mellitus. INTRODUCTION: Several randomized controlled trials have been conducted to assess the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes. Systematic reviews have been conducted on this topic but need to be updated. The findings from this review will be used to develop a clinical guideline for managing type 2 diabetes by Ayurvedic practitioners in India. INCLUSION CRITERIA: Randomized controlled trials assessing the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes in adults will be included in this systematic review. METHODS: The authors will search for a wide range of sources to find both published and unpublished studies, including, but not limited to, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and Allied and Complementary Medicine Database (Ovid). No language restrictions will be applied. The JBI systematic review methodology will be followed when conducting the review. Data synthesis will be conducted using narrative synthesis and meta-analyses, where appropriate. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42018118285.

Content, Structure, and Delivery Characteristics of Yoga Interventions for Managing Hypertension: A Systematic Review Protocol.

AIMS: This systematic review aims to summarize the content, structure, and delivery characteristics of yoga interventions used for managing hypertension. INTRODUCTION: Globally, hypertension-related morbidity and mortality are high. Yoga might be a potential solution for managing hypertension. Several systematic reviews have evaluated the effectiveness of yoga interventions for managing hypertension. There is a need to summarize the content, structure, and delivery characteristics of yoga interventions used for managing hypertension. INCLUSION CRITERIA: Randomized controlled trials assessing the effectiveness of yoga interventions for managing hypertension in adults and reporting either the content, structure, or delivery characteristics will be included in this systematic review. METHODS: The Joanna Briggs Institute systematic review methodology will be followed to conduct the review. We aim to search for a wide range of sources to find both published and unpublished studies. The following databases will be searched: MEDLINE, Embase, CINAHL, PsycINFO, Allied and Complementary Medicine (AMED), Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), Turning Research Into Practice (TRIP), AYUSH Research Portal, A Bibliography of Indian Medicine (ABIM), Digital Helpline for Ayurveda Research Articles (DHARA), CAM-QUEST, and Directory of Open Access Journals (DOAJ). The search for unpublished studies will include OpenGrey, EThOS, and ProQuest Dissertations and Theses. Databases will be searched from their inception dates, and no language restrictions will be applied. A narrative description of the findings will be written, structured around the aims of this systematic review. SYSTEMATIC REVIEW REGISTRATION NUMBER: CRD42019139404.

Yoga-Based Cardiac Rehabilitation After Acute Myocardial Infarction: A Randomized Trial.

BACKGROUND: Given the shortage of cardiac rehabilitation (CR) programs in India and poor uptake worldwide, there is an urgent need to find alternative models of CR that are inexpensive and may offer choice to subgroups with poor uptake (e.g., women and elderly). OBJECTIVES: This study sought to evaluate the effects of yoga-based CR (Yoga-CaRe) on major cardiovascular events and self-rated health in a multicenter randomized controlled trial. METHODS: The trial was conducted in 24 medical centers across India. This study recruited 3,959 patients with acute myocardial infarction with a median and minimum follow-up of 22 and 6 months. Patients were individually randomized to receive either a Yoga-CaRe program (n = 1,970) or enhanced standard care involving educational advice (n = 1,989). The co-primary outcomes were: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the European Quality of Life-5 Dimensions-5 Level visual analogue scale at 12 weeks. RESULTS: MACE occurred in 131 (6.7%) patients in the Yoga-CaRe group and 146 (7.4%) patients in the enhanced standard care group (hazard ratio with Yoga-CaRe: 0.90; 95% confidence interval [CI]: 0.71 to 1.15; p = 0.41). Self-rated health was 77 in Yoga-CaRe and 75.7 in the enhanced standard care group (baseline-adjusted mean difference in favor of Yoga-CaRe: 1.5; 95% CI: 0.5 to 2.5; p = 0.002). The Yoga-CaRe group had greater return to pre-infarct activities, but there was no difference in tobacco cessation or medication adherence between the treatment groups (secondary outcomes). CONCLUSIONS: Yoga-CaRe improved self-rated health and return to pre-infarct activities after acute myocardial infarction, but the trial lacked statistical power to show a difference in MACE. Yoga-CaRe may be an option when conventional CR is unavailable or unacceptable to individuals. (A study on effectiveness of YOGA based cardiac rehabilitation programme in India and United Kingdom; CTRI/2012/02/002408).

Yoga and Cardiovascular Health Trial (YACHT): a UK-based randomised mechanistic study of a yoga intervention plus usual care versus usual care alone following an acute coronary event.

OBJECTIVE: To determine the effects of yoga practice on subclinical cardiovascular measures, risk factors and neuro-endocrine pathways in patients undergoing cardiac rehabilitation (CR) following acute coronary events. DESIGN: 3-month, two-arm (yoga +usual care vs usual care alone) parallel randomised mechanistic study. SETTING: One general hospital and two primary care CR centres in London. Assessments were conducted at Imperial College London. PARTICIPANTS: 80 participants, aged 35-80 years (68% men, 60% South Asian) referred to CR programmes 2012-2014. INTERVENTION: A certified yoga teacher conducted yoga classes which included exercises in stretching, breathing, healing imagery and deep relaxation. It was pre-specified that at least 18 yoga classes were attended for inclusion in analysis. Participants and partners in both groups were invited to attend weekly a 6- to 12-week local standard UK National Health Service CR programme. MAIN OUTCOME MEASURES: (i) Estimated left ventricular filling pressure (E/e'), (ii) distance walked, fatigue and breathlessness in a 6 min walk test, (iii) blood pressure, heart rate and estimated peak VO2 following a 3 min step-test. Effects on the hypothalamus-pituitary-adrenal axis, autonomic function, body fat, blood lipids and glucose, stress and general health were also explored. RESULTS: 25 participants in the yoga + usual care group and 35 participants in the usual care group completed the study. Following the 3-month intervention period, E/e' was not improved by yoga (E/e': between-group difference: yoga minus usual care:-0.40 (-1.38, 0.58). Exercise testing and secondary outcomes also showed no benefits of yoga. CONCLUSIONS: In this small UK-based randomised mechanistic study, with 60 completing participants (of whom 25 were in the yoga + usual care group), we found no discernible improvement associated with the addition of a structured 3-month yoga intervention to usual CR care in key cardiovascular and neuroendocrine measures shown to be responsive to yoga in previous mechanistic studies. TRIAL REGISTRATION NUMBER: NCT01597960; Pre-results.

Incidence, prevalence, risk factors and health consequences of polypharmacy in adults in South Asia: a systematic review protocol.

OBJECTIVE: The objective of the systematic review is to summarize the incidence, prevalence, risk factors and health consequences of polypharmacy in adults in South Asia. INTRODUCTION: Several studies have been conducted in South Asia on the incidence, prevalence, risk factors and health consequences of polypharmacy in adults. Until now, no systematic review has been conducted on this topic. INCLUSION CRITERIA: Related epidemiological studies conducted on adults (aged 18 years and over) and residing in any country within South Asia (i.e. Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka) will be eligible for inclusion. METHODS: MEDLINE, Embase, CINAHL, PsycINFO, BNI, Web of Science, Scopus and AMED databases will be searched to identify published studies. The search for unpublished studies will be undertaken in EThOS, OpenGrey and ProQuest Dissertations and Theses. Databases will be searched from their inception dates and no language restrictions will be applied. The JBI systematic review methodology will be followed to conduct the review. Data synthesis will be conducted using narrative synthesis and meta-analyses, where appropriate.