Introduction of a clinical guideline to manage type-2 diabetes by ayurvedic practitioners in Nepal: intervention development and feasibility study

Diabetes (type 2) is a complex disorder with major health, social and economic consequences. The burden of diabetes is high in Nepal. Diabetes is one of the top diseases for which patients consult ayurvedic practitioners. A high proportion of diabetes patients use ayurvedic treatments, often from the beginning and exclusively and throughout their lives. These are particularly popular among rural, poor, older and tribal populations. Ayurveda originated in the Indian subcontinent, and many ayurvedic herbs grow in the Himalayan mountains. Ayurveda is a recognised medical system in Nepal, and ayurvedic practitioners are part of the health workforce in Nepal.

Despite the effectiveness and safety of several ayurvedic medicines for managing diabetes found in study settings, strong concerns remain about the sub-optimal diabetes management of many patients in ayurvedic clinical practice. The actions to be taken at different stages of the diabetes care pathway are largely left to the judgement of the individual ayurvedic practitioner, resulting in unacceptable variations in ayurvedic clinical practice. Many non-evidence based ayurvedic medicines are prescribed by ayurvedic practitioners, which can have serious adverse effects on patients. A potential solution could be the introduction of a clinical guideline that will make recommendations based on the best available evidence.

The main aim is to establish whether the introduction of a clinical guideline can improve the management of diabetes by ayurvedic practitioners as compared to usual ayurvedic management (i.e., without any clinical guideline) in Nepal. This will be tested in a future main study. Before this, we will develop the clinical guideline and will check with our participants if the main study can be conducted.

We will follow the standard clinical guideline development process. Recognising that the scientific evidence base is not large for many ayurvedic components (e.g., lifestyle), we will draw similar evidence from the standard western medicine clinical guidelines. A systematic review will be conducted on the effectiveness and safety of ayurvedic medicines in diabetes management, to generate evidence statements. These statements will be presented to an independent clinical guideline development committee (involving a range of stakeholders) for making the final decisions. Based on these decisions, the clinical guideline will be drafted and finalised.

Subsequently, a study will be conducted to check if the main study can be done. 12 Primary Health Centres (PHCs) with an ayurvedic practitioner will be randomly allocated either to the clinical guideline-based diabetes management group or the comparator group. At least 120 new diabetes patients, diagnosed by the participating ayurvedic practitioner, will be recruited. Quantitative data (numerical) will be collected and analysed on the study-specific issues, such as quantities that are needed to estimate study size of the main study, recruitment of PHCs and patients, follow-up of patients, and ayurvedic practitioners' adherence to the clinical guideline. Qualitative interviews will take place with all the 12 ayurvedic practitioners and 20-30 patients to explore how they have found taking part in the study and any particular issues experienced. Those who decline to participate in the study will be interviewed to explore the reasons behind.

If the feasibility of undertaking the main study is promising, the main study will be conducted. If found to be effective, diabetes patients will benefit from improved health outcomes, such as better blood glucose control and lower diabetes complications. The related future clinical, personal and economic burden on patients and their carers and families will be reduced.

The burden of type 2 diabetes (T2DM) is high in Nepal. Many T2DM patients, especially in rural areas, consult ayurvedic practitioners and use ayurvedic treatments. Ayurveda is a recognised medical system in Nepal, and ayurvedic practitioners are part of the health workforce in Nepal. Despite the clinical effectiveness and safety of several ayurvedic medicines for managing T2DM found in trial settings, strong concerns remain about the sub-optimal T2DM management of many patients in ayurvedic clinical practice. The overarching aim is to explore whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners as compared to usual ayurvedic management (i.e., without any clinical guideline). Intending to follow up this work with a future cluster randomised controlled trial (cRCT, the main study), the subsidiary objectives of this early phase study are:

1. To develop the clinical guideline: We will follow the standard clinical guideline development process. The scientific evidence base is not large for many ayurvedic components (e.g., lifestyle) and we will draw analogous evidence from the standard western medicine clinical guidelines. A systematic review will be conducted on the effectiveness and safety of ayurvedic medicines in T2DM management, to generate evidence statements. These statements will be presented to an independent clinical guideline development committee for making the final decisions. Accordingly, the clinical guideline will be drafted and finalised.

2. To determine the feasibility of undertaking the main cRCT: Primary Health Centres (PHCs) with an ayurvedic practitioner will be randomised to intervention or comparator groups. New cases of T2DM, diagnosed by the ayurvedic practitioner, will be recruited. Quantitative data will be collected to estimate essential parameters that are needed to design the main cRCT. Semi-structured interviews will be conducted to explore the study-specific issues.

The project has the potential to directly benefit type 2 diabetes (T2DM) patients, the health system and ayurvedic practitioners.

If the feasibility of undertaking the main study (cluster randomised controlled trial) is promising, the main trial will be conducted to determine the effectiveness of the intervention. If found to be effective, T2DM patients will benefit from improved health outcomes, such as better blood glucose control and lower T2DM complications. The related future clinical, personal and economic burden on T2DM patients and their carers and families will be reduced. The rural, poor, older and tribal populations will benefit the most as they rely heavily on ayurvedic treatments, thus reducing health inequalities in T2DM management. T2DM patients will be cared for in line with the best available evidence and in the same manner regardless of where or by which ayurvedic practitioner they are treated. During scaling-up, a 'consumer version' of the clinical guideline will be produced in local languages. It will inform them about what ayurvedic practitioners should be doing, enabling them to be accountable for their care and further influencing its adoption by ayurvedic practitioners. It will empower them to make more informed healthcare choices and to consider their personal needs and preferences in selecting the best option.

Health policymakers and managers will benefit from the availability of an effective and acceptable solution to manage T2DM. The related future economic burden on the health system and economy will be reduced. The clinical guideline may improve the efficiency of healthcare (through standardised care), providing better value for money. In the case of ayurvedic treatments of no, minimal or questionable value, they will benefit from the identified disinvestment opportunities, cost savings and opportunities for redirecting the resources (to effective but underused ayurvedic treatments). The clinical guideline can be used to do prospective and retrospective audits of ayurvedic practitioners (in managing T2DM): the recommendations (for actions at various stages of the T2DM care pathway) in it will provide ready process measures (review criteria) for rating the compliance with best care practices, which will support quality improvement activities. The provision of evidence-based care and reduction in unacceptable variations in ayurvedic clinical practice will send messages of commitment to excellence and quality, thus building patients' confidence in the health system and improving the public image.

The clinical guideline will ensure ayurvedic practitioners that the care they provide is based on the best available evidence and will enable them to have confidence in the approaches to care. It will assist them in the clinical decision-making process through clear recommendations for actions at various stages of the T2DM care pathway. It will close the gap between what they do to manage T2DM and what the evidence supports. It will reinforce their position in T2DM management and offer them medico-legal protection. They will potentially get a boost due to greater interest in their services and may enhance their job opportunities.

Given that T2DM is a global concern, the clinical guideline will be of interest in other countries, particularly in other South Asian countries (such as India, Sri Lanka, Bangladesh, Bhutan and Maldives) and in countries with South Asian ethnic minorities who often rely heavily on ayurvedic treatments. The ayurvedic management of T2DM is becoming increasingly popular in many high-income countries. The clinical guideline can be evaluated and implemented to manage T2DM in other settings or populations. Thus, the study has the potential to impact around the world.