Clinical guideline to manage diabetes by Ayurvedic practitioners: north–south partnership
Type 2 diabetes mellitus is a common chronic condition with significant health and socioeconomic consequences. In the Indian subcontinent, such as in Nepal, it is one of the major diseases for which people consult Ayurvedic (traditional medical system) practitioners and use Ayurvedic medicines. However, a high-quality clinical guideline, based on the best available scientific evidence, to manage this condition by Ayurvedic practitioners is not available. Ayurvedic practitioners, Western medicine practitioners (including diabetologists), pharmacognosists, systematic reviewers (including methodologists), medical statisticians, epidemiologists, sociologists, health policymakers and managers, and people with type 2 diabetes in the UK, Nepal and India came together to develop and evaluate a clinical guideline for Ayurvedic practitioners to manage type 2 diabetes.
The project fits well with the 2022 World Evidence-Based Healthcare Day theme “Partnerships for Purpose” as the overarching purpose of this north–south equitable research partnership was to improve the management of type 2 diabetes by Ayurvedic practitioners in Nepal. This cross-country project is a collaboration between experts with complementary strengths: methodological expertise in intervention development and evaluation (mostly in the UK and India), and experience working in large clinical networks (in Nepal). The project has brought together Western and traditional medical system experts. There is mutual academic benefit and capacity-building by cross-sharing of expertise and experience within the team.
The project has the potential to improve scientific links between the UK, Nepal, and India (and more broadly through wider collaborative links and networking). The main project partners are the University of Nottingham in the UK and the Nepal Health Research Council, the national apex body that promotes, coordinates and conducts health research in Nepal. Other project investigators are based at other world-class institutions, such as the London School of Hygiene and Tropical Medicine, University College London, University of Birmingham, Ministry of Health and Population (in Nepal), All India Institute of Medical Sciences, and Sree Chitra Tirunal Institute for Medical Sciences and Technology (in India).
We secured funding from the UK’s Department of Health and Social Care; Foreign, Commonwealth and Development Office; Medical Research Council; and Wellcome Trust Joint Global Health Trials to enable us to follow a systematic process to develop a clinical guideline for Ayurvedic practitioners to manage type 2 diabetes. We were guided by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the UK’s National Institute for Health and Care Excellence (NICE) manual for developing guidelines and the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. We started the project with a comprehensive systematic review on the effectiveness and safety of Ayurvedic medicines for managing type 2 diabetes1 and facilitated an internationally based guideline development group to give feedback and make recommendations. Now, we are conducting a feasibility cluster randomised controlled trial in Nepal to determine the possibility of undertaking the main trial.
The aim of the main trial will be to explore whether the introduction of a clinical guideline can improve the management of type 2 diabetes by Ayurvedic practitioners. If found to be effective, people with type 2 diabetes will benefit from improved health outcomes, such as better blood glucose control and lower type 2 diabetes complications. The related future clinical, personal and economic burden on people with type 2 diabetes, their carers and family, and the health system and economy will be reduced. People with type 2 diabetes will be cared for in line with the best available scientific evidence and in the same manner, regardless of where or by which Ayurvedic practitioner they are treated. It is anticipated that the clinical guideline may close the gap between what the Ayurvedic practitioners do to manage type 2 diabetes and what the scientific evidence supports. It may also deter the usage of Ayurvedic medicines with no, minimal or questionable value, thus promoting the usage of effective and safe Ayurvedic medicines. While this clinical guideline is developed for Ayurvedic practitioners in the Indian subcontinent, it will also be relevant in countries with South Asian ethnic minorities who often rely heavily on Ayurvedic treatments.
Before the start-up phase of the project, the project investigators were faced with bureaucratic challenges. Such challenges can result in negative impacts on north–south research partnerships and, ultimately, on the health of people. Initially, the research was planned to be conducted in India. Although we received the local research ethics approval on time, mandatory approval from a government committee in India (responsible for screening and clearance of proposals involving international collaboration/funding) was severely delayed after being rejected a few times – this was despite our research project being funded through highly prestigious funding agencies. We, as academic researchers, used various strategies to attempt to resolve this issue, but we were unable to overcome these obstacles. Ultimately, we discussed moving the project to another country in the Indian subcontinent, such as Nepal. (By the time we received approval in India, we had already started the project in Nepal.)
Moving the project to Nepal was not an easy task, but we did it successfully with the help of our Nepalese investigators and key stakeholders, including the Nepalese Government. We were lucky to engage the Nepal Health Research Council and the government, thanks to our common vision of a needs-sensitive, evidence-based intervention. Some of the most important lessons we learned were to have a backup plan, find potential partners based on a common vision, and have an early discussion with potential partners to reach a consensus and iron out any disagreements.
References
1. Chattopadhyay K, Wang H, Kaur J, Nalbant G, Almaqhawi A, Kundakci B, et al. Effectiveness and safety of Ayurvedic medicines in type 2 diabetes mellitus management: a systematic review and meta-analysis. Front Pharmacol. 2022;13:821810.
Authors
Kaushik Chattopadhyay1,2, Jo Leonardi-Bee1,2.
1. Lifespan and Population Health Academic Unit, School of Medicine, The University of Nottingham, Nottingham, UK
2. The Nottingham Centre for Evidence-Based Healthcare: A JBI Centre of Excellence, The University of Nottingham, Nottingham, UK
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