LETTER Year : 2018  |  Volume : 37  |  Issue : 3  |  Page : 173-174

Guidelines for ayush and non-AYUSH researchers for designing and reporting research studies

Venugopal Vijayakumar1, A Mooventhan2, Judu V Ilavarasu3
1 Department of Yoga, Government Yoga and Naturopathy Medical College and Hospital, Chennai, Tamil Nadu, India
2 Department of Naturopathy, Government Yoga and Naturopathy Medical College and Hospital, Chennai, Tamil Nadu, India
3 Division of Yoga and Physical Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India

Date of Submission29-Apr-2019Date of Decision09-Jan-2020Date of Acceptance10-Jan-2020Date of Web Publication10-Feb-2020

Correspondence Address:
Dr. Judu V Ilavarasu
Division of Yoga and Physical Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru - 560 019, Karnataka
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/asl.ASL_54_19

How to cite this article:
Vijayakumar V, Mooventhan A, Ilavarasu JV. Guidelines for ayush and non-AYUSH researchers for designing and reporting research studies. Ancient Sci Life 2018;37:173-4

Sir,

A recent advisory notice published by the ministry of AYUSH,[1] India in April 2019, on non-involvement of AYUSH experts in AYUSH based studies that are conducted and published, attracted our attention due to its implication on the current status of policy and practice in AYUSH research. We present this letter as our opinion about this important concern, and highlight pertinent factors that objectively evaluate the situation and hope this would initiate active discussion among major stakeholders and bring awareness about this issue.

Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa and Homeopathy (AYUSH) represent the alternative systems of medicine recognized by the Government of India. There are many studies that have challenged the efficacy of these traditional AYUSH based studies.[2],[3] Apart from these claims of non-effects or similar effects like comparison groups, these studies have also emphasized poor reporting of results.

The AYUSH advisory notice appears to be an admonitory response to sources of weak evidences in AYUSH research. Patient-specific treatment modality in AYUSH, specialized methods of drug preparation, ensuring proper delivery of intervention, knowledge of drug-medicinal herb interaction are some of the bottlenecks where presence of AYUSH practitioners alone can help research teams to make informed decisions and hence their involvement is highly supportive and even can be considered mandatory, without which we may run a risk of poor study designs.

On one side it may be true that non-AYUSH researchers and inexperienced AYUSH researchers who conduct poorly designed studies, with weaker interventions and publish weak evidences tarnish the validity of the time-tested traditional AYUSH practices, on the other hand we must also consider those factors that lead to such questionable reporting. Evidences produced from any well-designed study, conducted with good rigor and reported transparently must be accepted whether the defined outcomes of the study are favourable or unfavourable. Non-involvement of AYUSH researchers may be one such causes leading to poor studies but we must also inspect other motivational factors behind conducting and publishing such ill-designed studies.

In western countries where AYUSH is not so well-established, researchers still conduct research related to AYUSH streams. In this context, yoga deserves a special attention as yoga and yoga-based interventions are widely used as a tool for mental health and other ailments. Yoga is a complex multifactorial mind-body discipline and a way of life. Similar to other AYUSH disciplines, a number of decisions must be made in order to develop a disease-specific protocol that includes style of yoga, dosage and frequency of the intervention.[4] Wherever needed, suitable customization to suit the needs of target participants should also be recommended. Most western studies consider yoga as a form of physical activity and design interventions with a fewer sessions per week that lasts between 60 to 90 minutes. They are generally followed up by unsupervised home practice with poor adherence and might lead to weaker evidences.[5] Therefore among all the non-pharmacological interventions of AYUSH system, yoga is more likely to suffer from non-involvement of competent experts.

Apart from these, in India, the situation appears to be more intricate. It is a well-known fact that publication output is associated with career advancement and also it is being mandated by institutions. Where number is the benchmark, lower quality is no surprise. We must account for such publications which come under the category of poor reporting. It should be highlighted that AYUSH researchers especially in India too are not spared in criticism from other scientists, the main reasons highlighted are poor designing and reporting of the studies.[6] It is also emphasized that studies published from India tend to be more favourable.[7]

We need to balance the under claims of studies conducted by non-AYUSH researchers and also over claims of studies conducted by AYUSH researchers. Even though guidelines for good clinical practice exist for Ayurveda, Siddha, and Unani medicine, they have not been established yet as standard reporting guidelines such as CONSORT statement.[8] CONSORT is followed internationally to access the quality of reporting in scientific publications. So, even if these issues of poor study designing and reporting are highlighted, the problem will remain unless we develop, follow, and use in review processes such benchmarked reporting guidelines. This, we think is as an urgent need in streamlining AYUSH research. Once such a framework is published, then all other individual discipline-specific factors could be accommodated and quality measures can be devised. As most of the research works culminate in publication in various national and international journals, absence of policy documents which recommend a set of criteria to be considered for publication, disable editors to take an informed decision.

The following are our recommendations as immediate next step forward:

AYUSH ministry and premier AYUSH institutions in India should initiate development of policy documents for reporting guidelines for publication of AYUSH research. This can be added along with existing list of guidelines available at the Equator Network for various study designsThere should be development and enforcement of guidelines for industrial research involving drug preparation and drug trialsRevisiting the existing publication mandate associated with academic and career advancement and focus on quality and its societal reach rather than mere quantityStrengthening research methodology training in AYUSH educational institutions, as an early step towards developing enabled AYUSH trained researchersPromoting collaborative research, where experts of different disciplines contribute towards understanding clinical efficacy.

AYUSH can play an important role in realizing the dream of 'New India' by providing quality health care to its citizens. At present we are witnessing a highly receptive environment where the value of AYUSH systems in healthcare is widely recognized. However, such gaining acclaim and receptivity should be guarded with high quality reliable scientific evidences and AYUSH researchers must come forward to shoulder this responsibility.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

  References 
1.Advisory: Scientific Studies and Publication of Research Papers on AYUSH Drugs and Treatments by non-AYUSH Researchers/Scientists. Available from: http://ayush.gov.in/sites/default/files/Advisory.pdf. [Last accessed on 2019 Apr 27].  
    2.Wolff M, Memon AA, Chalmers JP, Sundquist K, Midlöv P. Yoga's effect on inflammatory biomarkers and metabolic risk factors in a high risk population – A controlled trial in primary care. BMC Cardiovasc Disord 2015;15:91.  
    3.Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005;366:726-32.  
    4.Aune D, Norat T, Leitzmann M, Tonstad S, Vatten LJ. Physical activity and the risk of type 2 diabetes: A systematic review and dose-response meta-analysis. Eur J Epidemiol 2015;30:529-42.  
    5.Skoro-Kondza L, Tai SS, Gadelrab R, Drincevic D, Greenhalgh T. Community based yoga classes for type 2 diabetes: An exploratory randomised controlled trial. BMC Health Serv Res 2009;9:33.  
    6.Elwy AR, Groessl EJ, Eisen SV, Riley KE, Maiya M, Lee JP, et al. A systematic scoping review of yoga intervention components and study quality. Am J Prev Med 2014;47:220-32.  
    7.Cramer H, Lauche R, Langhorst J, Dobos G. Are Indian yoga trials more likely to be positive than those from other countries? A systematic review of randomized controlled trials. Contemp Clin Trials 2015;41:269-72.  
    8.Equator Network. Available from: https://www.equator-network.org/reporting-guidelines. [Last accessed on 2019 Apr 27].  
    
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