1. Trends in Integrative Medicine:
Indian Scenario
Scope and Challenges
N.Srikanth
Deputy Director General
Central Council for Research in Ayurvedic Sciences (CCRAS) Ministry of AYUSH, Government of India, New Delhi

2. Scope of Presentation ….
Integrative Medicine
Need for integrative Healthcare
Policy Support
Some successful models of integrative medicine in National Health care delivery
Evidence base on Integrative Health Care
Understanding differences
Challenges
Way forward

3. Integrative Medicine BSIM Definition
Integrated Medicine is an approach to health and healing that provides patients with individually tailored health and wellbeing programmes which are designed to address the barriers to healing and provide the patient with the knowledge, skills and support to take better care of their physical, emotional, psychological and spiritual health.
Rather than limiting treatments to a specific specialty, integrated medicine uses the safest and most effective combination of approaches and treatments from the world of conventional and complementary/alternative medicine.
These are selected according to, but not limited to, evidence-based practice, and the expertise, experience and insight of the individuals and team members caring for the patient.

4. Integrative Medicine
NCCAM Definition
As defined by the National Center for Complementary and Alternative Medicine at the National Institutes of Health
Integrative medicine "combines mainstream medical therapies and CAM therapies for which there is some high-quality scientific evidence of safety and effectiveness."

5. Forms of Integrative Medicine
The relationship between modern and traditional
medicine has taken 4 broad forms
Monopolistic system. Modern medical doctors have the soul right to practice medicine.
Tolerance system. One of Co-existence where traditional medical practitioners, while not formally recognized, are permitted to practice in an unofficial capacity.
Parallel or dual health care system. as in India, where both modern and traditional medicine are separate components of the national health systems.
Inclusive Integrated model. Modern and traditional medicine are integrated at the level of medical education and practice (e.g. China, Vietnam).
Gerard Bodker, A framework for cost-benefit analysis of traditional medicine and conventional medicine; Traditional Medicine in Asia ,2002 WHO pp.159

6. Integration: Indian perspective
Ayurveda emphasizes to adopt & integrate knowledge of various sciences.
Ekam shaastramadheeyano na vidhyat shaastra nishchayam: Susruta Samhita
Use of the additions of the updated technology to enrich ones own system and use all the tools & techniques of the scientific community to make their science to go in pace with the present world.

7. Resurgence- Need for Integration
A resurgence of interest in Ayurveda and other AYUSH systems has resulted from the preference of health seekers towards
holistic approach
products of natural origin
About 80 % of population in India utilize AYUSH and LHTs to help meet their primary health requirements

8. Health Seeking attitude Role of AYUSH/TM
The most prevalent users of Traditional Medicine are individuals who have
Refractory conditions
Non–life-threatening conditions that may be chronic viz. neurological disorders, arthritis etc.
The second largest group of users are those struggling with
Chronic, potentially life-threatening diseases, such as Cancer and HIV/AIDS etc.

9. Health Seeking attitude Role of AYUSH/TM
Both groups turn to TM/AYUSH systems for a variety of reasons, such as
management as main treatment option
to improve immune functioning
to improve overall functionings
to improve quality of life
to cope with side effects from conventional therapies, and
to relieve symptoms related to their illness

10. Factors leading to go for AYUSH as stand alone /Integrative Health Care option
Culturally competent
Holistic approach
Time tested
Emphasis on prevention & integration
Easy Accessibility
Limitations of allopathic system
Inimitable Strength in Health promotion and Quality of life concerns especially in
Chronic illness
Refractory conditions

11. Policy Support : Integration and Mainstreaming
Focus 1
The National Population Policy-2000
Mainstreaming of ISM & H in the National RCH Program 2
National Health Policy on AYUSH -2002
Re-orientation, prioritization of research in AYUSH and to validate therapy and drugs in Chronic and Life Style Related Diseases 3
National Health Policy-2002
Ministry of Health and Family Welfare, Govt. of India 4
National Commission on Macro-economics and Health-2005
Health conditions and disability - adjusted life years (DALYs) lost in India results from Communicable diseases, Reproductive and Child Health conditions and Life style
related disorders 5
National Health Policy 2107
Mainstreaming and Integration

12. Some successful models of integrative medicine in National Health care delivery
NRHM :co-location of AYUSH facilities
Multi - system health care under one roof in primary /secondary health care setups in some states
Functional integration and cross referrals in tertiary health care setups and medical collages
Integration of Traditional Medicine into the Reproductive and Child Health Programme
NPCDCS
Research on Traditional Therapies which can be integrated to advantage

13. Synergy of AYUSH interventions with NRHM Source: www. mohfw. nic
Synergy of AYUSH interventions with NRHM Source:
Location of AYUSH dispensaries in PHCs in different States.
Appointment of AYUSH doctors and paramedics (pharmacists) on contractual basis in the primary health care system.
Inclusion of AYUSH modules in training of ASHA.
Inclusion of Punarnavdi Mandoor in the ASHA Kit for management of anaemia during pregnancy.
Inclusion of seven Ayurvedic and five Unani medicines in the RCH programme.
Establishment of specialty clinics, specialized therapy centres, and AYUSH wings in district hospitals supported through CSS.

14. Traditional Medicine in an Allopathic Set-up
Integrated health care / training at Institute of Medical Sciences, Banaras Hindu University, Varanasi ,Uttar Pradesh and MGIMS, Wardha ,Maharastra .
Ayurvedic Treatment in Safdarjung Hospital, New Delhi (A 1500-Bed Allopathic General Hospital)
Homoeopathic Treatment in Dr. R.M.L. Hospital, New Delhi ( A 900 Bed Allopathic General Hospital)
Ayurvedic /Unani /Yoga Treatment in Dr. R.M.L. Hospital, New Delhi ( A 900 Bed Allopathic General Hospital)

15. Evidence base on Integrative Health Care

16. R&D on Integration and mainstreaming of AYUSH National Health system Resource centre
Study on Role of AYUSH and Local Health Traditions Under National Rural Health Mission(NRHM)*
18 states across India
Implications of the NRHM strategy of mainstreaming AYUSH’ in terms
Coverage
Quality of services
Demand of services
- Validation of Local Health Traditions (LHTs)
Outcome
80-90% house holds aware about utility of AYUSH/LHTs
Co-located services are Well utilized in some states
Utility ; 1. Chronic illness 2. acute illness 3. Health promotion
70% Allopathic doctors viewed AUYSH is not rudimentary
*Status and Role of AYUSH and Local Health Traditions Under National Rural Health Mission- Report of a Study;National Health Systems Resource Centre, Ministry of Health & Family Welfare Government of India New Delhi; 2010

17. R&D on Integration and Mainstreaming of AYUSH a WHO India Office Collaboration
Feasibility integrating Ayurveda with Allopathic system of medicine in a tertiary health care hospital to the management of Osteoarthritis (Knee) - An operational Study*
Communication Among Ayurveda and Allopathic system Health care Providers
Awareness on System Strength
Functional integration and Cross referrals
Effective Ayurvedic intervention (KGMC Index )
Reduced burden of analgesics
Improved QOL and reduced burden of analgesics
*Supported by WHO India Office
Sulochana ,Vikas Gupta and Srikanth..N; Feasibility integrating Ayurveda with allopathic system of medicine in a tertiary health care hospital to management of Osteoarthritis (Knee)-An operational Study: A TECHNICAL REPORT; Central council for Research in Ayurveda and Siddha, Department of AYUSH, Ministry of Health & Family Welfare, Govt. of India, New Delhi 2007

18. R&D on Integration and mainstreaming of AYUSH ICMR Collaboration
Feasibility of introducing Indian systems of medicine (Ayurveda & Siddha) in the National RCH at the primary health care (PHC) Level: An Operational Study *
17 drugs developed through R&D
50 PHCs/CHCs
Integration with the Reproductive & Child Health program
Prevention & Management of morbidity & mortality
Prevention of complications antenatal , peri-natal and post natal
Extent for integration and efficacy of interventions
*CCRAS-ICMR Collaborative Project EFFECTIVENESS OF AYURVEDIC INTERVENTIONS FOR ANTE-NATAL CARE (GARBHINI PARICHARYA) AT PRIMARY HEALTH CARE LEVEL-A MULTICENTRE OPERATIONAL STUDYJournal          Journal of Research in Ayurveda and Siddha | Year : 2015 | Volume : 36 | Issue : 1-4 | Page : Author(s)1. Sulochana Bhat, 2. Ena Sharma, 3. Babita Yadav, 4. Omraj Sharma, 5. N. Srikanth, 6. Adarsh Kumar, 7. Prameela Devi, 8. Sarada Ota, 9. M. M. Padhi, 10. K.S. Dhiman

19. National program for prevention and Control of Cardiovascular Disease, Diabetes, Cancer and Stroke(NPCDCS) : A Successful Model of functional integration evident by benefits of integrative health care

20. NPCDCS PROGRAM
First ever National Programme on Integration and Mainstreaming of AYUSH in CHC level for NCDs in collaboration with MoH&FW
Demonstrated feasibility of Integration successfully in 3 districts of 3 States viz. Gaya (Bihar), Bhilwara (Rajasthan) & Surendranagar (Gujarat) through52 CHCs including 3 districts hospitals.
Revealed Efficacy of AYUSH interventions for Diabetes mellitus, Preventive Cardiology, Hypertension and Dyslipidemia
Screened population and extended health care services to 23,318 patients.
Conducted 358 awareness camps and provided services to about patients. Through Yoga classes and population benefited.
Forms an encouraging primary evidence for Integration of Ayurveda for designing an extending the programme across the Country.
Benefits of integration The Overall observation & Interim-analysis has revealed a successful attempt of functional Integration through delivering Ayurveda-Allopathy Integrative Health Care Services in the context of Non- Communicable Diseases with encouraging benefits of stand-alone Ayurveda therapies as well as benefits as add-on therapies
Disease N
Parameters
Benefits
Diabetes
287
FBS and PLBS
Out of Diabetic patients enrolled in AYUSH-NPCDCS Integration programme, it has been observed that in 287 patients, the dosage or components of Conventional medicines/prescription were either reduced or discontinued, in consultation and supervision of Allopathic doctors, after integrating the intervention of Ayurveda, lifestyle modification & Yoga.
Hypertension
141
Systolic and Diasystolic
Out of Hypertension patients enrolled in AYUSH-NPCDCS Integration programme, it has been observed that in 141 patients, the dosage or components of Conventional medicines/prescription were either reduced or discontinued, in consultation and supervision of Allopathic doctors, after integrating the intervention of Ayurveda, lifestyle modification &Yoga.
Treatment Group
Interventions A1
Lifestyle interventions & Yoga B1
Allopathic Medicines + Lifestyle interventions &Yoga A2
Ayurvedic Medicines + Lifestyle interventions & Yoga B2
Ayurvedic Medicines + Allopathic Medicines + Lifestyle interventions & Yoga

21. Advantages of integrative Healthcare Supported by Evidence
Traditional Therapies which can be integrated to advantage
Quality of life Cancer subjects
Ksharasutra in Anal fistula
Panchakarma for neurological disorders
Shailaja Chandra , Role of TSM in National Health Care Systems; Traditional Medicine in Asia ,2002 WHO pp.135

22. Eample-1:Benefits of integrative care in Cancer(n=400)
Increase in survival % with addition of Ayurveda therapy to conventional treatments ranging from …65-76%
Therapy
% Survival
Radiotherapy alone 17
Radiotherapy +Ayurveda 50
Chemo Therapy alone 39
Chemotherapy +Ayurveda 76
Radiotherapy +Chemotherapy 20
Radiotherapy +Chemotherapy Therapy +Ayurveda 65

23. Eample-2:Benefits of integrative care in Cancer
S. No.
Clinical Trial
Objectives 1
BREAST CANCER as an adjuvant to chemotherapy/ radiotherapy
AYUSH-QOL 2C
Study Design: Prospective double blind placebo controlled
Study Site: AIIMS, New Delhi
St. John’s Medical College, Bangalore
Clinical safety & efficacy
Improvement of quality of life
Overall survival
Event free survival
Progression free survival 2
LUNG CANCER as an adjuvant to chemotherapy/ radiotherapy
Study Site: Bhagwan Mahavir Cancer Hospital and Research Centre, Jaipur

24. Benefits of integrative care in Cancer
As compared to placebo group, AYUSH QOL 2C showed
Improvement in Weakness
Reduction in fatigue
Amelioration of anorexia
Positive impact over loss of appetite
Positive impact over effort intolerance
Significantly reduction in pain
Improvement in nausea and vomiting
Improvement in constipation
Improvement in sleep pattern
Better results were observed in patients on 4 cycles of chemotherapy

26. Panchakarma Approach
Panchakarma therapies for Chronic illness of Muscular and Bone System, Post CVA Neurovascular Complications(Hemiplegia ,Paraplegia,etc.)
Clinically Safe and Effective
Supported by Clinical trials

27. Bioavailability Enhancers –integrative health care
Ayurveda plant based bioavailability/bio-efficacy enhancers*
Leads from systematic investigations on Trikatu; Piper nigrum (black pepper),Piper longum (long pepper) and ginger
Isolated Piperine, a pure alkaloid molecule from Piper spp.
Bioavailability/ bio-enhancing activity
Reduced dose and same pharmacological activity of rifampicin amikacin, mupurocin, ciprofloxacin
Minimal Adverse effects (suppressing p-glycoprotein and cytochrome P450 enzymes)
Trikatu

28. Bioavailability Enhancers*
90% of the patients treated with Risorine were cured of tuberculosis with lesser side effects
Curtails treatment period of TB
Minimal inhibitory concentration (MIC)
Mutation prevention concentrastions (MPC)
Piper nigrum
*Bajad Sunil, Singh AK and Bedi KL, Liquid chromatographic method for determination of piperine in rat plasma: application to pharmacokinetics. J.Chromatography, 2002, B 776,

29. Drug Interactions& Safety studies of Ayurvedic drugs Evaluation of safety profile of herbs used in Ayurveda with CYP-450 enzymes inhibition method
Sl.
Plant &Markers 1
Piper longum
Piperine 2
Acorus calamus
A-asarone 3
Withania somnifera
Withanolide-A 4
Terminalia bellerica
Gallic acid 5
Terminalia chebula 6.
Bacopa monnieri
Bacoside A 7
Centella asiatica
Asiaticoside 8
Glycyrrhiza glabra
Glycyrrhizin 9
Emblica officinalis 10
Zingiber officinale
6-gingerol
CYP450-CO complex method-cDNA expressed recombinant human CYP 3A4 and CYP 2D6
Not shown potent inhibition of CYP isoforms compare to positive control ketoconazole and Qunidine.
Less likely to produce clinically significant drug interaction
Ponnusankar, Subrata Pandit, Ramesh Babu, Arun Bandyopadhyay, Pulok K. Mukharjee, Cytochrome P450 inhibitory potential of Triphala-A Rasayana from Ayurveda. Journal of Ethnopharmacology 133, (Elsevier).
Subrata Pandit, Pulok K. Mukharjee, Sivasankaran Ponnusankar, Murugan Venkatesh, N. Srikanth, Metabolism medicated interaction of x-asarone and Acorus calamus with CYP3A4 and CYP2D /j.fitote (Elsevier)

30. Drug Interactions& Safety studies of Ayurvedic drugs Evaluation of safety profile of herbs used in Ayurveda with CYP-450 enzymes inhibition method
Interaction of Piper longum with CYP isozymes was found to be highest among the selected plant and Zingiber officinale interaction was least.

31. Understanding the Differences
While designing the integrative protocols it is pivotal to comprehend differences in designing of the trials between
AYUSH
Modern Medicine

32. Understanding the Differences
Differences are mainly due to the
basic approach to health and disease perceptions
epistemological
AYUSH is holistic in approach in
diagnosis
prognosis
management

33. AYUSH/TM Vs Conventional
This holistic approach is its ‘strength’ as well as ‘Challenge ’
Holistic’ approach of AYUSH is indeed good in clinical practice
For ‘research’, however, this approach poses considerable difficulties to devise parameters and design suitable models for clinical studies/trials.

34. Challenges: Integration
Diverse concepts
Complex approaches
Clinical Trial Design
Diagnosis & Therapy
Clinical Efficacy
Outcome measures
Drug interaction
Harmonization

35. Challenges: Integration
Complexity of too many “variables” of in terms of ‘objective’ parameters as in case of ‘Prakriti’(psycho-somatic constitution of individual) in clinical trials.
Clinical investigations in Ayurveda are made difficult by factors such as use of complex, individualized treatments

36. Challenges :Integration
Their problems include difficulties in accruing, randomizing, and retaining patients and in identifying appropriate placebo interventions.
Strong commitment is required from the research community to create evidence and provide information to the public and health professionals.

37. The way forward– Integrated Healthcare
Conventional and non-conventional approaches to healthcare and those that practise them working together in an integrated approach offer a wider range of options for the greater benefit of patients.

38. Way forward

39. Thank You