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 -110058 srikanthccras@gmail.com

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

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.

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."

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

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.

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

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.

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

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

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

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  

Synergy of AYUSH interventions with NRHM Source: www. mohfw. nic Synergy of AYUSH interventions with NRHM Source: www.mohfw.nic.in/nrhm/htm 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.  

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)

Evidence base on Integrative Health Care

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

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

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 : 109-120Author(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

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

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 52709 population and extended health care services to 23,318 patients. Conducted 358 awareness camps and provided services to about 24808 patients. Through Yoga classes and 47283 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

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

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

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

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

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

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

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, 245-49

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, 2010. Cytochrome P450 inhibitory potential of Triphala-A Rasayana from Ayurveda. Journal of Ethnopharmacology 133, 120-125. (Elsevier). Subrata Pandit, Pulok K. Mukharjee, Sivasankaran Ponnusankar, Murugan Venkatesh, N. Srikanth, 2010. Metabolism medicated interaction of x-asarone and Acorus calamus with CYP3A4 and CYP2D6. 10. 1016/j.fitote.2010.11.009. (Elsevier)

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.

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

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

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.

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

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

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.

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.

Way forward

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