Author: Prof. Sanjeev Rastogi State Ayurvedic College and Hospital, Lucknow

1. Clinical Research in CAM: Requirements,
Complexities and Possibilities
Prof. Sanjeev Rastogi
State Ayurvedic College and Hospital, Lucknow

2. Medical Pluralism: A Global Trend
 Medical pluralism is defined as using more
than one medical system (both conventional
and CAM) for the purpose of offering health
and curing a disease
 Has a global trend
 Many countries have various CAM practices
along with Allopathy permitted under the law
of their land.
 That means medical pluralism is a state
recognized phenomenon
Allopathy
Homeopathy
Ayurveda

3.  Availability of additional health care knowledge besides Allopathy
 Pre existing Traditional health care knowledge
 Easy access to the newer knowledge related to health care originating at other places
 Existing gaps between expected and delivered in the conventional health care
 Increasing cost of conventional health care
 Belief of harm associated with synthetic medicine
 Local customs and Socio cultural belief
Why This is Trending ?

4. NCCIH
Various Kinds of CAM therapies

5. • Three Broad Categories
 Natural Products
 Mind Body Practices
 Practices based on their own science
• Natural products
 Herbs ( Botanicals )
 Vitamins and minerals
 Probiotics
 Dietary supplements
 Dietary supplements are most popular method of using CAM
(more popular than vitamins and minerals)
 Most commonly used natural product is fish oil.
Common CAM approaches

6.  Diverse procedures or techniques administered by a trained practitioner or teacher.
 Yoga
 Chiropractic
 Osteopathic Manipulation
 Meditation,
 Massage Therapy
 Acupuncture
 Relaxation Techniques
 Guided Imagery
 Progressive Muscle relaxation
 Breathing Exercise
 Tai Chi, Qi gong
 Healing Touch, Touch Therapy
 Movement Therapies
 Number of U.S. adults practicing yoga increased tremendously . About 36 million
practice yoga in US now , four times to the number observed in 2002
Mind Body Practices

7.  Other Complementary Health Approaches not neatly fitting into either of
these groups
 Traditional Therapies based on their own philosophy
 Ayurveda
 TCM
 Homeopathy
 Naturopathy
Other Traditional Health Practices

8. Conventional Health Care
(Allopathy)
Alternate Health Care
• Ayurveda
• Yoga ,
• Naturopathy
• Unani
• Siddha
• Homeopathy
• Sowa Rigpa
• Reiki
• Pranik Healing
• Spiritual therapy
• Electrotherapy
Medical Pluralism in India

9.  Fully functional and organized conventional health care
 Fully functional and recognized alternate health care
 Alternate health Care in India has well organized
 Education systems - Colleges /Universities
 Registration system – Councils
 Code of conduct - framed by respective councils
 Freedom of practice – Registration in the state boards
 Research policy – Research councils
What is Special of Indian Medical Pluralism

10. This scenario offers Indian citizens a complete freedom
to choose their preferred health care system
Allopathy
Ayurveda
Homeopathy
Complete Freedom to Choose

11.  Previous personal experience
 Experience of some one trustworthy
 Family member
 Friend / Colleague
 Search from internet / books
 Recommendation by the treating physician
 Advertisements
 Cost and affordability
 Availability and accessibility
 Non responsiveness of other therapies
 Disease specific choice ( acute and chronic conditions )
Evidenced based choice
Preferred Health Care System: How Do We Choose ?

12. Evidence based choiceExperience based
or empirical choice
How Do We Chose the Health Systems ?

13.  For Physicians :
 Choosing/ suggesting the best treatment option to their patients as per the
currently prevailing knowledge and resources.
 Cross Referrals regarding the best options available out side their sphere of
resources or knowledge , where they feel their patient may be benefitted
 For Patients :
 Choosing the best health care facility suiting to their clinical needs , affordability,
availability and accessibility
Evidence Based Decision Making

14. Maximum benefits with minimum efforts
Benefits of Evidence Based Decision Making

15. Patient’s Decisions
Based upon
1. Affordability
2. Accessibility
3. Availability
4. Priority
5. Liking
6. Experience of self or others
Physician’s Decisions
based on
1. Experience
2. Evidence
3. Suitability as per the
clinical need
Decision Making in Solo

16. Maximum possible benefits in a given condition
suiting to the personalized needs of the patient
Physician Patient
Decision Making in Concert

17. Help People in their Decision Making

18.  Favoring one intervention over the other
 Superiority
 Proving equal effects of the two with other advantages in one
 Equivalence
 Having a generalizability
 External validity
 Generated through a fool proof process
 Randomization, Blinding , Control, Good statistical tool, Large sample size
 Unbiased
 No Conflict of Interest
 Based on real life clinical situations
• No experimental evidences
Which Evidence to Make an Evidence Based Decision ?

19. Hierarchy of Evidences

20.  Need of research based evidence is diluted among practitioners for
 The system is already in use for hundreds of years.
 Interventions are known and are in use in various clinical conditions.
 Able to give variable responses
 Empirical evidences of safety
 Empirical evidences of effectiveness
Problems of Evidence in Ayurveda

21.  Dose and response relationship
 Special population dosing
 Pediatric
 Geriatric
 Pregnancy and lactation
 Doses in the presence of a concomitant illness
 Interactions
 Herb-herb interaction
 Herb Food interaction
 Herb Drug Interaction
 Primary and secondary end points of the interventions
 Deliverables in reference to the time
 Cost effective analysis
 Essential and supportive therapy
 Primary and maintenance therapy
And the list continues further ……….
Evidences in Ayurveda: Where are the Gaps ?

22.  Physicians are unable to answer the common
question related to the course of the therapy and
expected out comes.
 Patient’s choice of health care system is based on
belief and not on evidences
 Benefits or no benefits is just the matter of chance
What if the Rigorous Research Based Evidences are absent ?

23.  Issues of Diagnosing a clinical condition
 Based upon classical texts which are variable
 Complex clinical picture
 Ayurvedic diagnosis is not commonly used in ayurevdic practice
 Patient selection on the basis of ayurvedic diagnosis is difficult .
 Subjective variability of examination
 subjective variation in the clinical examination
 subjective variation in pathogenesis understanding of a disease
 Subjective variability in choice of interventions
 Different prescription for same condition by different physicians
 Subjective variability in determining SOP for the same procedures/ interventions
 Shirodhara moving /stable
 Nadi sweda/ sarwanga sweda
Problems of Clinical Research in Ayurveda

24.  Whole system management involving a complex regimen
 Drugs
 Food
 Procedure
 Problems of blinding the drugs
 Problems in preparing placebo for the prescribed drugs
 Multiple complex drug preparations often recognized by taste , smell and color
 Often the quality of the drug is attributed to organoleptic properties of a drug
 Large dose patterns cant be capsulated or tableted
 Preparations like asava/arishta , avaleha cant be disguised for their specific recognizable nature
 Local applications cant be disguised
Problems of Research in Ayurveda

25.  Self exposure to drugs is common in Ayurveda
 Home remedies/ Kitchen remedies
 Self medications through OTC products ( antidiabetic compounds )
 Self trial of herbal drugs recommended at various TV Channels/ Websites
 May mask or delay the actual effect of a compound during the trial
containing similar components
Self Medication and Home Remedies

26.  Issues of a comparative group
 Placebo
 Cant put a patient on placebo if a standard care is available
 Standard Care
 How to give allopathic drugs in an Ayurvedic setting
 Parallel ayurevdic care
 Comparing an unknown with another unknown
 Sham treatments
 Sadya virechana versus planned virechana
 May be associated with complications if the patient is not well prepared
 Waitlist control
 Patients not ready to be waitlisted if a treatment is available
 The disease may progress in the mean time
 Cross over studies
 Possibilities of herb drug interactions
Ethical Issues in Ayurveda Research

27.  Longitudinal interventional studies
 Single case designs/ N of one trials
 Observational studies
 Longitudinal cohort studies
 Observational studies to study the impact of treatments in a real clinical setting ( Case studies and Case series )
 Cross sectional studies
 Designing appropriate placebo for ayurvedic drugs where ever possible
 Elimination and re challenge studies
 Eliminate one or a few components from a compound to see if the drug is having the different effect than is
offered by the full combination. The missing components may then be reintroduced to see the effects are resumed
 Sham procedures
 Cross over studies with a clear wash out period
 Whole system research comparing the whole management and not the component of the management
Suggestions

28. 1. In a pluralistic health care model, many options of health care are going to exist
2. An evidence based decision making regarding the choice of health care on the
basis of individual needs is therefore highly required .
3. Every CAM system is required to generate their own pool of evidences to favor
them.
4. The difficulties in such evidence generation are required to be understood
5. Pragmatic plans for designing clinical research in CAM are required to be adopted
Key Message

29. Before we end… Beware of the Grey Shades of Research