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Complementary and Alternative Therapies: Herbal Medicines

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Title: Complementary and Alternative Therapies: Herbal Medicines


1
Complementary and Alternative Therapies Herbal
Medicines
Uncritical enthusiasm
Uninformed repulsion
Current methodologies not adequate
Where is the evidence?
2
Dr. Ranjit Roy Chaudhury Dr. Urmila Thatte India
Challenges in clinical evaluation of alternative
medicines
3
1. Literature search
  • Paucity of published data
  • Local Clinical Practice not documented
  • Good literature search difficult
  • Journals not indexed, not peer reviewed, poor
    quality data
  • Information in local language needs correct
    interpretation

4
2. Starting material
  • Identification and source of herb

Bacopa monnieri
Centella asciatica
Brahmi
5
2. Starting material
  • Single herb? Multiple herbs?
  • Purity WHO criteria
  • Continuous Supply, Quality Control and Stability
    of batches multi-centric studies
  • Standardisation of extract bioassay guided

6
Chemical markers vs. activity
  • Estrogenic activity found in a vegetable oil
  • Plant obtained in July Active that obtained
    in April Inactive
  • HPTLC fingerprinting

7
Chemical markers July Active vs. April
Inactive
Mobile phase - II
Mobile phase - I
Mobile phase - III
8
3. Pre-clinical work-up
  • How much toxicity testing is needed?
  • Local Regulatory status (India Categories)
  • Lack of pre-clinical data difficulty to
    extrapolate animal studies

9
4. Clinical Studies
  • Which formulation traditional/new
  • What dose (crude/extract), regimen, duration no
    pre-clinical data, rely on traditional literature

10
4. Clinical Studies planning protocol
  • Sample size
  • Choosing efficacy and safety variables and end
    points
  • Inclusion/Exclusion criteria
  • Individualisation constitution

11
Response to medications depends on prakriti
(constitution)
Anti-epileptic medication
responders
Non- responders
12
4. Clinical Studies Design
  • open label
  • observational
  • n1 studies
  • Add-on design ethics
  • Blinded studies difficult Assessor blind
    possible (ksharasootra)

13
4. Clinical Studies use of placebo
  • Ethics
  • Difficult to match colour, taste, odour, flavour
    or formulation of herbal product
  • Should be truly inert

14
Ethanol induced gastric mucosal damage in rats
Evans blue leakage in gastric tissue content
(ug/g)
IMP011

NS

placebo
plt 0.05 vs. D/W NS not significant vs.
IMP-011.
15
4. Clinical Studies RCTs
  • Reduces bias  
  • Difficult to design RCTs for alternative
    medicines
  • Involve complex interventions
  • Cultural and social influences
  • Are holistic in nature
  • Focus on symptoms
  • Intra inter variation in responses
  • Require long duration of therapy 

16
5. Pharmacokinetics
  • Plasma estimation of active molecules difficult
  • May be more than one active molecule
  • Metabolic changes during absorption possible
  • Effect kinetics attractive option

17
6. Ethics
  • Coinvestigator from alternative system
  • Standards of care of control group HIV research
  • Informed consent Meaningful, vernacular, easier?
  • Attitude towards alternative therapy safe
    patient information sheet may mislead

18
6. Ethics
  • Cultural overtones
  • Translating research findings into components of
    accessible care
  • Commercialisation of folklore medicine
    rights/share of tribe or community to be given

19
7. Regulatory Scenario
  • US FDA Europe food supplements FDA guidelines
    available
  • India
  • DCGI, State FDAs
  • Special emphasis on herbal research Categories

20
8. Analysis
  • What degree of improvement to expect?
  • What should be criteria for defining success?
  • Comparison with modern potent medicines?

21
8. Analysis
Rate of decrease in wound score

Students unpaired t-test plt0.01vs. GA

Recurrence of diarrhea in malnourished children
Chi square test plt0.001 vs. Control
22
5 rules for Clinical Research in Alternative
Medicines
  • Literature review look at traditional
    literature, collate experiential data, proper
    interpretation
  • Consult qualified expertise
  • GMP for investigational products
  • Plan a good protocol keep in mind the
    traditional medicine philosophy
  • Adhere to ethical and regulatory aspects
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