SELECTION OF SUITABLE METHODOLOGY FOR EVALUATION OF AYURVEDIC TREATMENTS MEDICINAL DRUGS

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• SELECTION OF SUITABLE METHODOLOGY FOR
  EVALUATION OF AYURVEDIC TREATMENTS / MEDICINAL
  DRUGS

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• SHORT PRESENTATION BY
• Sanjeev Sarmukaddam Biostatistics Consultant,
  MIMH, B.J. Medical College Sassoon Hospital
  Campus, Pune
• also associated with Center for Rheumatic
  Diseases, Pune

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• As pointed out often on evaluating complementary
  or alternative treatments, clinical trials are
  the best way of assessing the efficacy of
  treatments but not in their present form. The
  need is felt because many ayurvedic drugs even if
  found clinically useful, not proved to be
  significantly so in clinical trials.

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• Few possible techniques for this purpose are/were
  identified (and intend to throw more light on the
  proposed ones in protocol submitted to AYUSH in
  2004). These are just suggestions on the basis of
  difficulties realized in the field. They include

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•  Equivalence trial against an usual
  superiority/comparative trial
•        Use of evidence based randomization in
  adaptive allocation while applying play the
  winner rule
•      Zelens type A new design for randomized
  clinical trials, New Engl. Jr. Med. Vol, 300
  1242-1245 (1979) modification to reduce placebo
  effect

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• First suggestion was incorporated in Centers
  recently conducted trial. We proposed the
  post-hoc analysis by switching over to
  equivalence type methodology by adhering to
  principles by CPMP.

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• Clinical trials can be designed to be either
  pragmatic or explanatory. Pragmatic trials are
  designed to find out about how effective a
  treatment actually is in routine, everyday
  practice. Explanatory trials are designed to find
  out whether a treatment has any efficacy.

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Pragmatic clinical trials Hugh
MacPhersona, Complementary Therapies in Medicine
(2004) 12, 136140 A case is made for the
relevance of pragmatic trials in the evaluation
of alternative and complementary
medicine. Pragmatic trials are useful in
answering questions about how effective a therapy
is when compared to some standard or accepted
treatment.
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They also overcome some specific difficulties
that can be encountered with explanatory trials
of complementary therapies, for example when
evaluating complex packages of care.
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Explanatory trials Vs Pragmatic trials
1.Evaluate efficacy, Compare effectiveness 2.Pla
cebo controlled, Not placebo controlled 3.Patients
blinded to minimise bias, Patients unblinded
to maximise synergy
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• In the light of these facts, few more definite
  suggestions can be made.

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• SAFETY is of paramount importance which is
  inherently an accepted strength of Ayurved

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• Weighing SAFETY is very important. We should find
  out ways to do that.

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• To find role of SAFETY in one of the CRD
  trials, we analyzed data of paracetomol
  consumption and change in knee status by RIDIT
  analysis. Following table shows this as an
  example.

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OA-EXPLORATORY-KNEE STATUS CHANGE ON COMPLETION
A RIDIT (relative to identified distribution)
ANALYSIS
Interpretation (for mean Ridit gt0.5)More than
half of the time a randomly selected subject from
C group will have more extreme value
(improvement) than a randomly selected subject
from the reference group (Placebo and Glucosamine)
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 Other points to be considered are

• - Can we use Ayurved medicines to maintain
  remission or consolidate therapy results after
  the more aggressive modern medicines have dealt
  with the initial severe stage? Some sort of
  INTERFACE, is not it?
• - Platform formulation and Augmenters (Anupan
  i.e. vehicle/medium is also important in Ayurved)

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• -Interaction studies and sub-group identification
• -Specific differential diagnosis / sometimes it
  becomes essential to distinguish between
  treatment sensitive insensitive patients to
  help tailor the treatment better

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Disease subsets and drug response

• Drug activity could be better understood with
  proper statistical study of Ayurvedic disease
  subsets concepts.

Ayurvedic diagnostics
Statistical inputs
Santarpana
Drug response
Disease Subsets
Regression
Apatarpana

• Person with analytical vision can differentiate
  disease conditions with multiple aspects.