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Clinical Trial of Homoeopathic Preparations of
Amyleum Nitrosum, Azathioprine, Cocainum
Muriaticum and Cyclosporine in HIV Disease
Dr. V.P. Singh
Central Council for Research in Homoeopathy
New Delhi
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Since the presentation of the first cases of
immunodeficiency in homosexual men in 1981 inNew York and California, HIV infection has come
a long way and is currently a Global health
emergency (WHO). It is now the leading cause
of death in most parts of the World and the
fourth biggest killer globally.
Introduction
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By the End of 2006
39.5 million people were living with HIV Globally
5.7 million of these were in India
11000 new HIV infections reported every day
2.9 million people died of AIDS in 2005
HIV infections increasing among women at a fastpace
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CCRH and HIV
CCRH undertook a pilot research study in 1989
to ascertain whether homoeopathy can play arole in the treatment and management of HIV
infection
The study was undertaken at the RRI, Mumbai(May, 1989) and CRU, Chennai (October, 1991)
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CCRH and HIV
The results obtained during the pilot study
prompted a randomized placebo controlled studyat Mumbai (1995-97). The results of the study
were published in the British Homeopathic
Journal (1999)
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Early Years of Epidemic in India
In the late 1980s and early 1990s, no ARV drugs
were available in India People with HIV were referred to the Councils
Office at New Delhi for treatment
All these people were asymptomatic. As suchthey were treated on the basis of theircharacteristic mental/emotional, physicalattributes
The treatment also included extensive counselingand dietary advice
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ar y ears o p em c nIndia
Clinical presentation usually comprised of:
Anxiety about future
Fear of impending death
This caused:
Anorexia and Insomnia
Occasionally:
Diarrhea and weight loss
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HIV-PathogenesisHIV-Pathogenesis
HIV causes a slow decline in immune capacity
The infected person remains asymptomaticinitially
When his CMI is compromised, he becomessusceptible to a multitude of opportunistinfections
Still later develops a clinical state called AIDS
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Evolution of New Hypothetical Model
Based on the analogy that the damage starts at
cellular and molecular level and clinically activedisease develops only when organism stops
responding efficiently to invading microbes WILL
IT HELP ?
If treatment is aimed at restoring or maintaining
the capacity of T helper cells responsible for
instituting CMI?
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Evolution of New Hypothetical Model
Whether drug substances that are known immune
suppressors in material doses would help if usedin homoeopathic potencies ?
If they work, how long would their action last ?
And whether they would work equally well in
asymptomatic and people with intermediary and
advanced stage ?
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Evolution of New Hypothetical Model
These questions prompted a search for such
drug substances which can be tried
The first one was Amyleum Nitrosum, the
popper which was blamed for immune deficiency
in 1981-82
Later Cyclosporine and Azathioprine, both used
on people with organic transplants
Cocaine, another drug which is discredited withhaving killer effect on T helper cell and causing
rapid replication of HIV
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Objective
An objective was thus evolved which was-
To clinically evaluate the role of Amyleum
Nitrosum in Asymptomatic infection and to see
whether it could help:
delay the progression of HIV infection andoccurrence of OIs, and
whether clinical improvement corroborate with
corresponding rise in CD4/CD8 count
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Additions of New Medicines for Trial
Later Cyclosporine, Azathioprine,
and Cocainum Muriaticum were also added tothe list of medicines for trial
Azathioprine was potentised in 6, 9, 12
potencies initially and later in 30, 200 and 1M
potencies
Cyclosporine was procured from Ainsworth, UKin 30CH and raised to 200 CH potency
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Methodology
A study was conducted at New Delhi between
April 1998 and March 2003
237 HIV infected individuals including, 96
Females and 8 children less than 10 years ofage were enrolled in the study
Three of these individuals were suffering from
concurrent Hepatitis B infection and 2 were
reactive to VDRL
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Homoeopathic Medicines Used
Amyleum Nitrosum, Azathioprine,
Cocainum Muriaticum and Cyclosporine wereprimarily used as medicines under trial
Other Homoeopathic medicines were used onlyduring seasonal minor ailments based on
presenting signs and symptoms.
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Other Homoeopathic Medicines Used
Arsenicum album
Azadirachta indica Belladonna Borax Bryonia alba Calcarea carbonicum Carbo animalis China officinalis Colocynthis Dulcamara
Ficus religiosa Gelsemium sempervirens Hepar sulphuris calc.
Kali bichromicum
Kali carbonicum Kali Chloricum
Kali muriaticum
Lycopodium clavatum
Mercurius solubilis
Natrum muriaticum
Nitricum acidum
Nux vomica
Pulsatilla
Rhus toxicodendron
Sepia
Silicea
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Assessment of Outcome
The response to the treatment was assessed at
the end of the study and was based on thechange in clinical presentation
The response to treatment was also assessed
by the haematological and immunologicalinvestigations such as CD4/CD8 counts
Most of these investigations were conducted at
the Councils HIV Research Laboratory
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Assessment of Outcome
Parameters adopted for Assessment:
Clinical status
Immunological status
Quality of life
Response to
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Response toTherapy
Asymptomatic stage (At Entry) 149
Maintaining asymptomatic status 134
Progress to PGL Stage 02
Progress to ARC 00
Progress to Opportunistic infections 05
Under observation 08
PGL stage (At Entry) 01 Improvement (became Asymptomatic) 01
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Response to Therapy
ARC stage (At Entry) 25
Improvement 14
Not improved 04
Progressed to OIs 05
Under observation 02
OIs/AIDS (At Entry) 14
Improvement 07
Progressed to ARC 01
No improvement 01
Under observation 05
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Response to Therapy
Immunological status
Repeat CD4 + Count 103 cases*
Increase in CD4 Count 48 cases
No Change/Drop in CD4 Count 55 cases
* 80 of the cases had presented with CD4
cells
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Changes in CD4 Counts
CD4+ T-Lymphocyte
Count
Before
treatment
During treatment
Total no.of cases*
Improved Not improved
Range T M F T M F T M F
More than
1000/cumm1 - 1 - - - 1 - 1
Between 500 to
1000/cumm
22 6 16 17 4 3 5 2 3
Between 200 to500/cumm
62 40 22 25 20 5 37 20 17
Between 100 to
200/cumm
16 7 9 4 2 2 12 5 7
Less that 100
cells/cumm
2 1 1 2 1 1 - - -
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Response to Treatment: Symptoms
48 46
34 32
14
42 42
29 26
12
0
1020
30
40
50
60
loss
of
appetite
weakness
feve
r
cou
gh
diarrho
ea
presented
Improved
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Response to Treatment- Symptoms
1
11
5
16
12
16
1
10
5
1112
14
024
6
81012
141618
Lymp
hade
nopa
thy
candidia
sis
ulce
rs
weigh
tloss
h
erpe
szo
ster
derm
atiti
s
presented
Improved
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Observations and Discussion-1
The results showed that clinical improvement
does not necessarily corroborate withimprovement in CD4 Counts, universally
adopted parameter for the assessment of
effects of therapy
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Observations and Discussion-2
People with HIV and CD4 Counts over 500/cu.mm
respond more favourably at cellular level thanthose having lower Counts between 200-500
However, surprising was that both of the 2subjects whose CD4 Counts were lower than
100/cu.mm at entry showed increase in CD4
Counts and clinical improvement
Observations and Discussion
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Observations and Discussion-
3
Significant observation was that many subjectsunder treatment experienced emotional andphysiological stability despite decline in CD4Counts
Another significant observation was that subjectsunder study did not develop any opportunistinfections even after 7-8 years of infection
Most subjects experienced improvement in qualityof life
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Observations and Discussion-4
Only one subject manifested steady rise in CD4
Count over a period of 5 years without any drop
All other subjects who manifested changes in
CD4 Counts manifested fluctuations, sometime
drop and some time rise in CD4 Count which
can not be explained
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Observations and Discussion-5
Another significant observation was that
candidiasis-oral ulcers, a hall mark ofprogressive HIV infection and known to recur
frequently, responded favourably to
homoeopathic therapy
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Observations and Discussion-6
Clinical observation indicate a definite, intricaterelationship between Stress, malnutrition,sedentary habits and absence of psychologicalsupport from the family and friends and immunesystem
All these factors adversely affect immunesystem
On the other hand removal of one or more or allthese factors was seen to have a salutary effect
on immune system
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Conclusion
It is difficult to make a definitive conclusion as
CD4 estimation facility was not readily availablein the country in 1998 and only 103 subjects hadrepeat CD4 Counts
Another reason for not making a definitiveconclusion is that management of HIV infectionis a complex activity. Medicine alone does nothelp people with HIV. There are many other
issues which need to be addressed to
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Conclusion
However, based on the results it can safely be
assumed that: Specific Homoeopathic medicines which
affect immune system in material doses, can
be used for the treatment of Asymptomatic
HIV infection
These medicines can also be used in HIV+
people with CD4 Counts over 500/cu.mm with
varying results
New
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New
Studies
As a logical follow up, CCRH has undertaken two
multicentric studies
AMulticentric Clinical Trial of Homoeopathic Therapy
in HIV Infection at Mumbai, Chennai, Imphal,
Gudiwada and New Delhi A Multicentric Clinical Trial of Homoeopathic
Preparations of Amyleum Nitrosum,
Azathioprine,Cocainum Muriaticum and Cyclosporine
in HIV Infection at New Delhi, Mumbai and Gudiwada
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Thank You