Clinical Trial of Homoeopathic Preparations of Amyleum Nitrosum, Azathioprine, Cocainum Muriaticum and Cyclosporine in HIV Disease- a study report

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

Since the presentation of the first cases of immunodeficiency in homosexual men in 1981 in New 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

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 fast pace

CCRH and HIV
CCRH undertook a pilot research study in 1989 to ascertain whether homoeopathy can play a role in the treatment and management of HIV infection
The study was undertaken at the RRI, Mumbai (May, 1989) and CRU, Chennai (October, 1991)

CCRH and HIV
The results obtained during the pilot study prompted a randomized placebo controlled study at Mumbai (1995-97). The results of the study were published in the British Homeopathic Journal (1999)

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 Council’s Office at New Delhi for treatment
All these people were asymptomatic. As such they were treated on the basis of their characteristic mental/emotional, physical attributes
The treatment also included extensive counseling and dietary advice

Early Years of Epidemic in India
Clinical presentation usually comprised of:
Anxiety about future
Fear of impending death
This caused:
Anorexia and Insomnia
Occasionally:
Diarrhea and weight loss

HIV-Pathogenesis
HIV causes a slow decline in immune capacity
The infected person remains asymptomatic initially
When his CMI is compromised, he becomes susceptible to a multitude of opportunist infections
Still later develops a clinical state called AIDS

Evolution of New Hypothetical Model
Based on the analogy that the damage starts at cellular and molecular level and clinically active disease 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?

Whether drug substances that are known immune suppressors in material doses would help if used in 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 ?

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 with having killer effect on T helper cell and causing rapid replication of HIV

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 and occurrence of OIs, and
whether clinical improvement corroborate with corresponding rise in CD4/CD8 count

Additions of New Medicines for Trial
Later Cyclosporine, Azathioprine, and Cocainum Muriaticum were also added to the 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, UK in 30CH and raised to 200 CH potency

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 of age were enrolled in the study
Three of these individuals were suffering from concurrent Hepatitis B infection and 2 were reactive to VDRL

Homoeopathic Medicines Used
Amyleum Nitrosum, Azathioprine, Cocainum Muriaticum and Cyclosporine were primarily used as medicines under trial
Other Homoeopathic medicines were used only during seasonal minor ailments based on presenting signs and symptoms.

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

Assessment of Outcome
The response to the treatment was assessed at the end of the study and was based on the change in clinical presentation
The response to treatment was also assessed by the haematological and immunological investigations such as CD4/CD8 counts
Most of these investigations were conducted at the Council’s HIV Research Laboratory

Assessment of Outcome
Parameters adopted for Assessment:
Clinical status
Immunological status
Quality of life

Response to Therapy
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

Response to Therapy
ARC stage (At Entry) 25
Improvement 14
Not improved 04
Progressed to OIs 05
OIs/AIDS (At Entry) 14
Improvement 07
Progressed to ARC 01
No improvement 01

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 <500

Changes in CD4 Counts T F More than 1000/cumm Between 500 to 1000/cumm CD4+ T-Lymphocyte Count Before treatment During treatment Total no. of cases* Improved Not improved Range M T M F T M F 1 - 1 - - - 1 - 1 22 6 16 17 4 3 5 2 3 Between 200 to 500/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 - - -

Response to Treatment: Symptoms

Response to Treatment- Symptoms

Observations and Discussion-1
The results showed that clinical improvement does not necessarily corroborate with improvement in CD4 Counts, universally adopted parameter for the assessment of effects of therapy

People with HIV and CD4 Counts over 500/cu.mm respond more favourably at cellular level than those having lower Counts between 200-500
However, surprising was that both of the 2 subjects whose CD4 Counts were lower than 100/cu.mm at entry showed increase in CD4 Counts and clinical improvement

Significant observation was that many subjects under treatment experienced emotional and physiological stability despite decline in CD4 Counts
Another significant observation was that subjects under study did not develop any opportunist infections even after 7-8 years of infection
Most subjects experienced improvement in quality of life

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

Another significant observation was that candidiasis-oral ulcers, a hall mark of progressive HIV infection and known to recur frequently, responded favourably to homoeopathic therapy

Clinical observation indicate a definite, intricate relationship between Stress, malnutrition, sedentary habits and absence of psychological support from the family and friends and immune system
All these factors adversely affect immune system
On the other hand removal of one or more or all these factors was seen to have a salutary effect on immune system

Conclusion
It is difficult to make a definitive conclusion as CD4 estimation facility was not readily available in the country in 1998 and only 103 subjects had repeat CD4 Counts
Another reason for not making a definitive conclusion is that management of HIV infection is a complex activity. Medicine alone does not help people with HIV. There are many other issues which need to be addressed to

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 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

Thank You

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Clinical Trial of Homoeopathic Preparations of Amyleum Nitrosum, Azathioprine, Cocainum Muriaticum and Cyclosporine in HIV Disease- a study report

by hompath on Jun 29, 2008

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Clinical Trial of Homoeopathic Preparations of Amyleum Nitrosum, Azathioprine, Cocainum Muriaticum and Cyclosporine in HIV Disease- a study report — Presentation Transcript