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

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.

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

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 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)

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

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

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

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?

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?

Evolution of New Hypothetical Model 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 ?

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 ?

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

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

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

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

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.

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

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

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

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

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 Under observation 02 OIs/AIDS (At Entry) 14 Improvement 07 Progressed to ARC 01 No improvement 01 Under observation 05

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

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

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

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

Observations and Discussion-2 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

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

Observations and Discussion-3 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

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

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

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

Observations and Discussion-5 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

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

Observations and Discussion-6 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

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

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

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

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

Thank You