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

Dr. V.P. SinghCentral 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-PathogenesisHIV-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?

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 ?

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

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• 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

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/cumm

1 - 1 - - - 1 - 1

Between 500 to 1000/cumm

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

48 46

34 32

14

42 42

29 26

12

0102030405060

presented

Improved

Response to Treatment- Symptoms

1

11

5

16

12

16

1

10

5

1112

14

024681012141618

presented

Improved

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

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

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

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

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

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

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