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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

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

1. 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.
3. 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
4. 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)
5. 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)
6. 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
7. Early Years of Epidemic in India
* Clinical presentation usually comprised of:
o Anxiety about future
o Fear of impending death
o This caused:
o Anorexia and Insomnia
o Occasionally:
o Diarrhea and weight loss
8. 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
9. 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?
10. 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 ?
11. 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
12. 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:
o delay the progression of HIV infection and occurrence of OIs, and
o whether clinical improvement corroborate with corresponding rise in CD4/CD8 count
13. 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
14. 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
15. 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.
16. 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
17. 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
18. Assessment of Outcome
* Parameters adopted for Assessment:
+ Clinical status
+ Immunological status
+ Quality of life
19. 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
20. 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
21. Response to Therapy
* Immunological status
o Repeat CD4 + Count 103 cases*
o Increase in CD4 Count 48 cases
o No Change/Drop in CD4 Count 55 cases
o * 80 of the cases had presented with CD4 cells <500
22. 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 - - -
23. Response to Treatment: Symptoms
24. Response to Treatment- Symptoms
25. 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
26. Observations and Discussion-2
* People with HIV and CD4 Counts over 500/ 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/ at entry showed increase in CD4 Counts and clinical improvement
27. 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
28. 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
29. 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
30. 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
31. 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
32. Conclusion
* However, based on the results it can safely be assumed that:
o Specific Homoeopathic medicines which affect immune system in material doses, can be used for the treatment of Asymptomatic HIV infection
o These medicines can also be used in HIV+ people with CD4 Counts over 500/ with varying results
33. New Studies
* As a logical follow up, CCRH has undertaken two multicentric studies
o AMulticentric Clinical Trial of Homoeopathic Therapy in HIV Infection at Mumbai, Chennai, Imphal, Gudiwada and New Delhi
o 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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Comment by Dr Ajay Yadav on August 13, 2009 at 1:19am
thanks a lot gina
Comment by Gina Tyler DHOM on August 12, 2009 at 12:40pm
thought you might like these links related to AIDS/Homeopathy
march2008 AIDS E-Newsletter

more on what is behind the origin /causefactor of AIDS
(the expr. hep-vaccine programe in calif/SF/NY)=roots of AIDS

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