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

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  • 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
  • 2.
    • 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:
      • Anxiety about future
      • Fear of impending death
      • This caused:
      • Anorexia and Insomnia
      • Occasionally:
      • 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:
      • delay the progression of HIV infection and occurrence of OIs, and
      • 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
      • 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
  • 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:
      • 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/ with varying results
  • 33. 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
  • 34.
    • Thank You