Final Report Co-infection of HIV and Tuberculosis

Results for Patients with Co-infection of HIV and Tuberculosis; A Study in Ukraine Using the Complex Homeopathic

ENERCEL®

EFFICACY OF ENERCEL® FOR STAGE IV ACQUIRED IMMUNODEFICIENCY SYNDROME [AIDS] WITH CO-INFECTION OF TUBERCULOSIS IN CHERNIGOV, UKRAINE

FINAL REPORT

Background:

Enercel® is a complex homeopathic medication that has been used successfully in the treatment of many infections including drug-sensitive and multi-drug resistant tuberculosis; hepatitis B and C; and diarrhea in children. Tuberculosis and HIV are the #1 and #2 causes of death from infectious diseases in the world. Together as a co-infection, they result in a much more severe and rapidly-progressive illness than either alone. Both of them cause the immune system to work much less efficiently against the other.

Aims:

To evaluate Enercel’s® efficacy in treating patients with HIV and TB co-infection at Regional Antituberculosis Hospital in Chernigov, Ukraine. Specifically, to evaluate improved immune system function (by measuring T-helper or CD4 cells); lessen or eliminate the amount of HIV virus in the bloodstream (HIV viral load); and to verify the elimination of tuberculosis in the lungs (sputum AFB smears and cultures).   

Methods: (3 Groups)

Group #1:  Enercel® plus standard TB treatment, no antiretroviral medications [ARV]

  1. 50 cc of Enercel® given intravenously twice per day for 1 month followed by once daily for 3 months
  2. 7 cc via nebulizer once daily
  3. 2 puffs into each nostril three times per day
  4. 20 drops sublingually twice per day
  5. Standard Tuberculosis medications (drug sensitive TB)

 

Group #2:  Enercel® plus standard TB treatment and ARVs

  1. 50 cc of Enercel® given intravenously twice per day for 1 month followed by once daily for 3 months
  2. 7 cc via nebulizer once daily
  3. 2 puffs into each nostril three times per day
  4. 20 drops sublingually twice per day
  5. Standard Tuberculosis medications (drug sensitive TB)
  6. Antiretroviral medications which consist of 3 or more standard medications given for HIV infection

 

Group #3:  No Enercel®, standard TB treatment and ARV

  1. Standard Tuberculosis medication (drug sensitive TB)
  2. Antiretroviral medications which consist of 3 or more standard medications given for HIV infection
  3. No Enercel®

 

All patients were evaluated by sputum AFB smears and culture, HIV viral load (VL) and CD4 count. Quality-of-Life (QOL) was assessed on a scale of 0 to 100, with 100 being severe incapacitation and 0 being perfect health. Toxicity was monitored by biochemistry panels and complete blood counts.

Results:

After 4 months, there are 11 evaluable patients on Enercel® for AIDS [three patients were not included in these results because they dropped out due to their relapse into intravenous drug or alcohol abuse].

For the 9 patients with AIDS on Enercel®alone :

  • 100% of the patients treated with Enercel® became AFB-smear negative indicating elimination of tuberculosis in the lungs
  • QOL scores improved from a mean of 47.3 at baseline to 14.1 at 4 months (with lower numbers meaning better general health).
  • CD4 counts improved in 100% of patients, from a baseline mean value of 230.7 to a mean value of 330.2 cells/mm3 after 4 months (indicating an improved immune system).
  • Mean viral load counts decreased in all patients, from a baseline of 479,002.8 to 185,599.9 copies/ml at 4 months (meaning a significant drop [62%] in the amount of HIV particles in the bloodstream).
  • 100% of these patients had terminal, Clinical Stage IV AIDS, yet there were no deaths during the study period.  

Individual results

Enercel® alone:  (without ARV)

1)      The sickest patient had disseminated herpes simplex at enrollment with a CD4 count of 60 cells/mm3 and viral load 130,811 copies/ml.

  1. Within 10 days, his herpes infection resolved;
  2. at 4 months his CD4 count had risen to 100 cells/mm3
  3. and his viral load decreased to 10,957 copies/ml.

2)      Patient #2

  1. Start:                CD4 count of 66 cells/mm3  and a viral load of 397,187 copies/ml;
  2. At 4 months:   CD4 count of 111 cells/mm3 and viral load of 45,241 copies/ml.

3)      Patient #3

  1. Start:                CD4 count of 358 cells/mm3 and a viral load of 41,603 copies/ml;
  2. At 4 months:   CD4 count of 404 cells/mm3 and viral load of 21,879 copies/ml.

4)      Patient #4

  1. Start:                 CD4 count of 61 cells/mm3 and a viral load of 294,136 copies/ml;
  2.  At 4 months:  CD4 count of 139 cells/mm3 and viral load of 10,290 copies/ml.

5)      Patient #5

  1. Start:                 CD4 count of 481 cells/mm3 and a viral load of 177,879 copies/ml;
  2. At 4 months:    CD4 count of 532 cells/mm3 and viral load of 17,931 copies/ml.

6)      Patient #6

  1. Start:                 CD4 count of 233 cells/mm3 and a viral load of 2,674,129 copies/ml;
  2. At 4 months:    CD4 count of 581 cells/mm3 and viral load of 1,400,045 copies/ml.

7)      Patient #7

  1. Start:                  CD4 count of 360 cells/mm3 and a viral load of 35,428 copies/ml;
  2. At 4 months:     CD4 count of 458 cells/mm3 and viral load of <40 copies/ml.

8)      Patient #8

  1. Start:                  CD4 count of 345 cells/mm3 and a viral load of 181,619 copies/ml;
  2. At 4 months:     CD4 count of 388 cells/mm3 and viral load of 73,204 copies/ml.

9)      Patient #9

  1. Start:                   CD4 count of 112 cells/mm3 and a viral load of 378,233 copies/ml;
  2. At 4 months:      CD4 count of 259 cells/mm3 and viral load of 90,812 copies/ml.

 

Enercel® + antiretrovirals:

1)      Patient #1

  1. Start:                  CD4 count of 87 cells/mm3 and a viral load of 630,073 copies/ml;
  2. At 3 months:     CD4 count of 338 cells/mm3 and viral load of <40 copies/ml.

2)      Patient #2

  1. Start:                  CD4 count of 459 cells/mm3 and a viral load of 5,192,532 copies/ml;
  2. At 3 months:     CD4 count of 788 cells/mm3 and viral load of <40 copies/ml.

One control patient on ARV alone had no detectable HIV particles in the blood, but his CD4 count did not change [baseline 28 cells/mm3 and after 3 months it was 29 cells/mm3]. Consequently, his AFB smear, which was negative at baseline, became positive at 3 months. Similarly, the second control patient had undetectable viral load, but his CD4 count did not change significantly [140 cells/mm3 at baseline and 152 cells/mm3 after 2 months]. He developed a high fever and died after 2 ½ months.

It should be noted here that 6 patients were evaluated and not enrolled into the study because of various exclusion criteria (including continuing alcohol and/or drug abuse) and all 6 have died during the study period.

Enerpuncture™:

Acupuncture injection point therapy using Enercel® (Enerpuncture™) was used to treat 3 patients:

  • One patient had a right-sided stroke from TB meningitis. She was treated with 4 months of Enerpuncture™ on her right upper and lower extremities. She is now able to move her right shoulder and arm and she can walk with a slight limp.
  • Another patient had HIV/TB nerve damage of his lower extremities to the point that he could not stand without support. He is now able to walk on his own with a cane.
  • Similarly, a third patient had bilateral lower weakness and walked with a cane; after 4 months he was able to walk without support.

 

Conclusions:

 

  • Enercel® is effective in eliminating tuberculosis in the lungs with a very short treatment regime.
  • Enercel® is a safe, low-cost, homeopathic medication that has shown preliminary efficacy in the management of HIV infection associated with tuberculosis.
  • Immune system function was improved, HIV in the bloodstream was markedly reduced and tuberculosis was eliminated in the lungs.
  • Analysis of control patients suggest that antiretrovirals are effective in reducing viral load in patients with very low CD4 counts, but they remain at risk for opportunistic infections and/or have a delayed or absent rise in CD4 count.
  • The addition of Enercel®to ARV treatment results in a rapid elimination of viral particles in the bloodstream and swift reconstitution of the immune system.

 

These results are particularly noteworthy for the following four reasons:

1)      Co-infection with TB and HIV is much more difficult to treat than either infection alone.

2)      This is the first study to show that a single medication [Enercel®] is able to effectively treat both a severe viral [HIV] and bacterial [TB] infection simultaneously.

3)      Each enrolled patient had Clinical Stage 4 HIV/AIDS– the most severe stage and the most difficult to treat with standard therapy alone.

4)      Elimination of TB from the lungs in a short time period will have a tremendous economic impact as well as reducing the chances of multiple drug resistant strains of tuberculosis.

 

 

Table 1: Values over time in the Enercel® alone groups

Month Patient # CD4 Viral Load
Patient # 1
Baseline

60

130,811

Month 1

74

60,666

Month 2

93

34,212

Month 3

106

55,399

Month 4

100

10,957

Patient # 2

Baseline

66

397,187

Month 1

87

233,581

Month 2

98

60,666

Month 3

108

60,243

Month 4

111

45,241

Patient # 3

Baseline

358

41,603

Month 1

544

44,926

Month 2

405

96,872

Month 3

458

63,262

Month 4           404

21,879

Patient # 4

Baseline

61

294,136

Month 1

151

227,145

Month 2

127

96,872

Month 3

132

            **ND
Month 4

139

10,290

Patient # 5

Baseline

481

177,879

Month 1

503

121,986

Month 2

651

47,841

Month 3

633

30,809

Month 4

532

17,931

Patient # 6

Baseline

233

2,674,129

Month 1

252

375

Month 2

391

1,885,818

Month 3           209     1,132,513
Month 4           581     1,400,045

Patient # 7

Baseline

360

35,428

Month 1

466

15,867

Month 2

546

8,228

Month 3           447             5,199
Month 4           458             < 40
Patient #8
Baseline

345

181,619

Month 1

263

207,628

Month 2

287

100,016

Month 3

370

         67,605

Month 4           388          73,204
Patient #9
Baseline

112

378,233

Month 1

81

502,236

Month 2

225

213,260

Month 3           247       81,907
Month 4           259       90,812

 

Table 2: Values over time in the Enercel® + Antiretrovirals group

Month Patient # CD4 Viral Load
       
Patient # 1
Baseline

87

630,073

Month 1

352

750

Month 2

318

64

Month 3

338

               <40

Patient #2
Baseline

459

5,192,532

Month 1

438

               <40

Month 2

378

               <40

Month 3

788

               <40

**  Not Done—because of too little blood to analyze

 

This information has far reaching implications in the battle to control Tuberculosis, which remains one of the leading causes of death worldwide. In 2010, nearly 9 million new cases were reported.  The highest numbers of deaths occur in patients with co-infection of HIV and Tuberculosis.

The World Health Organizations DOTS (directly observed treatment, short course) has definitely improved results. However, because it requires the patient to take a complex combination of pills every day for 6-9 months; a healthcare provider to supervise the treatment during that time; the fact that the patient can experience significant side effects while taking this medication many patients end the treatment prematurely.  These complexities lead to failed treatments and the greater danger of developing multiple drug resistant strains of tuberculosis when patients stop taking the medicine and then start taking it again.

An earlier study suggests  that the addition of Enercel® to TB medications can eliminate TB in as little as 10 to 30 days instead of 6-9 months; resulting in a huge savings in the cost of treatment not only for the state (many countries have government programs funded to control TB) but also for the patient.  Without the fear of spreading TB, patients can return to life with their  family, friends  and  get back  to work and while enjoying the benefit of an improved quality of life.

Summary:

 

Enercel® has been shown to:

  1. 1.       Eliminate TB in the lungs in combination with anti-TB medications;
  2. 2.       Substantially improve the QOL of HIV patients;
  3. 3.       Improve the immune system function of HIV patients;
  4. 4.       Significantly decrease the viral load of HIV patients.

The World Health Organization and many large foundations are focusing on developing treatment regimens that are shorter and easier to implement, as well as the treatment and reduction of HIV infections.  Imagine the implication of a product that can be used to ameliorate both diseases without adverse side effects and reduce treatment times for TB.

 

Graphs

Enercel Plus ARV's Viral Loads

Enercel Plus Anti-Retroviral Drugs- CD4 Counts

 These next set of graphs (CD4 counts & Viral loads) are individual graphs for patients without the Anti-Retroviral Drugs and only ENERCEL®

CD4 counts in patients with AIDS using Enercel only

 

Viral loads in patients with AIDS using Enercel only

CD4 counts in patients with AIDS using Enercel only Patient 2Viral loads in patients with AIDS using Enercel only Patient 2

CD4 counts in patients with AIDS using Enercel only Patient 3Viral loads in patients with AIDS using Enercel only Patient 3

CD4 counts in patients with AIDS using Enercel only Patient 4Viral loads in patients with AIDS using Enercel only Patient 4CD4 counts in patients with AIDS using Enercel only Patient 5Viral loads in patients with AIDS using Enercel only Patient 5CD4 counts in patients with AIDS using Enercel only Patient 6Viral loads in patients with AIDS using Enercel only Patient 6CD4 counts in patients with AIDS using Enercel only Patient 7Viral loads in patients with AIDS using Enercel only Patient 7CD4 counts in patients with AIDS using Enercel only Patient 8Viral loads in patients with AIDS using Enercel only Patient 8CD4 counts in patients with AIDS using Enercel only Patient 9Viral loads in patients with AIDS using Enercel only Patient 9Graphs showing CD4 and Viral loads for all 9 patients

 

Viral loads in patients with AIDS using Enercel only combinedCD4 counts in patients with AIDS using Enercel only combined graphs

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