Homeopathic Growth Factors, Chapter 9

Homeopathic Growth Factors as Treatment for HIV Recovery of Homeostasis and Functional Immune System
BARBARA BREWITT
MICHAEL TRAUB
CARL HANGEE -BAUER
LYN PATRICK
LEANNA J . STANDISH

Chapter 9
SETTING THE STAGE FOR POSSIBILITY

Look Again—Another Perspective
Conventional medical wisdom has largely avoided the immune system in its quest for human immunodeficiency virus (HIV) treatments, instead favoring designer drugs targeted to every part of HIV’s outer coat or enzymatic mechanism. However, human survival depends on the immune system. Our bodies protect themselves from the daily barrage of changing pathogens via complex adaptive immune mechanisms that recognize “self” versus “nonself” elements. When these mechanisms break down, our bodies suffer from diseases such as HIV. It therefore makes sense that the treatment of immune system diseases is best addressed by bolstering the immune system—a goal that can be accomplished because of recent developments in human growth factors (GFs).

Cellular immunity, which is unique to vertebrates, specifically recognizes “self” as it evolves, while also being flexible and capable of specifically attacking “nonself” invaders or pathogens. These adaptive mechanisms are grounded in a cell-to-cell communication network that bridges the immune and neuroendocrine systems.¹³ This integration of physical, emotional, and hormonal sensations creates an adaptive cellular immune response, which produces billions of T lymphocytes that specifically attack newly recognized foreign pathogens.

Misinterpretation of Clinical Effects of Growth Factors

Cell-to-cell communication occurs via signaling molecules such as GFs, cytokines, neuropeptides, neurotransmitters, and some hormones. GFs are multifunctional, small polypeptides that regulate and effectively coordinate immune communication, enabling the immune system to work as a cohesive whole.^4,5 Because of their crucial role in maintaining a healthy immune system, pharmacological doses of GFs were tested in clinical studies during the early 1990s for treatment of HIV disease. However, clinical and other in vitro studies on highdose GFs evoked unwanted and unpredictable effects, such as increased HIV replication, suppression of lymphocyte proliferation, lymph node swelling, and inhibition of macrophage function.

These side effects caused many researchers to largely abandon a GF treatment approach in favor of other strategies aimed at killing HIV. ^6-10 They did not recognize that these abnormally high concentrations of growth were the reason for the adverse effects. Actually, the side effects supported the theory of the homeopathic law of similars and justified their medical use at low homeopathic concentrations. Conventional researchers chose to directly attack HIV viral mechanisms, whereas homeopathic medical researchers chose to support the body’s immune system.

Dr. Samuel Hahnemann’s law of similars states, “If a substance can cause symptoms or unwanted side effects at high concentrations, the same substance may effectively treat the symptoms when prepared homeopathically.” ¹¹ His writings also clarify the theory that the more powerful the substance, the more dilute it must be for therapeutic effectiveness. ¹² His years of clinical observation taught him a guiding principle of pharmacology, namely, that “a drug directly affects the body, and then the body reacts to the drug, producing either healing or adverse symptoms.” A toxic concentration of a drug evokes the first symptoms of toxicity in the organ or organs where the drug action is most efficacious.

Currently, conventional treatment largely consists of antiviral (AV) drugs designed to inhibit replication of HIV. However, these new drugs are not designed to renew, repair, or mimic cellular communication, which is the cornerstone of immune system health. HIV replication patterns are nonlinear and complex, and treatment with highly active antiretroviral therapy (HAART) has not effectively stopped viral replica tion. ^13,14 Unfortunately, 78% of people taking HAART are resistant to one form or another of these drugs, and 27% are resistant to all HAART drugs. ¹⁵ About 12% of these patients are infected with a strain of HIV that has mutated in a region for which current drugresistant tests can not account, suggesting that up to 90% of people taking HAART experience drug resistance due to HIV viral mutations. Another 40% of people on HAART suffer from unwanted side effects, such as insulin resistance and hyperglycemia.¹⁶ People who either live in underdeveloped countries or lack economic resources find that the cost of HAART therapy is out of reach and that the therapy has unwanted, unacceptable side effects.

GFs, which were used and rejected at pharmacological concentrations in the 1990s, can be practical, safe, and economically feasible when used homeopathically. Homeopathic GFs (hoGFs) represent one frontier of medical practice, which is rooted in fundamental healing principles that integrate the mental, emotional, and spiritual living truths within the physical body. ¹⁷ Medical practitioners have a responsibility to research and identify potentially effective healing approaches that awaken the body’s innate and adaptive ability to survive, thrive, and defend itself as an integrated whole without causing adverse side effects. This can now be accomplished because of advances in new homeopathic human GF products.

The Immune System Must Destroy HIV

Contrary to almost all research reports and after more than 15 years of research into the cause and potential cure for AIDS, the message remains the same: the human immune system must destroy HIV. ^18,19 Researchers from the National Institutes of Health (NIH) report that even the most sophisticated of today’s antiretroviral (ART) AIDS drugs may never completely cure HIV infected individuals. After conventional drug therapy causes HIV levels to drop initially, the virion’s outer coat mutates and becomes drugresistant. HIV sequesters itself deep into the lymphatic vessels and lymph nodes, the exclusive home territory of the immune system, where the virus is largely protected from drug access. At this point HIV viral load becomes stable at some level, whether at 100,000 RNA copies/ml or at undetectable levels, but the virus is still present. Whatever the patient’s contributing factors to viral load stability, including age, gender, lifestyle, and nutritional status may be, the task of final elimination and management of the viral invasion is ultimately up to the immune system. Thus the popular concept that HAART eliminates high turnover rates of HIV is giving way to new attempts to restore immune function and reestablish homeostasis. ^20-22

The Immune System Relies on cell-to-cell Communication

The immune system, like HIV, is highly dynamic, mobile, and adaptive. The one thing that HIV particles lack in comparison to immune cells is cell-to-cell communication, which is the Achilles’ heel of all viruses. HIV particles act like single soldiers attacking a cohesive armory of immune cells. cell-to-cell communication may be the key to successfully overcoming HIV infection.

Macrophages play a central role in the complex, nonlinear communication dynamics underlying immune responses. The immune system’s homeostasis depends on cell-to-cell signaling feedback loops. ²³ Circulating monocytes and tissue macrophages, strategically located in prominent organs, stimulate adaptive immune responses by secreting GFs and presenting (exposing) foreign antigens to CD4⁺ T-cells surfaces. ^24-26 GF signals and antigen presentation stimulate clonal expansion of highly targeted CD4⁺ T-cells to aggressively search for and destroy foreign invaders. GFs are biologically active polypeptide proteins that stimulate cell proliferation, modulate cell growth, alter gene expression, and sustain healthy homeostasis by supporting complex intercellular and intersystemic communications. ^5,27,28 After the initial activation, T-cells secrete other types of GFs, such as interleukins (ILs) and cytokines, to coordinate the immune response against foreign antigens.

When given proper GF signals and correct nutritional support for repair, the immune system is capable of restoring billions of CD4⁺ T-cells on a bimonthly basis ^21,22 while also repairing and rebuilding tissue. GFs are the body’s guides to complete healing through their ability to orchestrate healing processes, repair damaged DNA segments, and increase the uptake of nutrients. Researchers can take advantage of these healing abilities in the battle against HIV.

HIV Breaks Down cell-to-cell Communication in the Immune System

Macrophages, the immune system’s frontline defenders, and CD4⁺ T-cells are primary targets for HIV infection. ²⁹ One of the first aberrations to occur during HIV infection is the abnormal production of GFs by macrophages. ^30-32 HIV particles sabotage macrophages to secrete GFs that increase virion replication. ^30,33-38 Once a macrophage becomes infected, its presentation of antigen to CD4⁺ T-cells perpetuates continual infection.

HIV is cytotoxic to T-cells and its precursors. ^39-41 Binding the HIV-gp120 surface to the CD4⁺ T-cells surface stimulates cell signals that evoke inappropriate activities, such as premature programmed cell death (apoptosis), unresponsiveness to antigen presentation (anergy), or reactivity against selfantigen (autoimmunity). ^29,42 Because HIV has a rapid bimonthly replication, 25% of CD4⁺ T-cells within the lymph nodes are infected during the early stages of the infection process. ^21,22,43 This constant immune reactivity depletes other CD4⁺ T-cells–dependent immune response cells, such as CD8⁺ T-cells, natural killer (NK) cells, and B cells. ³⁹

As HIV disease continues, immune dysfunction deepens, resulting in the destruction of lymph node and lymph vessel architecture. ⁴⁴ At this point a person becomes susceptible to opportunistic infections (OIs) by bacteria, other viruses, and fungi. Protection of tissue integrity throughout the body, whether lean body mass (LBM) or lymph node histology, correlates with longterm survival.^45,46 Unfortunately, the widespread use of HAART has not reduced incidences of wasting. ^47-48b

Under What Conditions Can the Immune System Effectively Overcome HIV?

A monumental struggle takes place between CD4⁺⁺ T-cells killing of HIV and HIV replication dynamics in an infected person’s body. ^{21,22,44,49,50} The struggle can be represented as two periodic, oscillating forces opposing one another; i.e., when CD4⁺ T-cells are high, more HIV is destroyed, and when HIV replication is high, more CD4⁺ T-cells undergo infection and cell death.

The randomness or irregularity of immune response activities that becomes unpredictable over time in HIV infection fits exactly with the definition of chaos. Chaos theory proposes that turbulence results when two forces constantly oppose each other within the same physiological system. ^51,52 Over time, this turbulence progresses and reaches a transition point, whereby chaos appears. Chaos drives one of the two opposing forces to collapse. The most effective way to rescue the favored force from entering into this destructive chaos is to introduce a periodic attractor. ⁵³ A periodic attractor is another force that parallels and stabilizes a favored force. The periodic attractor provides support for feedback control mechanisms. The feedback stabilizes the favored force and drives the unwanted force to an undesired bifurcation point and inevitable collapse. In the scenario between HIV and immune cells, this means reinforcing the replication dynamics of CD4⁺ T-cells and displacing the dynamics of HIV. GFs are ideal candidates to serve as periodic attractors, since GFs control every aspect of the immune system: (1) immune responsiveness, (2) wound healing, (3) tissue repair, and (4) cell growth under healthy or infected conditions.

The concepts of homeostasis, selfdefense, and selfrecovery are fundamental principles of homeopathy as articulated by the law of similars. ^17,54,55 The restoration of cellular immunity and the reestablishment of homeostasis are central issues in HIV disease; thus a homeopathic GF (hoGF) approach seems logical as a viable, nontoxic, affordable, and effective way to provide an HIVinfected person with a periodic attractor. HoGFs are predicted to improve immune system function (see Chapter 16). ^17,56

The clinical practices of homeopathy have shown effectiveness for the last 200 years and have been proven efficacious by many statistical studies. ^57-59 For example, Dr. Madeleine Bastide’s research group in France proved the nonlinear, doserelated effectiveness of homeopathic epidermal GF in stimulating and inhibiting cell proliferation in vitro. ⁶⁰ IGF-1 at homeopathic concentrations inhibits HIV1 replication in cultured cells. ⁶¹ Randomized, doubleblind, placebocontrolled clinical studies at three different test sites also demonstrated that homeopathic recombinant human growth hormone (rhGH) provided physiological and psychological benefits similar to injectable rhGH while simultaneously eliminating symptoms that match those resembling common side effectsof pharmacological rhGH. ⁶² Using hoGFs thus offers an opportunity to gain therapeutic benefits while avoiding adverse side effects.

Two approaches can be used to identify which GFs might act as periodic attractors in a clinical setting: (1) the Hahemannian method of symptom appraisal and (2) analyses of common molecular and genetic regulatory sites shared by both HIV and GFs. The first method involves carefully applying the law of similars to symptoms of HIV infection and GFs. Table 91 presents the major organs and early symptoms of HIV infection with the known adverse side effects of pharmacological doses of some GFs. The symptom picture is created by high concentrations of four GFs: (1) insulinlike GF-1 (IGF-1), (2) plateletderived GF (PDGF), (3) transforming GF-beta (TGF-ß), and (4) granulocytemacrophage colonystimulating factor (GMCSF). These GFs closely matched early presenting symptoms of HIV infection, thus making them potential candidates for clinical study.

Table 9-2 provides additional information from studies in vivo and in vitro regarding the adverse side effects of these four GFs on the immune system when used at higherthannormal physiological concentrations. The reports of adverse side effects on immune responsiveness strengthened the rationale for selecting these specific GFs for homeopathic treatment of HIV. High concentrations of these GFs suppress and inhibit both lymphocyte and macrophage proliferation and stimulate HIV replication.

The second method for selecting these GFs was their wellcharacterized molecular and genetic activities. IGF-1, PDGF, TGF-ß, and HIV compete for the same G protein signaling processes, now identified as requisite coreceptors for HIV infection of human cells. ^63,64 G proteins are the first site of information transfer from the cell membrane surface to its DNA. At the genetic level, these GFs use the same genetic transcription AP1 site that HIV also targets: a regulatory area that controls what gene is expressed into viable proteins. ^65-67 This is the key decision point that determines whether HIV viral proteins or needed human proteins will be synthesized. It is during the early G1 phase of the cell cycle that critical decisions are made regarding cell fate, such as cell proliferation, cell differentiation, or cell death. Also during this phase, HIV manipulates cell cycle dynamics to upregulate HIV expression and replication, while concurrently displacing feedback communications necessary for healthy cell function. Figure 9-1 schematically represents the roles of PDGF, IGF-1, and TGF in regulating cell fate.

Table 9-1

Table 9-2

In our investigation, we selected homeopathic IGF-1, PDGF, TGF-ß1, and GM-CSF to clinically evaluate therapeutic efficacy. Preliminary clinical studies on HIVpositive patients receiving subtleenergy electromagnetic signals simulating hoGFs demonstrated appropriate GF potencies to raise CD4⁺ and CD8⁺ T-cells counts (see Chapter 16). Homeopathic potencies* selected for clinical testing were (1) 1 M IGF-1, (2) 30 C and 1 M PDGFBB, (3) 30 C and 1 M TGF-ß1, and (4) 200 C GM-CSF. Treatment efficacy was determined by measurements of CD4⁺ and CD8⁺ T-cells, HIV viral load, total body weight (BW), LBM, and general inflammation, as determined by the erythrocyte sedimentation rate (ESR). Four clinical studies were conducted: two doubleblind, placebocontrolled studies and two followup studies over a 2 ½ year period as shown in Table 9-3.

We tested the homeopathic law of similars with regard to these specific GFs that act like periodic attractors to restore immune function in 85 HIVpositive participants. The average length of HIV infection was between 7 to 20 years in 75% of patients and between 1 to 6 years in the remainder of patients. The median period of time between HIV infection and the onset of clinical symptoms of AIDS was 10 to 12 years in Western countries. ^39,68

*Homeopathic potencies are equivalent to very low concentrations of drugs, such that 30 C =10 ^{- 60} molar, 200 C =10 ^-400 molar, and 1 M =10^{- 2000} molar (also called 1000 C).

Figure 9-1 Diagram of cell cycle. The classically understood phases of the cell cycle include (1) resting G0 , (2) active G1 , (3) DNA synthesis S, (4) synthesis of proteins necessary for cell division G2 , and (5) cell division M. Growth factor PDGF acts as a competence factor to drive the cell from G0through G1 via positive (+) feedback. After cells become competent in G1 , they reach another time lag that prevents their progression from G1 to S phase, where DNA synthesis occurs. IGF-1 acts as a progression factor that enables cells to enter S phase via positive feedback. PDGF often couples with progression factors, such as IGF-1, to assure that T-cells complete all phases of DNA synthesis and reach the stage of mitosis. TGF -ß1 plays two important regulatory roles in the cell cycle. First, TGF -ß1provides negative feedback to cells, such as T-cells, to inhibit cell growth. Second, TGF -ß1 induces programmed cell death (apoptosis) when appropriate. During the G1 phase of the cell cycle, major decisions are made regarding cell division, cell differentiation, and cell death. (Data from Moses et al, CIBA Found Sympos, 157:6680, 1991; Pimentel, Handbook of growth factors: vol. 1: general basic aspects, Ann Arbor, Mich., 1994, CRC Press; Pledger et al, Proc Natl Acad Sci USA 74(10):4481 4485, 1977; Pledger et al, Proc Natl Acad Sci U S A 75(6):28392843, 1978; Schimpff et al, Acta Endocrinol (Copenh) 102(1):2126, 1983; Stiles et al, Proc Natl Acad Sci U S A 76:12791284, 1979.)

Figure 9-1

Replication of Results in Different Eras of Antiretroviral Therapy

Patient and study designs are described in Table 9-3. There were enough similarities in terms of years of infection and preference for natural therapies for comparisons between studies. In Studies A, C, and D, 80% of the participants were naïve to ART, whereas only 25% of Study B participants were naïve to ART.

Regardless of treatment or placebo in Study A, a high correlation existed between immune cells that normally have tightly controlled feedback loops between them; i.e., CD4⁺ and CD8⁺ T-cells (correlation coefficients of 0.7 or greater, p <0.001). However, in Study B, where ART therapy was three times more common before study enrollment, this correlation between CD4⁺ and CD8⁺ T-cells was not observed. This lack of correlation in Study B raised questions about the reproducibility of Study A findings and the possibility that ART therapy may disrupt tightly regulated cell-to-cell communication between CD4⁺ and CD8⁺ T-cells within the body. However, other researchers found a high correlation between changes in CD4⁺ T-cells counts and CD8⁺ T-cells counts in HIVpositive individuals. ⁶⁹

Treatment with hoGFs stabilized CD4⁺ T-cells counts when placebo and hoGF treatment groups were matched for sex and baseline CD4⁺ T-cells counts (Figure 92). These hoGF treatment findings were replicated through multisite testing 2 years later. Longterm stability in CD4⁺ T-cells counts was maintained in the original hoGF group (n= 10) over a 12 month period (see Figure 16-3). CD4⁺ T-cells count is an important and accepted indicator of HIV disease progression. ^20,70 Because of rapid immune system dynamics, a treatment effect is observable within 14 days. ⁷⁰ For example, the placebo groups in both Studies A and B had a downward trend, losing approximately -85 CD4⁺ T-cells/µl. These losses of CD4⁺ T-cells indicated disease progression. A good indicator for hoGF treatment efficacy was the increase of 16 CD4⁺ T-cells counts/l after the placebo group crossed over to hoGF treatment. The replication of findings in the treatment group and their stark difference from CD4⁺ T-cells losses in the placebo group suggested that hoGFs represent a periodic attractor capable of rescuing diseaserelated declines in CD4⁺ T-cells.

Under conditions where HIV positive men are not using antiretroviral or chemotherapeutic agents, losses of –51 CD4⁺ T-cells/µl in 6 months are expected. ⁷¹ HIV disease progression also averaged losses of –85 to –100 CD4⁺ T-cells/µl/year compared to –6 CD4⁺ T-cells/µl/year losses in HIVpositive longterm nonprogressors or –7 CD4⁺ T-cells/µl/yr in healthy controls undergoing normal aging. ⁷² The patients taking hoGFs were aligned with the categories of HIVpositive, longterm nonprogressors and healthy persons. Only 5% of the population of HIVpositive individuals are nonprogressors; thus it was unlikely that everyone in the hoGF treatment groups were longterm nonprogressors at the time of study entry. ^45,73 The more reasonable conclusion was that hoGFs acted as periodic attractors.

Table 9-3

CD8⁺ T-cells counts also stabilized in hoGFs (Figure 9-3). There were no statistical differences noted in total white blood immune cell (WBC) counts between the treatment and placebo groups suggesting that the hoGF effect was specific to cells, specifically restoring these cells to the immune system. CD4⁺ and CD8⁺ immune cells worked together in a coordinated attack on HIV.⁷⁴ The high correlation between these two cell types in patients who were naïve to ART and the stability of these two cell types gained in patients administering hoGF suggests that restoration of homeostasis occurred in the treatment groups.

LONG TERM FOLLOWUP

We lost contact with the study subjects for 9 months after the beginning of the HAART era with widespread use of protease inhibitors (PIs). To understand how hoGFs compared with AV therapies, we initiated Study D. At entry into Study D, three new subgroups of patients had formed voluntarily, as shown in Table 9-3, mixing persons from the previous Study A placebo group into the hoGF group. Because of this heterogeneous grouping and the passage of time, baseline CD4⁺ T-cells counts were lower at entry into Study D. The three groups were followed quarterly over the course of the next year.

The trends of CD4⁺ T-cells counts between hoGF, AV, and natural therapies (NAT) differed over time (Figure 9-4). Average CD4⁺ T-cells counts increased by +23 cells/µl in persons on hoGF treatment. In contrast, persons on AV had a downward trend of –29 CD4⁺ T-cells/µl. There was also a downward trend of -41 CD4⁺ T-cells/µl in the people on NAT without GFs. These findings again support the theory that hoGFs act over the long term as periodic attractors to strengthen the immune system, enabling expansion of the CD4⁺ immune cell pool. On the other hand, neither AV nor NAT therapies successfully strengthened the immune system. At the end of Study D, CD4⁺ T-cells counts ofpatients using hoGFs were not statistically different than those of patients using AV therapy (see Figure 9- 4).

If the immune system is strengthened by hoGF treatment, then it would be expected that OIs, (responsible for most HIVrelated morbidity and mortality) would be reduced. This was the case. No hospitalizations or OIs occurred in the hoGF group in Studies A, C, and D. However, as might be predicted, losses in CD4⁺ T-cells counts in the NAT group were coupled with 40% of hospitalizations by the third quarter of Study D due to OIs and other diseaserelated infections. Twentyfive percent of the AV group also were hospitalized for the same reasons. OIs of 20% and 17% occurred in the placebo groups of Studies A and B, respectively. Similarly, we experienced one case of an OI, herpes zoster, after 1 month of hoGF treatment (3% incidence) in Study B. This led us to believe that hoGF treatment may not prevent an OI from progressing once it has begun, but it may prevent an OI from taking hold by stimulating appropriate protective immune responses.

Figure 9-4

Naïve cells, which are subsets of CD4⁺ and CD8⁺ T-cells, may best characterize functional immunity and are relatively resistant to productive HIV infection.75 Naïve cells with the CD45RA⁺ antigenic marker can be fully primed to kill their target, even HIV. We studied naïve CD4⁺ T-cells to evaluate functional immunity. The hoGF treatment group increased approximately +19 naïve cells/µl within the first month, which leveled out to 10 cells/µl by the second month (Figure 9-5). In contrast, the placebo group had a downward trend of -7 naïve cells/µl throughout the study. An average increase of +19 naïve cells/µl within the first month of hoGF treatment was significant. ART did not show similar short term increases. ¹⁴ Triple combination ART took more than 36 months to raise the CD45RA⁺ population by 50 cells/µl. ¹⁴ Once activated, naïve cells returned home to the peripheral lymphatic tissue out of the blood stream to provide cell mediated immunity. The decrease in naïve cell counts during the second month of GF treatment may reflect homing events. Increases in naïve cells in patients using hoGFs supported the conclusion that cellmediated immunity was strengthened and became more functional than before their use.

FUNCTIONAL IMMUNITY REDUCES INFLAMMATION AND INCREASES IDEAL WEIGHT AND LEAN MASS

A functional immune system would additionally protect tissue integrity, prevent inflammation, and prevent infection. We used ESR measures to determine general inflammation and infection in the body (Figure 96). Before widespread evaluation of HIV viral load, research showed that ESR values, in addition to CD4⁺ T-cells counts and ß₂ microglobulin, were beneficial in assessing the stage of HIV.⁷⁶ Patients randomized to hoGF treatment at Study A entry had higherthannormal levels of ESR. Treatment reduced these levels to normal levels 4 months later (p< 0.02). In contrast, the placebo group's ESR trends rose from normal to higher than normal during the same time period. Longterm follow up showed that patients who remained on hoGF remained in the normal ESR range for 2 ½ years. In contrast, the AV and NAT groups, who had above normal ESR levels at Study D entry, remained out of normal range for a majority of the time (Figure 97). Again, this finding suggested that a unique functional cellular immunity was operating with hoGFs that reduced the stress of the immune system by reducing inflammation and infection in the body, in contrast to the immunity operating with AV or NAT therapies.

Figure 9-7	Figure 9-8

Deterioration in cellular immunity and tissue integrity contributes to early symptoms of lost LBM, weight loss, and cell death. ^32,77,78 During the early stages of the HIV epidemic, a direct correlation existed between weight loss, disease progression, and death.^79,80 The same GFs secreted by macrophages to activate CD4⁺ T-cells also stimulated cell growth, cell repair, and anabolic processes. Loss of cell signaling leads to loss of cell mass and LBM, even in otherwise asymptomatic HIV infected individuals . ^46,77 Given this correlation, it would be expected that any therapy that supported anabolic processes would also necessarily increase cell-to-cell communication.

Incidences of wasting are increasing at an alarming rate, despite primary HIV ART, which has reduced incidences of bacterial infections and other disease complications. ^47,48,81 Weight loss is characterized by intermittent periods of acute weight loss interspersed with periods of recovery. ⁷⁷ Today, with widespread use of AV therapy and increased incidences of lipodystrophy, hyperlipidemia, and hyperglycemia, researchers find that BW is not as good an indicator of disease progression as are measures of LBM. ⁸² Specifically, when LBM is reduced to 65% of the ideal BW, life can no longer be supported. ⁷⁷ Measurements of LBM are even better predictors of longterm survival than CD4⁺ T-cells counts. ⁴⁶

Homeopathic GFs were selected for their ability to increase cell-to-cell communication and for their known positive effects on cell growth. Before the widespread use of AV/PI therapy, such as the time of Studies A and C, total weight loss was a major concern during HIV infection. There was statistically significant net weight gain on GF treatment in Study A (+2.84 ±1.65 lbs), and this finding was reproduced in new patients in Study C (Figure 9-8). However, the placebo group in Study A, who were taking only natural supplements, lost –3.39± 1.10 lbs (p <0.01). When patients on placebo crossed over to treatment in Study C, their BWs increased an average of +0.18 ± 0.11 lbs/month. There was continued weight gain of +9.64 ± 3.80 lbs in the treatment group of Study A that was followed for the next 8 months. These findings of weight gain supported a preliminary conclusion that hoGFs increased cell-to-cell communication necessary for anabolic growth.

Once practices of HAART became popular, particularly during the time of Study B, incidences of lipodystrophy rose, and most HIVinfected patients became overweight. In Study B, between 75% to 80% of patients had been on a AV/PI protocol before entering the study. Both the hoGF treatment and placebo groups lost weight, –2.3 ± 0.9 lbs and –1.8 ± 1.8 lbs, respectively, during the 2month study (Figure 9-9, A). Persons in Study A were largely naïve to AV therapy compared to persons in Study B, a majority of whom had used AV therapies. The confounding issue of lipodystrophy required another form of BW analysis (i.e., ideal BW and LBM).

Figure 9-9

We analyzed the percentage of people in both study groups A and B who were below, within, and above their ideal weight (Table 9-4). We found that 20% and 17% of the patients in the lessthanideal BW categories at Studies A and B entry, respectively, moved into the ideal BW category by the time they exited the study. No one in the placebo groups experienced any changes in ideal BW. In Study A, we found no change in the percentage of people who were overweight either before or after treatment. In contrast, Study B showed a significant change in the percentage of people who moved from the overweight category to the underweight category. At the start of Study B, 69% of patients were in the overweight category, a figure that decreased to 17% after treatment. Some of these people (26%) became underweight, whereas 8% of the people who were underweight transitioned to their ideal BW. Another 29% of the overweight group entered the ideal BW group. Although the placebo had no effect on weight change, hoGF treatment stimulated changes leading to ideal BW.

However, BW alone is an unreliable measure of cellular and tissue health. Study B also measured LBM via bioelectric impedance analysis (BIA).83,84 LBM statistically differed between the hoGF treatment group and the placebo group within the first month (Figure 9-9, B; p =0.01). The placebo group lost an average of –3.6 ±1.3 lean lbs within the first month and –3.3 ± 1.6 lbs by the second month. The treatment group had no LBM loss during either the first month (-0.04 ±0.8 lbs) or the second month (-0.33 ±0.89 lbs). LBM distinctly indicated that cellular immunity was supported with hoGF compared to placebo. The statistical significance of weight gain in Study A (p= 0.001) and maintenance of LBM in Study B (p= 0.01) support the conclusion that hoGFs sustained cell mediated immunity during HIV infection compared to placebo.

Table 9-4

If hoGF treatment acted as a periodic attractor and strengthened the immune system, then in theory, HIV viral load would decrease. The hoGF treatment may weaken HIV replication dynamics. We evaluated HIV viral load because it indicates the speed of disease progression. HIV viral load tests were not available until the last 2 months of Study A and thereafter. Viral loads decreased on hoGF treatment in all studies, ranging from an average 0.3 log decrease to a 0.7 log decrease, depending on how high the viral load was at entry and how long the patient was on hoGFs (Figure 9-10). Downward trends in viral loads were reproducible in the various studies and were similar, paralleling general downward trends. Higher viral loads dropped dramatically within a 4month period, since those patients increased the dosage frequency of hoGF to four times/day.

In contrast, the placebo group’s viral load moved upward (Figure 9-10, A), until they crossed over to hoGF treatment (data not shown). The upward trend in viral load was reproducible. We noted that in Study B, both the placebo and hoGF treatment groups began with similar viral loads. However, within 8 weeks of the study, the outcomes were very different, with the hoGF treatment group having statistically lower viral load levels than the placebo group (p< 0.05). Throughout our studies, those patients using either placebo or NAT therapies experienced increased viral loads. In our longterm followup of Study D, people using AV therapy showed signs of either viral resistance or viral mutation (Figure 9-10, B), which is an expected common occurrence using this conventional AV treatment strategy. ⁸⁵ This resistance was not observable in either longterm followup of people using hoGFs in Study C and Study D (Figures 9-10, A and B). Although absolute numbers of HIVRNA copies/ml were not different between hoGF and AV treatments, there were signs of viral resistance in AV. HoGFs probably acted as periodic attractors to simultaneously strengthen the immune system while weakening HIV, which fits the chaos theory.

SIGNIFICANCE AND SUMMARY

Cell-to-cell communication is unique to multicellular organisms and humans. It is not found in HIV virions. Thus the human immune system has an advantage in its battle against singlesoldiervirion particles. The immune system fights foreign invaders by using wellorchestrated and integrated immune response networks that operate effectively via cell-to-cell feedback loops. In this way, immune cells work together in a coordinated effort that involves cell-to-cell communication. It is no surprise that HIV’s first disruption in the body involves a breakdown of GF cellular communication networks that would normally facilitate immune cell-to-cell signaling, the cornerstones for immune strength and renewal.⁸⁶

B

Figure 9-10

In general, HIV replication dynamics and CD4⁺ immune cell replication dynamics are complete opposites and become increasingly complex over time. Generally, when high numbers of CD4⁺ T-cells exist, low HIV viral load also exists, and vice versa; when high numbers of viable HIV virions exist, greater infection and low CD4⁺ T-cells counts exist as well. As cell death increases and the periodic transitions between HIV replication and CD4⁺ T-cells replication become more frequent, turbulence occurs within the body. This situation becomes more complex and chaotic over time. This chaos leads to an inevitable collapse of one of the two opposing forces. Conditions similar to this periodic and chaotic activity have been modeled for Bcell (humoral) immunity and antibody production using chaos theory.⁸⁷

We applied chaos theory to cellular immunity and HIV infection to gain insight and derive new medical approaches for treating HIVpositive patients. Within chaos theory there exists the concept of a periodic attractor that supports the normal replication dynamics of the CD4⁺ T-cells in an inherently complex system that involves feedback loops. In chaos theory, the periodic attractor creates greater stability (and hence rescues) CD4⁺ immune cells. As one force is stabilized, the other force ( i.e., HIV replication cycles) should be directed toward an undesired transition (bifurcation) that leads toward destructive chaos and collapse. We proposed that a periodic attractor could be identified to strengthen the immune system and hence, according to chaos theory, drive HIV to a predicted weakened end.

The concepts of homeostasis, selfdefense, and selfrecovery are fundamental principles of homeopathy, as articulated by the law of similars. ^54,55 The restoration of cellular immunity and the reestablishment of homeostasis are central issues in healing from HIV disease; thus we integrated the concepts of periodic attractors, homeopathy, and GF biotechnology to strengthen cellular immunity. Using the homeopathic law of similars, we chose four hoGFs (IGF-1, PDGF, TGF-ß1, and GM-CSF) to provide positive support of immune system feedback loops, to stabilize CD4⁺ T-cells dynamics, and to slow HIV disease progression.

We enrolled more than 85 HIVpositive persons from eight different cities and conducted two randomized, doubleblinded, placebocontrolled studies and two followup studies over 2 ½ years. In three of the studies, the persons enrolled were using only selfselected natural medicines, and we added either hoGFs or placebo to the study design. In the final study, we conducted followup comparison studies on these persons using hoGFs, ARTs, or only their favorite selfselected natural medicines.

The studies showed that hoGFs stabilized immune responsiveness and protected tissue integrity. On average, no CD4⁺ T-cells were lost in the hoGF treatment groups in either of the doubleblinded, placebocontrolled studies. There were increases in naive cell counts, which is a good indicator of cellular immunity. There was maintenance of LBM and the achievement of ideal BW. Likewise, in both of the open label followup studies, littletono disease progression was observed in the persons using hoGFs. At entry of Study D, 21 months postentry, individuals using hoGFs generally increased their CD4⁺ T-cells counts. There were no hospitalizations, no OIs, and no measures of general inflammation or general infection in the tests we ran. These people were not experiencing wasting. Their HIV viral loads trended steadily downward. People using hoGFs over the course of 2 ½ years had HIV viral loads equal to that of people using AV therapy without any sign of viral resistance. No toxic or adverse events occurred with people using hoGFs at these potencies. HoGF treatment significantly slowed disease progression.

In contrast, patients who used only NATs of their choice or placebo with their NATs experienced HIVdisease progression. In longterm followup of persons using only NATs, viral loads reached 1.5 log higher than entry. There were reproducible losses of CD4⁺ T-cells and reproducible rises in HIV viral loads. We also measured losses of naive cells, losses of LBMs, 40% hospitalizations, and OIs. There were upward trends in general inflammation and infection similar to those reported previously in HIV positive individuals using only NATs. ⁸⁸

The major natural therapies chosen by the patients consisted largely of spiritual practices, vitamin C, vitamin B₁₂ , garlic, zinc, unspecified Chinese herbs, acupuncture, and betacarotene. Our studies point to a genuine need for systematic analyses of NATs and their combinations with and without hoGFs. An enhanced therapeutic effect may be established between hoGFs and the correct combination of other natural medicines. The use of alternative therapies with and without supplemental ART by HIVpositive persons is widespread. ⁸⁹ It is critical that complementary and alternative medicine (CAM) practitioners develop, evaluate, and design effective protocols for their patients.

Patients who used ARTs experienced a decrease in viral loads; however, they showed signs of viral resistance. Also, a low HIV viral load, yet high levels of general infection and inflammation levels, noted by high ESR values, suggested that the cellular immune system was not functioning well. There were some losses of CD4⁺ T-cells counts, 25% hospitalizations, and OIs. The inadequate immune response inferred by these findings is not surprising, since antiretroviral drugs are designed to kill HIV. Antiretroviral drugs are not designed to support, renew, or repair immune function. In addition, AV drugs are toxic in a way that weakens the body. Wellknown adverse side effects include: (1) nausea, (2) headaches, (3) fatigue, (4) anemia, (5) diarrhea, (6) peripheral neuropathy, (7) rashes, (8) lipodystrophy, (9) fevers, (10) leukopenia, and (11) bloating. Lesswell known side effects such as hypertriglyceridema, kidney stones, insulinresistant diabetes, hyperlipidemia, and taste aversion were also reported. ^70,81 HIV infection and abnormal fat distribution also raise the risk for metabolic abnormalities of cardiovascular disease and insulin resistance.16

Although the sample size of each of the individual studies was small, when taken together, the results undeniably demonstrate that the law of similars applies to hoGFs. We found significant, positive, reproducible, metabolic, and immunological effects from this combination of hoGFs. The longer a person remained on hoGF treatment, the more statistically significant was his or her decline in HIV viral load. Longterm homeopathic treatment slowed disease progression equivalent to that of HIVpositive longterm nonprogressors. The positive findings from hoGFs and the reverse findings on people using selfselected natural therapies with or without placebo support a credible hypothesis that hoGFs acted like a periodic attractor, rescuing the cellular immune system and weakening HIV replication.

The benefits of the hoGF treatment approach can be summarized as follows:

1. Stabilized or increased CD4⁺ T-cells—reproduced through multisite testing
2. Increased CD4⁺ T-cells counts over 1 year of followup
3. Increased naïve CD T-cells
4. Achieved ideal BW and maintained LBM
5. Gained appropriate weight
6. Stopped inflammation and infection in the body
7. Reduced HIV viral load
8. Experienced no adverse side effects
9. Protected against onset of OIs and other general infections that lead to hospitalizations

The studies reported in this chapter differ from classical homeopathic and clinical studies that treat each person using an individualized case approach. ^55,90 Our four studies used one therapeutic protocol for all HIVpositive patients that involved oral administration of a combination of four hoGFs. Dr. Samuel Hahnemann’s principle of selecting the correct simillimum, * using the law of similiars, may be required to select the correct periodic attractor for the symptoms manifesting in the patient. The hoGF approach did not provide therapeutic protection for everyone; a very small percentage of patients on hoGF treatment gained no LBM, some patients experienced declines in CD4⁺ T-cells counts, and some patients experienced increased viral loads. For these patients, the simillimum was not identified.

*The simillimum is a substance that is most similar to a person’s symptoms and whose homeopathic application will act the fastest, the longest, and the deepest in healing the person of the symptoms.

GFs are well characterized proteins, tested in vitro, in vivo, and in clinical studies. The adverse side effects of GFs are often available in peerreviewed journals and pharmaceutical publications. We selected GFs that were available at the time of these studies and that had side effects that best matched early and primary symptoms of HIV infection. Thus our approach is generally recognized as one of similars versus one of simillimum. Because HIV is a worldwide pandemic, this similars approach is practical. Using an individualized case approach may prove efficacious, but it is an impractical approach for most people.

Molecular biologists discovered that the same GF signaling molecules that support immune surveillance also support wider surveillance throughout the entire body.¹ GFs, cytokines, and neuropeptides are the communication molecules that integrate the feedback between our emotions and the immune system.^1,91 The whole mental psyche from which we assign meaning to our environment and our life is singularly integrated into our immune system and is dependent on GF signaling. ^1-3 GFs regulate cell growth, DNA expression, and tissue repair throughout the body, not just in the immune system. We found that hoGFs provided positive clinical, metabolic, and immunological outcomes in HIV positive patients. This approach restored immune responsiveness and protected tissue integrity while simultaneously weakening HIV replication. HoGFs offer a nontoxic, affordable, and effective treatment option for HIV infected persons whose economic resources or prescribed treatment options do not include AV therapy.

Acknowledgments

I would like to acknowledge and thank all of the participants in these studies who desire, demand, and have the right to nontoxic medicines that strengthen their immune systems and recover their health. It was their commitment to find a safer alternative that made these doubleblind, placebocontrolled studies possible. I thank Lark Lands, PhD, and Lusijah Marx, PhD, for assisting us with recruitment of participants who live fully with HIV infection. I thank the additional clinical investigators and coordinators across the country who made these clinical studies possible: Corrine Furnari, RPA, CCN; Larry Lyle, DO; Gloria Nepstead; Judy Peabody, ND; Brian Smith, DC; and Laura Wailes, MA. In addition, I thank the many people whose donations made these studies possible, especially Biomed Comm Inc, for its generous support in time and financial resources.