Friday, March 13, 2009

High Dilution Growth Factors/Cytokines: Positive Immunologic, Hematologic and Clinical Effects in HIV/AIDS Patients

High Dilution Growth Factors/Cytokines: Positive Immunologic, Hematologic and Clinical Effects in HIV/AIDS Patients

Source : Bastyr University Research Institute

Barbara Brewitt, PhD; Leanna Standish, ND, PhD Biomedical Explorations, Seattle, WA; Bastyr University Health Clinic, Seattle, WA

Objective: Determine efficacy of administering 4 high dilution cytokines; platelet-derived growth factor BB, insulin-like-growth factor-1, transforming growth factor beta 1, and granulocyte-macrophage colony simulatin factor (GM-CSF).

Methods: Sixteen weeks treatment group ("TX")/placebo group ("PL"): CD4 counts 200-500 and 16 weeks open label study: CD4 counts 1250550, 10 drops/3X day/bottle p.o. growth factor type or placebo. Exclusion criteria: antiretroviral or steroidal therapy. Monthly evaluations: T/B lymphocytes, blood chemistry plus lipids, complete blood count, platelets, erythrocyte sedimentation rate (ESR), weigh, opportunistic infections (OIs) and HIV viral load (open label only). Growth factors/cytokines diluted (10-60, 10-400, 10-2000 molar), well beyond Avogadro's number.

Results: TX/PL started with CD4s of 330±14 cells/ul (SEM). TX (n=13) raised CD4 & CD8 counts by 13±12 cells/uL and 83±4 cells/uL, respectively, vs. -55±15 CD4 cells/uL (p<0.008) by 16 weeks and -246±60 CD8 cells/uL (p<0.04 within group) by 20 weeks in placebo group (n=9). TX had no OIs vs. 20% Ois in PL. ESR with treatment decreased from 19±3 to 11±2 mm/hr between 8th and 16th week (p<0.01) vs. no change in placebo group, 20±5 to 17±4 mm/hr. TX gained +2.0±1.0 lbs vs. -4.0±1.4 lbs. in the placebo (p<0.01). Viral load was measured monthly in a separate group of patients (n=8) with CD4 count of 242±23 cells/uL. Viral decreased from 203,400±106,300 to 105,000±43,500 RNA copies/mL after 16 weeks of treatment, a decrease of 0.3 log unit. When PL patients were crossed over to treament for another 16 weeks, CD4, CD8 counts and viral load stabilized (112,000±19,000 RNA copies/mL) plus weigh loss was reversed. Eight patients completed 11 months of treatment with ending viral loads of 19,500±6,000 and 38% had no detectable virus, with CD4 and CD8 counts stable at baseline values. Twenty-five percent of patients were thrombocytopenic. During their first month of treatment, platelets rose 23% (111,000±22,000 to 136,000±29,000 plt/uL); 57% patients achieved normal values. Two patients enrolled in a single high dilution GM-CSF treatment, rose from 16,000 to 48,000 and 141,000 to 174,000 plt/uL after only one month of treatment.

Results suggest that unknown biophysical mechanisms of high dilutional growth factors/cytokines may exert immunological effects in HIV/AIDS.

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