High Dilution Growth Factors/Cytokines: Positive Immunologic, Hematologic and Clinical Effects in HIV/AIDS Patients
Barbara Brewitt, PhD; Leanna Standish, PhD, ND, MS, LAc, 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.
