Moducare use in Bacterial, Fungal, Yeast, Viral and Mycobacterium infections.

Tuberculosis (TB)

In a double-blind controlled study, the use of sterols/sterolins as adjunctive therapy helped TB patients recover faster, gain more weight, and exhibit less inflammation than those taking a placebo.

Donald PR, et al: A randomised placebo-controlled trial of the efficacy of beta-sitosterol and its glucoside as adjuvants in the
treatment of pulmonary tuberculosis. Int J Tuberc Lung Dis 1997; 1: 518-22

 
In an open label study, HIV positive patients with CD4 cell counts above 500 cells/μl  blood and who were not using antiretroviral drug therapy showed stable CD4 cells counts and a decrease in their plasma viral loads after employing the BSS:BSSG mixture for up to 40 months. This group of patients maintained a predominantly TH1 profile indicating that their cell mediated immunity response accounted for both their viral control and prevention of CD4 cell loss.

Human Immunodeficiency Virus (HIV) Study scientific abstract.

Reference: Bouic PJD, Clark A, Brittle W, Lamprecht JH, Freestone M, Liebenberg RW. Plant sterol/sterolin supplement use in a cohort of South African HIV-infected patients—effects on immunological and virological surrogate markers. South  African Med J 2001; 91: 848–50.

Study: In an open label pilot study, 123 HIV positive patients (who were not on any retroviral medications) were given a proprietary mixture of sterol/sterolin supplement (Moducare®) on a daily basis over a period of 39 months. Subjects who participated in this study were evaluated at 0, 1, 2, 3 months and then every four months thereafter for body mass, concomitant conditions (e.g. opportunistic infections), CD4 lymphocyte cell count and viral loads. For study purposes,  patients were stratified into 3 groups based on CD4 counts at the beginning of the trial: CD4 < 200/μl (n = 10), CD4 200 –  500/μl (n = 66), CD4 > 500/μl (n = 47).

Results: Patients with a CD4 count of less than 200/μl showed a significant reduction in the median percentage and absolute numbers of CD4 cells/μl from baseline values of 11% and 134 CD4/μl to 7% and 23 CD4/μl respectively after 21 months. However, despite this first group’s decrease in immunologically active CD4 cells, there was no significant change in the  patients’ viral load from baseline (4.23 log) to the end of the trial (4.60 log) period. Similarly, patients in Group 2 whose CD4 count was between 200 – 500/μl, showed no significant changes in median CD4 percentage (19% at baseline compared to 18.5% at completion), median CD4 count (349 versus 275/μl) and plasma viral load (5.06 log in contrast to 5.15 log) during the 39 months they were evaluated.Like the outcomes seen in the other two groups, patients in the third and most immunologically stable group (CD4 > 500/μl) exhibited no changes in their CD4 immune markers. They did however have a significant reduction in plasma viral load of 1.48 log from 4.59 log at the beginning of the study to 3.11 log at 30 months. Moreover, 15% (7/47) of patients within this group had no detectable plasma viral count after 12 months of therapy with plant sterols/sterolins.

Clinical Summary: Although these results should be confirmed in a controlled clinical trial, HIV positive patients whose CD4 count is above 500/μl may be able to stabilize their CD4 cell counts and reduce their viral load through the judicious use of a plant sterol/sterolin mixture (Moducare®) at a dose of 1 capsule 3 times a day between meals.

Additional reference: Breytenbach, U. et al: Flow cytometric analysis of the Th1-Th2 balance in healthy individuals and patients infected with the human immunodeficiency virus (HIV)  receiving a plant sterol/sterolin mixture. Cell Biol Int 2001; 25, 43-49.

Preparation of the immune system by Immune Modulation

Study: In this paper, the immunological actions of sterols/sterolins (Moducare®) were considered by both in vitro and in vivo experiments. In the first in vitro study, venous blood was drawn from healthy laboratory volunteers and employed as a source of T cells. These T cells were added to cell cultures and incubated along with 3H-thymidine and stimulated suboptimally with a mitogen for 72 hours. Varying concentrations of beta- sitosterol (BSS), beta-sitosterol glucosides (BSSG), and a 100:1 ratio of BSS/BSSG (Moducare®) were then added to these mixtures and laboratory markers of immune response such as T cell proliferation, CD25 and HLA-DR activation, IL-2 secretion, gamma interferon release, and natural killer (NK) cell activity were recorded. In the in vivo portion of the trial, six volunteers ingested one capsule of Moducare® (20mg BSS and 0.2mg BSSG) 3 times a day for four weeks. Two volunteers were given placebo capsules at the same dosing schedule. Blood samples were collected at 0, 1, 2 and 4 weeks. The resulting T cells were incubated with 3H-thymidine and stimulated maximally with the PHA mitogen allowing the researchers to evaluate T cell proliferation at baseline and day 30.

Results: In vitro results demonstrated that although both phytosterols (BSS and BSSG) enhance the proliferative response of T cells to mitogen stimulation at very low concentrations, a 100:1 ratio of BSS to BSSG provided a larger stimulatory effect than could be achieved by the individual phytosterols and sterolins alone. Moducare® at a concentration of 1 μg/ml was able to double the expression of CD25 and HLA-DR activation antigens on T cells, and increase the secretion of IL-2 (ranging from 17 to 23%) and gamma interferon (ranging from 36 to 41%) compared to controls. In addition, the combination of BSS/BSSG (100:1) at 1 μg/ml was consistently more active at stimulating the lytic action of NK cells (effector) on a cancer K562 cell line (target) than BSS or BSSG on their own. Different effector:target ratios were tested ranging from 12,25,50 and 100:1 and for all these cell ratios the BSS/BSSG stimulated NK cells were the most effective.

 In vivo results from the eight volunteers concluded that compared to baseline values, T cell proliferative responses increased from 20 to 920% in those taking Moducare® over 4 weeks compared to a relatively unchanged (–2 to 13%) reaction in the placebo group.

Clinical Summary: The unique combination of plant sterols/sterolins as found in the product Moducare® significantly enhances the laboratory markers of immunity both in vitro and in vivo.