Moducare Immune Regulator-Modulator-Anti-inflammatory

[Guest guest]

What do you think? Reduces humoral activity :

most studies to date have investigated the ability of Moducare® to control

inflammation or induce a shift from a predominantly humoral immune response to a

more protective cellular response (i.e. TH2 to TH1 shift).

My MD suggested this to help with the " allergic " feelings I was having.

Realizing the immne system is complicated, not sure what to think.

Thanks, Robin

MONOGRAPH: MODUCARE®

http://www.moducare.com/resmonograph.asp

Moducare® is a proprietary mix of plant sterols and sterolins in a clinically

proven ratio of 100:1. This mixture is derived from a natural pine source and is

encapsulated in a base of rice flour. The recommended dosage is one capsule

three times per day to be taken between meals in the absence of any animal fats.

The Moducare® mixture has been shown to have immune modulating properties. It

has been shown, both in vitro as well as in vivo, to have the following

immunological activities:

Enhances the cellular division of peripheral blood lymphocytes when these are

activated by stimuli [1];

Enhances the killing ability/cytotoxicity of specialized cells responsible for

immune surveillance, namely the Natural Killer cells

(NK cells) [1];

Enhances the ability of T lymphocytes to release the factors that ultimately

regulate cellular functions in the body. These T cells

(TH1 helper cells) are antagonist to the activity of other helper cells (TH2)

that promote the functions of B lymphocytes [2];

The mixture of sterols/sterolins has anti-inflammatory properties by switching

off the release of pro-inflammatory factors such as Interleukin 6 (IL6) and

Tumor Necrosis Factor-alpha (TNF-) from activated monocytes [3];

Increases the secretion of IL12, the cytokine released from antigen-presenting

cells that promotes the differentiation of precursor T-helper cells into the

more polarized TH1 cells;

The mixture has adreno-cortical effects by decreasing the cortisol:DHEA ratio

suggestive that it enhances the synthesis of DHEA which ultimately, decreases

the release of cortisol [4].

Numerous clinical studies have shown the efficacy of plant sterols/sterolins in

vivo. Based on the biological activities described above, most studies to date

have investigated the ability of Moducare® to control inflammation or induce a

shift from a predominantly humoral immune response to a more protective cellular

response (i.e. TH2 to TH1 shift). Therefore, studies have been conducted in

several infectious diseases as well as chronic inflammatory conditions and in

models of immune stress. Briefly, these include:

The investigation of Moducare® as adjuvants in the treatment of pulmonary

tuberculosis. This double-blind, placebo-controlled study showed that patients

having received the capsules containing the sterols/sterolins had less

inflammation, recovered from the mycobacterial infection faster (faster

resolution of lung lesions) and recovered their immunological status faster [5].

Other markers of efficacy included higher weight gain. All patients had received

standard anti-tuberculosis therapy.

The sterols/sterolins mixture was tested in a clinical study (double-blind,

placebo-controlled) conducted in marathon runners, a model of the effects of

excessive exercise on the immune system. Such individuals are prone to transient

immune suppression due to the activation of several endocrinological shifts that

ultimately lead to decreased immunity. This study showed that the marathon

runners had less inflammation post event (lower IL6 plasma levels), less

haematological disturbances (less lymphopaenia and less neutrophilia in the

peripheral blood) and maintained their adreno-cortical status compared to their

baseline values [6]. The study thus showed that Moducare® was able to abrogate

the immunological shifts that usually accompany endurance exercise.

The use of the mixture by HIV-infected individuals has been extensively studied

[7]. It has been shown to prevent the decline of CD4 cell numbers (a surrogate

marker of disease progression), decrease the plasma viral loads of patients and

maintain a relatively intact immune profile despite the chronic viral infection.

This implies that the use of the immune modulator by HIV-infected individuals

would prevent the deterioration of the immunity and the maintenance of effective

cellular responses to the virus [8].

In a clinical model of chronic inflammation, Rheumatoid arthritis patients were

followed over a period of 6 months and this study (double-blind,

placebo-controlled) showed attenuation of indices of disease activity due to the

potent anti-inflammatory properties of the sterols/sterolins [9].

In an open-labeled study, allergic rhinitis and sinusitis patients were followed

over a period of 12 weeks and again, the degree of allergic responses showed

significant changes accompanied by clinical improvement and symptomatic relief

of patients. Markers of efficacy included decrease in serum IgE levels, decrease

in the TH2 cell activity, less turbinate hypertrophy and rhinonorea, etc [10].

To date, no drug-drug interactions have been observed in patients using

Moducare®. It is advisable for patients to inform their clinicians of their

intention to use this supplement. It has to be understood that it does not

replace conventional medication, especially those used for life-threatening

diseases. Moducare® should be viewed as an adjunct to help shift the immune

responses to a more balanced status and to control chronic inflammation.

At present, patients having received solid organ or tissue transplants should

avoid the use of this immune modulator. This is based on the ability of the

sterols/sterolins in the current formulation to promote cellular immune

mechanisms, the same mechanisms being responsible for graft rejection.

J.D. Bouic, Ph.D., August 2002

A PILOT STUDY OF THE CLINICAL EFFECTS OF A MIXTURE OF BETA-SITOSTEROL AND

BETA-SITOSTEROL GLUCOSIDE IN ACTIVE RHEUMATOID ARTHRITIS (RA)

Ingrid Louw, Anne Halland, Panaroma Hospital,

http://www.moducare.com/resabstracts.asp?process=view & artID=38

Jacques Desire Bouic, University of Stellenbosch,

Marga Freestone, Essential Sterolin Products (Pty) Ltd,

Johan Lamprecht, University of Stellenbosch

Introduction: The mixture of Beta-sitosterol (BSS) and Beta-sitosterol glucoside

(BSSG) has demonstrated anti-inflammatory activities in vitro, inhibiting the

secretion of IL6 and TNF-alpha from activated monocytes. Both factors are

implicated in the pathogenis of RA.

Objective: Could the BSS:BSSG mixture result in the improvement of active RA as

assessed by ACR 20% response criteria?

Methods: After a two-week placebo run-in phase, patients with active RA were

randomised to receive either 20mg BSS/0.2mg BSSG capsules tid or placebo (225mg

carrier) tid for 24 weeks. Mean demographics of the patient groups were similar.

All patients had active RA as defined by ACR criteria. Stable DMARD doses was

required for 3 months prior to the start and for the duration of the study. No

new DMARD therapy could be initiated during the study. Patient response was

assessed in terms of ACR response criteria (>20% improvement). Significant

changes between active and placebo groups were calculated with the

Kruskal-Wallis 2-sample test. Changes within a group relative to baseline were

calculated with the Wilcoxon rank test.

Results: 18 Patients were enrolled (8 on actives and 10 on placebo). In the

active group, statistically significant changes were measurable in the mean

tender joint count (85% ACR response); patient's assessment of pain (28%

response); patient's global assessment of disease activity (33% response);

physician's global assessment of pain (47%) and the MHAQ decreased (47%

response). The ESR also decreased significantly (56% response). The placebo

group had no significant improvement in the ACR 20% improvement criteria. At 24

weeks, significant differences between groups with regards to tender joint

count, MHAQ, physician's global assessment and patient's assessment of disease

activity were demonstrated. The BSS:BSSG mixture was well tolerated and no

serious adverse events were recorded.

Conclusion: The result of this pilot study, taken with the safety profile of

BSS:BSSG justifies larger double-blind studies in active rheumatoid arthritis

patients.

Abstract presented at Nutrition Week, San Diego, CA Feb.24, 2002 by Dr.

P.J.D.Bouic

http://www.moducare.com/resabstracts.asp?process=view & artID=37

FLOW CYTOMETRIC ANALYSIS OF THE TH1-TH2 SHIFT IN ALLERGIC INDIVIDUALS USING

MODUCARE ™ (STEROLS/STEROLINS)

Myers, L and Bouic, PJD.

Proc. 26th Annu Cong Physiol Soc S. Afr. 1998; Abstract 178.

Study:

A placebo-controlled blinded pilot study was performed on 24 atopic individuals

(mainly pollen sensitivity) over a 12-week period. To determine whether the

balance between TH1 and TH2 CD4 cells differs between allergic and non-allergic

individuals, several laboratory and clinical markers of activity were measured.

Four groups were followed: allergic persons were given either placebo or active

Moducare™ capsules and the lymphokine profile was determined at baseline and

again 4 weeks later. A group of non-allergic persons serving as controls was

similarly formed. Blood lymphocytes were analysed using flow cytometry.

Results:

It was shown that allergic persons exhibited significantly raised IL4 containing

CD4+ cells at

the start of the study when compared to the non-allergic control group. The

intake of

Moducare™ induced a significant decrease in IL4 in both allergic as well as in

the control

groups. It was interesting to note that, unlike the allergic persons, the

non-allergic controls

receiving the sterols/sterolins capsules increased their IFN-y CD4+ cells after

4 weeks of

therapy.

Statistically significant changes occurred with the allergic individuals in the

following: less rhinorea, less turbinate hypertrophy, less post nasal drip

symptoms, lower IgE plasma levels and higher TH1 producing cells. Subjective

improvements were reported by the patients themselves when use of an

international questionnaire was made to record patient symptoms.

Clinical Summary:

The TH1-Th2 response in allergic individuals appears perturbed when compared to

that of

healthy, non-allergic controls. Moducare ™ appears to decrease the synthesis of

IL4 in allergic persons as well as in healthy controls.