Megamin

Megamin has been offered in Europe as a dietary supplement since 1998. Megamin is the brand name for TMAZ (tribomechanical activated zeolite clinoptilolite), a special prepared framework quartz mineral.

Ingredients

Megamin consists of a micronized natural mineral named clinoptilolite, one of numerous zeolites (tectosilicates). Zeolites are oxides with three-dimensional, microporous, crystalline and well-defined structures that contain aluminium, silicon, and oxygen in their regular framework. Cations and water are located in the pores, cavities or channels.

Mechanisms of action

Zeolites act as absorbents, have catalytic properties and are commonly used as ion exchanger in the detergent industry. Zeolites added to livestock feed have been shown to absorb toxins that are damaging and even fatal to the growth of the animals, while the basic structure of the zeolite is biologically neutral. Aquarium hobbyists can find zeolite products in pet stores as they make remarkable binders of ammonia and other toxins. Most municipal water supplies are processed through zeolites before public consumption.

By applying a special procedure, the so-called dynamic tribomechanical activation of zeolite (TMAZ), the properties of clinoptilolite are claimed to be enhanced. It is claimed that the active surface and the electrostatic charge are enlarged and the particle-size is diminished, which in turn increases the capacity of absorption and ion exchange. As a result the mineral is said to act as a strong antioxidant, with the ability to intercept and neutralize free radicals in the human body 1.

Claims of efficacy/alleged indications

For the above reason TMAZ is claimed to sustain the immune system. That is why proponents regard it as potentially useful not only in cancer patients but also in diabetes mellitus, chronic wounds and liver diseases. In particular, the manufacturer advises its use for malignant and haematological diseases. During the application of chemotherapy TMAZ is said to strengthen general health, inhibit adverse effects of cytostatic agents, enhance general physical condition, reduce anaemia, lessen pain and therefore minimize the use of analgesics, reduce vomiting and nausea, improve appetite, weight and hair loss 1– as it is stated at the manufacturer’s homepage2. Furthermore, TMAZ is suggested to exhibit a direct anti-tumour effect 3, 4. The provider claims “best effects” for adenoma, glioblastoma und melanoma 5.

Application and dosage

Megamin is available in powder and capsule form and in different combinations with calcium, magnesium, ascorbic acid and herbal additives (green tea, nettle, pollen), as well as phytochemicals (Lycopenomin). The provider recommends an oral intake of up to 16 capsules (500 mg) per day.

Prevalence of use

According to the manufacturer, from 1997 to 2001, 30,000 patients have taken self-administered Megamin In particular, it claims, 7,000 cancer patients have used the supplement in Austria, Croatia, Germany, Italy and Slovenia 6.

Legal issues/costs

Despite the manufacturer’s claims for the benefits of Megamin, the product is not licensed but is sold as a dietary supplement. Costs are approximately € 100 to € 150/month for the user.

Six overviews and five preclinical trials exist. Only one study was identified as a clinical trial 6, as the majority of the studies were not published by independent scientists. No randomized controlled trials were found.

Clinical trials

The only trial retrieved from PUBMED did not confirm the preclinical assessment on adverse or anti-tumour effects. Ivkovic reported an increase of total antioxidant status by significantly increased CD4+, CD19+, and HLA-DR+ lymphocyte counts and a significantly decreased CD56+ cell count 6.

Case series

The manufacturer reports remissions in 80% of about 250 documented cancer histories within three to five months of treatment with TMAZ (personal communication). Therefore, in 2001 the AGBKT Study Group conducted a best case series 13 in collaboration with the only TMAZ provider 14.

In this study, the provider selected 32 cases of various cancer cases showing the best response to treatment. These were examined subsequently by the AGBKT Study Group. There was a distinct discrepancy between the judgement of the provider and the study group regarding the course of the disease. The provider reported 21 complete remission and 11 partial remission whereas the AGBKT Study Group could only confirm sufficient documentation of partial remissions in six cases, which were attributed to previous or concomitant conventional therapy (chemotherapy or/and radiation). None of these remission cases were exclusively attributable to the effect of TMAZ.

Pre-clinical studies

In in-vivo studies, TMAZ has shown a direct effect on malignant cells. Zarkovic showed a reduction of pulmonary metastases in mice by administration of a combination of doxorubicin and TMAZ 7. Pavelic reported an antimetastatic and immunostimulatory effect (NK-cell-activation and induction of apoptosis) of TMAZ in mice, as well as TMAZ inhibition of protein kinase B and induction of expression of tumour suppressor proteins 8.

TMAZ has shown a potential to improve adverse effects of conventional therapy modalities in rodent models. Muck-Seler reported a decrease of binding to serotonergic receptors in the brain of mice with mammary carcinoma, which indicates a likely antiemetic effect 9. Martin-Kleiner reported an influence of electrolytes and erratic effects on haematopoiesis in TMAZ-treated mice 10. Tatrai could not show any carcinogenic activity of clinoptilolite type zeolite in rats 11.

Because of the absence of controls, the quality of all cited preclinical studies is poor. There is no convincing evidence for the claimed effects by clinical research 12.

The results of preclinical studies and hypotheses put forward for the mode of action are not conclusive and do not provide evidence about pharmacokinetics resorption/elimination) or toxicology in humans. The only clinical trial does not prove any claimed anticancer effect.

According to the provider, Megamin can “stimulate the immune system by activating T-cells” 5. Paradoxically it also binds T-cell-receptors and –antigens in autoimmune diseases resulting in death of the T-cells“ 5.

In addition it remains unclear, in what way the antioxidant properties can take effect, since the manufacturer claims that the “particles do not enter the body in high concentrations”. TMAZ shall rather “be taken up by lymphoid tissue into liposome” (personal communication with the provider).

Digestibility

Extensive studies have been carried out on the synthetic zeolite A due to its use in consumer products. These studies have demonstrated that type A zeolite is essentially non-toxic via oral, dermal, ocular, and respiratory routes of exposure 15.

Clinoptilolite, the natural zeolite contained in Megamin, was studied thoroughly as well and according to the provider is non-toxic 7, 8 . But only preclinical toxicological research exists about TMAZ, which showed no harm to animals 8. Toxicological research in humans has not been performed; harm to humans cannot therefore be excluded.

Pharmacokinetics / pharmacodynamics

Regrettably, no data are available on the gastrointestinal resorption or oral bioavailability of TMAZ in humans. No clinical research on pharmacokinetic exists. There are several potential dangers that can be associated with TMAZ:

1. Ion exchangers containing zeolites are well known for being used as water softeners – this softening process is due to exchanging sodium for calcium. Because of the different ways sodium can bind to trace elements a deficiency of potassium, sodium, selenium, iron, calcium, magnesium etc could occur in humans, if there is no enteral absorption of the TMAZ-complex.

In the same way, trace elements like potassium, selenium, iron, calcium, magnesium etc could be exchanged for sodium (which is bound to TMAZ). If there is no enteral resorption of these formatted TMAZ-trace-element-complexes, the deficiencies of trace elements will result. Such deficiencies can cause diseases, e g anaemia (due to deficiency of iron) or hypocalcaemic hyperventilation (due to deficiency of calcium).

2. On the other hand, there are data that clinoptilolite can bind/remove ammonia or toxins, whereby it could possibly have a positive effect, for instance, in liver diseases 16,17. But for that reason interactions with (orally taken) medicine or drugs are plausible by binding, catalysis or ion exchange catalyzed by TMAZ. This again causes reduced effects of the respective drug/medicine.

3. In contrast to this, if there should be any considerable resorption of TMAZ bound with calcium, calcification of blood vessels (with consecutive diseases like arteriosclerosis, coronary heart disease, occlusive arterial diseases etc.) or homeostasis disorder (hypercalcaemia) is possible, because the exchange process is reversible 18.

Carcinogenetic / teratogenitic effects

Data exist that clinoptilolite exhibits carcinogenic activity if it is inhaled 19, 20, although there are preclinical suggestions disproving this 11. No long-term observations exist. Furthermore, there are no reliable data available about TMAZ use during pregnancy or breastfeeding. Pavelic reported a decreased pup’s weight and consequently a higher mortality of pups of mice treated with TMAZ during pregnancy. The author points to an increased number of pups per litter as the reason for this 8.