Meriva« is a patented formulation
of curcumin, a dietary phenolic, with
soy lecithin (non-GMO)(1).
The two compounds form a non-covalent adduct in a 1:2 weight ratio, and two parts of microcrystalline cellulose are then added to improve formulation, with an overall contents of curcumin of 20%.
Turmeric has a long history of medicinal use, especially to support healthy inflammation(2), and many of its traditional uses have been mechanistically validated in cellular systems as well as in animal models of disease. Indeed, with almost 3000 pre-clinical investigations, curcumin is one of the best investigated products of the whole biomedical literature(2). These studies have demonstrated that curcumin acts as a master switch of inflammation by acting at level of enzymes (COXs and LOs) and transcription factors (NF-kB) level, as well as at their genomic expression(3). However, little clinical evidence of efficacy has so far been reported, and most of the beneficial effects of curcumin are suggested by epidemiological studies, supported by studies in animal models, extrapolated from studies in vitro, but not validated clinically(2). This paradoxical situation is mainly due to the poor absortption of curcumin with a dismally low oral absorption, characterized by plasma concentrations that are barely overcome 50 ng/mL after administration of dosages as high as 12 g/die(4).
Curcumin, just like most dietary phenolics, is sparingly soluble both in water and in oily solvents, but shows polar groups (two phenolic hydroxyl and one enolic hydroxyl) that can interact via hydrogen bondings and polar interactions with complementary group, like the polar heads of phospholipids. Thus, phosphatidylcholine has a highly polarized head, with the negative charge of a phosphate group and the positive charge of the choline ammonium group, and can complex a variety of poorly soluble phenolics, including curcumin(1). By embedding curcumin into the environment of phospholipids, curcumin is shielded from water-triggered degradation while, at the same time, the rapid exchange of phospholipids between biological membranes and the extracellular fluids can shuttle it into biological membranes, boosting its cellular captation.
A 2007 study published in the journal Cancer Chemotherapy
and Pharmacology(5) demonstrated Meriva«'s superior bioavailability compared to a
standardized curcumin extract in rats.
Meriva« improved plasma Cmax and AUC of curcuminoids by 20-fold and levels of curcumin in the liver increased by much more then a 20 folds.
A high oral load of unformulated curcumin (340 mg/Kg) and an amount of Meriva« of 1.8 g/Kg, (corresponding to 340 mg/Kg of curcumin), were administered by oral gavage to Male Wistar rats. The presence of curcumin and metabolites was evaluated at 15, 30, 60 and 120 minutes after administration in plasma, liver and intestinal mucosa. In accordance with previous studies, 99% of curcumin was present in plasma as glucuronides, with the remaining 1% being curcumin sulphate and free curcumin. Complexation with phospholipids led to a marked increase in the concentration of all the plasma curcuminoids (over 23 fold in the case of glucuronides, ca 5-fold in the case of free curcumin, and ca 1.5-fold in the case of sulphates). Since glucuronides are by far the prevailing plasma curcuminoids, the overall bioavailability of curcumin, as expressed in plasma curcuminoids and calculated from AUC values, was improved by over 23-fold when this compound was administered as Meriva® compared to the unformulated natural product.
In a comparative pharmacokinetic study in humans(6), the absorption of each single curcuminoid present in commercial curumin was compared between two dosages of Meriva® (1.0 and 1.9 g, corresponding to 209 and 376 mg of curcuminoids respectively) and one dosage of the corresponding unformulated curcuminoid mixture (1.8 g). The overall increase of curcuminoid absorption from Meriva® was ca. 29-fold (27-fold for the low dosage, 31-fold for the high dose). The increase of curcuminoid absorption was ca 20-fold for monomolecular curcumin, but 50 to 60 fold higher for demethoxycurcumin and bisdemethoxycurcumin, with demethoxycurcumin, and not curcumin, being the major plasma curcuminoid with both dosages of Meriva®. Remarkably, demethoxycurcumin is more potent than curcumin in many assays.
The improved absorption, and possibly also a better plasma curcuminoid profile, might underlie the clinical efficacy of Meriva® at doses significantly lower than unformulated curcuminoid mixtures.
* Normalized AUCs, expressed in ng/mL(plasma) x h/mg ingested, were devided by the AUC of the reference to calculate the relative absorption values.
In a recent registry study(7), Meriva® was evaluated for its efficacy in 50 patients affected by bone health challenge (X-ray diagnosis confirmation).
The symptoms were evaluated by the WOMAC score; mobility was studied by walking performance on the treadmill and the overall inflammatory response function was assessed by measurements of C-reactive protein plasma concentration.
The trial was conducted over a three months’ period, and the patients were randomly divided into two groups receiving
respectively Meriva® 1 g/die (in two separate administrations) and the “best available treatment”, or the “best available treatment” alone, as defined by the patients’ general practitioners or specialists. The treadmill performance (10% inclination, 3 Km/h speed) showed an improvement of 201% of the initial walked distance at two months, and a further improvement (+44%) at three months from the beginning of the study. These positive results were complemented by secondary end-points, namely the decrease in supplemental therapy use (63% in the Meriva® group vs 12% in the treatment group) and the decrease in gastrointestinal complications (38% in Meriva® vs 15% in controls (p<0.05).
In a further registry study(8), the activity of Meriva® for the complementary treatment bone health was further confirmed in a larger and longer (8 months) investigation, that enrolled 100 patients and was, otherwise, methodologically similar to the previous one, including the dosage (1 g/day of Meriva®, corresponding to 200 mg curcumin/day in two separate administrations). The results showed that the Meriva®-treated group enjoyed a statistically significant reduction in all primary clinical endpoints, the Western Ontario and McMaster Universities (WOMAC) score (decreased from 80.6 to 33.2), the Karnofsky Performance Scale (improved
from 73.3 to 92.2), and the treadmill walking performance test. These results were complemented by the evaluation of a series of inflammatory response function markers wider than the one considered in the first study (interleukin [IL]-1b, IL-6, soluble CD40 ligand [sCD40L], soluble vascular cell adhesion molecule (sVCAM)-1, and erythrocyte sedimentation rate [ESR]) that also showed a marked reduction in the Meriva® treated group. Conversely, no significant variation was observed in the “best available treatment” control group.
In a trial on 106 individuals(9) affected by eye health challange since at least 2 years was carried out. A 1200 mg/die dosage of Meriva® was administered (two tablets per day) for at least twelve months, complementing the therapy already in course. 86% of individuals in the Meriva«group enjoyed a subjective improvement of the overall well being after only 4/6 weeks, with a remarkable reduction in eye health challanges number. Also the number of subjects affected by eye health challanges relapses decreased by over 80%. This suggests that the prolonged intake of Meriva®, in association to standard treatment, is useful in supporting ocular health. Furthermore in a recent pilot study, the daily use of 1 g/day of Meriva®, associated with the standard treatment, has shown to ameliorate the visual acuity, supporting healthy vision quality.(10) These results qualify Meriva® as a safe ingredient with a strong potential even in poorly vascolarized tissues as the ocular bulb is.
In another registry study(11), 50 individuals were treated with Meriva® (1g/day) to evaluate its ability to support a healthy circulatory system. Participants were divided in two groups. The first one received Meriva® for 4 weeks while the second group was used as a control. Microcirculation was measured instrumentally (laser doppler flowmetry, pO2) and observationally (evaluation of the foot), after 4 weeks of treatment, the Meriva® group showed an amelioration of all the parameters investigated, as well as a general amelioration of the quality of life, as measured by the Karnofsky scale. Finally in a recent registry study(12) on 61 subjects evaluated Meriva« efficacy in supporting healthy prostate function compared to the best standard management (BSM) available.
Signs and symptoms were evaluated using the International Prostate Symptom Score (IPSS). A first group of 33 subjects were administered with BSM in association with Meriva« at the dosage of 500 mg/day for at least 24 weeks, while the remaining 28 volounteers (control group) were administered with only BSM.
All IPSS scores and quality of life improved in both groups, while in the Meriva« arm were significantly better than in the BSM-only group (p<0.05 for IPSS and p<0.01 for quality of life).
All these results underline the nutritional potential of curcumin as a natural ingredient to address the body’s nflammation response function.
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9. Allegri P., Mastromarino A. Management of chronic anterior uveitis relapses: efficacy of the treatment with oral phospholipidic curcumin. Long term follow-up, Clinical Ophtalmology 2010, 4, 1-6
10. Steigerwalt, R., et al., Meriva(R), a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy. Panminerva Med, 2012. 54(1 Suppl 4): p. 11-6.
11. Appendino G. et al.,"Potential role of curcumin phytosome (Meriva) in controlling the evolution of diabetic microangiopathy. A pilot study" Panminerva Medica 2011, 53 (3 Suppl 1):43-90
12. Ledda A., Belcaro G., Dugall M., Luzzi R., Scoccianti M., Togni S., Appendino G., Ciammaichella G. Meriva«, a lecithinized curcumin delivery system, in the control of benign prostatic hyperplasia: a pilot, product evaluation registry study. Panminerva Med. 2012 54(Suppl. 1 to No. 4): 17-22