Rx Medical Foods




Pioneering Prescription Medical Nutrition

Our prescription products work to rebalance and restore metabolic processes that have shifted due to specific problems or through the natural course of aging.
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Science

LIMBREL SCIENCE

Limbrel® (flavocoxid) is a prescription medical food product for the clinical dietary management of the metabolic processes underlying osteoarthritis. It is composed primarily of baicalin and catechin, two members of a large class of botanical molecules called flavonoids which are known to have anti-inflammatory properties in addition to many other physiological activities. The components of flavocoxid were identified after screening of hundreds of botanical extracts for inhibitory activity against the primary enzymes involved in the inflammatory response, cyclooxygenase (COX) and lipoxygenase (LOX). After identification of these active molecules, they were extracted, concentrated and the proportions for optimal anti-inflammatory activity determined. The activity of Limbrel is supported by many published peer reviewed scientific and clinical papers describing its molecular mechanism of action, effectiveness, and safety in the management of osteoarthritis in humans. Briefly, Limbrel acts by inhibiting COX-1, COX-2 and 5-LOX in a modest and balanced fashion. Limbrel is also a potent antioxidant that reduces production of inflammatory molecules derived from oxidation of preinflammatory fatty acid molecules. Thus, Limbrel that provides excellent anti-inflammatory activity by modestly and evenly inhibiting four different inflammatory pathways while maintaining a favorable safety profile.

 

Limbrel 500

GOAL: multicenter, open label, post marketing study of flavocoxid a dual pathway inhibitor, anti-inflammatory agent of botanical origin

Within a 'real world' clinical rheumatology practice setting, flavocoxid demonstrated significant efficacy in the management of OA in multiple patient types and displayed significant potential for reducing the possibility of adverse GI side-effects and use of gastroprotective agents associated with more traditional OA medications. A limitation of this study was that it was open-label and not rigorously controlled. The large population may compensate for this lack of control.

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Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee.

Flavocoxid, a first-in-class flavonoid-based therapeutic that inhibits COX-1 and COX-2 as well as 5-LOX, was as effective as naproxen in managing the signs and symptoms of OA of the knee. Flavocoxid demonstrated better UGI, renal (edema), and respiratory safety profiles than naproxen.

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Flavocoxid inhibits phospholipase A2, peroxidase moieties of the cyclooxygenases (COX), and 5-lipoxygenase, modifies COX-2 gene expression, and acts as an antioxidant.

The multiple mechanisms of action for flavocoxid relating to arachidonic acid (AA) formation and metabolism were studied in vitro. Flavocoxid titrated into rat peritoneal macrophage cultures inhibited cellular phospholipase A2 (PLA(2)) (IC(50) = 60μg/mL). In in vitro enzyme assays, flavocoxid showed little anti-cyclooxygenase (CO) activity on COX-1/-2 enzymes, but inhibited the COX-1 (IC(50) = 12.3) and COX-2 (IC(50) = 11.3μg/mL) peroxidase (PO) moieties as well as 5-lipoxygenase (5-LOX) (IC(50) = 110μg/mL). No detectable 5-LOX inhibition was found for multiple traditional and COX-2 selective NSAIDs. Flavocoxid also exhibited strong and varied antioxidant capacities in vitro and decreased nitrite levels (IC(50) = 38μg/mL) in rat peritoneal macrophages. Finally, in contrast to celecoxib and ibuprofen, which upregulated the cox-2 gene, flavocoxid strongly decreased expression. This work suggests that clinically favourable effects of flavocoxid for management of osteoarthritis (OA) are achieved by simultaneous modification of multiple molecular pathways relating to AA metabolism, oxidative induction of inflammation, and neutralization of reactive oxygen species (ROS).

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A medicinal extract of Scutellaria baicalensis and Acacia catechu acts as a dual inhibitor of cyclooxygenase and 5-lipoxygenase to reduce inflammation.

A mixed extract containing two naturally occurring flavonoids, baicalin from Scutellaria baicalensis and catechin from Acacia catechu, was tested for cyclooxygenase (COX) and 5-lipoxygenase (5-LOX) inhibition via enzyme, cellular, and in vivo models. The 50% inhibitory concentration for inhibition of both ovine COX-1 and COX-2 peroxidase enzyme activities was 15 microg/mL, while the mixed extract showed a value for potato 5-LOX enzyme activity of 25 microg/mL. Prostaglandin E2 generation was inhibited by the mixed extract in human osteosarcoma cells expressing COX-2, while leukotriene production was inhibited in both human cell lines, immortalized THP-1 monocyte and HT-29 colorectal adenocarcinoma. In an arachidonic acid-induced mouse ear swelling model, the extract decreased edema in a dose-dependent manner. When arachidonic acid was injected directly into the intra-articular space of mouse ankle joints, the mixed extract abated the swelling and restored function in a rotary drum walking model. These results suggest that this natural, flavonoid mixture acts via "dual inhibition" of COX and LOX enzymes to reduce production of pro-inflammatory eicosanoids and attenuate edema in an in vivo model of inflammation.

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