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Dr. Guy Chamberland, PhD, Master Herbalist Health Professional Summary: DEVIL’S CLAW ROUTE OF ADMINISTRATION : oral DOSAGE FORM / STRENGTH: Tablet of 500 mg extract, equivalent to 2 g of the dried secondary root of Devil’s Claw (Harpagophytum procumbens) ACTIVE INGREDIENT: Extract standardized to 5% harpagoside. Contains 25 mg of harpagoside per tablet. NON MEDICINAL INGREDIENT: Nutrateric®: proprietary enteric coating THE ENTERIPHYTE Nutrateric® ADVANTAGE Enteriphyte’s Devil’s Claw from Curaphyte Technologies is coated with a proprietary enteric coating (Nutrateric®). Enteric-coated tablets are used to maintain efficacy despite exposure to gastric acids since harpagosides, the active ingredients, are considered unstable in gastric juices. This coating allows for a delayed-release in the small intestines and prolongs the period of exposure of the herb’s benefits. The enteric coating also acts to protect the patient by minimizing adverse effects, such as GI upset and digestive distress. INDICATIONS Devil’s Claw is indicated for use with patients suffering from acute and chronic pain. Devil’s Claw is a natural NSAID with COX-2 inhibition properties. Over 23 clinical trials have been performed in patients with osteoarthritis, rheumatoid arthritis, or lower back pain using Devil’s Claw. CLINICAL USE Low back pain: According to published clinical trials, between 2 to 9 grams total of dried secondary root (or equivalent amounts of an extract) were administered in 2 or 3 doses daily. Each tablet of Devil Claw’s PLUS contains the equivalent of 3.7 grams of dried secondary root. Osteoarthritis: For treatment of painful osteoarthritis, a duration of two to three months is recommended. According to published clinical trials, 2 to 2.6 grams of dried secondary root (or equivalent amounts of an extract) were administered in 2 or 3 doses daily for up to two months. Each tablet of Devil Claw’s PLUS contains the equivalent of 3.7 grams of dried secondary root. Trials demonstrated equivalence: Dr. Guy Chamberland, PhD, Master Herbalist Osteoarthritis: knee and hip 57 mg harpagoside/day vs. 100mg Diacerhein Low back pain: 60 mg harpagoside/day vs. 12.5 mg Vioxx Rheumatoid arthritis: 60 mg harpagoside/day vs. Phenylbutazone (300mg/day for days: 1-4; 200mg/day for days: 5-28) MODE OF ACTION Anti-inflammatory properties: Extracts of DC demonstrated anti-inflammatory properties in animal models of acute inflammation/pain. Harpagoside inhibited both arachidonic acid metabolism pathways. Down regulation of iNOS expression in rat mesangial cells by Harpagophytum extracts has been reported. Extract prevented TNF-alpha synthesis; the latter, however, having a greater inhibitory effect on COX-2 pathway products. Extracts showed inhibitory effects on phorbol ester-induced COX-2 expression in mouse skin, as well as inhibition of TPA-induced COX-2 expression in human breast epithelial cells and in mouse skin. Extract was able to suppress enhanced production of matrix-degrading enzymes (matrix metalloproteinases) via the inhibition of the synthesis of inflammatory cytokines has also been reported. Analgesic properties: Administration of 20mg/kg of harpagoside produced an analgesic effect similar to that of phenylbutazone at 50mg/kg. PHARMACODYNAMICS / PHARMACOKINETICS In a blood sample taken from a human two hours after ingesting a Devil’s Claw extract containing 44 mg harpagoside, the harpagoside level was 15.4 ng/ml. Oral administration of 600 mg extract containing 25% harpagoside led to plasma levels of 32.3 ng/ml after 1.3 hours, which, subsequently, rapidly decreased. A second peak was observed after 8 hours. Harpagoside elimination half-life has been reported as 5.6 hours. CONTRAINDICATIONS: Do not use during pregnancy or breastfeeding as lack of evidence does not support safe use. PRECAUTIONS General: known allergy/hypersensitivity to Devil's claw. Some of the adverse effects of Devil's claw may be attributable to allergic rather than dose-dependent effects. Cardiovascular: use cautiously in patients with heart disease, especially patients with arrhythmias or taking antiarrhythmic agents, due to potential negative inotropic effects of Devil's claw. In rabbits, Devil's claw has been associated with negative chronotropic, as well as positive and negative inotropic effects. However, these effects have not been clearly documented in humans. Gastrointestinal: GI side effects have been reported in some individuals receiving Devil's claw in studies, including mild gastrointestinal upset, diarrhea, anorexia, or loss of taste. Enteric coating was not used in those studies. Drug interactions: no cytochrome P450 induction or inhibition. STORAGE: Devil’s Claw Plus tablets should be stored at room temperature (15 to 25 degrees Celsius).