Description

NEO- 100% NATURAL PAIN RELIEF™    60 CPS                

 Help relieve pain, swelling and inflammation (anti-inflammatory)

Aide à soulager la douleur, l’enflure et l’inflammation mineures

NPN : 80083967

[60 Capsules]                                   [610 mg]

Palmitoylethanolamide (PEA),           

TREATING THE PAIN FROM THE SOURCES

 Help relieve pain, swelling and inflammation

                                 (Anti-inflammatory)        

• Effective relief from chronic inflammation
• Provides natural pain relief
• Helps prevent damage caused by persistent inflammation
• Highly bioavailable Ultra micronized Palmitoylethanolamide + Bromelain

 

NEO-100% NATURAL PAIN RELIEF™ contains a patented form of Palmitoylethanolamide (PEA), and bioactive Bromelain that have been studied for their inflammation reducing properties. All these purest ingredients work together to help prevent abnormal inflammatory response, reducing pain and preventing chronic inflammation from the sources.

 

SUPPLEMENT FACTS
Serving Size: 1 Veggie Capsule
Pain formula
PEA (Micronized powder) Palmitoylethanolamide Bromelain ( 2000 DGU/g) Equivalent at 24 000 FCC papain units per dose	600 mg 10 MG (24000 FCC)

 

Non medicinal ingredients: Capsule: Microcrystalline cellulose, Hypermellose

SUGGESTED USE: Helps relieve pain, swelling and inflammation (anti-inflammatory)

Recommended Dose: Take 1- veggie-capsule twice daily, or as directed by your health care professional.

Dosage recommandée : Prendre 1  capsule végétarienne deux  fois par jour ou selon les directives de votre professionnel de la santé.

Duration of Use: For use beyond 2 months, consult a health care practitioner.

Durée d’utilisation : Pour utilisation au-delà de 2 mois, consulter un praticien de la santé

CAUTION: Consult a health care practitioner if symptoms persist or worsen. If you are pregnant or breastfeeding, If you have a gastrointestinal lesion/ ulcer, are taking an anticoagulant/ blood thinner, anti-inflammatory or antibiotic, or are having surgery, consult a health care practitioner prior to use.

Contraindications:

(With Bromelain) Mild gastrointestinal symptoms (nausea, vomiting, or cramping) or rare allergic reactions have been known to occur in which case, discontinue use.

Inflammation – A Self-defense Process

Inflammation is a necessary process for survival of any species during infection, injury, damage and repair but persistent inflammation is the cause of numerous diseases. In healthy tissue there is a balance between agents that promote inflammation and those that block it. When there is an infection or injury, the pro-inflammatory agents (like tumor necrosis factor, interleukins, NF- kappaB etc) rally to eliminate the infection or damage and return the tissue to health. When health is restored, these pro-inflammatory agents return to normal levels. In some cases however, the immune system switches from an acute mode to chronic, low grade- inflammation that can persist for months or years. Low grade chronic inflammation is a feature of many chronic diseases including, atherosclerosis (damage of blood vessels), arthritis, diabetes, kidney disease, high blood pressure, cancer and even obesity!

Tackling Persistent Inflammation

One way is through the use of natural anti-inflammatory agents. Unlike the pharmaceutical agents, the natural agents have multiple benefits including: non-specificity, multiple mechanisms of action, considerably lower toxicity, synergistic action and many of these herbs have been used for hundreds of years. However, many of these natural ingredients are inherently poorly absorbed and therapeutic concentrations are difficult to achieve in tissues. Happy Biopharma Inc. is pleased to introduce a novel and a powerful formula for addressing chronic inflammation.

NEO-PAIN RELIEF™ is a multiple ingredient formula with powerful, and patented ingredients that have been clinically studied. Moreover, these natural ingredients are subjected to a unique and safe process (industry first) that forms ultra-micronized particles that are small enough to easily penetrate the intestinal lining and enter the blood thereby considerably enhancing the absorption and bioavailability of these ingredients. The proof of course is in the results.

 

Each Veggie-Capsule of NEO-100% natural PAIN RELIEF™ contains:

– Palmitoyl Ethanolamide (PEA)

The discovery that palmitoylethanolamide, a member of the N-acylethanolamine family which is produced from the lipid bilayer on-demand, is capable of exerting antiallodynic and anti-hyperalgesic effects by down-modulating both microglial and mast cell activity has led to the application of this fatty acid amide in several clinical studies of neuropathic pain, with beneficial outcome and no indication of adverse effects at pharmacological doses.

Collectively, over 3000 research studies have confirmed that palmitoylethanolamide act as a disease-modifying agent for controlling inflammatory responses and related chronic and neuropathic pain.

 

PEA: mechanism(s) of action

The mechanism(s) underlying PEA action in NP remain to be fully defined. PEA, however, appears to function as an anti-inflammatory and pain-reliever with more than one ‘‘modus operandi’’, and able to modulate the ‘‘endocannabinoidome’’ in a safer and more therapeutically efficacious way (Maione et al. 2013). In 2005, the transcription factor peroxisome proliferator activated receptor alpha (PPAR-a) was identified as one possible target mediating the anti-inflammatory actions of PEA (LoVerme et al. 2005a, b).

 

-Bromelain (2000 DGU/gr)

Bromelain is derived from the stem of the pineapple plant (Ananas comosus).1

The pineapple protease, bromelain, selectively inhibits the biosynthesis of proinflammatory prostaglandins, apparently by indirect action.

Experimental and clinical studies reveal that Bromelain exhibits anti-inflammatory properties, which include:

1. a) Inhibition of the biosynthesis of pro-inflammatory prostaglandins and induction of prostaglandin E1 (which tends to inhibit inflammation)
2. b) Activation of proteolytic activity at sites of inflammation and fibrinolysis activity via the plasminogen-plasmin system (Bromelain stimulates the conversion of plasminogen to plasmin, which in turn activates fibrinolytic activity, dissolving fibrin-based clots and reducing swelling).
3. c) Bromelain has also been shown to reduce plasma kininogen levels, which inhibits the production of kinins. Kinins are known to cause inflammation, swelling and pain.

 

Clinical Application

• Anti-Inflammatory Agent For Arthritis

In clinical trials, PEA and Bromelain supplementation has been shown to reduce swelling and pain in patients with rheumatoid and osteoarthritis. In one study, twenty-five patients with severe rheumatoid arthritis, three patients with osteoarthritis and one patient with gout who had residual joint swelling and impaired mobility following long-term corticosteroid therapy, were given Bromelain (20 to 40 mgs, 3-4 times daily). Twenty-eight percent of patients reported excellent improvement in regards to swelling and pain, forty-five percent had good results, fourteen percent had fair results and fourteen percent had poor results, including the patient with gouty arthritis.

 

• Sports Injuries and Blunt Injuries to the Musculoskeletal System

The effect of orally administered Bromelain or the reduction of swelling, bruising, healing time, and pain following various surgical procedures has been demonstrated in several clinical studies. In the study by Tassman, et al, after oral surgery, swelling decreased within 3.8 days with Bromelain, compared with 7 days for the placebo in a double-blind study. In the same study, pain duration was reduced within 5.1 days in the Bromelain group, compared with 8.1 days in the placebo group.

• Neuropathic pain

Background and currently available therapeutics (and why we need something better)

Neuropathic pain (NP), as defined by the International Association for the Study of Pain, results from damage or disease affecting the somatosensory system (Jensen et al. 2011). Depending on localization of the lesion or disease, peripheral or central NP may take place. The former can be caused by various diseases (e.g., diabetes mellitus, herpes zoster, human immunodeficiency virus infection), medical interventions (e.g., chemotherapy, surgery), and injuries (e.g., brachial plexus avulsion). In addition, pain associated with particular disorders, i.e. osteoarthritis and pelvic diseases correlated to chronic pain, exhibits both neuropathic and inflammatory components (McDougall and Linton 2012; George et al. 2012). Central NP states are most often caused by stroke, spinal cord injury or multiple sclerosis (Kerstman et al. 2013). Individuals suffering from NP experience compromised health and quality of life worse compared to patients with severe chronic diseases. In peripheral NP, or painful neuropathy, the chronic pain is not a symptom of injury, but rather the pain is itself the disease process. Data emerging from recent epidemiological studies show that NP is more common than previously thought, with a significant health and economic impact (Smith and Torrance 2012). Approximately, 3–4.5 % of the global population is affected by NP, with the rate of incidence increasing as the global population ages (Toth et al. 2009; Smith and Torrance 2012).

A wide range of analgesic medications are currently marketed. Tricyclic antidepressants, dual serotonin/norepinephrine reuptake inhibitors, calcium channel a2-c ligands (i.e., gabapentin and pregabalin), and topical lidocaine are recommended as first-line treatment options on the basis of the results of randomized clinical trials, with opioid analgesics and tramadol generally as second-line treatments (Dworkin et al. 2010). Despite the numerous treatment options for relieving NP, less than half of all patients experience clinically meaningful pain relief, which is more often than not only partial (Mao et al. 2011). Patients frequently experience major adverse effects which lead to discontinuation of treatment. Clearly, there is a strong need for novel analgesics that are more effective and safer than existing drugs when used over a long period (Nightingale 2012; O’Connor 2009; Langley et al. 2013 Many investigators now believe that new strategies for improving pain management should focus on developing drugs targeting the underlying mechanism(s) of pain, rather than pain intensity only (Varrassi et al. 2011; Dworkin et al. 2010; Dworkin 2012). An important development in this direction has been the discovery that initiation and maintenance of NP involve communication between neurons and non-neuronal immunocompetent cells, such as mast cells and microglia, together with a cascade of pro and anti-inflammatory cytokines (Ren and Dubner 2010; Calvo et al. 2012; Sacerdote et al. 2013). Lesion or disease of the somatosensory nervous system not only profoundly alters the function of primary sensory neurons and their central projection pathways, but is associated also with a robust immune response at virtually every level of the somatosensory system. Mast cells are immune cells particularly located within tissues at the boundary of the external environment, in close proximity to blood vessels and nerve endings (Tsai et al. 2011). A close association between mast cells and neighboring sensory nerves has long been recognized (Levy et al. 2012; Forsythe and Bienenstock 2012).

Palmitoylethanolamide: an N-acylethanolamine with anti-inflammatory and pain-relieving properties

Given the risks posed by inflammation to the organism, it would not be unreasonable to expect that nature may have endowed us with the capacity for auto-defense. Indeed, we now know that pathways exist which are capable of generating molecules involved in such protective mechanisms, being activated following different types of tissue damage or stimulation of inflammatory responses and nociceptive fibers. Chronic inflammatory processes such as those sustaining NP are opposed by a program of resolution that includes the production of lipid mediators able to switch off inflammation (Serhan and Savill 2005; Buckley et al. 2013). Given that chronic inflammatory conditions may lower the levels or actions of these molecules (Zhu et al. 2011), it can be argued that administration of such lipid mediators might provide an avenue ‘‘to commandeer Nature’s own anti-inflammatory mechanisms and induce a ‘‘dominant’’ program of resolution’’ (Tabas and Glass 2013).

CLINICAL STUDIES WITH P.E.A

PEA treatment in chronic lumbosciatalgia was accompanied by a significant reduction in non-steroidal anti-inflammatory drug use (Canteri micronized PEA was demonstrated in a large number of (more than 600) patients suffering from chronic pain caused by different etiopathogeneses, including nerve root compression, osteoarthritis, postherpetic neuralgia, diabetic polyneuropathy, pain associated with chemotherapy induced neuropathy, among others—suggesting the PEA effect to be independent of pain etiopathogenesis (Gatti et al. 2012). In multiple myeloma patients undergoing treatment with thalidomide/bortezomib and having painful neuropathy, a 2-month treatment with micronized PEA (300 mg BID) led to a reduction of pain intensity paralleled by a partial improvement of neurophysiological function of all myelinated fiber groups (Truini et al. 2011). PEA treatment also improved electrophysiological parameters in patients with carpal tunnel syndrome (Conigliaro et al. 2011) also when occurring in patients with diabetes (Assini et al. 2010). Chronic pain associated with diabetic neuropathy is reported responsive to treatment with micronized PEA (Schifilliti et al. 2013), as is pudendal neuralgia (Calabro` et al. 2010), and chronic pain associated with vestibulodynia (Murina et al., 2013)—endometriosis (Indraccolo and Barbieri 2010; Cobellis et al. 2011; Giugliano et al. 2013), or adolescent dysmenorrhea (Fulghesu et al. 2010). In patients afflicted by chronic temporomandibular joint pain.

 

CAUTION: Consult a health care practitioner if symptoms persist or worsen. If you are pregnant or breastfeeding, If you have a gastrointestinal lesion/ ulcer, are taking an anticoagulant/ blood thinner, anti-inflammatory or antibiotic, or are having surgery, consult a health care practitioner prior to use.

Contraindications:

(With Bromelain) Mild gastrointestinal symptoms (nausea, vomiting, or cramping) or rare allergic reactions have been known to occur in which case, discontinue use.

 

References:

Tausssig SJ et al. Bromelain, the enzyme complex of pineapple (Ananas comosus) and its clinical

application. An update. J Ethnopharmacol. 1988;2:191-203

2. Ako H et al. Isolation of fibrinolysis enzyme activator from commercial Bromelain. Arch Int Pharmacodyn.

1981;254:157-67

3. Taussing S. The mechanism of the physiological action of Bromelain. Med Hypothesis 1980;6:99-104
4. Seligman B. Bromelain: an anti-inflammatory agent. Angiology. 1962;13:508-10
5. Pirotta F et al. Bromelain – a deeper pharmacological study. Note I. Anti-inflammatory and serum

fibrinolytic activity after oral administration in the rat. Drugs Exp Clin Res. 1978;4:1-20

6. Tassman G et al. Evaluation of a plant proteolytic enzyme for the control of inflammation and pain. J Dent

Med 1964;19:3-77

An Innovative Natural Health Solution

HAPPY BIOPHARMA inc.                                                                CALGARY, AB T2K 6J1, CANADA

www.happybiopharma.com                                                        info@happybiopharma.com