Medical Food for

Osteoarthritis

Medical Foods   An FDA regulated category of products that are intended

for the dietary management of a disease or condition that has distinct nutritional requirements.   FDA category in between dietary supplements and drugs

  Used under supervision of a medical professional

  Requires a higher level of science than dietary supplements   Adequate to justify the claim that they are beneficial for

management of a disease or condition

  Ingredients must be Generally recognized as safe (GRAS)

Medical Food for Osteoarthritis

NSAID Side Effects   GI complaints – nausea, heartburn,

dyspepsia, abdominal pain

  May occur in up to 40% patients with chronic NSAID use

  Bleeding ulcer

  Kidney damage that may persist even after drug withdrawal

  Cardiovascular events (MI, stroke)

  Congestive heart failure

  NSAIDs responsible for ≈19% of hospital admissions with CHF

  The burden of illness from NSAID-related CHF may exceed that from gastrointestinal tract damage.

  Hospitalization and death:

  Approximately 107,000 patients are hospitalized annually for NSAID-related GI complications

  At least 16,500 NSAID-related deaths occur each year among arthritis patients alone

  Statistics do not include deaths ascribed to the use of over-the-counter NSAIDS

Acetaminophen side effects:

  The leading cause of acute liver failure

  Kidney toxicity

“A large majority of patients with serious GI complications due to NSAIDs do not even have preceding mild side effects.” - Arch Inter Med. Vol. 156;1530-1536; July 1996

Normal Ulceration

Dyspepsia

Renal Dysfunction

Edema

Hypertension

CV Dysfunction

No Treatment Traditional NSAIDs COX-2 Inhibitors

COX-1 COX-2 5-LOX 5-LOX 5-LOX COX-1 COX-1 COX-2 COX-2

AA AA AA

Arachidonic Acid Metabolism

Burnett et al., 2006

Reduced Inflammation; Virtually No Side Effects with Flavocoxid (mixed extract of natural flavonoids)

DIET

ANTIOXIDANT

Products  Ra,o  of                              

COX-­‐1/COX-­‐2  inhibi,on  

Inhibits  5-­‐LOX   An,oxidant     Side  Effects  

                   

Aspirin   15:1   NO   NO   causes  blood  thinning,  reduces  GI  repair  

Ibuprofen   8:1   NO   NO  increases  blood  pressure,  

dyspepsia,  GI  bleeding,  inhibit  mitochondrial  func>on  

                   

Flavocoxid   1:1   YES                                                                                                                                                          

YES  ORAC=5,517  

virtually  no  side  effects  observed  in  clinical    trials  

                   Rofecoxib   1:250   NO   NO   increases  blood  cloAng,  risk  of  

heart  aCack  Celecoxib   1:432   NO   NO  

Acetaminophen  No    

COX1/COX2  inhibi>on  

NO  NO  

(depletes  glutathione)  

liver  toxicity  

As Effective as Naproxen in Managing Knee Osteoarthritis

…without the negative side effects

Flavocoxid 500 mg BID

Benefits of Arthroben™

  Reduces inflammation   Balanced inhibition of COX-1, COX-2, 5-LOX

  Offers potent antioxidant protection to reduce joint deterioration

  Increases joint mobility and function

  Stimulates joint repair, and provides nutritional building blocks for cartilage, ligaments (and skin)

  Not associated with the negative side effects that are commonly seen with NSAIDs & other drugs

  Safe for patients on warfarin (Coumadin)   Little or no effect on prothrombin times (PT)

Serving size 20 g

Flavocoxid 250 mg

Fortigel 5.0 g

Verisol 2.5 g

Recommended Use   Mix 11 grams (approx. 1 1/2

tablespoons) in 8 ounces of water

  1 serving daily   Initially may use 2 servings daily

(loading phase)   2 to 12 weeks depending on

patient response

ArthrobenTM is available in a delicious tasting apple flavored

powder

Patient Education Materials

Understanding Osteoarthritis

SpineLumbar vertebrae

Changes in joint shape

cause painful compression

of surrounding nerves

What is osteoarthritis?

Osteoarthritis (OA), also called degenerative joint disease or osteoarthrosis, is the most common form of

arthritis, currently affecting as many as 40 million people in the U.S. It is characterized by a gradual loss of

cartilage and overgrowth of bone within one or more joints. The cartilage surface, once firm and smooth,

becomes soft, rough and irregular. Erosion of cartilage may continue until bony surfaces come in contact with

each other. OA can occur in almost any joint, most commonly the knees, hips, spine, hands or feet.

What causes osteoarthritis?

OA is a slow, progressive disease that begins at the cellular level in the joint cartilage, often with a traumatic

event. The exact cause of cartilage deterioration is unknown, but is generally related to single or repetitive

injuries, normal wear and tear over time and chemical changes within the joint.

Spine

Elbow joint

Hip

Wrist and finger joints:

Carpometacarpal

Metacarpophalangeal

Interphalangeal

Areas affectedby arthritis

Ankle and foot joints:

Metatarsophalangeal

Temporomandibular joint (TMJ)

Shoulder joint

Knee

Anatomical artw

orkand

text ©2013

ScientificPublishing, Ltd., Elk

Grove

Village, IL. USA

Joint capsule

Synovium

Synovial fluid

Articular cartilage

Ligament and muscle

Periosteum

Spongy bone

Compact bone

KneeCross section (patella removed)

Healthy Knee

B

C

D

E

F

G

A

A. Bone cyst

B. Stretched and weakened joint capsule

C. Death of superficial layer of exposed bone

D. Irritated synovium with fragments of deteriorating cartilage

E. Inhibited nutrient delivery (from damaged synovium and

decreased use of joint due to pain)

F. Attempted cartilage repair by synovium

G. Increased friction from failure of formation of lubricant film

Bone spurs (osteophytes)

Cartilage damage

Head of femur

Femur

Ilium

Sacroiliac joint

Cartilage erosion of the articular

surface of the acetabulum

HipCoxal joint

Humeral head

Cartilage damage

Loss of joint space

Humerus

Scapula

Clavicle

ShoulderGlenohumeral joint

Why can most NSAIDS cause serious side effects?

The main reason why most NSAIDS (nonsteroidal anti-inflammatory drugs), prescription or OTC

(over the counter), can cause serious side effects is their mode of action – how they work.

NSAIDS include traditional NSAIDS and selective COX-2 inhibitors. Both are designed to relieve

OA symptoms by inhibiting the COX-1 and COX-2 enzymes that produce key inflammatory

molecules. However, these molecules also have other functions, such as protecting the stomach

lining or keeping blood vessels open. Excessive inhibition of the COX enzymes may destroy the

necessary balance between these molecules or reduce their levels below what is required for

other normal body functions.

NSAIDS do not control production of all inflammatory molecules that contribute to side effects.

In addition to the two COX pathways, 5-LOX or the leukotriene pathway is a critical part of our

body’s inflammatory response system. Many people have heard of leukotrienes because of their

roles in upper airway inflammation (asthma). Leukotrienes also lead to inflammation and damage

to the joints, as well as harming other vital organs in our body. Because NSAIDS do not inhibit

5-LOX, they leave leukotriene levels unchecked, and therefore potential side effects can arise.

What can I do to minimize the side effect risks for me?

It is possible to minimize side effects. Your practitioner can work with you to weigh the benefits and risks of any therapy

for your OA. Follow your practitioner’s directions on lifestyle changes and non-medicinal approaches, such as heat and

massage. Always tell your practitioner what non-prescription and other prescription medications you are taking. Ask

your physician what possible side effects you should be aware of from your prescriptions. When evaluating a

prescription for osteoarthritis, ask your physician if it is an NSAID and if it works on the 5-LOX or leukotriene pathway.

Once osteoarthritis occurs, what sustains it or

makes it worse?

OA may worsen due to continued wear and tear, including excess weight bearing or overuse

of the joint. However, our body’s self-repair system might also be to blame. When joints are

damaged, the body starts an inflammatory response which, itself, can damage cartilage. There

are many inflammatory molecules in an OA joint. Of these, some of the most important are

produced by the commonly recognized enzymes cyclooxygenase 1 and 2 (COX-1, COX-2)

and 5-lipoxygenase (5-LOX).

Normal joint

Cartilage

Joint space

Affected joint

Bone spurs (osteophytes)

Cartilage damage

Loss of joint space

Foot1st metatarsophalangeal joint

Arthroben is a medical food for the dietary management

of osteoarthritis and musculoskeletal inflammation related to athletic or other physical activity

What therapies are available for osteoarthritis?

Currently there is no cure for OA, but a great deal can be done to manage the disease and improve functional

abilities to perform daily activities. Always follow your physicians’ directions on diet and exercise, which could

be the most important elements of OA therapy.

Acetaminophen is typically the first medication used to relieve pain. NSAIDS (nonsteroidal anti-inflammatory

drugs) are the commonly prescribed medications. Most NSAIDS are about equally effective, but some patients

may respond better to one NSAID or another. In some cases, cortisone can be injected directly into a joint to

relieve pain. However, cortisone and most NSAIDS can cause serious side effects. A prescription product

containing only natural ingredients is gaining support from more physicians as a first prescription

choice because it has very few side effects. When all other methods fail, surgery might become an option.

Surgery can range from modifying a joint to completely replacing a joint with an artificial one.

Bone spurs (osteophytes)

Cartilage damage and loss of joint space

WristCarpometacarpal joint

Bone thickening

Cartilage damage

and loss of joint space

Bone spurs (osteophytes)

HandDistal interphalangeal joint

Bone spurs (osteophytes)

Cartilage damage and

loss of joint space

Bone thickening

The freedom to move.

The power to heal.

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