How many of your patients or customers (If you are a pharmacist) chronically administer either NSAIDs or prescription options in attempt to control their pain?

The business of pills for pain, whether over the counter or prescription is staggeringly large.

Millions of patients and sufferers deal chronically with joint pain or headache pain.

The chronic use of analgesics is accompanied by a host of well Known and described health risks and side-effects.

Chronic use of NSAIDs can cause bleeding, ulcers, increased risk of coronary events, liver failure, kidney failure, hemorrhagic stroke and in the case of headaches/migraines, over-use of NSAIDs and prescription acute drugs, an increase in the frequency of headaches referred to as MOH (medication over-use headaches).

Certain of the prescription drugs available to treat migraine pain work by agonizing serotonin receptors and narrowing blood vessels. This mechanism is potentially dangerous to people with coronary artery disease or angina.  Unfortunately, so much of CAD is undiagnosed, making it difficult to measure who truly is at risk.

THE INGREDIENTS:  Ginger, Boswellia, Feverfew, Magnesium

Ginger  

A side by side clinical study, published in the Journal of Phytotherapy Research (May 2013) comparing the efficacy and side-effects of the ginger phytochemical component to a popular triptan drug for ablative treatment in chronic migraines sufferers, demonstrated that the  phytochemical was equally as effective in pain reduction or elimination within 2 hours of administration, as the triptan but with little or no side-effects.

Furthermore, the ginger phytochemical demonstrated  a P2Y12 anti-platelet mechanism  with no reported bleeding risk as well as  Cox-1/Cox-2/ 5 Lipooxygenase inhibition  anti-inflammatory mechanisms of action, which distinguished it from NSAIDs. Dual inhibitors of cyclooxygenase and 5-lipoxygenase may have a better therapeutic profile and have fewer side effects than non-steroidal anti-inflammatory drugs.

In regards to arthritic knee pain, the ginger phytochemical, as a monotherapy, in a randomized clinical trial published in the Journal of Arthritis and Rheumatism Nov. 2001 of 247 arthritis patients with knee pain was found to reduce knee pain in a statistically significant manner. Both knee pain on standing and secondary efficacy variable showed a consistently greater response in the active group. Decreases in the Western Ontario and Mcmaster Universities composite index of approximately 30% were recorded, as did the use of rescue medication in the active ginger group. Mild and transient GI side-effects were higher in the active group.

Finally, in addition to the analgesic benefits of the ginger phytochemical, a clinical study of Type-2 diabetics, published in THE INTERNATIONAL JOURNAL OF FOOD SCIENCES AND NUTRITION (Feb. 14, 2013)  demonstrated broad and  substantial glycemic control benefits in type 2 diabetics. Clinically and statistically significant reductions of several markers were reported:

1-     HBa1C (glycated hemoglobin)

2-     Fasting plasma glucose

3-     Insulin levels

4-     Triglycerides

5-     C-reactive protein (an inflammatory marker)

6-     Prostaglandin E2 (PGE2 an inflammatory marker)

Special Aflapin Boswellia Serrata Extract – The Second Antiinflammatory/ Analgesic Phytochemical

Indian frankincense (Boswellia serrate) has been used for centuries to treat arthritis. Some clinical studies support its use in chronic inflammatory diseases likeCrohn’s, ulcerative colitis, rheumatoid arthritis and bronchial asthma. Boswellia is an excellent alternative to NSAIDs.

The active ingredients are referred to as boswellic acids, with beta boswellic acid being the major component. The absorption of boswellic acids is less than ideal, thereby necessitating processing regimens that enhance their absorption.

Until the advent of Aflapin due to poor absorption of the active boswellic acids, doses of 500-1,500 mg/day were necessary to achieve sufficient analgesic relief.  Because of the patented processing of Aflapin the therapeutic dose is down to 100-200 mg/day.

A randomized, clinical trial examining the efficacy of Aflapin in patients with knee pain, was published in the Int. J. Med. Sci. 2011;8(7):615-22. Epub 2011 Oct 12. .” The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne’s Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA.” (A quote from the published paper).

Aflapin provides more potential benefits than other non-enhanced boswellic acid products in recovering articular cartilage damage or protection from proteolytic degradation which occurs in osteoarthritis and rheumatoid arthritis.

Combining the Cox-1, Cox-2 inhibition mechanisms of action in the ginger phytochemcical with the 5 lipo-oxygenase inhibition of  Aflapin, creates a unique, and broad acting anti-inflammatory/analgesic, with little side-effects.

Special Super Critical CO2 Feverfew Extract

This specific type of feverfew extract is identified in the American Academy of Neurology’s evidenced-based guideline for migraine prevention.  So what is it doing in a pain/analgesic pill?

The addition of this special feverfew extract adds yet another mechanism of action to the broad therapeutic actions of the new pill. The concept of regulating arthritis at the transcriptional factor level NFkappaB) of gene expression may be more effective than monotherapy at preventing joint cell destruction.

Animal and human ex-vivo studies demonstrate marked suppression of joint destruction in synovial cells of rheumatoid arthritis patients  when parthenolide, one of the active lactones in feverfew was added.. Feverfew robustly inhibited NFkappaB activation and joint destruction in pre-clinical models.

We normally do not add ingredients that don’t yet have clinical data supporting them.  But in the case of parthenolide (feverfew) when coupling the clinical data showing prophylactic efficacy with the potential benefits of NFkappaB inhibition, we decided we needed to include this exciting active ingredient.

Magnesium

Magnesium is perhaps the most essential mineral needed to control inflammation in the body.  It is known that magnesium deficiency leads to increases in inflammatory prostaglandins as well as C-reactive protein and inflammatory conditions deplete magnesium.

Additionally, magnesium antagonizes the NMDA (N-methyl d-aspartate) receptor which is directly involved in the transmission of pain.

Researchers have documented that consumption of less than 50% of the RDA for magnesium doubles the risk of blood vessel, inflammatory damage.

Low magnesium can cause problems with your skeletal muscles, sore muscles, back neck and shoulder pain and headaches. Osteoporosis and rheumatoid arthritis sufferers are often magnesium deficient.

It is difficult to imagine a broad functioning  analgesic that shouldn’t include magnesium.

The evidence is compelling, for patients and pharmacy customers who are chronically consuming either OTC or prescription pain meds, it’s time to try something healthier.

To the Best of Health,

Curt Hendrix,  M.S., C.C.N., C.N.S.