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The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell Membrane (NEM) for the treatment of joint and connective tissue discomfort & pain.
It is estimated that 140 million adults in the U.S. suffer from some form of joint or connective tissue (JCT) disorder (i.e. arthritis, lupus, gout, fibromyalgia, neck or back pain, etc.). As the population ages, this estimate is expected to grow rapidly. Traditional treatments for most of these disorders attempt to address only the symptoms (pain, inflammation, and discomfort) associated with the diseases. This usually involves the use of analgesics (i.e. acetaminophen, oxycodone, propoxyphene) or non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, diclofenac, celecoxib), alone or in combination. Most of these treatments have shown limited effectiveness in randomized controlled clinical trials (RCTs) or are known to have significant and sometimes severe side effects. To avoid the cardiac risks, gastrointestinal issues , and dependency issues associated with traditional JCT treatments (particularly with long-term use), many patients have turned to complementary and alternative medicines (CAMs) such as dietary supplements.
Glucosamine, chondroitin, and methylsulfonylmethane (MSM) alone and in combination, are widely marketed as dietary supplements to treat joint pain due to osteoarthritis (OA). Other vitamins, minerals, and botanicals such as kava, pine bark extract, capsicum, boswellia root extract, turmeric/curcumin, etc. are also marketed for various JCT pain maladies. We present here the use of eggshell membrane as a possible new natural therapeutic for JCT disorders. A single center, open label human clinical study was conducted to evaluate the efficacy and safety of NEM® as a treatment for pain associated with joint and connective tissue disorders. Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were then evaluated for pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEM Treatment 1 | Experimental | NEM Formulation X (#0802), 500 mg, once daily, orally |
|
| NEM Treatment 2 | Experimental | NEM Formulation Y (#0505), 500 mg, once daily, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEM Formulation X | Dietary Supplement | see Treatment Arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of this study was to evaluate the mean effectiveness of NEM® in relieving general pain associated with moderate Joint & Connective Tissue disorders. | 7 & 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. | 7 & 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D Leu, D.Ph., N.D. | Principal Investigator | |
| Kevin J Ruff, Ph.D., MBA | ESM Technologies, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leu Private Practice | Jenks | Oklahoma | 74037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19554094 | Result | Ruff KJ, DeVore DP, Leu MD, Robinson MA. Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies. Clin Interv Aging. 2009;4:235-40. doi: 10.2147/cia.s5797. Epub 2009 Jun 9. |
| Label | URL |
|---|---|
| Study published in Clinical Interventions in Aging | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D005356 | Fibromyalgia |
| D001168 | Arthritis |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
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| NEM Formulation Y | Dietary Supplement | see Treatment Arms |
|
|
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D017437 | Skin and Connective Tissue Diseases |