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Integr Med (Encinitas). 2016 Oct;15(5):34-44.

In Vivo Osteoinduction: Evaluating 2-Beta Coxatene as an Immunoinductive Compound and Novel Ingredient for Joint Support.

Author information

1
is a registered dietician and independent consultant in private practice in Pickens, South Carolina. James J. Scaffidi, bs c, dnm (c) is chief executive officer and president of ZyCal Bioceuticals Healthcare Company, Inc, in Toms River, New Jersey.

Abstract

CONTEXT:

Osteoarthritis (OA) is a degenerative joint disease characterized by progressive loss of articular cartilage. Many treatments lack the ability to stimulate the growth of native cartilage tissue while they simultaneously increase joint comfort. For the past few decades, dietary supplements have been investigated for the ability to both address joint inflammation and stimulate cartilage tissue.

OBJECTIVES:

The present study intended to examine the supplement's in vivo osteoinductive capabilities and clinical efficacy for overall joint health.

DESIGN:

The research team designed a randomized, double-blind, comparative clinical trial.

SETTING:

The study took place via telephone interviews.

PARTICIPANTS:

Participants had self-reported OA of a weight-bearing joint (ie, of the knee, hip, spine, or ankle). Patients were recruited using the Health Science Institute, a consumer supplement newsletter.

INTERVENTION:

Participants in the intervention group were blindly given 135 mg of 2-Beta Coxatene (2BCT) orally, which contained (1) a custom blend of low-dose Cyplexinol, an osteoinductive protein complex derived from bovine bone tissue, and (2) Boswellia serrata resin enriched to 65% 3-O-Acetyl-11-keto-β-Boswellic acid. A positive control group was blindly given 1500 mg of glucosamine hydrogen chloride and 1200 mg of chondroitin sulfate. Participants took the supplements for 3 mo.

OUTCOME MEASURES:

A histological evaluation was performed on an athymic rat to test the supplement's in vivo osteoinductive capabilities. A negative control, commercially purchased, unhydrolyzed type 2 collagen was used for that test. Participants were evaluated for parameters of pain and joint function at baseline (day 0) and at days 7, 30, and 90 using the Western Ontario and McMaster Universities (WOMAC) OA index and a visual analogue scale (VAS).

RESULTS:

The histological evaluation of the athymic rat confirmed that the Cyplexinol component of the 2BCT was positive for de novo bone tissue and collagen synthesis, corroborating osteoinduction. In the clinical trial, the intervention group reported significant decreases of 57.4%, 52.5%, and 58% in normalized WOMAC scores for pain, stiffness, and joint functionality, respectively, from baseline to postintervention. The control group reported a decrease of 17.5%, 18.1%, and 23.9% for pain, stiffness, and joint functionality, respectively. For the intervention group, pain intensity and frequency, as measured by the VAS, also decreased 57.1% and 56.3%, respectively, from baseline to postintervention, whereas the control group showed a decrease in VAS scores of 18.0% and 14.8%, respectively. In total, an average of 81.2% of participants administered the 2BCT had reported a statistically significant improvement from baseline to postintervention, compared with 22.9% of participants administered glucosamine and chondroitin.

CONCLUSIONS:

In vivo studies confirmed that the bioactive proteins (Cyplexinol) within the 2BCT stimulated de novo bone and cartilage tissue production, demonstrating osteoinduction. The intervention group reported greater improvements in the psychometric evaluations that assessed joint comfort when compared with participants given the glucosamine and chondroitin. The results suggest that 2BCT may provide a novel and synergistic response to preserving joint homeostasis and improving quality of life.

PMID:
27980494
PMCID:
PMC5145012

Conflict of interest statement

Author Disclosure Statement There were no conflicts of interest to disclose for the research. At the time of the study, the primary author was an unpaid independent consultant with her own separate private practice.

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