Clinical Assessment of Low-dose Osteoinductive Protein as a Stand-alone Regimen in Self-reported Osteoarthritis.

CONTEXT

Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It affects more than 20 million people in the United States, who mostly are older than age 45 y. No specific treatment exists to halt the progressive cartilage degeneration of osteoarthritis or to repair the damaged cartilage. Alternatives to pharmaceuticals include natural therapies and nutritional supplements.

OBJECTIVE

The present study examined the clinical response to daily supplementation with bioactive protein complex containing a collagen type 2 network, with associated growth factors, and osteoinductive proteins, known as bone morphogenetic proteins (BMPs).

DESIGN

The research team designed an open-label preliminary study.

SETTING

Joint evaluations were self-administered by participants at their residences.

PARTICIPANTS

Participants were 44 individuals with self-reported osteoarthritis in the hip, knee, or ankle (ie, in weight-bearing joints).

INTERVENTION

Participants self-administered orally a low-dose form of the ingredient (ie, 150 mg of Cyplexinol(®) Standard, once daily for 4 wk).

OUTCOME MEASURES

Four parameters-pain intensity, frequency of pain, activity level, and strength-were evaluated using a visual analog scale (VAS), both at baseline and at the end of the 4-wk period.

RESULTS

Pain intensity decreased 45% on a 10-cm VAS from 2.85 cm (P = .0001; 95% CI, 2.54, 3.16) at baseline to 1.41 cm (P = .0001; 95% CI, 1.18, 1.64) at wk 4. Pain frequency decreased 55% from 3.16 cm (P = .0001; 95% CI, 2.88, 3.44) at baseline to 1.22 cm (P = .0001; 95% CI, 0.85, 1.59) at wk 4. Activity level increased from 1.58 cm (P = .0001; 95% CI, 1.34, 1.82) at baseline to 2.91 cm (P = .0001; 95% CI, 2.71, 3.11) at wk 4. Strength increased 80% from 1.24 cm (P = .0001; 95% CI, 0.91, 1.57) at baseline to 2.10 cm (P = .0001; 95% CI, 1.73, 2.47) at wk 4.

CONCLUSIONS

The 44 participants reported subjective improvements in pain frequency and intensity as well as in activity level following administration of Cyplexinol(®). The results from this study identify the possible pathways associated with cartilage degradation, pain, and inflammation, which should be the focus of future research, and they suggest that the ingredient can be effective in helping to maintain joint homeostasis.