Evaluation of the efficacy and safety of a food supplement made of collagen hydrolysate 1200 mg/day versus placebo during six months, in subjects with joint pain at the lower or upper limbs or at the lumbar spine.
Comparative double-blind randomized multicenter study in parallel groups.
200 patients of both genders of at least 50 years old with joint pain assessed as ≥30 mm on a visual analogical scale (VAS).
Collagen hydrolysate 1200 mg/day or placebo during six months.
Main outcome measure:
Comparison of the percentage of clinical responder between the active collagen hydrolysate group and the placebo group after six months of study. A responder subject was defined as a subject experiencing a clinically significant improvement (i.e. by 20 percent or more) in the most painful joint using the VAS score. All analyses were performed using an intent-to-treat procedure.
At six months, the proportion of clinical responders to the treatment, according to VAS scores, was significantly higher in the collagen hydrolysate (CH) group 51.6 percent, compared to the placebo group 36.5 percent (p<0.05). However, there was no significant difference between groups at three months (44.1 percent vs. 39.6 percent, p=0.53). No significant difference in terms of security and tolerability was observed between the two groups.
This study suggests that collagen hydrolysate 1200 mg/day could increase the number of clinical responders (i.e. improvement of at least 20 percent on the VAS) compared to placebo. More studies are needed to confirm the clinical interest of this food supplement.
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