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Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Arrigo F G Cicero, Nicolò Girolimetto, Crescenzio Bentivenga, Elisa Grandi, Federica Fogacci, Claudio Borghi
Diseases 2020 8(3):26

Bibliography

PubMed
PMID 32650511
PubMed Central
PMC7564147
Competing interests
The authors declared no conflict of interest.

Study snapshot

DesignRandomized, double-blind, placebo-controlled clinical trial
Model60 adults with symptomatic knee osteoarthritis
Samplen=60
Intervention200 mg/day full-spectrum sodium hyaluronate formulation (FS-HA) versus placebo
Duration56–60 days
EndpointsVAS pain; WOMAC; Lequesne Functional Index; Knee range of motion; Rescue analgesic/NSAID use

What the study showed, in plain terms

This short randomized trial tested 200 mg/day of a full-spectrum sodium hyaluronate formulation in 60 adults with symptomatic knee osteoarthritis.

By about eight weeks, pain VAS and WOMAC pain were significantly lower than placebo, and the active group reported less use of rescue pain medication.

The signal is clinically relevant, but the study was exploratory, short and specific to a proprietary full-spectrum formulation.

Key findings

  • VAS pain and WOMAC pain favored FS-HA over placebo by the final visit.
  • Rescue NSAID/analgesic use was lower with FS-HA.
  • Several function measures improved from baseline in the active group.

What this study can and cannot tell us

  • Short-term pilot trial with 60 participants.
  • Tested a proprietary full-spectrum formulation, limiting generalization to all oral HA products.
  • Not designed to establish structural or disease-modifying effects.

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