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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 537
Population
537 patients with knee OA
Methods
double-blind, placebo-controlled trial, randomised to receive skimmed milk containing either LcS or placebo daily for 6 months
Blinding
Double-blind
Duration
6 months
  • Large Human Trial
  • Highly Cited
  • Rigorous Journal
Knee osteoarthritis (OA) treatment is challenging due to inefficacy and adverse effects of current medications. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. We aimed to investigate the effect of probiotic Lactobacillus casei Shirota (LcS) on patients with knee OA. 537 patients with knee OA were enrolled in this double-blind, placebo-controlled trial, who were randomised to receive skimmed milk containing either LcS or placebo daily for 6 months. Primary outcome was defined as changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and VAS (visual analog scale) scores. Secondary outcome was defined as changes in serum levels of high sensitivity C-reactive protein (hs-CRP). After 6 months of treatment, both WOMAC and VAS scores were significantly improved in the LcS groups of patients compared to the placebo group. Serum levels of hs-CRP were also significantly lower in patients receiving LcS than placebo. Strong linear correlations were observed between serum hs-CRP levels and WOMAC and VAS scores. LcS consumption could serve as a novel therapeutic option in the clinical management of knee OA, improving treatment outcome likely through reducing serum hs-CRP levels.

Research Insights

  • After 6 months of treatment, both WOMAC and VAS scores were significantly improved in the LcS groups of patients compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    daily consumption of skimmed milk containing Lactobacillus casei Shirota
  • Serum levels of hs-CRP were also significantly lower in patients receiving LcS than placebo.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    daily consumption of skimmed milk containing Lactobacillus casei Shirota
  • After 6 months of treatment, both WOMAC and VAS scores were significantly improved in the LcS groups of patients compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    daily consumption of skimmed milk containing Lactobacillus casei Shirota
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