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Saccharomyces boulardii improves clinical and paraclinical indices in overweight/obese knee osteoarthritis patients: a randomized triple-blind placebo-controlled trial.

  • 2024-05-18
  • European journal of nutrition 63(6)
    • Neda Dolatkhah
    • Alireza Jafari
    • Fariba Eslamian
    • Vahideh Toopchizadeh
    • Parviz Saleh
    • Maryam Hashemian

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 70
Population
70 patients with KOA
Methods
randomly assigned to receive probiotics or placebo supplements for 12 weeks
Duration
12 weeks
  • Rigorous Journal

Purpose

This study aimed to determine the effect of the probiotic Saccharomyces boulardii (S. boulardii) in patients with knee osteoarthritis (KOA).

Methods

In this study, 70 patients with KOA were recruited via outpatient clinics between 2020 and 2021 and randomly assigned to receive probiotics or placebo supplements for 12 weeks. The primary outcome was a change in pain intensity according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.

Results

Sixty-three patients completed the trial. A linear mixed analysis of covariance (ANCOVA) model analysis showed that probiotic was better than placebo in decreasing the pain intensity measured by visual analogue scale (VAS) [-2.11 (-2.59, -1.62) in probiotic group and -0.90 (-1.32, -0.48) in placebo group, p = 0.002] and WOMAC pain score [-3.57 (-4.66, -2.49) in probiotic group and -1.43 (-2.33, -0.53) in placebo group, p < 0.001]. The daily intake of acetaminophen for pain management significantly decreased in the probiotic group [-267.18 (-400.47, -133.89) mg, p < 0.001] that was significantly better than placebo (p = 0.006). Probiotic significantly decreased the serum levels of high-sensitivity C-reactive protein (hs-CRP) inflammatory index [-2.72 (-3.24, -2.20) µg/ml] and malondialdehyde (MDA) oxidative stress index [-1.61 (-2.11, -1.11) nmol/ml] compared to the placebo (p = 0.002 and p < 0.001, respectively). Probiotic was better than placebo in increasing the scores of role disorder due to physical health (p = 0.023), pain (p = 0.048) and physical health (p = 0.031).

Conclusion

Probiotic S. boulardii supplementation in patients with KOA significantly improved pain intensity, some dimensions of QoL, and inflammatory and oxidative stress biomarkers with no severe side effects.

Trial registry

Registered on the Iranian clinical trial website ( http://www.irct.ir : IRCT20161022030424N4) on 2019-09-02.

Research Insights

Adverse Events Reported

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