RESUMO
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.
RESUMO
The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.