The effect of propolis supplementation on inflammatory factors and oxidative status in women with rheumatoid arthritis: Design and research protocol of a double-blind, randomized controlled

Abstract

Backgrounds and aims Rheumatoid arthritis (RA), is immune-inflammatory disease which is associated with great pain and disability. Overproduction of pro-inflammatory cytokines and oxidative stress play an important role in RA pathogenesis and related outcomes. The aim of this study was to evaluate the effects of propolis on inflammatory biomarkers and oxidative stress status in RA patients. Methods/design Randomized, placebo-controlled, and double-blind clinical trial aiming to recruit 48 patients with RA. Block randomization will be used. An intervention group will receive 500 mg/twice a day propolis capsules for 3 months and control group will receive the placebo for the same dose and duration. The oxidative stress status (malondialdehyde (MDA), total antioxidant capacity (TAC), total oxidant status (TOS), superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx)), and inflammatory biomarkers (interleukin-17 (IL-17), Tumor necrosis factor alpha (TNF-α), High-sensitivity C-reactive protein (hs-CRP)), lipid profile (total cholesterol (TC), high density lipoprotein (HDL-c), low density lipoprotein (LDL-c), and triglyceride (TG)) and also physical activity, anthropometric indices, clinical and nutritional status will be measured at beginning and end of this study. The primary analysis will be based on theintention-to-treat principle. Discussion If this randomized clinical trial shows the reduction in inflammatory cytokines and oxidative stress and improves clinical outcome, it would provide evidence for other clinical trials to evaluate the efficacy of propolis supplementation in RA patients.

Propolis and Their Active Constituents for Chronic Diseases

“…Several factors have been reported to facilitate the release of IL-1, IL-6 and TNF-α-like proinflammatory cytokines [59]. Depressing inflammatory conditions may be beneficial in RA [61]. The suppressive effect of an ethanolic extract of propolis was estimated by Park et al against an arthritis rat model, and they proposed an anti-inflammatory effect resulting from inhibition of prostaglandin production [62].…”

Molecular Insights into Royal Jelly Anti-Inflammatory Properties and Related Diseases

“…Early recognition and the beginning of treatment as soon as possible are crucial as the immune process can be considerably altered if this condition is identified and treated within three to six months of the onset of symptoms [44]. Results of RA therapy (steroids and anti-TNF drugs) in the elderly are unsatisfactory due to age-related loss in organ function, comorbidities, and body composition changes [45].…”

The effect of propolis supplementation on cardiovascular risk factors in women with rheumatoid arthritis: A double‐blind, placebo, controlled randomized clinical trial

“…Propolis is a resinous honeybees product that has a plant origin and contains substances with biological activity (Salatino et al, 2011; Salehi‐Sahlabadi et al, 2020). The beneficial effects of propolis are mostly attributed to the phenolic components such as flavonoids (flavonols, flavones, flavanones, dihydroflavonols), terpenoids, steroids, amino acids, and aromatic aldehydes (Burdock, 1998; Farooqui et al, 2010; Nattagh‐Eshtivani et al, 2021). There is remarkable evidence indicating that propolis exhibits properties such as antioxidant, antimicrobial, anti‐inflammatory, immunomodulatory, anti‐diabetic, anticancer, and cardioprotective activities (Chiu et al, 2020; Daleprane & Abdalla, 2013; Farooqui et al, 2010; Zakerkish et al, 2019).…”