Effect of Crocus sativus (Saffron) Intake on Top of Standard Treatment, on Disease Outcomes and Comorbidities in Patients with Rheumatic Diseases: Synthesis without Meta-Analysis (SWiM) and Level of Adherence to the CONSORT Statement for Randomized Controlled Trials Delivering Herbal Medicine Interventions

Abstract

Rheumatic diseases (RDs) are often complicated by chronic symptoms and frequent side-effects associated with their treatment. Saffron, a spice derived from the Crocus sativus L. flower, is a popular complementary and alternative medicine among patients with RDs. The present systematic review aimed to summarize the available evidence regarding the efficacy of supplementation with saffron on disease outcomes and comorbidities in patients with RD diagnoses. PubMed, CENTRAL, clinicaltrials.gov and the grey literature were searched until October 2021, and relevant randomized controlled trials (RCTs) were screened for eligibility using Rayyan. Risk of bias was assessed using the Cochrane’s Risk of Bias-2.0 (RoB) tool. A synthesis without meta-analysis (SWiM) was performed by vote counting and an effect direction plot was created. Out of 125 reports, seven fulfilled the eligibility criteria belonging to five RCTs and were included in the SWiM. The RCTs involved patients with rheumatoid arthritis, osteoarthritis and fibromyalgia, and evaluated outcomes related to pain, disease activity, depression, immune response, inflammation, oxidative stress, health, fatigue and functional ability. The majority of trials demonstrated some concerns regarding overall bias. Moreover, the majority of trialists failed to adhere to the formula elaborations suggested by the CONSORT statement for RCTs incorporating herbal medicine interventions. Standardization of herbal medicine confirms its identity, purity and quality; however, the majority of trials failed to adhere to these guidelines. Due to the great heterogeneity and the lack of important information regarding the standardization and content of herbal interventions, it appears that the evidence is not enough to secure a direction of effect for any of the examined outcomes.

Therapeutic effects of saffron and its components on neurodegenerative diseases

“…Saffron can prevent oxidative damage by a reduction in the concentration of endogenous ROS and a reduction in the production of pro-inflammatory biomarkers [ 118 , 119 ]. Crocin can improve cognitive disorders to some extent by targeting hippocampal apoptosis and oxidative stress [ 47 ].…”

Antioxidant and Anti-Inflammatory Properties of Hydroxyl Safflower Yellow a in Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials

“…Modern pharmacology and molecular biology studies have verified that HSYA can exert anti-inflammatory, antioxidant ( He et al, 2021 ), and antiischemia reperfusion injury ( Bai et al, 2020 ) effects and is widely used in the treatment of acute or chronic cardiovascular and cerebrovascular diseases ( Xu et al, 2021 ; Geng et al, 2018 ). It has been shown to play a role in ameliorating cognitive impairment ( Zhang et al, 2021a ), rheumatic diseases ( Tsiogkas et al, 2021 ), and osteoporosis ( Wang et al, 2021b ) and regulating glucose and lipid metabolism ( Sun et al, 2021 ), providing new perspectives for exploring the development and application of HSYA in the health care industry ( Sun et al, 2021 ).…”

Therapeutic potential of saffron in brain disorders: From bench to bedside

“…Published research indicated that saffron can slow down the oxidative damage reducing the concentrations of the ROS produced (Tsiogkas et al, 2021). The production in a great amount of ROS in MS patients may affect the antioxidant defense system of the CNS and can lead to further demyelination and loss of the neurons (Offen et al, 2004).…”