Sahebari Maryam, Heidari Hossein, Nabavi Shima, Khodashahi Mandana, Rezaieyazdi Zahra, Dadgarmoghaddam Maliheh, Hosseinzaheh Hossein, Abbasi Shaghayegh, Hashemzadeh Kamila
Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Community Medicine Department, faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Avicenna J Phytomed. 2021 Jul-Aug;11(4):332-342. doi: 10.22038/AJP.2020.17280.
Recently, saffron ( L. from the Iridaceae family) has been characterized by its antioxidant, anti-inflammatory and analgesic effects. This study aimed to evaluate the effect of saffron on disease activity in patients with rheumatoid arthritis (RA).
This is a double-blind, placebo-controlled, randomized clinical trial (RCT) performed on 55 newly- diagnosed RA patients without previous treatment, who were randomly divided into intervention (included 28 cases) and control groups (consisted of 27 individuals). Standard therapy including prednisolone, oral methotrexate, folic acid, vitamin D, calcium, and alendronate, was administered similarly in both groups. Patients received a 100 mg saffron pill/day (pure saffron powder) or placebo besides the standard protocol. The placebo had the same shape as the saffron pills. Follow up of DAS28ESR disease activity score was done on the 30th, 45th and 90 day of the study.
There was no difference between the intervention and control groups regarding to the DAS28ESR at the end of the study. However, a significant decrease in DAS28-ESR was observed in each group compared to the first visit (p=0.001). The results also showed no significant difference in the incidence of side effects in both groups.
In summary, patients who received pure saffron pills (100 mg/day) in addition to standard therapy did not have a significant difference in improvement of disease activity from the patients on standard therapy.
最近，藏红花（鸢尾科植物）已被证实具有抗氧化、抗炎和镇痛作用。本研究旨在评估藏红花对类风湿关节炎（RA）患者疾病活动度的影响。
这是一项双盲、安慰剂对照的随机临床试验（RCT），对55例未经治疗的新诊断RA患者进行，这些患者被随机分为干预组（28例）和对照组（27例）。两组均同样给予包括泼尼松龙、口服甲氨蝶呤、叶酸、维生素D、钙和阿仑膦酸钠在内的标准治疗。除标准治疗方案外，患者每天服用100毫克藏红花丸（纯藏红花粉）或安慰剂。安慰剂与藏红花丸形状相同。在研究的第30天、45天和90天对DAS28ESR疾病活动评分进行随访。
研究结束时，干预组和对照组在DAS28ESR方面无差异。然而，与首次就诊相比，每组的DAS28 - ESR均显著降低（p = 0.001）。结果还显示两组副作用发生率无显著差异。
总之，除标准治疗外接受纯藏红花丸（100毫克/天）的患者与接受标准治疗的患者在疾病活动度改善方面无显著差异。
