Comparison of ozone therapy and routine medical treatment effect on disease severity and serum level changes of IL-33 in patients with remitting-relapsing multiple sclerosis: A parallelled randomised clinical trial

Ebrahim Kouchaki , Nazanin Arabzadeh , Hossein Akbari , MohammadHosein Sheybani-Arani , Fatemeh Khajavi-Mayvan , Hassan Nikoueinejad
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Abstract

Introduction

IL-33 is an inflammatory cytokine involved in the pathogenesis of Multiple sclerosis (MS) as an autoimmune inflammatory disease. Ozone therapy has been shown to improve the symptoms of the disease in previous studies. Given the limitations of previous studies, we investigated the effect of adding ozone therapy to conventional medical treatment in remitting-relapsing multiple sclerosis (RR-MS) patients from the points of disease severity and blood levels of IL-33.

Methods

This clinical trial was performed on 66 RR-MS patients, among whom 55 finished the study. The patients were divided randomly into two groups; one group (intervention) received ozone therapy in addition to the routine medical treatment, and the other group (control) received only routine medical treatment. The level of IL-33 was measured by ELISA, and the severity of the disease was measured by an expanded disability status scale (EDSS) in all patients before and after the treatment. Finally, the relationship between the serum levels of IL-33 and EDSS score with the type of treatment was evaluated. The research project was registered at the International Center for the Registration of Clinical Trials in Iran (IRCT20171105037262N3).

Results

Our findings showed that the serum levels of IL-33 in the ozone plus medical-treated group significantly decreased compared to the medical-treated group (P<0.001). The EDSS score also decreased significantly in the ozone plus medical-treated group compared to the medical-treated group (P=0.019).

Conclusion

Ozone therapy reduces the severity of RR-MS. Such an effect may be influenced by modifying IL-33 levels.

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比较臭氧疗法和常规药物治疗对缓解-复发性多发性硬化症患者疾病严重程度和血清 IL-33 水平变化的影响:平行随机临床试验
导言IL-33是一种炎症细胞因子,与多发性硬化症(MS)这种自身免疫性炎症疾病的发病机制有关。以往的研究表明,臭氧疗法可改善该病的症状。鉴于以往研究的局限性,我们从疾病的严重程度和血液中 IL-33 的水平出发,研究了在常规药物治疗的基础上对缓解-复发型多发性硬化症(RR-MS)患者进行臭氧治疗的效果。患者被随机分为两组,一组(干预组)在常规治疗的基础上接受臭氧治疗,另一组(对照组)仅接受常规治疗。所有患者在治疗前后的 IL-33 水平均通过酶联免疫吸附法测定,疾病严重程度则通过残疾状况扩展量表(EDSS)测量。最后,还评估了血清中 IL-33 水平和 EDSS 评分与治疗类型之间的关系。研究项目已在伊朗临床试验注册国际中心注册(IRCT20171105037262N3)。结果我们的研究结果表明,与药物治疗组相比,臭氧加药物治疗组的血清 IL-33 水平显著下降(P<0.001)。臭氧加药物治疗组的 EDSS 评分也比药物治疗组明显降低(P=0.019)。臭氧疗法可减轻 RR-MS 的严重程度,这种效果可能受 IL-33 水平变化的影响。
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