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临床试验/NCT07519824
NCT07519824已完成不适用

The Role of Bioelements in Fibromyalgia: Disease Activity or Depression-Anxiety?

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Fibromyalgia Impact Questionnaire (FIQ).

研究概览

简要总结

The aim of this observational study was to determine the levels of serum bioelements in patients with fibromyalgia syndrome and to evaluate the relationship of these bioelements with disease activity, depression and anxiety.

primary hypothesis: Are serum bioelement levels of women with fibromyalgia syndrome different from healthy people? secondary hypothesis: Are serum bioelement levels associated with disease activity? Are serum bioelement levels associated with depression and anxiety?

详细描述

Fibromyalgia Syndrome (FMS) is a chronic painful musculoskeletal condition characterized by widespread pain, muscle tenderness, and fatigue (1). Its prevalence is between 2 and 4 percent (2). While it can occur in all ages and genders, the majority of cases are women between the ages of 30 and 50 (3). Fibromyalgia syndrome is a clinical syndrome and is diagnosed according to specific diagnostic criteria (4).

The etiology and pathophysiology of FMS are not fully understood. Genetic predisposition, traumatic, inflammatory, hormonal, and immunological factors, stress, depression, and anxiety are thought to trigger this syndrome (5). Studies have indicated that an imbalance in antioxidant enzymes plays a role in the pathogenesis of FMS (6). Bioelements such as selenium, iron, zinc, and copper are known to be required as cofactors for many antioxidant enzymes (7,8). Furthermore, FMS symptoms such as fatigue, muscle weakness, irritable bowel, and paresthesia are similar to those of magnesium deficiency. Low magnesium levels can lead to decreased energy production in the body, leading to feelings of fatigue, muscle weakness, and cramps (9,10). Furthermore, there is strong evidence that essential element deficiencies can lead to the development of depression or anxiety (11). Studies have reported a significant correlation between magnesium, iron, and zinc levels and the incidence of depressive symptoms. When magnesium is deficient, personality changes such as apathy, depression, confusion, anxiety, and delirium can be observed (12). Furthermore, serum zinc concentrations were found to be significantly lower in patients with generalized anxiety disorder compared to the control group, while serum copper, manganese, and iron levels were significantly higher (13).

Research is ongoing to elucidate the etiopathogenesis and disease activity of FMS patients. No studies have been found in the literature that have evaluated the relationship between bioelement levels and disease activity, anxiety, depression in FMS patients in the same study. The aim of this cross-sectional, single-center, controlled study was to determine serum selenium, magnesium, iron, copper, manganese, and zinc levels in patients diagnosed with FMS compared to controls, and to evaluate the relationship of these bioelements to disease activity, depression and anxiety.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mentally competent
  • Women over the age of 18

排除标准

  • Over 65 years of age
  • Pregnancy
  • Systemic inflammatory rheumatic disease
  • Socioculturally uncommunicative individuals
  • Infection
  • Malignancy
  • Coagulopathy
  • Peripheral circulatory disorder

研究组 & 干预措施

control group

The control group consisted of individuals with a similar age distribution, no history of chronic pain, and who did not meet the exclusion criteria

干预措施: bioelements (Other)

fibromyalgia group

After applying the exclusion criteria, with expert diagnosis considered as the gold standard, 50 patients were selected who were diagnosed with FMS according to the 2010 FMS diagnostic criteria of the American Rheumatology College (14) with symptoms for at least 3 months, widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9.

干预措施: bioelements (Other)

结局指标

主要结局

Fibromyalgia Impact Questionnaire (FIQ).

时间窗: Baseline

The FIQ was developed to measure functional status in patients with FMS, and its validity and reliability in the Turkish population were determined by Sarmer et al. The total score ranges from 0 to 100, with a higher score indicating greater disease impact.

次要结局

  • Visual Analog Scale (VAS)(Baseline)
  • Hospital Anxiety and Depression Scale (HAD)(Baseline)
  • Nottingham Health Profile (NHP)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Ukbe Baykut

doctor

Ankara City Hospital Bilkent

研究点 (1)

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