Rodríguez-Castillejo Paula Mª, Fernández-de-Las-Peñas César, Alburquerque-Sendín Francisco, Rodrigues-de-Souza Daiana P
Department of Nursing, Pharmacology and Physical Therapy, Faculty of Medicine and Nursing, University of Córdoba, 14004 Córdoba, Spain.
Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28922 Alcorcón, Spain.
J Clin Med. 2021 Oct 18;10(20):4776. doi: 10.3390/jcm10204776.
Evidence supports the presence of comorbid conditions, e.g., irritable bowel syndrome (IBS), in individuals with fibromyalgia (FM). Physical therapy plays an essential role in the treatment of FM; however, it is not currently known whether the IBS comorbidity is considered in the selection criteria for clinical trials evaluating physiotherapy in FM. Thus, the aim of the review was to identify whether the presence of IBS was considered in the selection criteria for study subjects for those clinical trials that have been highly cited or published in the high-impact journals investigating the effects of physical therapy in FM. A literature search in the Web of Science database for clinical trials that were highly cited or published in high-impact journals, i.e., first second quartile (Q1) of any category of the Journal Citation Report (JCR), investigating the effects of physical therapy in FM was conducted. The methodological quality of the selected trials was assessed with the Physiotherapy Evidence Database (PEDro) scale. Authors, affiliations, number of citations, objectives, sex/gender, age, and eligibility criteria of each article were extracted and analyzed independently by two authors. From a total of the 412 identified articles, 20 and 61 clinical trials were included according to the citation criterion or JCR criterion, respectively. The PEDro score ranged from 2 to 8 (mean: 5.9, SD: 0.1). The comorbidity between FM and IBS was not considered within the eligibility criteria of the participants in any of the clinical trials. The improvement of the eligibility criteria is required in clinical trials on physical therapy that include FM patients to avoid selection bias.
有证据表明，纤维肌痛（FM）患者存在共病情况，如肠易激综合征（IBS）。物理治疗在FM的治疗中起着至关重要的作用；然而，目前尚不清楚在评估FM物理治疗的临床试验选择标准中是否考虑了IBS共病情况。因此，本综述的目的是确定在那些被高度引用或发表在高影响力期刊上、研究物理治疗对FM影响的临床试验中，研究对象的选择标准是否考虑了IBS的存在。在科学网数据库中检索被高度引用或发表在高影响力期刊上的临床试验，即《期刊引证报告》（JCR）任何类别的第一、第二四分位数（Q1），这些试验研究了物理治疗对FM的影响。使用物理治疗证据数据库（PEDro）量表评估所选试验的方法学质量。两位作者独立提取并分析每篇文章的作者、所属机构、被引次数、研究目的、性别、年龄和纳入标准。根据被引标准或JCR标准，从总共412篇已识别的文章中，分别纳入了20项和61项临床试验。PEDro评分范围为2至8分（平均：5.9，标准差：0.1）。在任何一项临床试验的参与者纳入标准中，均未考虑FM与IBS之间的共病情况。在纳入FM患者的物理治疗临床试验中，需要改进纳入标准以避免选择偏倚。
