School of Health and Wellbeing, University of Southern Queensland, Ipswich, Australia.
School of Behavioural & Health Sciences, Australian Catholic University, Strathfield, Australia.
Cochrane Database Syst Rev. 2023 Apr 19;4(4):CD014816. doi: 10.1002/14651858.CD014816.pub2.
BACKGROUND: Systemic lupus erythematosus (SLE) is a rare, chronic autoimmune inflammatory disease with a prevalence varying from 4.3 to 150 people in 100,000, or approximately five million people worldwide. Systemic manifestations frequently include internal organ involvement, a characteristic malar rash on the face, pain in joints and muscles, and profound fatigue. Exercise is purported to be beneficial for people with SLE. For this review, we focused on studies that examined all types of structured exercise as an adjunctive therapy in the management of SLE. OBJECTIVES: To evaluate the benefits and harms of structured exercise as adjunctive therapy for adults with SLE compared with usual pharmacological care, usual pharmacological care plus placebo and usual pharmacological care plus non-pharmacological care. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 30 March 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of exercise as an adjunct to usual pharmacological treatment in SLE compared with placebo, usual pharmacological care alone and another non-pharmacological treatment. Major outcomes were fatigue, functional capacity, disease activity, quality of life, pain, serious adverse events, and withdrawals due to any reason, including any adverse events. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our major outcomes were 1. fatigue, 2. functional capacity, 3. disease activity, 4. quality of life, 5. pain, 6. serious adverse events, and 7. withdrawals due to any reason. Our minor outcomes were 8. responder rate, 9. aerobic fitness, 10. depression, and 11. anxiety. We used GRADE to assess certainty of evidence. The primary comparison was exercise compared with placebo. MAIN RESULTS: We included 13 studies (540 participants) in this review. Studies compared exercise as an adjunct to usual pharmacological care (antimalarials, immunosuppressants, and oral glucocorticoids) with usual pharmacological care plus placebo (one study); usual pharmacological care (six studies); and another non-pharmacological treatment such as relaxation therapy (seven studies). Most studies had selection bias, and all studies had performance and detection bias. We downgraded the evidence for all comparisons because of a high risk of bias and imprecision. Exercise plus usual pharmacological care versus placebo plus usual pharmacological care Evidence from a single small study (17 participants) that compared whole body vibration exercise to whole body placebo vibration exercise (vibrations switched off) indicated that exercise may have little to no effect on fatigue, functional capacity, and pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). The study did not report disease activity, quality of life, and serious adverse events. The study measured fatigue using the self-reported Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue), scale 0 to 52; lower score means less fatigue. People who did not exercise rated their fatigue at 38 points and those who did exercise rated their fatigue at 33 points (mean difference (MD) 5 points lower, 95% confidence interval (CI) 13.29 lower to 3.29 higher). The study measured functional capacity using the self-reported 36-item Short Form health questionnaire (SF-36) Physical Function domain, scale 0 to 100; higher score means better function. People who did not exercise rated their functional capacity at 70 points and those who did exercise rated their functional capacity at 67.5 points (MD 2.5 points lower, 95% CI 23.78 lower to 18.78 higher). The study measured pain using the SF-36 Pain domain, scale 0 to 100; lower scores mean less pain. People who did not exercise rated their pain at 43 points and those who did exercise rated their pain at 34 points (MD 9 points lower, 95% CI 28.88 lower to 10.88 higher). More participants from the exercise group (3/11, 27%) withdrew from the study than the placebo group (1/10, 10%) (risk ratio (RR) 2.73, 95% CI 0.34 to 22.16). Exercise plus usual pharmacological care versus usual pharmacological care alone The addition of exercise to usual pharmacological care may have little to no effect on fatigue, functional capacity, and disease activity (low-certainty evidence). We are uncertain whether the addition of exercise improves pain (very low-certainty evidence), or results in fewer or more withdrawals (very low-certainty evidence). Serious adverse events and quality of life were not reported. Exercise plus usual care versus another non-pharmacological intervention such as receiving information about the disease or relaxation therapy Compared with education or relaxation therapy, exercise may reduce fatigue slightly (low-certainty evidence), may improve functional capacity (low-certainty evidence), probably results in little to no difference in disease activity (moderate-certainty evidence), and may result in little to no difference in pain (low-certainty evidence). We are uncertain whether exercise results in fewer or more withdrawals (very low-certainty evidence). Quality of life and serious adverse events were not reported. AUTHORS' CONCLUSIONS: Due to low- to very low-certainty evidence, we are not confident on the benefits of exercise on fatigue, functional capacity, disease activity, and pain, compared with placebo, usual care, or advice and relaxation therapy. Harms data were not well reported.
背景:系统性红斑狼疮(SLE)是一种罕见的慢性自身免疫性炎症性疾病,患病率在每 100,000 人中为 4.3 至 150 人不等,即全球约有 500 万人患病。系统性表现常包括内脏器官受累、特征性面颊红斑、关节和肌肉疼痛以及严重疲劳。运动据称对 SLE 患者有益。在本次综述中,我们重点关注了研究各种类型的结构性运动作为 SLE 管理的辅助治疗的研究。
目的:评估结构性运动作为 SLE 成人辅助治疗与常规药物治疗、常规药物治疗加安慰剂和常规药物治疗加非药物治疗相比的益处和危害。
检索方法:我们使用了标准的、广泛的 Cochrane 检索方法。最新检索日期为 2022 年 3 月 30 日。
选择标准:我们纳入了将运动作为 SLE 常规药物治疗的辅助治疗与安慰剂、常规药物治疗单独使用和另一种非药物治疗(如疾病信息教育或放松疗法)进行比较的随机对照试验(RCTs)。主要结局为疲劳、功能能力、疾病活动度、生活质量、疼痛、严重不良事件以及任何原因(包括任何不良事件)导致的退出。
数据收集和分析:我们使用了标准的 Cochrane 方法。我们的主要结局是 1. 疲劳,2. 功能能力,3. 疾病活动度,4. 生活质量,5. 疼痛,6. 严重不良事件,7. 任何原因导致的退出。我们的次要结局是 8. 应答率,9. 有氧健身,10. 抑郁,11. 焦虑。我们使用 GRADE 评估证据的确定性。主要比较是运动与安慰剂的比较。
主要结果:我们纳入了 13 项研究(540 名参与者)。这些研究比较了运动作为辅助治疗(抗疟药、免疫抑制剂和口服糖皮质激素)与安慰剂加常规药物治疗(一项研究);常规药物治疗(六项研究);以及另一种非药物治疗,如放松疗法(七项研究)。大多数研究存在选择偏倚,所有研究都存在实施和检测偏倚。由于高风险偏倚和不精确性,我们降低了所有比较的证据确定性。
运动加常规药物治疗与安慰剂加常规药物治疗的比较:来自一项小型研究(17 名参与者)的证据表明,全身振动运动与全身安慰剂振动运动(关闭振动)相比,可能对疲劳、功能能力和疼痛几乎没有影响(低确定性证据)。我们不确定运动是否会导致更少或更多的退出(非常低确定性证据)。该研究未报告疾病活动度、生活质量和严重不良事件。该研究使用自我报告的慢性疾病治疗功能评估-疲劳量表(FACIT-Fatigue),0 到 52 分;得分越低表示疲劳程度越低。未运动的人自评疲劳程度为 38 分,而运动的人自评疲劳程度为 33 分(MD 低 5 分,95%置信区间为 13.29 分低至 3.29 分高)。该研究使用自我报告的 36 项简短健康问卷(SF-36)的身体功能领域,0 到 100 分;得分越高表示功能越好。未运动的人自评身体功能为 70 分,而运动的人自评身体功能为 67.5 分(MD 低 2.5 分,95%置信区间为 23.78 分低至 18.78 分高)。未运动的人自评疼痛为 43 分,而运动的人自评疼痛为 34 分(MD 低 9 分,95%置信区间为 28.88 分低至 10.88 分高)。与安慰剂组(10%,1/10)相比,运动组(27%,3/11)有更多的参与者退出研究(RR 2.73,95%置信区间为 0.34 至 22.16)。
运动加常规药物治疗与常规药物治疗单独使用的比较:在常规药物治疗的基础上增加运动可能对疲劳、功能能力和疾病活动度几乎没有影响(低确定性证据)。我们不确定运动是否能改善疼痛(非常低确定性证据),或是否会导致更少或更多的退出(非常低确定性证据)。严重不良事件和生活质量未报告。
运动加常规治疗与另一种非药物干预(如疾病信息教育或放松疗法)的比较:与教育或放松疗法相比,运动可能会轻微减轻疲劳(低确定性证据),可能会改善功能能力(低确定性证据),可能对疾病活动度没有影响(中等确定性证据),也可能对疼痛没有影响(低确定性证据)。我们不确定运动是否会导致更少或更多的退出(非常低确定性证据)。生活质量和严重不良事件未报告。
作者结论:由于低至非常低确定性证据,我们对运动在疲劳、功能能力、疾病活动度和疼痛方面的益处与安慰剂、常规治疗或建议和放松疗法相比并不确定。危害数据报告不充分。
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