Theadom Alice, Cropley Mark, Smith Helen E, Feigin Valery L, McPherson Kathryn
National Institute for Stroke and Applied Neuroscience / Person Centred Research Centre, Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland, New Zealand, 1142.
Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD001980. doi: 10.1002/14651858.CD001980.pub3.
Mind-body interventions are based on the holistic principle that mind, body and behaviour are all interconnected. Mind-body interventions incorporate strategies that are thought to improve psychological and physical well-being, aim to allow patients to take an active role in their treatment, and promote people's ability to cope. Mind-body interventions are widely used by people with fibromyalgia to help manage their symptoms and improve well-being. Examples of mind-body therapies include psychological therapies, biofeedback, mindfulness, movement therapies and relaxation strategies.
To review the benefits and harms of mind-body therapies in comparison to standard care and attention placebo control groups for adults with fibromyalgia, post-intervention and at three and six month follow-up.
Electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), EMBASE (Ovid), PsycINFO (Ovid), AMED (EBSCO) and CINAHL (Ovid) were conducted up to 30 October 2013. Searches of reference lists were conducted and authors in the field were contacted to identify additional relevant articles.
All relevant randomised controlled trials (RCTs) of mind-body interventions for adults with fibromyalgia were included.
Two authors independently selected studies, extracted the data and assessed trials for low, unclear or high risk of bias. Any discrepancy was resolved through discussion and consensus. Continuous outcomes were analysed using mean difference (MD) where the same outcome measure and scoring method was used and standardised mean difference (SMD) where different outcome measures were used. For binary data standard estimation of the risk ratio (RR) and its 95% confidence interval (CI) was used.
Seventy-four papers describing 61 trials were identified, with 4234 predominantly female participants. The nature of fibromyalgia varied from mild to severe across the study populations. Twenty-six studies were classified as having a low risk of bias for all domains assessed. The findings of mind-body therapies compared with usual care were prioritised.There is low quality evidence that in comparison to usual care controls psychological therapies have favourable effects on physical functioning (SMD -0.4, 95% CI -0.6 to -0.3, -7.5% absolute change, 2 point shift on a 0 to 100 scale), pain (SMD -0.3, 95% CI -0.5 to -0.2, -3.5% absolute change, 2 point shift on a 0 to 100 scale) and mood (SMD -0.5, 95% CI -0.6 to -0.3, -4.8% absolute change, 3 point shift on a 20 to 80 scale). There is very low quality evidence of more withdrawals in the psychological therapy group in comparison to usual care controls (RR 1.38, 95% CI 1.12 to 1.69, 6% absolute risk difference). There is lack of evidence of a difference between the number of adverse events in the psychological therapy and control groups (RR 0.38, 95% CI 0.06 to 2.50, 4% absolute risk difference).There was very low quality evidence that biofeedback in comparison to usual care controls had an effect on physical functioning (SMD -0.1, 95% CI -0.4 to 0.3, -1.2% absolute change, 1 point shift on a 0 to 100 scale), pain (SMD -2.6, 95% CI -91.3 to 86.1, -2.6% absolute change) and mood (SMD 0.1, 95% CI -0.3 to 0.5, 1.9% absolute change, less than 1 point shift on a 0 to 90 scale) post-intervention. In view of the quality of evidence we cannot be certain that biofeedback has a little or no effect on these outcomes. There was very low quality evidence that biofeedback led to more withdrawals from the study (RR 4.08, 95% CI 1.43 to 11.62, 20% absolute risk difference). No adverse events were reported.There was no advantage observed for mindfulness in comparison to usual care for physical functioning (SMD -0.3, 95% CI -0.6 to 0.1, -4.8% absolute change, 4 point shift on a scale 0 to 100), pain (SMD -0.1, CI -0.4 to 0.3, -1.3% absolute change, less than 1 point shift on a 0 to 10 scale), mood (SMD -0.2, 95% CI -0.5 to 0.0, -3.7% absolute change, 2 point shift on a 20 to 80 scale) or withdrawals (RR 1.07, 95% CI 0.67 to 1.72, 2% absolute risk difference) between the two groups post-intervention. However, the quality of the evidence was very low for pain and moderate for mood and number of withdrawals. No studies reported any adverse events.Very low quality evidence revealed that movement therapies in comparison to usual care controls improved pain (MD -2.3, CI -4.2 to -0.4, -23% absolute change) and mood (MD -9.8, 95% CI -18.5 to -1.2, -16.4% absolute change) post-intervention. There was no advantage for physical functioning (SMD -0.2, 95% CI -0.5 to 0.2, -3.4% absolute change, 2 point shift on a 0 to 100 scale), participant withdrawals (RR 1.95, 95% CI 1.13 to 3.38, 11% absolute difference) or adverse events (RR 4.62, 95% CI 0.23 to 93.92, 4% absolute risk difference) between the two groups, however rare adverse events may include worsening of pain.Low quality evidence revealed that relaxation based therapies in comparison to usual care controls showed an advantage for physical functioning (MD -8.3, 95% CI -10.1 to -6.5, -10.4% absolute change) and pain (SMD -1.0, 95% CI -1.6 to -0.5, -3.5% absolute change, 2 point shift on a 0 to 78 scale) but not for mood (SMD -4.4, CI -14.5 to 5.6, -7.4% absolute change) post-intervention. There was no difference between the groups for number of withdrawals (RR 4.40, 95% CI 0.59 to 33.07, 31% absolute risk difference) and no adverse events were reported.
AUTHORS' CONCLUSIONS: Psychological interventions therapies may be effective in improving physical functioning, pain and low mood for adults with fibromyalgia in comparison to usual care controls but the quality of the evidence is low. Further research on the outcomes of therapies is needed to determine if positive effects identified post-intervention are sustained. The effectiveness of biofeedback, mindfulness, movement therapies and relaxation based therapies remains unclear as the quality of the evidence was very low or low. The small number of trials and inconsistency in the use of outcome measures across the trials restricted the analysis.
身心干预基于身心与行为相互关联的整体原则。身心干预采用的策略被认为可改善心理和身体健康,旨在让患者在治疗中发挥积极作用,并提升人们的应对能力。纤维肌痛患者广泛使用身心干预来帮助管理症状并改善健康状况。身心疗法的例子包括心理疗法、生物反馈、正念、运动疗法和放松策略。
比较身心疗法与标准护理及注意力安慰剂对照组对成年纤维肌痛患者干预后、干预后三个月及六个月随访时的益处和危害。
截至2013年10月30日,对Cochrane对照试验中心注册库(CENTRAL)、MEDLINE(Ovid)、EMBASE(Ovid)、PsycINFO(Ovid)、AMED(EBSCO)和CINAHL(Ovid)进行了电子检索。对参考文献列表进行了检索,并联系了该领域的作者以识别其他相关文章。
纳入所有针对成年纤维肌痛患者的身心干预相关随机对照试验(RCT)。
两位作者独立选择研究、提取数据并评估试验的低、不明确或高偏倚风险。任何差异通过讨论和共识解决。对于连续结果,若使用相同的结果测量和评分方法,则采用平均差(MD)进行分析;若使用不同的结果测量,则采用标准化平均差(SMD)进行分析。对于二分类数据,采用风险比(RR)及其95%置信区间(CI)的标准估计。
识别出74篇描述61项试验的论文,主要为4234名女性参与者。研究人群中纤维肌痛的严重程度各不相同,从轻度到重度。26项研究在所有评估领域被归类为低偏倚风险。优先呈现身心疗法与常规护理比较的结果。低质量证据表明,与常规护理对照组相比,心理疗法对身体功能(SMD -0.4,95%CI -0.6至-0.3,绝对变化-7.5%,0至100分制上2分的变化)、疼痛(SMD -0.3,95%CI -0.5至-0.2,绝对变化-3.5%,0至100分制上2分的变化)和情绪(SMD -0.5,95%CI -0.6至-