Imamura Mari, Robertson Clare, Hudson Jemma, Whibley Daniel, Aucott Lorna, Gillies Katie, Beasley Marcus, Stevens Martin J, Manson Paul, Dulake Debra, Abhishek Abhishek, Tang Nicole Ky, Macfarlane Gary J, Brazzelli Miriam
Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA.
Health Technol Assess. 2025 May;29(20):1-228. doi: 10.3310/GTBR7561.
Fibromyalgia is a chronic condition characterised by widespread musculoskeletal pain. Sleep problems are reported by 92% of people living with fibromyalgia.
To evaluate the effectiveness and safety of interventions for the management of fibromyalgia-related sleep problems; explore the experiences of people with fibromyalgia-related sleep problems and examine the content of patient-reported outcome measures for 'sleep quality'.
We conducted: (1) a network meta-analysis of randomised controlled trials to compare the effectiveness of pharmacological and non-pharmacological interventions; (2) a systematic thematic synthesis of qualitative evidence; (3) a content analysis of existing patient-reported outcome measures validated in people with fibromyalgia. Major electronic databases were searched in November 2021.
One hundred and sixty-eight studies were included in the effectiveness synthesis. The network meta-analysis assessing sleep quality included 35 treatment categories from 65 studies (8247 participants). Most studies were at high overall risk of bias. There is some evidence that compared with placebo or sham treatments, some forms of exercise [i.e. land-based aerobic exercise training in combination with flexibility training (standardised mean difference -4.69, credible interval -8.14 to -1.28) and aquatic-based aerobic exercise training (standardised mean difference -2.63, credible interval -4.74 to -0.58)] may improve sleep. There is also a suggestion that land-based strengthening exercise, psychological and behavioural therapies with a focus on sleep, electrotherapy, weight loss, dental splints, antipsychotics and tricyclics may have a modest effect on sleep, but credible intervals are wide. For other interventions, there is no clear evidence of beneficial effects on sleep. Our certainty of current evidence was predominantly low to very low. The thematic synthesis highlighted the bidirectional relationship between sleep and pain. Twenty-one sleep domains were identified across five patient-reported outcome measures. The domain most frequently identified was sleep maintenance. The Pittsburgh Sleep Quality Index was the most comprehensive tool (15 domains), followed by the Medical Outcomes Study Sleep Scale (11 domains).
Quantitative studies varied considerably in terms of characteristics of interventions, control treatments and type of outcome measures. In the network, most interventions were compared with placebo, sham treatment or usual care and not with another active treatment. In general, studies were small, unblinded and of short duration (median 12 weeks). For the qualitative synthesis and patient-reported outcome measures analysis, it is unclear whether study participants are adequately representative of the wider population of fibromyalgia patients due to poor reporting of demographic data.
Some forms of exercise may be effective for managing sleep problems in people with fibromyalgia. However, heterogeneity, imprecision and low quality of the current evidence base preclude any firm conclusions. Qualitative data indicate that poor sleep is a common, profoundly disabling problem for people with fibromyalgia that negatively affects their other symptoms (e.g. pain), health and well-being. While we found heterogeneity among the item content of the patient-reported outcome measures, all capture constructs associated with sleep quality and, conceptually, are similar enough to be combined in a synthesis.
High-quality research is needed to investigate which interventions are more likely to be effective for treating fibromyalgia-related sleep problems. Future studies must be designed in collaboration with fibromyalgia patients and include an appropriate comparator treatment. Pre-registration of study protocols is essential.
This study is registered as PROSPERO CRD42021296922.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR132999) and is published in full in ; Vol. 29, No. 20. See the NIHR Funding and Awards website for further award information.
纤维肌痛是一种以广泛的肌肉骨骼疼痛为特征的慢性疾病。据报告，92%的纤维肌痛患者存在睡眠问题。
评估用于管理纤维肌痛相关睡眠问题的干预措施的有效性和安全性；探究有纤维肌痛相关睡眠问题患者的经历，并检查患者报告的“睡眠质量”结局指标的内容。
我们进行了：（1）对随机对照试验的网状Meta分析，以比较药物和非药物干预措施的有效性；（2）对定性证据的系统主题综合分析；（3）对在纤维肌痛患者中验证过的现有患者报告结局指标的内容分析。2021年11月检索了主要电子数据库。
有效性综合分析纳入了168项研究。评估睡眠质量的网状Meta分析包括来自65项研究（8247名参与者）的35种治疗类别。大多数研究总体偏倚风险较高。有一些证据表明，与安慰剂或假治疗相比，某些形式的运动[即陆上有氧运动训练与柔韧性训练相结合（标准化均数差-4.69，可信区间-8.14至-1.28）和水上有氧运动训练（标准化均数差-2.63，可信区间-4.74至-0.58）]可能改善睡眠。也有迹象表明，陆上强化运动、以睡眠为重点的心理和行为疗法、电疗法、减肥、牙托、抗精神病药物和三环类药物可能对睡眠有适度影响，但可信区间较宽。对于其他干预措施，没有明确证据表明对睡眠有有益影响。我们目前证据的确定性主要为低至极低。主题综合分析突出了睡眠与疼痛之间的双向关系。在五项患者报告结局指标中确定了21个睡眠领域。最常确定的领域是睡眠维持。匹兹堡睡眠质量指数是最全面的工具（15个领域），其次是医学结局研究睡眠量表（11个领域）。
定量研究在干预措施特征、对照治疗和结局指标类型方面差异很大。在网状分析中，大多数干预措施与安慰剂、假治疗或常规护理进行比较，而非与另一种活性治疗进行比较。总体而言，研究规模小、未设盲且持续时间短（中位数为12周）。对于定性综合分析和患者报告结局指标分析，由于人口统计学数据报告不佳，尚不清楚研究参与者是否能充分代表更广泛的纤维肌痛患者群体。
某些形式的运动可能对管理纤维肌痛患者的睡眠问题有效。然而，当前证据基础的异质性、不精确性和低质量排除了得出任何确凿结论的可能性。定性数据表明，睡眠不佳是纤维肌痛患者常见的、严重致残的问题，会对他们的其他症状（如疼痛）、健康和幸福感产生负面影响。虽然我们发现患者报告结局指标的项目内容存在异质性，但所有指标都涵盖了与睡眠质量相关的结构，并且在概念上相似到足以在综合分析中合并。
需要高质量的研究来调查哪些干预措施更有可能有效治疗纤维肌痛相关睡眠问题。未来的研究必须与纤维肌痛患者合作设计，并包括适当的对照治疗。研究方案的预注册至关重要。
本研究注册为PROSPERO CRD42021296922。
本奖项由国家卫生与保健研究所（NIHR）卫生技术评估计划资助（NIHR奖项编号：NIHR132999），并全文发表于；第29卷，第20期。有关进一步的奖项信息，请参阅NIHR资助与奖项网站。
