Background:Patients with inflammatory arthritis (IA) often present limitations in daily life due to unpredictability, severity and chronicity of the disease, reduced functional ability and health-related quality of life. Moreover, sleep disturbances or disorders have been reported in up to 40-90% of patients with IA [1-3]. Sleep disturbances are further associated with pain, fatigue, mental well-being and disease activity [4]. As chronic us of hypnotic drugs are associated with tolerance and side effects, there is growing interest in non-pharmacological management to improve sleep.Objectives:With a systematic review and meta-analysis, our primary objective was to evaluate the evidence of non-pharmacological interventions targeting sleep in patients with IA. Primary outcome was sleep domains, while secondary objectives were based on the core outcome domains for IA trials and harms.Methods:Following protocol closure, a systematic search was undertaken in MEDLINE, CENTRAL, PsycINFO, CINAHL, ClinicalTrials.gov, ACR and EULAR in September 2020. Eligible studies were randomised trials with adults with IA and concomitant sleep disturbances or disorders, comparing a non-pharmacological intervention targeting sleep disturbances or disorders to another non-pharmacological intervention, a pharmacological intervention or standard care. Screening of titles, abstracts, and subsequent full text assessment were conducted independently by two reviewers using the Covidence tool. Randomisation, blinding, and adequacy of analyses was assessed using the Cochrane’s RoB tool and the overall quality of evidence was rated using GRADE methodology. Disagreements were resolved at consensus meetings with last authors. Effect sizes for continuous outcomes were based on the standardised mean difference (SMD), combined using standard random-effects meta-analysis (all with 95% CIs).Results:Six trials (308 patients) were included in the quantitative synthesis. Two trials included patients with the sleep disorder insomnia and the remaining four trials included patients with sleep disturbances. Sleep domains were measured with Pittsburgh Sleep Quality Index (PSQI) or Insomnia Severity index (ISI). Three trials reported improvement on sleep following foot reflexology, auricular plaster therapy, and exercise. The overall meta-analysis presented in the figure of forest plot for self-reported sleep suggests that non-pharmacological interventions have a potentially large effect size of -0.80 (95% CI, -1.33 to -0.28) on sleep. However, the quality of the evidence was assessed as corresponding to low, given that the body of the evidence was rated down twice, due to serious study limitations and inconsistency.Conclusion:Although the effect of non-pharmacological interventions targeting sleep disturbances or the sleep disorder insomnia was statistically highly significant, the implication for clinical practice is questionable because of the overall quality evidence. None of the core outcomes used in contemporary IA trials have indicated clinical benefit in favour of non-pharmacological interventions targeting sleep disturbances or disorders.In conclusion, more rigorous research on non-pharmacological management of sleep disturbances and disorders is urgently needed, also aimed at specific sleep disorders, in order to fully reveal the clinical utility of these novel treatment options. At this point, non-pharmacological treatment of sleep disturbances or disorders is promising and potentially highly effective, and may have the potential to persistently decrease the symptom burden and increase the quality of life of patients with IA.References:[1]Li et al., Psychol Health Med. 2019 Sep;24(8):911-924[2]Haugeberg et al., Arthritis Res Ther. 2020 Aug 26;22(1):198[3]Wali et al., J Clin Sleep Med. 2020 Feb 15;16(2):259-265[4]Løppenthin et al., Clin Rheumatol. 2015 Dec;34(12):2029-39Disclosure of Interests:Kristine Marie Latocha: None declared, Katrine Løppenthin: None declared, Safa Al-Bazy: None declared, Tannie Albrechtsen: None declared, Helle Jensen: None declared, Mikkel Østergaard Speakers bureau: Abbvie, Celgene, Eli-Lilly, Janssen, Novartis, Pfizer, Roche, Sanofi and UCB, Consultant of: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Grant/research support from: Abbvie, BMS, Merck, Celgene, Novartis, Poul Jennum: None declared, Bente Appel Esbensen: None declared, Robin Christensen: None declared
Objective. Patients with inflammatory arthritis have a high risk of sleep disturbances and disorders. The objective was to evaluate the evidence of nonpharmacologic interventions targeting sleep disturbances or disorders in patients with inflammatory arthritis.Methods. A systematic search was undertaken from inception to September 8, 2020. We included randomized trials concerning nonpharmacologic interventions applied in adults with inflammatory arthritis and concomitant sleep disturbances or disorders. The primary outcome was the sleep domain, while secondary outcomes were core outcome domains for inflammatory arthritis trials and harms. The Cochrane Risk of Bias tool was applied, and the overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation criteria. Effect sizes for continuous outcomes were based on the standardized mean difference, combined using randomeffects meta-analysis.Results. Six trials (308 patients) were included in the quantitative synthesis; 3 of these reported improvement in sleep in favor of the nonpharmacologic interventions. The meta-analysis of the sleep domains indicated a large clinical effect of -0.80 (95% confidence interval -1.33, -0.28) in favor of nonpharmacologic interventions targeting sleep disturbances or disorders. The estimate was rated down twice for risk of bias and unexplained inconsistency; this risk was assessed as corresponding to low-quality evidence. None of the secondary core outcomes used in contemporary inflammatory arthritis trials indicated a clinical benefit in favor of nonpharmacologic interventions targeting sleep.Conclusion. Nonpharmacologic interventions targeting sleep disturbances/disorders in patients with inflammatory arthritis indicated a promising effect on sleep outcomes, but not yet with convincing evidence.
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