Watts Gareth J, Clark Katherine, Agar Meera, Davidson Patricia M, McDonald Christine, Lam Lawrence T, Sajkov Dimitar, McCaffrey Nicola, Doogue Matthew, Abernethy Amy P, Currow David C
Department of Palliative Care, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.
BMJ Open. 2016 Nov 29;6(11):e013177. doi: 10.1136/bmjopen-2016-013177.
Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses.
A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0-100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained.
Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences.
ACTRN12610000464066.
对于许多患有进行性危及生命疾病的患者来说，呼吸困难仍然是一种非常普遍且令人痛苦的症状。针对慢性呼吸困难的循证干预措施有限，因此持续需要开展高质量研究以制定管理策略，从而最佳地缓解这一复杂症状。先前的研究表明，选择性5-羟色胺再摄取抑制剂（如舍曲林）可能在减轻呼吸困难方面发挥作用。本文介绍了一项大型、有足够效力的随机研究方案，该研究旨在评估舍曲林在患有进行性危及生命疾病的人群中治疗慢性呼吸困难的效果。
在这项多中心、双盲研究中，共有240名改良医学研究委员会呼吸困难量表评分为2级或更高的参与者将被随机分组，接受舍曲林或安慰剂治疗28天。剂量每3天递增一次，最大剂量为每日100毫克。主要结局将是比较舍曲林与安慰剂在缓解最严重呼吸困难强度方面的疗效，这一强度通过0至100毫米视觉模拟量表进行评估。还将记录一些其他的结局指标、呼吸困难描述以及照料者评估，以确保对参与者的呼吸困难进行充分分析，并能够开展经济学分析。参与者也可以选择继续接受盲法治疗，直到研究数据收集完成或净效益停止。将对主要和次要结局进行适当的统计分析，以描述所获得的大量数据。
所有参与研究的地点均已获得伦理批准。研究结果将提交至同行评审期刊发表，并在国内和国际会议上展示主要研究发现。
ACTRN12610000464066。
