Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs. Sixty-four patients with FMs were recruited. Patients were randomly assigned to either the experimental group (EG) or the control group (CG). The EG received 10 HRV-BF training sessions in addition to pharmacological standard therapy. The CG received standard therapies for 10 weeks. The FMs impact on daily life, sleep regularity, sense of coherence, depression symptoms and pain has been assessed as primary outcomes, quality of life as secondary. 23 (71.9%) of EG patients completed the intervention and 20 (62.5%) of the CG were re-evaluated at time T1. No side effects were reported. It was not found any statistical differences between groups over time in primary and secondary outcomes. The HRV-BF intervention did not demonstrate efficacy in both primary and secondary outcomes. However, it is quite feasible in terms of drop-out rate and side effects. Further studies with larger sample sizes are needed to determine its actual efficacy.

中文翻译：

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心率变异性生物反馈训练对睡眠障碍的功效和纤维肌痛的影响：II 期随机对照试验的结果

纤维肌痛综合征 (FM) 是一种慢性肌肉骨骼疼痛疾病，其特征是睡眠障碍、疲劳和认知功能障碍。旨在改善自我调节和增强副交感神经系统的心率变异性生物反馈 (HRV-BF) 已被证明对多种疼痛综合征有效，但其在 FM 中的疗效尚未得到充分研究。该 II 期试验旨在评估 HRV-BF 在 FM 中引起的改善的可行性和初步测量。招募了 64 名 FM 患者。患者被随机分配到实验组（EG）或对照组（CG）。除了药理学标准治疗外，EG 还接受了 10 次 HRV-BF 培训课程。 CG 接受了为期 10 周的标准治疗。 FM 对日常生活、睡眠规律、连贯感、抑郁症状和疼痛的影响被评估为主要结果，生活质量为次要结果。 23 名 (71.9%) EG 患者完成了干预，20 名 (62.5%) CG 在时间 T1 进行了重新评估。没有副作用的报道。随着时间的推移，没有发现组间的主要和次要结果存在任何统计差异。 HRV-BF 干预在主要和次要结局方面均未显示出有效性。但从脱落率和副作用来看，还是相当可行的。需要更大样本量的进一步研究来确定其实际功效。