■自主神经系统功能障碍(ANSD),目前还没有治疗方法,对2型糖尿病(T2D)患者的预后有负面影响。胸骨上的骨膜压力敏感性(PPS)可能是自主神经系统功能障碍(ANSD)的量度。我们测试了基于非伤害性感觉神经刺激的非药物PPS反馈指导治疗方案,已知减少PPS,改变了授权,治疗满意度,以及T2D患者的生活质量,与常规治疗相比。
■分析单个中心的次要端点,双臂,平行组,观察者失明,T2D患者的随机对照试验。参与者被随机分配到非药物干预作为常规治疗的附加治疗。通过五份经过验证的问卷评估终点:糖尿病特异性赋权(DES-SF),糖尿病治疗满意度(DTSQ)生活质量(QOL)(WHO-5),临床压力体征(CSS),和自我报告的健康状况(SF-36)。样本量计算基于主要终点HbA1c。
■我们包括144名参与者,71个分配给主动干预,73个分配给对照组。与对照组相比,主动干预显示糖尿病特异性赋权得到改善(p=0.004),DTSQ(p=0.001),和SF-36自我报告的健康状况(p=0.003),并倾向于改善生活质量(WHO-5)(p=0.056)。这些发现在临床上与Cohen效应大小为0.5至0.7有关。
■这种非药物干预,旨在减少PPS,因此ANSD,改善糖尿病特异性赋权,治疗满意度,与常规治疗相比,自我报告的健康状况。建议的干预措施可能是对T2D常规治疗的补充。
UNASSIGNED: Autonomic nervous system dysfunction (ANSD), for which presently no treatment exists, has a negative impact on prognosis in people with type 2 diabetes (T2D). Periosteal pressure sensitivity (PPS) on sternum may be a measure of autonomic nervous system dysfunction (ANSD). We tested if a non-pharmacological PPS-feedback-guided treatment program based on non-noxious sensory nerve stimulation, known to reduce PPS, changed empowerment, treatment satisfaction, and quality of life in people with T2D, compared to usual treatment.
UNASSIGNED: Analysis of secondary endpoints in a single center, two-armed, parallel-group, observer-blinded, randomized controlled trial of individuals with T2D. Participants were randomized to non-pharmacological intervention as an add-on to treatment as usual. Endpoints were evaluated by five validated questionnaires: Diabetes specific Empowerment (DES-SF), Diabetes Treatment Satisfaction (DTSQ), quality of life (QOL) (WHO-5), clinical stress signs (CSS), and self-reported health (SF-36). Sample size calculation was based on the primary endpoint HbA1c.
UNASSIGNED: We included 144 participants, 71 allocated to active intervention and 73 to the control group. Active intervention compared to control revealed improved diabetes-specific empowerment (p = 0.004), DTSQ (p = 0.001), and SF-36 self-reported health (p=0.003) and tended to improve quality of life (WHO-5) (p = 0.056). The findings were clinically relevant with a Cohen\'s effect size of 0.5 to 0.7.
UNASSIGNED: This non-pharmacological intervention, aiming to reduce PPS, and thus ANSD, improved diabetes-specific empowerment, treatment satisfaction, and self-reported health when compared to usual treatment. The proposed intervention may be a supplement to conventional treatment for T2D.