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A Biopsychosocial approach to primary hypothyroidism : treatment and harms data from a randomized controlled trial

机译:一种针对原发性甲状腺功能减退症的生物心理疗法:随机对照试验的治疗和危害数据

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摘要

Background: Hypothyroidism is a common endocrine condition. There is evidence to suggest that, for a proportion of sufferers, the standard medical treatment does not completely reverse the constitutional and neuropsychiatric symptoms brought about by this condition. The management of hypothyroidism follows a biomedical model with little consideration given to alternative management approaches. There exists anecdotal evidence and case reports supporting the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET) for this population. The aim of this study was to explore the potential short-medium term clinical efficacy and safety of NET for individuals with primary hypothyroidism. Design: Placebo-controlled, blinded, parallel groups, randomized trial. Methods: Ninety adults with a diagnosis of primary hypothyroidism were recruited from Sydney, Australia. Blinded participants were randomized to either the NET or placebo group and received ten intervention sessions over a six week period. The primary outcome involved the measurement of states of depression using the DASS-42 questionnaire. Secondary outcomes included thyroid function, thyroid autoimmunity testing, SF-36v2 questionnaire, resting heart rate and temperature measurement. Outcomes were obtained at baseline, seven weeks and six months. Questionnaires were completed at the private clinics, and serum measures were obtained and analysed at commercial pathology company locations. Heart rate and temperature were also measured daily by participants. Linear mixed-effects models were used to analyse the continuous outcomes. Unadjusted odds ratios with 95% confidence intervals were calculated for the binary outcomes. Results: Participants were randomly allocated to the NET (n=44) and placebo (n=46) groups. A proportion of the sample displayed neuropsychiatric disturbances and alterations in quality of life measures at baseline. There were no statistically significant or clinically relevant changes in the primary or secondary outcomes between the NET and placebo groups at time seven weeks or six months. There were a few short-lived minor adverse events reported in both the NET and placebo groups that coincided with the application of the intervention. Conclusions: The application of the NET intervention appears to be safe, but did not confer any clinical benefit to the participants in this study and is unlikely to be of therapeutic use in a hypothyroid population.
机译:背景:甲状腺功能减退是一种常见的内分泌疾病。有证据表明,对于一定比例的患者,标准药物治疗不能完全逆转这种情况带来的体质和神经精神症状。甲状腺功能减退症的治疗遵循生物医学模型,很少考虑其他治疗方法。有轶事证据和案例报告支持对该人群使用基于生物心理社会的干预措施,称为神经情感技术(NET)。这项研究的目的是探讨NET对原发性甲状腺功能减退症患者的潜在短期中长期临床疗效和安全性。设计:安慰剂对照,盲法,平行组,随机试验。方法:从澳大利亚悉尼市招募了90名诊断为原发性甲状腺功能减退症的成年人。将失明的参与者随机分为NET或安慰剂组,并在六周内接受了十次干预。主要结果涉及使用DASS-42问卷测量抑郁状态。次要结果包括甲状腺功能,甲状腺自身免疫测试,SF-36v2问卷,静息心率和体温测量。在基线,七个星期和六个月获得结果。在私人诊所完成问卷调查,并在商业病理公司所在地获得血清分析并进行分析。参与者还每天测量心率和体温。线性混合效应模型用于分析连续结果。计算二元结果的未调整比值比,置信区间为95%。结果:参与者随机分为NET组(n = 44)和安慰剂组(n = 46)。一部分样本在基线时表现出神经精神障碍和生活质量测量的改变。 NET和安慰剂组在7周或6个月的时间里,主要或次要结局没有统计学上显着或临床相关的变化。 NET和安慰剂组均报告了一些短暂的轻微不良事件,与干预措施的应用相吻合。结论:NET干预的应用看来是安全的,但并未给该研究的参与者带来任何临床益处,并且不太可能在甲状腺功能减退的人群中进行治疗。

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