Department of Chiropractic, Macquarie University, NSW, 2109 Australia.
Trials. 2010 Nov 15;11:106. doi: 10.1186/1745-6215-11-106.
Hypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring normal thyroid stimulating hormone levels. Generally this management strategy is effective and well tolerated. However, there is research to suggest that a significant proportion of hypothyroid sufferers are being inadequately managed. Furthermore, hypothyroid patients are more likely to have a decreased sense of well-being and more commonly experience constitutional and neuropsychiatric complaints, even with pharmacological intervention.The current management of hypothyroidism follows a biomedical model. Little consideration has been given to a biopsychosocial approach to this condition. Within the chiropractic profession there is growing support for the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET) for this population.
METHODS/DESIGN: A placebo-controlled, single-blinded, randomised clinical pilot-trial has been designed to assess the influence of Neuro-Emotional Technique on a population with primary overt hypothyroidism. A sample of 102 adults (≥18 years) who meet the inclusion criteria will be randomised to either a treatment group or a placebo group. Each group will receive ten treatments (NET or placebo) over a six week period, and will be monitored for six months. The primary outcome will involve the measurement of depression using the Depression, Anxiety and Stress Scale (DASS). The secondary outcome measures to be used are; serum thyroid stimulating hormone, serum free-thyroxine, serum free-triiodothyronine, serum thyroid peroxidase auto-antibodies, serum thyroglobulin auto-antibodies as well as the measurement of functional health and well-being using the Short-Form-36 Version 2. The emotional states of anxiety and stress will be measured using the DASS. Self-measurement of basal heart rate and basal temperature will also be included among the secondary outcome measures. The primary and secondary measures will be obtained at commencement, six weeks and six months. Measures of basal heart rate and basal temperature will be obtained daily for the six month trial period, with recording to commence one week prior to the intervention.
The study will provide information on the influence of NET when added to existing management regimens in individuals with primary overt hypothyroidism.
ANZCTR Number: 12607000040460.
甲状腺功能减退症是一种常见的内分泌疾病。患有这种疾病的人通常通过补充合成甲状腺激素来进行治疗，目的是缓解症状并恢复正常的促甲状腺激素水平。一般来说，这种治疗策略是有效且耐受良好的。然而，有研究表明，相当一部分甲状腺功能减退症患者的治疗并不充分。此外，即使进行药物干预，甲状腺功能减退症患者也更有可能感到不适，并且更常见的是出现身体和神经精神方面的抱怨。目前对甲状腺功能减退症的治疗遵循生物医学模式。对于这种疾病，很少考虑采用生物心理社会方法。在整脊专业领域，越来越多的人支持使用一种名为神经情绪技术（NET）的基于生物心理社会的干预方法来治疗这一人群。
方法/设计：本研究设计了一项安慰剂对照、单盲、随机临床试验，以评估神经情绪技术对原发性显性甲状腺功能减退症患者的影响。符合纳入标准的 102 名成年人（≥18 岁）将被随机分配到治疗组或安慰剂组。每组将在六周内接受十次治疗（NET 或安慰剂），并监测六个月。主要结局指标将使用抑郁、焦虑和压力量表（DASS）测量抑郁程度。将使用的次要结局测量指标包括：血清促甲状腺激素、血清游离甲状腺素、血清游离三碘甲状腺原氨酸、血清甲状腺过氧化物酶自身抗体、血清甲状腺球蛋白自身抗体，以及使用短格式 36 版第 2 版测量的功能健康和幸福感。焦虑和压力的情绪状态将使用 DASS 进行测量。基础心率和基础体温的自我测量也将作为次要结局测量指标之一。主要和次要测量指标将在开始时、六周和六个月时获得。基础心率和基础体温的测量将在六个月的试验期间每天进行，记录将在干预前一周开始。
该研究将提供关于在原发性显性甲状腺功能减退症患者中添加 NET 对现有治疗方案的影响的信息。
澳大利亚新西兰临床试验注册中心编号：12607000040460。
