NEUROMUSCULAR CONDITION THERAPY-DYSSYNERGIC DEFECATION

神经肌肉状况治疗-不协同排便

• 批准号: 6517713
• 负责人: Satish SC Rao
• 金额: $ 25.28万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6517713
• 关键词: alternative medicine; behavior therapy; behavioral /social science research tag; behavioral medicine; biofeedback; clinical research; clinical trials; constipation; dietary control; gastrointestinal disorder chemotherapy; gastrointestinal motility /pressure; habits; health behavior; health care cost /financing; home health care; human subject; human therapy evaluation; laxative; nutrition related tag; personal log /diary; quality of life

Constipation affects 4 million Americans, predominantly women and the elderly. Its pathophysiology is incompletely understood and its treatment is unsatisfactory. Laxative-dependent, and unable to accomplish natures' call, many resort to desperate treatments. About 50 percent of patients with constipation exhibit uncoordinated or dyssynergic defecation. Uncontrolled studies suggest that biofeedback therapy may improve symptoms in these patients. But, whether the improvement is due to the behavioral intervention or a consequence of excess attention is not known. Biofeedback therapy is labor-intensive, expensive and only available in a few centers. In order to treat the many patients in the community, a home-based, self-training program is essential. Our proposal addresses three objectives; 1) to determine the efficacy of biofeedback therapy by performing a randomized controlled study in patients with dyssynergic defecation. After diagnostic evaluation with colon transit study, anorectal manometry and stool diaries, 90 patients will be randomized to receive standard treatment consisting of diet, habit-training and laxatives or biofeedback therapy consisting of neuromuscular conditioning or sham feedback therapy. Short-term (3 month) and long-term (12 month) assessments of anorectal physiology-defecation index, anal relaxation, fecom expulsion time and colon transit time and symptomatology-bowel satisfaction score, straining effort, laxative consumption score and stool form and consistency will be performed. 2) To investigate the efficacy of home-training versus office-based biofeedback therapy and if it is cost-effective, 100 patients will be randomized to receive either home-training using a hand-held portable device and a silicon probe or biofeedback therapy for 3 months. Anorectal physiology and symptoms will be assessed and actuarial costs of each treatment will be compared. 3) For a condition that is entwined with psyche there is no information on quality of life or psychosocial function. We wish to investigate these parameters with validated instruments, SF-36 and SCL-90-R in 90 patients, before and after treatment and compare this with two controlled groups. This may provide impetus for new treatments such as psychotherapy. This first controlled study will determine the efficacy and scientific basis for a safe and alternative therapy for difficult defecation, provide new information that could facilitate home self-training and assess the impact of treatment on anorectal physiology, symptoms, quality of life and psychosocial aspects.

康诺利影响着400万美国人，主要是妇女和老年人。 其病理生理学尚未完全了解，其治疗也不令人满意。 依赖泻药，无法完成自然的召唤，许多人求助于绝望的治疗。大约50%的便秘患者表现出排便不协调或不协调。 非对照研究表明，生物反馈疗法可能会改善这些患者的症状。 但是，这种改善是由于行为干预还是过度关注的结果尚不清楚。生物反馈疗法是劳动密集型的，昂贵的，只有少数中心可用。 为了治疗社区中的许多患者，以家庭为基础的自我训练计划是必不可少的。 我们的建议有三个目的：1）通过对排便协同失调患者进行随机对照研究，确定生物反馈治疗的疗效。 在通过结肠运输研究、肛门直肠测压和粪便日记进行诊断评估后，90例患者将随机接受标准治疗（包括饮食、习惯训练和泻药）或生物反馈治疗（包括神经肌肉调节或假反馈治疗）。 将对肛门直肠生理学-排便指数、肛门松弛、粪便排出时间和结肠通过时间以及排便学-肠道满意度评分、用力、泻药消耗评分和粪便形状和稠度进行短期（3个月）和长期（12个月）评估。 2)为了研究家庭训练与基于办公室的生物反馈治疗的有效性，如果其具有成本效益，则将100名患者随机接受使用手持便携式设备和硅探针的家庭训练或生物反馈治疗3个月。将评估肛门直肠生理学和症状，并比较每种治疗的精算成本。 3)对于与心理交织在一起的疾病，没有有关生活质量或心理社会功能的信息。 我们希望调查这些参数与验证的工具，SF-36和SCL-90-R在90例患者，治疗前后，并比较这与两个对照组。 这可能为新的治疗方法，如心理治疗提供动力。 这项首次对照研究将确定排便困难的安全替代疗法的疗效和科学依据，提供新的信息，促进家庭自我训练，并评估治疗对肛门直肠生理学，症状，生活质量和心理社会方面的影响。