Paré Pierre, Lee Joanna, Hawes Ian A
Centre hospitalier affilié universitaire de Québec--Hôpital du Saint-Sacrement, Université Laval, 1050 Chemin Sainte-Foy, Quebec City, Quebec.
Can J Gastroenterol. 2010 Mar;24(3):189-95. doi: 10.1155/2010/362130.
To determine whether strategies to counsel and empower patients with heartburn-predominant dyspepsia could improve health-related quality of life.
Using a cluster randomized, parallel group, multicentre design, nine centres were assigned to provide either basic or comprehensive counselling to patients (age range 18 to 50 years) presenting with heartburn-predominant upper gastrointestinal symptoms, who would be considered for drug therapy without further investigation. Patients were treated for four weeks with esomeprazole 40 mg once daily, followed by six months of treatment that was at the physician's discretion. The primary end point was the baseline change in Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire score.
A total of 135 patients from nine centres were included in the intention-to-treat analysis. There was a statistically significant baseline improvement in all domains of the QOLRAD questionnaire in both study arms at four and seven months (P<0.0001). After four months, the overall mean change in QOLRAD score appeared greater in the comprehensive counselling group than in the basic counselling group (1.77 versus 1.47, respectively); however, this difference was not statistically significant (P=0.07). After seven months, the overall mean baseline change in QOLRAD score between the comprehensive and basic counselling groups was not statistically significant (1.69 versus 1.56, respectively; P=0.63).
A standardized, comprehensive counselling intervention showed a positive initial trend in improving quality of life in patients with heartburn-predominant uninvestigated dyspepsia. Further investigation is needed to confirm the potential benefits of providing patients with comprehensive counselling regarding disease management.
确定针对以烧心为主的消化不良患者的咨询和赋能策略是否能改善健康相关生活质量。
采用整群随机、平行组、多中心设计,将九个中心分配为向出现以烧心为主的上消化道症状(年龄在18至50岁之间)且将被考虑进行药物治疗而无需进一步检查的患者提供基本咨询或全面咨询。患者接受为期四周的每日一次40毫克埃索美拉唑治疗,随后六个月的治疗由医生自行决定。主要终点是反流和消化不良生活质量(QOLRAD)问卷评分的基线变化。
来自九个中心的总共135名患者纳入意向性分析。在四个月和七个月时,两个研究组的QOLRAD问卷所有领域在基线时均有统计学显著改善(P<0.0001)。四个月后,全面咨询组的QOLRAD评分总体平均变化似乎大于基本咨询组(分别为1.77和1.47);然而,这种差异无统计学意义(P=0.07)。七个月后,全面咨询组和基本咨询组之间QOLRAD评分的总体平均基线变化无统计学意义(分别为1.69和1.56;P=0.63)。
标准化的全面咨询干预在改善以烧心为主的未经调查的消化不良患者生活质量方面显示出积极的初始趋势。需要进一步研究以证实为患者提供有关疾病管理的全面咨询的潜在益处。