Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia: A Randomized Comparison of Different Prescribing Behaviors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Compliance of Flupentixol-Melitracen
研究概览
简要总结
The study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of FD symptoms and the drugs' effects might improve compliance with psychoactive agent regimens among FD patients.
详细描述
Antidepressive agents have been proved to be effective in the treatment of functional dyspepsia (FD) patients. However, one of the factors that limit therapeutic benefit is the poor compliance with prescribed drugs. The possible reasons for lack of compliance include the patient's health beliefs (e.g., that people who took such agents is possibly considered insane in China), lack of knowledge about antidepressants (that they are addictive or can be stopped on recovery), and aversion to side effects. The investigators propose to examine whether different clinician-patient communication methods could affect adherence to antidepressant drugs in functional dyspepsia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •met the ROME III criteria for FD;
- •education level no lower than high school;
- •Hospital Anxiety and Depression Scale (HADS) score > 8 respectively;
- •absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
- •absence of H. pylori infection
排除标准
- •known allergy to omeprazole, flupenthixol or melitracen;
- •any evidence of organic digestive diseases;
- •reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms;
- •severe psychological symptoms that affected life and work;
- •pregnancy or breastfeeding;
- •recent myocardial infarction or cardiac arrhythmias;
- •previous gastric surgery;
- •use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
研究组 & 干预措施
Flupentixol-Melitracen(psychological and GI) + Omeprazole
The patients in Group 1 were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
干预措施: Flupentixol-Melitracen(psychological and GI) + Omeprazole (Drug)
Flupentixol-Melitracen(psychological) + Omeprazole
The patients in Group 2 were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
干预措施: Flupentixol-Melitracen(psychological) + Omeprazole (Drug)
Flupentixol-Melitracen(without explanation) + Omeprazole
In Group 3, the patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
干预措施: Flupentixol-Melitracen(without explanation) + Omeprazole (Drug)
proton pump inhibitor
Prescribe Omeprazole.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Compliance of Flupentixol-Melitracen
时间窗: weeks 1, 2, 4, 8
The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.
次要结局
- Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8(week 0 and 8)
- Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8(week 0 and 8)
研究者
Shengliang Chen
professor,chief physician
RenJi Hospital