A Study to Evaluate the Role of Alternative Medicine in Difficult to Treat GERD Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Decrease by 50% in the RDQ scores as compared to baseline at the end of the study period
研究概览
简要总结
Patients with refractory GERD on BID PPI's assigned to the acupuncture group will have significant improvement in their symptoms after receiving acupuncture for 6 weeks as compared to sham acupuncture given for the same duration.
Primary Aim 1:To determine the efficacy of acupuncture in the treatment of refractory GERD.
Participants with refractory GERD on BID PPIs randomized to yoga will have a significant relief in the symptoms of reflux.
Primary Aim 2:To determine the efficacy of yoga in the treatment of refractory GERD.
详细描述
BACKGROUND
Prevalence and burden of disease:
Gastroesophageal reflux disease (GERD) defined as presence of symptoms of heartburn and/or acid regurgitation is a common chronic disorder. It is a significant health problem especially in the Western population associated with a huge economic burden and impaired quality of life (1, 2). The prevalence of GERD in the adult population of the United States is 40% (symptoms at least once a month). Approximately 20% report GERD related symptoms weekly while 14% report them on a daily basis.
The leading gastrointestinal symptoms evaluated in a primary care office setting are those related to a diagnosis of GERD. The mainstay of treatment for GERD symptoms at present time are proton pump inhibitors (PPI) in combination with life style changes. In fact, PPI have become one of the most commonly written prescriptions, trends suggesting that per year scripts have doubled since 1999. It is estimated that Americans spend in excess of 10 billion US dollars/year on PPIs and two of the top five selling drugs in the United States are PPIs (5). For patients who prefer to refrain from long-term medication use, may benefit from acid-reflux surgeries such as Nissen fundoplication. However, acid-reflux reducing procedures are associated with operative morbidity and mortality including several complications including gas bloat syndrome. A large number of patients who undergo surgery for reflux symptoms may eventually relapse and require PPIs. Thus, treatment of reflux, either pharmacological or surgical, is costly (6-9) and presents a significant economic burden on the health-care delivery system.
Social Impact of the disease:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be a Kansas City VA Hospital patient.
- •18 yrs or older.
- •agreeable to randomization.
- •patients with refractory GERD on bid PPI.
- •negative endoscopy in the last 5 yrs.
- •able to follow simple instructions and perform simple exercises.
- •capable of giving informed consent.
排除标准
- •GERD with known complications e.g. peptic stricture.
- •Hepatitis C.
- •Peripheral neuropathy.
- •Irritable bowel syndrome
- •Previous acupuncture.
- •any other major co morbidity e.g. scleroderma etc.
- •chronic anticoagulation.
- •pregnancy/lactation.
- •prior h/o esophageal surgery.
- •H/o of Barrett's esophagus.
- •Esophageal cancer.
结局指标
主要结局
Decrease by 50% in the RDQ scores as compared to baseline at the end of the study period
时间窗: 1 year
次要结局
- Improvement in reflux related quality of life (QOLRAD) scores at the end of the study by 50%(1 year)
- Decrease by 50% in the baseline RDQ scores at 12 and 26 week follow up after the completion of the study(1 year)
研究者
PRATEEK SHARMA
Principal Investigator
Midwest Biomedical Research Foundation