Abstract:
BACKGROUND:Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this procedure. METHODS/DESIGN:This is a protocol for a randomized, patient-blinded, assessor-blinded, sham-controlled trial. Sixty participants with symptoms of gastroesophageal reflux disease, who have previously undergone standard treatment, will be recruited from August 2015 at Kyung Hee University Korean Medicine Hospital. The participants will be allocated to either the electroacupuncture (n = 30) or the sham electroacupuncture group (n = 30); the allocation will be concealed from both the participants and the assessors. The EA group will undergo penetrating acupuncture at 18 fixed points and two optional points chosen using the pattern identification for gastroesophageal reflux disease. Electrical stimulation will be applied at some of the acupoints. The sham electroacupuncture group will undergo nonpenetrating acupuncture without electrical stimulation at 18 nonspecific points, each of which will be only 2 cm away from the true acupoints used in the electroacupuncture group. In both groups, the procedure will be performed using the Park device. The treatment will last for 6 weeks (with two sessions each week), and the outcome will be evaluated at baseline, 3 weeks, and 6 weeks. The primary outcome will be the proportion of responders with adequate symptom relief, whereas the secondary outcomes will comprise the results of the Nepean dyspepsia index; the Korean gastrointestinal symptom rating scale; the EQ-5D™; levels of gastrin, motilin, and inflammatory cytokines; the perceived stress scale; the qi-stagnation questionnaire; the patient global impression of change; and the spleen qi deficiency questionnaire. DISCUSSION:The results of this trial will provide information about the efficacy and safety of electroacupuncture in the treatment of gastroesophageal reflux disease symptoms, as well as evidence regarding the use of electroacupuncture to treat gastroesophageal reflux disease in real clinical practice. TRIAL REGISTRATION:Clinical Research Information Service Identifier, KCT0001653 . Registered on 12 October 2015.
journal_name
Trialsjournal_title
Trialsauthors
Han G,Leem J,Lee H,Lee Jdoi
10.1186/s13063-016-1371-8subject
Has Abstractpub_date
2016-05-17 00:00:00pages
246issue
1issn
1745-6215pii
10.1186/s13063-016-1371-8journal_volume
17pub_type
杂志文章,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many in...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3768-7
更新日期:2019-12-02 00:00:00
abstract:BACKGROUND:The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-140
更新日期:2014-04-23 00:00:00
abstract:BACKGROUND:Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism. First-line therapy with synthetic disease-modifying antirheumatic drugs (sDMARD) is insufficiently effective in 40% of cases and these patients are treated with biotherapies. The increased use of these drugs each year is becomin...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04683-7
更新日期:2020-08-31 00:00:00
abstract:BACKGROUND:Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs). Direct admission, defined as admission to hospital without first receiving care in the hospital's ED, may offer benefi...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04889-9
更新日期:2020-11-30 00:00:00
abstract:BACKGROUND:State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-13-135
更新日期:2012-08-10 00:00:00
abstract::Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot' studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children's righ...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/1745-6215-15-287
更新日期:2014-07-16 00:00:00
abstract:BACKGROUND:The German welfare system follows the principle "rehabilitation rather than pension," but more than the half of all disability pensioners did not utilize medical rehabilitation before their early retirement. A major barrier is the application procedure. Lack of information about the opportunity to utilize re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0968-7
更新日期:2015-09-29 00:00:00
abstract:BACKGROUND:Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatmen...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-351
更新日期:2014-09-06 00:00:00
abstract:BACKGROUND:High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3950-y
更新日期:2019-12-27 00:00:00
abstract::After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. ...
journal_title:Trials
pub_type: 杂志文章,已发布勘误
doi:10.1186/s13063-018-3089-2
更新日期:2018-12-24 00:00:00
abstract:BACKGROUND:Randomised clinical trials are the 'gold standard' for evaluating the effectiveness of healthcare interventions. However, successful recruitment of participants remains a key challenge for many trialists. In this paper, we present a conceptual framework for creating a digital, population-based database for t...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-016-1381-6
更新日期:2016-05-26 00:00:00
abstract:BACKGROUND:Patients affected by hepatic cirrhosis show reductions in muscle mass and function, with poor quality of life and functional performance. As such, resistance training with blood flow restriction (BFR-RT) could be a useful therapeutic tool for health promotion. Thus, we aim to verify the effects of this inter...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04410-2
更新日期:2020-05-29 00:00:00
abstract:BACKGROUND:Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Sympt...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-10-92
更新日期:2009-09-30 00:00:00
abstract:BACKGROUND:Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Mos...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1628-2
更新日期:2016-10-21 00:00:00
abstract:BACKGROUND:Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss w...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-393
更新日期:2013-11-19 00:00:00
abstract:BACKGROUND:Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed on family members. A multidisciplinary approach to rehabilitation for people with Parkinson's is re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-250
更新日期:2011-11-23 00:00:00
abstract:BACKGROUND:Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2% of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels, impairing haemostasis and thus worsening the ongoing...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-13-110
更新日期:2012-07-17 00:00:00
abstract:BACKGROUND:It is reported that nursing is one of the most vulnerable jobs for developing depression. While they may not be clinically diagnosed as depressed, nurses often suffer from depression and anxiety symptoms, which can lead to a low level of patient care. However, there is no rigorous evidence base for determini...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0554-z
更新日期:2015-01-31 00:00:00
abstract:BACKGROUND:Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. METHODS/DESIGN:The Decreasing Delirium through Music (DDM) study is a three-arm, single-blin...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2324-6
更新日期:2017-11-29 00:00:00
abstract:BACKGROUND:The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (CDA) created an implementation strategy to improve the implementation of its 2008 guidelines. This s...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-44
更新日期:2010-04-23 00:00:00
abstract:BACKGROUND:Low back pain (LBP) is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. L...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-216
更新日期:2011-10-04 00:00:00
abstract:BACKGROUND:Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-418
更新日期:2014-10-29 00:00:00
abstract::Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance, but the optimal methodology to define the critical path for nove...
journal_title:Trials
pub_type: 杂志文章,meta分析,评审
doi:10.1186/s13063-015-1050-1
更新日期:2015-11-14 00:00:00
abstract:BACKGROUND:There are marked disparities between pre-school children in key skills affecting school readiness, disparities that commonly persist and influence children's later academic achievements, employment, and adjustment. Much of this disparity is linked to socio-economic disadvantage and its impact on the home lea...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-018-2700-x
更新日期:2018-08-22 00:00:00
abstract:BACKGROUND:There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-265
更新日期:2013-08-20 00:00:00
abstract:BACKGROUND/AIMS:Prediabetes and diabetes disproportionately impact Latino youth, yet few diabetes prevention programs have prioritized inclusion of this underrepresented population. This report describes the recruitment process, yields, associated costs, and phenotypic characteristics of Latino youth with obesity and p...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04658-8
更新日期:2020-08-14 00:00:00
abstract:BACKGROUND:Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist....
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3585-z
更新日期:2019-08-13 00:00:00
abstract:BACKGROUND:Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-3087-4
更新日期:2019-01-14 00:00:00
abstract:BACKGROUND:Glenohumeral osteoarthritis can, in the most severe cases, require surgery with insertion of a shoulder arthroplasty. A design with a stem in the humeral bone canal is currently regarded as the standard treatment option in patients who have an intact rotator cuff function, but complications related to the st...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04763-8
更新日期:2020-10-07 00:00:00
abstract:BACKGROUND:The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporti...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2335-3
更新日期:2017-12-22 00:00:00