Chung Vincent C H, Wong Charlene H L, Ching Jessica Y L, Sun Wai Zhu, Ju Yan Li, Hung Sheung Sheung, Lin Wai Ling, Leung Ka Chun, Wong Samuel Y S, Wu Justin C Y
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Hong Kong.
BMJ Open. 2018 Mar 27;8(3):e018430. doi: 10.1136/bmjopen-2017-018430.
INTRODUCTION: This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). METHODS AND ANALYSIS: This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, -negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. ETHICS AND DISSEMINATION: The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. TRIAL REGISTRATION NUMBER: ChiCTR-IPC-15007109; Pre-result.
引言：本试验旨在比较电针（EA）联合按需使用胃复安与等待接受EA联合按需使用胃复安在改善功能性消化不良（FD）患者症状及生活质量方面的有效性和成本效益。 方法与分析：这是一项单中心、务实、随机平行组优效性试验，比较（1）EA联合按需使用胃复安组与（2）等待接受EA联合按需使用胃复安组的结局。将招募132例（每组66例）经内镜确诊为阴性的FD患者。入选患者将分别接受：（1）10周内进行20次EA治疗加按需使用胃复安；或（2）按需使用胃复安，并被列入EA等待名单，这使他们在等待12周后有权在10周内接受20次EA治疗。主要结局将是12周内两组中症状得到充分缓解的患者比例的组间差异。次要结局将包括患者报告的总体症状和个体症状的变化、内皮消化不良指数、营养饮料测试、9项患者健康问卷（PHQ9）和7项广泛性焦虑障碍量表（GAD7）。将正式评估不良事件。直接医疗成本结果和欧洲五维度健康量表（EQ-5D）问卷结果也将用于评估成本效益。分析将遵循意向性分析原则，使用适当的单变量和多变量方法。将进行考虑这些结局缺失数据的混合模型分析。成本效益分析将采用既定方法进行。 伦理与传播：本研究由中国香港特别行政区政府健康与医学研究基金资助。已获得香港中文大学-新界东集群联合临床研究伦理委员会批准。结果将在同行评审期刊上发表，并在国际会议上传播。 试验注册号：ChiCTR-IPC-15007109；预结果。
J Gastroenterol Hepatol. 2019-7-4
Neurogastroenterol Motil. 2018-2-28
Clin Gastroenterol Hepatol. 2017-1-10
Otolaryngol Head Neck Surg. 2016-10
Clin J Gastroenterol. 2013-10
J Neurogastroenterol Motil. 2015-7-30
Med Clin North Am. 2014-3-18
Aliment Pharmacol Ther. 2013-9
J Dig Dis. 2013-12
Zotero 插件