Electroacupuncture plus standard of care for managing refractory functional dyspepsia: protocol of a pragmatic trial with economic evaluation.

Abstract

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, Helicobacter pylori-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.

• Authors: Vincent C H Chung, Charlene H L Wong, Jessica Y L Ching, Wai Zhu Sun, Yan Li Ju, Sheung Sheung Hung, Wai Ling Lin, Ka Chun Leung, Samuel Y S Wong, Justin C Y Wu
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 3 Pg. e018430 (03 27 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 29593017 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Chemical References

• Aminobenzoates
• Drug Combinations
• Magnesium Compounds
• Aluminum Hydroxide
• Atropine
• Gastro-caine

Topics

• Adolescent
• Adult
• Aged
• Aluminum Hydroxide (economics, therapeutic use)
• Aminobenzoates (economics, therapeutic use)
• Atropine (economics, therapeutic use)
• Cost-Benefit Analysis (economics)
• Drug Combinations
• Dyspepsia (economics, therapy)
• Electroacupuncture (economics, methods)
• Female
• Hong Kong
• Humans
• Magnesium Compounds (economics, therapeutic use)
• Male
• Middle Aged
• Patient Satisfaction
• Quality of Life
• Research Design
• Standard of Care (economics)
• Surveys and Questionnaires
• Treatment Outcome
• Waiting Lists
• Young Adult