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.
- functional dyspepsia
- randomized controlled trial
- economic evaluation
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WZS, YLJ, SSH, WLL and KCL contributed equally.
Contributors Study concept and design: VCHC. Drafting of the manuscript: VCHC, CHLW. Critical revision of the manuscript for important intellectual content: VCHC, SYSW, JCYW. Administrative, technical or material support: CHLW, JYLC, WZS, YLJ, SSH, WLL, KCL. Figure preparation: CHLW. All authors reviewed the manuscript, approved all the contents and agreed on the submission.
Funding This trial is funded by the Health and Medical Research Fund, Hong Kong SAR Government (ref no: 12130211).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (ref no: 2014.552 T). The protocol, informed consent form, participant recruitment materials and other request documents were reviewed and approved by this committee before implementation.
Provenance and peer review Not commissioned; externally peer reviewed.
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