Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial

Area of Science:

• Gastroenterology
• Integrative Medicine
• Clinical Trials

Background:

• Functional dyspepsia (FD) is a common gastrointestinal disorder with controversial treatment options.
• The efficacy of acupuncture for FD remains debated, necessitating rigorous clinical investigation.

Purpose of the Study:

• To evaluate the effectiveness of true acupuncture (TA) compared to sham acupuncture (SA) in treating functional dyspepsia.
• To provide robust evidence regarding acupuncture's role in managing FD symptoms.

Main Methods:

• A multicenter, two-arm, randomized, sham-controlled trial involving 200 participants with functional dyspepsia.
• Participants were assigned to either TA (syndrome differentiation points) or SA (sham points) groups, receiving 20 electroacupuncture sessions over 4 weeks.
• Primary outcome: absence of dyspeptic symptoms at 16 weeks; secondary outcomes included validated quality-of-life and dyspepsia questionnaires.

Main Results:

• The primary outcome data regarding symptom absence at 16 weeks is pending analysis.
• Secondary outcome measures, including the Short-Form Leeds Dyspepsia Questionnaire and Nepean dyspepsia index, will provide further insights into treatment effects.

Conclusions:

• The study is designed to definitively assess the therapeutic value of acupuncture for functional dyspepsia.
• Dissemination of findings in a peer-reviewed journal and at international congresses will inform clinical practice and future research.