Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

Area of Science:

• Gastroenterology
• Integrative Medicine
• Clinical Trials

Background:

• Postprandial distress syndrome (PDS), a form of functional dyspepsia (FD), significantly reduces patients' quality of life (QoL).
• While acupuncture shows promise for FD, research specifically targeting PDS is limited.
• This study addresses the need for evidence on acupuncture's role in managing PDS.

Purpose of the Study:

• To evaluate the feasibility of conducting a clinical trial on acupuncture for PDS.
• To determine the preliminary efficacy of acupuncture in treating PDS symptoms.
• To assess acupuncture's impact on QoL, depression, and anxiety in PDS patients.

Main Methods:

• A multi-center, two-arm, blinded pilot randomized controlled trial (RCT) involving 42 participants.
• Participants were randomized to receive either verum or minimal acupuncture for 12 sessions over four weeks.
• Outcomes included overall treatment effect, symptom improvement, QoL, and psychological assessments at multiple time points.

Main Results:

• The study is designed to assess the proportion of participants showing improvement at the end of treatment.
• Secondary outcomes will measure symptom severity, QoL, and psychological well-being.
• Data analysis will determine feasibility and provide preliminary efficacy data for future larger trials.

Conclusions:

• This pilot RCT will establish the feasibility of acupuncture interventions for PDS.
• Findings will inform the design of larger trials investigating acupuncture's efficacy for PDS.
• The study aims to provide evidence for acupuncture as a potential treatment for PDS.