治験レーダー

Overall Treatment Effect (OTE) Response Rate at Week 3

The overall treatment effect will be assessed using a 7-point Likert scale evaluating the change in gastrointestinal symptoms compared with baseline. Participants who report "improved" or "extremely improved" will be considered responders. The response rate will be calculated as the proportion of participants achieving improvement at the end of the 3-week treatment period.

Week 3

Main Symptom Elimination Rate at Week 3

The elimination rate of the main symptoms will be defined as the proportion of participants whose primary symptoms score is 0 (no symptoms) at week 3. In the postprandial distress syndrome (PDS) subtype, the main symptoms include postprandial fullness and/or early satiety. In the epigastric pain syndrome (EPS) subtype, the main symptoms include epigastric pain and/or burning. For participants with combined PDS and EPS, the main symptoms include both symptom categories.

Week 3

Global Overall Symptom (GOS) Score

The Global Overall Symptom (GOS) scale will be used to assess the severity of eight dyspeptic symptoms, including epigastric pain, epigastric burning, regurgitation, postprandial fullness, nausea/vomiting, belching, early satiety, and heartburn. Each symptom is rated on a 7-point Likert scale ranging from 1 (no problem) to 7 (very severe problem). Changes in GOS scores will be evaluated over time to assess symptom improvement.

Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

Nepean Dyspepsia Index (NDI) Score

Health-related quality of life in patients with functional dyspepsia will be evaluated using the Nepean Dyspepsia Index (NDI). The NDI quality-of-life total score ranges from a minimum of 0 to a maximum of 100, where higher scores indicate a better health-related quality of life (less impairment from dyspepsia). The scale measures the impact of dyspepsia on multiple aspects of daily life, including tension, interference with daily activities, eating/drinking, knowledge/control, and work/study. Changes in NDI scores will be assessed during treatment and follow-up.

Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

Hospital Anxiety and Depression Scale (HADS) Score

The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression in participants. The HADS consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale score ranges from a minimum of 0 to a maximum of 21. If combined into a total score, the minimum is 0 and the maximum is 42. For both the subscales and the total score, higher scores indicate higher levels of anxiety and depression (a worse outcome). Changes in HADS scores will be evaluated to explore the psychological effects of the intervention.

Baseline (Week 0), Week 3, Week 7, Week 11, and Week 15

Expectation of Electroacupuncture Treatment

Before treatment, participants will be asked to evaluate their expectations regarding the effectiveness of electroacupuncture using a 5-point scale (strongly agree, agree, neutral, disagree, strongly disagree) in response to the statement that electroacupuncture will significantly improve their symptoms.

Baseline (Week 0)

Blinding Assessment

Participants will be asked to guess whether they received electroacupuncture or sham electroacupuncture after the first treatment session and after the sixth treatment session in order to assess the effectiveness of blinding.

Baseline (after Session 1) and Week 3 (after Session 6)

Treatment Adherence

Treatment adherence will be evaluated by recording whether participants complete the scheduled treatment sessions and outcome assessments. Reasons for withdrawal, exclusion, or loss to follow-up will also be documented.

Week 0, Week 3, and Week 15

Safety Outcomes (Adverse Events)

All adverse events occurring during the study period will be recorded and evaluated to assess the safety of electroacupuncture treatment.

From baseline to Week 15