Klinische Studien Radar

Symptom Improvement Rate at Week 4

The primary outcome is the percentage of participants experiencing symptom improvement using the 7-point Likert scale for Overall Treatment Effect (OTE). The Overall Treatment Effect (OTE) questionnaire was categorized as "extremely worse than baseline," "worse than baseline," "slightly worse than baseline," "no change," "slightly improved than baseline," "improved than baseline," or "much improved than baseline." Participants will rate their symptom severity compared to baseline, and those reporting "improved than baseline" or "much improved than baseline"will be considered responders. The primary outcome will assess the efficacy of 5 Hz and 100 Hz electroacupuncture compared to sham treatment.

4 weeks after the start of treatment.

Main Symptom Resolution Rate at Week 4

The second primary outcome is the rate of complete resolution of the main symptoms of functional dyspepsia at week 4. For Postprandial Distress Syndrome (PDS), the primary symptoms are postprandial fullness and early satiety; for Epigastric Pain Syndrome (EPS), the main symptoms are epigastric pain and burning. Complete resolution is defined as a score of 0 for the respective main symptoms on a validated symptom severity scale. The severity of each symptom is divided into: no symptoms (0 points), mild (1 point), moderate (2 points), and severe (3 points). The outcome will compare the resolution rates between the 5 Hz, 100 Hz, and sham electroacupuncture groups.

4 weeks after the start of treatment.

Global Overall Symptom (GOS) Score Change

The Global Overall Symptom (GOS) score assesses eight symptoms associated with functional dyspepsia (e.g., epigastric pain, burning, fullness, early satiety, nausea, bloating). Scores range from 1 (no problem) to 7 (very severe problem). Scoring is as follows: 1 = no problem (no symptoms); 2 = minimal problem (can be easily ignored); 3 = mild problem (can be ignored with effort); 4 = moderate problem (cannot be ignored, but does not interfere with daily activities); 5 = moderately severe problem (cannot be ignored, occasionally limits daily activities); 6 = severe problem (cannot be ignored, often limits concentration on daily activities); 7 = very severe problem (cannot be ignored, severely limits daily activities. The change from baseline to week 4 will be compared between the 5 Hz, 100 Hz, and sham electroacupuncture groups.

Baseline to Week 4

Nepean Dyspepsia Index (NDI) Score Change

The Nepean Dyspepsia Index (NDI) evaluates the impact of dyspepsia on patients \'quality of life across five domains (e.g., tension, interference with daily activities). The change in NDI score from baseline to week 4 will be used to assess the efficacy of the interventions in improving quality of life. Higher scores on the Nepean Dyspepsia Index (NDI) indicate more severe symptoms

Baseline to Week 4

Hospital Anxiety and Depression Scale (HADS) Score Change

The Hospital Anxiety and Depression Scale (HADS) measures levels of anxiety and depression, which are often associated with functional dyspepsia. Changes in HADS scores from baseline to week 4 will be evaluated to determine if electroacupuncture has an impact on emotional well-being. The scores of anxiety and depression subscales are divided into: 0-7 points for no symptoms; 8-10 points for suspected presence; 11-21 points for definite presence; When scoring, 8 points is the starting point, that is, both suspected and symptomatic are positive.

Baseline to Week 4

Treatment Expectation Score

Participants\' expectations regarding the effectiveness of electroacupuncture will be assessed using a 5-point Likert scale (e.g., strongly agree to strongly disagree) prior to the first treatment. This outcome will be used to determine the role of treatment expectations in the perceived efficacy of electroacupuncture.

Prior to the first treatment (Baseline)

Blind evaluation

Participants perception of whether they received real or sham electroacupuncture will be assessed after the 1st and 6th treatment sessions to evaluate the effectiveness of blinding in the sham group.

immediately after 1st and 6th treatment sessions