Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome

Functional Dyspepsia Symptom Severity Scale Scores

The scale assesses the frequency and severity of four functional dyspepsia symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning. For each symptom, frequency is rated on a 5-point scale ranging from 1 (never) to 5 (present throughout the day), and severity is rated on a 4-point scale ranging from 1 (none) to 4 (severe).

Global Impression Scale for Dyspepsia Symptom Relief

Participants will evaluate the overall relief of dyspepsia-related symptoms during the previous 2 weeks using a 7-point scale: 1 = markedly worse, 2 = worse, 3 = slightly worse, 4 = no relief, 5 = slight relief, 6 = marked relief, and 7 = complete relief. Higher scores indicate greater overall symptom relief.

Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) Score

The IBS-SSS assesses abdominal pain severity, the number of days with abdominal pain during a 14-day period, abdominal distension severity, satisfaction with bowel habits, and the extent to which irritable bowel syndrome interferes with daily life. Higher scores indicate greater symptom severity.

Traditional Chinese Medicine Syndrome Score

The Traditional Chinese Medicine syndrome score assesses 15 symptoms: epigastric fullness, epigastric pain, reduced appetite, heartburn or a burning sensation, belching or acid regurgitation, excessive clear salivation, a sensation of obstruction in the throat, thirst without a desire to drink, lower abdominal distension or pain, limb weakness, shortness of breath, disinclination to speak, heaviness of the body and limbs, aversion to cold, and loose stools. Each item is rated from 0 (none) to 3 (severe). The item scores are summed to obtain a total score ranging from 0 to 45, with higher scores indicating greater symptom severity.

Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL) Score

The IBS-QOL questionnaire used in this study contains 13 items assessing the impact of bowel problems on feelings of helplessness, embarrassment, time spent in the bathroom, health concerns, body image, daily planning, happiness, comfort when discussing bowel problems, frustration, social relationships, food intake, sexual life, and anger. Each item is rated from 0 (not at all) to 4 (completely true), with higher raw scores indicating a greater negative impact of bowel problems on quality of life.

Patient-Reported Outcome (PRO) Scale Total Score

The 38-item Patient-Reported Outcome scale assesses upper and lower gastrointestinal symptoms, appetite- and eating-related symptoms, body weight, fatigue, sleep, emotional status, social activities, work-related functioning, and fear of gastroscopy. Each item is scored from 0 to 4. The item scores are summed to obtain a total score ranging from 0 to 152, with higher scores indicating a greater symptom burden and greater functional impact.

36-Item Short Form Health Survey (SF-36) Scores

The SF-36 assesses self-reported general health, changes in health status, physical functioning, limitations in work and daily activities due to physical or emotional health, social functioning, bodily pain, vitality, emotional well-being, and general health perceptions. Scores will be calculated using the item-specific response weights specified in the questionnaire.

Fecal Gut Microbiome Metagenomic Profiles

Fecal samples will undergo metagenomic analysis to characterize gut microbial profiles and their changes across the specified sampling time points.

Blood and Urine Metabolomic Profiles

Blood and urine samples will undergo metabolomic analysis to characterize metabolic profiles and their changes across the specified sampling time points.