Anxiety Related to Metabolic Associated Fatty Liver Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years (inclusive), any gender; 2. Meet diagnostic criteria for MAFLD; 3. Diagnosed with MAFLD using MRI-derived proton density fat fraction (MRI-PDFF), with hepatic steatosis =5%; 4. Meet diagnostic criteria for anxiety disorder, with HAM-A scores ranging from 14 to 28; 5. If taking oral anti-anxiety medications, stable dosage must be maintained for =4 weeks; 6. No severe cognitive impairment or mental disorders, capable of understanding and completing scale assessments; 7. Patients agree to participate, have signed informed consent, and commit to all study visits, examinations, and treatments per protocol.
Exclusion criteria
Exclusion criteria: 1. Suspected hepatobiliary diseases from other causes based on history/lab tests, including but not limited to: HBV/HCV infection, alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, cirrhosis, primary sclerosing cholangitis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatocellular carcinoma (or family history); 2. Clinical evidence of cirrhosis or hepatic decompensation; 3. Severe renal insufficiency defined as serum creatinine (Scr) =178µmol/L or eGFR <60ml/min; 4. Severe primary diseases in cardiovascular, urinary, or hematopoietic systems; malignancies or other severe comorbidities; 5. Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c=9.5%), antidiabetic medication adjustments within 2 months prior, or history of severe hypoglycemia; 6. Thyroid disorders including hyperthyroidism, hypothyroidism, or subclinical hypothyroidism; 7. Severe mental disorders (e.g., schizophrenia, bipolar disorder) or history of suicide attempts; 8. Received systematic acupuncture treatment within past 3 months; 9. Pregnant/lactating women or women of childbearing potential refusing approved contraception during study; 10. Participation in other clinical trials within past 3 months; 11. Severe fear of acupuncture or documented allergic reactions; 12. Other conditions deemed unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| 36-Item Short Form Health Survey;Self-Rating Anxiety Scale;Liver and kidney function;blood lipids;Blood Routine;Fasting Plasma Glucose;Homeostasis Model Assessment of Insulin Resistance;Body Mass Index (BMI);FibroScan; | — |
Countries
China
Contacts
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine