Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes mellitus, affecting 35%-50% of diabetic patients. Its pathogenesis involves metabolic disorders induced by hyperglycemia and dyslipidemia, leading to irreversible damage to neurons and vascular endothelial cells. Distal symmetric polyneuropathy (DSPN) is the most representative form, characterized by distal pain, numbness, and sensory loss, which may progress to ulcers, gangrene, and even amputation in severe cases.
Current modern medical treatments for DPN primarily focus on nutritional nerve support, antioxidative stress, and microcirculation improvement, but these approaches are limited in variety and may carry side effects. Traditional Chinese Medicine (TCM) offers advantages including higher safety and diverse therapeutic options.
Based on long-term clinical observation, our research group proposes that the core pathogenesis of DPN is Qi-Yin deficiency with blood stasis obstructing collaterals. The treatment principle is to nourish Yin, supplement Qi, activate blood circulation, and unblock collaterals, with Zuogui Jiangtang Shuluo Formula (ZGJTSLF) as the primary prescription. Previous studies have shown that ZGJTSLF can improve TCSS scores and nerve conduction velocity in DPN patients compared with mecobalamin, but high-level evidence is still lacking.
This randomized, parallel-controlled trial aims to evaluate the clinical efficacy of ZGJTSLF in treating DPN, with TCSS score and nerve conduction velocity as primary outcomes. Metabolomics and lipidomics will be employed to compare metabolic profiles between healthy controls and DPN patients before and after ZGJTSLF treatment, aiming to identify potential biomarkers and explore the underlying mechanisms.
Meet the diagnostic criteria for type 2 diabetes mellitus with distal symmetric polyneuropathy (DSPN) according to Western medicine standards.
Meet the TCM syndrome differentiation criteria for consumptive thirst complicated with arthromyodynia of the pattern of Qi-Yin deficiency with blood stasis.
Glycated hemoglobin (HbA1c) between 6.5% and 9.0% (inclusive).
Aged 35 to 75 years (inclusive) at the time of screening, regardless of gender.
Patients with type 1 diabetes mellitus or other specific types of diabetes mellitus.
Women who are pregnant, breastfeeding, planning pregnancy, or taking oral contraceptives long-term.
Neuropathies caused by other conditions, including but not limited to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, epilepsy, spinal cord injury, cervical or lumbar spine lesions (nerve root compression, spinal stenosis, cervical or lumbar degenerative diseases), neuromuscular diseases, severe arterial or venous vascular diseases (venous thrombosis, lymphangitis, etc.), sequelae of cerebrovascular disease, or post-surgical status of lower extremity vasculature.
History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to study enrollment.
Parallel
Zuogui Jiangtang Shuluo Formula
DrugOral decoction, twice daily for 4 weeks.
Mecobalamin
DrugTablet, 0.5 mg per dose, three times daily orally for 4 weeks.
Change in Nerve Conduction Velocity (NCV)
NCV measurements include motor nerve conduction velocity of the median, ulnar, tibial, and common peroneal nerves, and sensory nerve conduction velocity of the median and sural nerves.
Change in Toronto Clinical Scoring System (TCSS) Score
The Toronto Clinical Scoring System (TCSS) assesses neuropathic symptoms, sensory function, and reflexes. Neuropathic symptoms include foot pain, numbness, tingling, and ataxia; each symptom is scored 1 if present and 0 if absent (maximum 4 points). Sensory function tests include light touch, pain, temperature, vibration, and position sense; each test is scored 1 if abnormal and 0 if normal (maximum 5 points). Reflexes include knee and ankle reflexes bilaterally; each reflex is scored 0 if normal, 1 if reduced, and 2 if absent (maximum 8 points). The total score ranges from 0 to 19, with higher scores indicating more severe neuropathy.
Change in Traditional Chinese Medicine (TCM) Syndrome Score
The TCM syndrome score assesses primary and secondary symptoms according to the Guiding Principles for Clinical Research of New Traditional Chinese Medicines and the Clinical Diagnosis and Treatment Guidelines for Diabetic Peripheral Neuropathy in TCM (2016 Edition). Primary symptoms (limb weakness, limb pain and/or numbness) are graded as none, mild, moderate, or severe, scored 0, 2, 4, or 6, respectively (maximum 12 points). Secondary symptoms (fatigue, shortness of breath, spontaneous sweating, night sweating, feverish sensation in palms and soles, soreness and weakness of waist and knees, localized stabbing pain aggravated at night, dry and scaly skin, and purplish lips) are graded as none, mild, moderate, or severe, scored 0, 1, 2, or 3, respectively (maximum 18 points). The total score ranges from 0 to 30, with higher scores indicating more severe symptoms.
Change in Fasting Blood Glucose (FBG)
Venous blood will be collected after at least 8 hours of fasting. Fasting blood glucose (FBG) will be measured using an automated biochemical analyzer, with the unit expressed as mmol/L.
Change in Glycated Hemoglobin (HbA1c)
Fasting venous blood will be collected. Glycated hemoglobin (HbA1c) will be measured using high-performance liquid chromatography (HPLC) and expressed as a percentage (%), reflecting the average blood glucose level over the preceding 2-3 months.
Change in DN4 Questionnaire Score
The DN4 (Douleur Neuropathique 4) questionnaire is a validated screening tool for neuropathic pain, consisting of 10 items (7 related to symptom description and 3 related to clinical examination). The total score ranges from 0 to 10, with a score ≥4 indicating the presence of neuropathic pain.
Change in Visual Analog Scale (VAS) for Pain
The VAS consists of a 100-mm horizontal line, with the left end labeled "0" (no pain) and the right end labeled "100" (worst imaginable pain). Participants will mark the line according to their average pain intensity over the past 24 hours, and the distance in millimeters will be recorded as the pain score.
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