Add-on Rehmannia-6-Based Chinese Medicine in Type 2 Diabetes and CKD: A Multicenter Randomized Controlled Trial

Area of Science:

• Nephrology
• Endocrinology
• Integrative Medicine

Background:

• Diabetes is the primary cause of chronic kidney disease (CKD) and kidney failure worldwide.
• Diabetic nephropathy, characterized by increased albuminuria, significantly impacts CKD progression.
• Assessing real-world effectiveness of traditional Chinese medicine (TCM) for diabetic kidney disease is crucial.

Purpose of the Study:

• To evaluate the effectiveness of Rehmannia-6-based TCM as an add-on therapy for patients with type 2 diabetes and CKD.
• To assess the impact of TCM on the estimated glomerular filtration rate (eGFR) and albuminuria levels.
• To determine the safety profile of TCM in this patient population.

Main Methods:

• A randomized, assessor-blind, standard care-controlled, multicenter trial involving 148 adult patients.
• Participants had type 2 diabetes, eGFR of 30-90 ml/min per 1.73 m², and urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g.
• Patients were randomized to receive either add-on TCM (Rehmannia-6-based granules) or standard care alone for 48 weeks.

Main Results:

• The TCM group experienced a significantly slower decline in eGFR compared to the standard care group (2.7 ml/min per 1.73 m² per year less decline, P=0.04).
• While the reduction in albuminuria was not statistically significant, the trend favored the TCM group (11% slower increment).
• Adverse events were comparable between the TCM and standard care groups, indicating a favorable safety profile.

Conclusions:

• Rehmannia-6-based Chinese medicine treatment stabilized eGFR in patients with type 2 diabetes, stage 2-3 CKD, and severely increased albuminuria.
• TCM can be considered a valuable adjuvant therapy to standard care for managing diabetic nephropathy.
• Further research should explore long-term outcomes and optimal integration of TCM in diabetic kidney disease management.