Efficacy of Combined Abelmoschus manihot and Irbesartan for Reduction of Albuminuria in Patients With Type 2 Diabetes and Diabetic Kidney Disease: A Multicenter Randomized Double-Blind Parallel Controlled Clinical Trial

What is it about?

The traditional medicine Abelmoschus Manihot has long been used to treat kidney disease in China. We have recently performed a multicenter randomized double-blind and parallel controlled clinical trial to evaluate the efficacy and safety of A. Manihot, alone and in combination with irbesartan, for reduction of albuminuria and proteinuria in patients with type 2 diabetes (T2D) with diabetic kidney disease (DKD). A total of 413 T2D patients with DKD from 9 hospitals were randomly assigned to the irbesartan, A Manihot and combined treatment groups at a 1:1:1 ratio. Irbesartan was prescribed at a dose of 150 mg/d. In the A Manihot group, a 2.5 g huangkui capsule was prescribed 3 times per day. In the combined treatment group, both A Manihot and irbesartan were used. The duration of intervention was 24 weeks. The values of urine albumin-creatinine ratio (ACR) were measured every 4 weeks. The 24-hour urine proteinuria, UPCR, e-GFR, hs-CRP, Hb1C and other clinical parameters were examined at 0, 12 and 24 weeks. Our results demonstrate that baseline characteristics in the irbesartan, A Manihot and combined treatment groups were similar; mean values of ACR were 847.04±39.28, 761.69±39.77 and 797.23±37.59 (mg/g), respectively. Post-treatment mean values of ACR in the three groups were reduced by -89.07±51.17, -146.06±45.52, and -262.31±39.08 mg/g, respectively (A Manihot vs. irbesartan P=0.087, Combined treatment vs. irbesartan P<0.001). Twenty-four hours proteinuria in the irbesartan, A Manihot and combined treatment groups decreased by -102.55±129.15, -387.04±127.99, and -526.99±100.24 mg, respectively (P=0.005 and 0.001). We thus conclude that A. Manihot combined with irbesartan effectively reduced albuminuria and proteinuria in patients with T2D and DKD.

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