Academic Journal
Add-on Rehmannia-6–Based Chinese Medicine in Type 2 Diabetes and CKD ; A Multicenter Randomized Controlled Trial
| العنوان: | Add-on Rehmannia-6–Based Chinese Medicine in Type 2 Diabetes and CKD ; A Multicenter Randomized Controlled Trial |
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| المؤلفون: | Chan, Kam Wa, Kwong, Alfred Siu Kei, Tan, Kathryn Choon Beng, Lui, Sing Leung, Chan, Gary C.W., Ip, Tai Pang, Yiu, Wai Han, Cowling, Benjamin John, Taam Wong, Vivian, Lao, Lixing, Feng, Yibin, Lai, Kar Neng, Tang, Sydney C.W. |
| المصدر: | Clinical Journal of the American Society of Nephrology ; ISSN 1555-9041 1555-905X |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health) |
| سنة النشر: | 2023 |
| الوصف: | Background Diabetes is the leading cause of CKD and kidney failure. We assessed the real-world effectiveness of Rehmannia-6–based Chinese medicine treatment, the most used Chinese medicine formulation, on the change in eGFR and albuminuria in patients with diabetes and CKD with severely increased albuminuria. Methods In this randomized, assessor-blind, standard care–controlled, parallel, multicenter trial, 148 adult patients from outpatient clinics with type 2 diabetes, an eGFR of 30–90 ml/min per 1.73 m 2 , and a urine albumin-to-creatinine ratio (UACR) of 300–5000 mg/g were randomized 1:1 to a 48-week add-on protocolized Chinese medicine treatment program (using Rehmannia-6–based formulations in the granule form taken orally) or standard care alone. Primary outcomes were the slope of change in eGFR and UACR between baseline and end point (48 weeks after randomization) in the intention-to-treat population. Secondary outcomes included safety and the change in biochemistry, biomarkers, and concomitant drug use. Results The mean age, eGFR, and UACR were 65 years, 56.7 ml/min per 1.73 m 2 , and 753 mg/g, respectively. Ninety-five percent ( n =141) of end point primary outcome measures were retrievable. For eGFR, the estimated slope of change was −2.0 (95% confidence interval [CI], −0.1 to −3.9) and −4.7 (95% CI, −2.9 to −6.5) ml/min per 1.73 m 2 in participants treated with add-on Chinese medicine or standard care alone, resulting in a 2.7 ml/min per 1.73 m 2 per year (95% CI, 0.1 to 5.3; P = 0.04) less decline with Chinese medicine. For UACR, the estimated proportion in the slope of change was 0.88 (95% CI, 0.75 to 1.02) and 0.99 (95% CI, 0.85 to 1.14) in participants treated with add-on Chinese medicine or standard care alone, respectively. The intergroup proportional difference (0.89, 11% slower increment in add-on Chinese medicine, 95% CI, 0.72 to 1.10; P = 0.28) did not reach statistical significance. Eighty-five adverse events were recorded from 50 participants (add-on Chinese medicine versus control: 22 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.2215/cjn.0000000000000199 |
| DOI: | 10.2215/CJN.0000000000000199 |
| الاتاحة: | http://dx.doi.org/10.2215/cjn.0000000000000199 https://journals.lww.com/10.2215/CJN.0000000000000199 |
| رقم الانضمام: | edsbas.8F2BAFA1 |
| قاعدة البيانات: | BASE |
| DOI: | 10.2215/cjn.0000000000000199 |
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