Zhao Jing, Tostivint, Isabelle, Xu Lingdong, Huang Jihan, Gambotti, Laetitia, Boffa, Jean-Jacques, Yang Min, Wang Ling, Sun Zhuxing, Chen Xiaolan, Liou-Schischmanoff, Amélie, Baumelou, Alain, Ma Teng, Lu Guoyuan, Li Ling, Chen Dai, Piéroni, Laurence, Liu Bingkai, Qin Xiao, and He Weiming
Objective To evaluate the efficacy and safety of Abelmoschus manihot (A. Manihot) alone and in combination with irbesartan, for reduction of albuminuria in patients with type 2 diabetic kidney disease. Methods A multicenter randomized double-blind and parallel controlled clinical trial was performed in 9 hospitals of Jiangsu Province (Affiliated Hospital of Nanjing University of Chinese Medicine, First People's Hospital of Changzhou, First People's Hospital of Xuzhou, Wuxi People's Hospital, Affiliated Hospital of Nantong University, Taizhou Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Soochow University, Zhongda Hospital, Southeast University, Changzhou Hospital of Traditional Chinese Medicine) from May 2017 to March 2021. Huangkui capsule, as a traditional Chinese medicine, is made from the ethanol extract of flowers in A. Manihot. All enrolled patients were randomly assigned to the irbesartan group [irbesartan tablets (150 mg/dose, 1 dose/day) +Huangkui capsule simulant (2.5 g/dose, 3 doses/day)], Huangkui capsule group [Huangkui capsule (2.5 g/dose, 3 doses/day) +irbesartan simulant (150 mg/dose, 1 dose/day)], and combined treatment group [irbesartan tablets (150 mg/dose, 1 dose/day) +Huangkui capsule (2.5 g/dose, 3 doses/day)]. The duration of intervention was 24 weeks. Urinary creatinine and urinary albumin were detected at baseline and 24 weeks after treatment, and the urinary albumin-to-creatinine ratio was calculated to observe the change value and rate of UACR compared with baseline. The occurrence of adverse events, adverse reactions, serious adverse events, serious adverse events, and adverse events leading to withdrawal were recorded and the incidence was calculated. One-way analysis of variance (ANOVA), χ² test or Fisher's exact test were used to compare among groups. Results A total of 413 patients with type 2 diabetic kidney disease were included, including 138 in the irbesartan group, 137 in the Huangkui capsule group and 138 in the combined treatment group. After 24 weeks of treatment, the UACR changes of three groups were (-89.07±51.17) mg/g in the irbesartan group, (-146.06±45.52) mg/g in the Huangkui capsule group, and (-262.31±39.08) mg/g in the combined treatment group. The rate of UACR change was (-5.21±6.12)% in the irbesartan group, (-11.89±5.75)% in the Huangkui capsule group, and (-28.56±4.65)% in the combined treatment group, respectively. There were significant differences between the combined treatment group and the irbesartan group in the change value and rate of UACR (P<0.001), while there were no statistical differences between the Huangkui capsule group and irbesartan group (P>0.05). After 24 weeks of treatment, there were no significant differences in the incidence of adverse events, adverse reactions, serious adverse events and serious adverse reactions among the 3 groups (P>0.05). Conclusion The combination of irbesartan and Huangkui capsule can reduce the level of UACR in patients with type 2 diabetic kidney disease, and it shows good efficacy and safety in the treatment of albuminuria in patients with type 2 diabetic kidney disease. [ABSTRACT FROM AUTHOR]