title: A Clinical Multicenter Randomized Controlled Study on JianpiQinghua Decoction in Treating Stage 3 Chronic Kidney Disease with A Syndrome Type of Dampness-heat due to Spleen Deficiency.
abstract: Objective To evaluate the clinical effectiveness of JianpiQinghua decoction in treating stage 3 chronic kidney disease (CKD3) with syndrome type of dampness-heat due to spleen deficiency. Methods A multicenter, randomized, controlled, prospective, double-blind, and double-simulation study was undertaken. A total of 270 CKD3 patients with syndrome type of dampness-heat due to spleen deficiency from the outpatient departments of six general hospitals were randomly divided into telmisartan+analog traditional Chinese medicine (TA) group, traditional Chinese medicine+analog telmisartan (TCMA) group, and telmisartan+traditional Chinese medicine (TTCM) group, in which the corresponding treatment was applied in addition to basic treatment. Six months later, changes in the traditional Chinese medicine (TCM) clinical symptom scores and renal functions before and after treatment were compared among these three groups. Results Of these 270 CKD3 patients who had been enrolled in this study, 30 cases lost to follow-up. The baseline data were comparable among these three groups. After treatment, the TCM clinical symptom scores of both syndrome of spleen-qi deficiency and dampness-heat in TA group were significantly higher than those in TCMA group and TTCM group (P<0.001). With the treatment time prolonged, the TCM clinical symptom scores showed similar descending trends in TCMA group and TTCM group but were different from that in TA group. After treatment, abnormal creatinine rate decreased (P=0.003), and these three treatments and their interactions with each visit had no effect on serum urea nitrogen value (P=0.270, P=0.520); with prolonged treatment, the estimated glomerular filtration rates in three groups tended to be relatively stable after the first rise. The liver function and abnormal serum potassium rate were not statistically significant before and after treatment (P>0.05). Conclusions JianpiQinghua decoction can improve clinical symptoms of TCM in CKD3 patients with syndrome type of dampness-heat due to spleen deficiency and thus improve the quality of life and prognosis. The clinical efficacy of JianpiQinghua decoction alone or combined with telmisartan is superior to telmisartan monotherapy.
authors.affiliation: Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.
authors.forename: Ke-Na
authors.initials: KN
authors.lastname: Yu
authors.affiliation: Department of Nephrology, Renji Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200021, China.
authors.forename: Zhao-Hui
authors.initials: ZH
authors.lastname: Ni
authors.affiliation: Department of Nephrology, Shanghai No.6 People's Hospital, Shanghai 200233, China.
authors.forename: Nian-Song
authors.initials: NS
authors.lastname: Wang
authors.affiliation: Department of Nephrology, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200118, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Peng
authors.affiliation: Department of Nephrology, Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 2004371, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Nephrology, Shanghai Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Zhang
authors.affiliation: Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China.
authors.forename: Li-Qun
authors.initials: LQ
authors.lastname: He
mesh_terms: D001562:Benzimidazoles / Q000627:therapeutic use; D001565:Benzoates / Q000627:therapeutic use; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional; D008517:Phytotherapy; D011446:Prospective Studies; D011788:Quality of Life; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy*; D000077333:Telmisartan
chemical_list: D001562:Benzimidazoles; D001565:Benzoates; D004365:Drugs, Chinese Herbal; D000077333:Telmisartan