EFFECTIVENESS OF LONG-TERM SHICHIMOTSUKOKATO TREATMENT IN IMPROVING eGFR SLOPE IN PATIENTS WITH CHRONIC KIDNEY DISEASE: A RETROSPECTIVE SINGLE-ARM STUDY

 

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https://storage.unitedwebnetwork.com/files/1099/3d97cdd9c23154ddae99661f295c20a1.pdf
EFFECTIVENESS OF LONG-TERM SHICHIMOTSUKOKATO TREATMENT IN IMPROVING eGFR SLOPE IN PATIENTS WITH CHRONIC KIDNEY DISEASE: A RETROSPECTIVE SINGLE-ARM STUDY

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Kazushi
Uneda
Kazushi Uneda uneda@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Kampo Medicine Aizuwakamatsu Japan * Aizu Medical Center, Fukushima Medical University Department of Endocrinology, Metabolism, Diabetology and Nephrology Aizuwakamatsu Japan
Yoshihiro Sato tenjin27@jasmine.ocn.ne.jp Tenjinbashi Clinic Internal Medicine Fukushima Japan -
Naoyuki Furukawa furu-nao@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Kampo Medicine Aizuwakamatsu Japan -
Akira Kaneko akira726@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Kampo Medicine Aizuwakamatsu Japan -
Tadamichi Mitsuma tmitsuma@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Kampo Medicine Aizuwakamatsu Japan -
Shigeatsu Hashimoto raijinsh@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Endocrinology, Metabolism, Diabetology and Nephrology Aizuwakamatsu Japan -
Eiichi Tahara e-tahara@fmu.ac.jp Aizu Medical Center, Fukushima Medical University Department of Kampo Medicine Aizuwakamatsu Japan -
 
 
 
 
 
 
 
 

Chronic kidney disease (CKD) is a major public health concern worldwide and is associated with increased risks of end-stage kidney disease, cardiovascular events, and mortality. Although new therapeutic agents such as sodium–glucose cotransporter-2 inhibitors and mineralocorticoid receptor antagonists have recently become available, further development of novel treatment strategies remains necessary. Shichimotsukokato (SCMKT), a representative formula in Japanese Traditional (Kampo) Medicine composed of seven crude drugs, has historically been used to treat kidney diseases. Experimental studies have demonstrated its renoprotective and antihypertensive effects. However, clinical evidence on the long-term effects of SCMKT on renal function is still limited. This study aimed to evaluate the effect of one-year administration of SCMKT on the estimated glomerular filtration rate (eGFR) slope in patients with CKD.

This retrospective, single-arm, observational study included outpatients with CKD who were treated with SCMKT at Fukushima Medical University Aizu Medical Center and Tenjinbashi Clinic between April 2019 and May 2025 (UMIN000058358). Eligible patients were aged ≥18 years, had been taking SCMKT continuously for at least one year, and had available eGFR data from one year before initiation, at initiation, and one year after initiation of SCMKT therapy. The primary endpoint was the change in eGFR slope between the pretreatment and posttreatment periods. The pretreatment eGFR slope was determined from one year before to the initiation of SCMKT, and the posttreatment slope from initiation to one year after. The eGFR slope was calculated using the least-squares regression method. Secondary endpoints included changes in systolic and diastolic blood pressure, qualitative proteinuria, and the occurrence of adverse events.

Twelve patients met the inclusion criteria (mean age, 77.8 years; 58.3% male). The mean baseline eGFR was 38.7 ± 10.0 mL/min/1.73 m², and most participants were classified as CKD stage G3b. Hypertensive nephrosclerosis was the most common primary cause of CKD. Moreover, over 90% of the patients had concomitant hypertension, and 75% were prescribed renin–angiotensin aldosterone system (RAAS) inhibitors. The mean eGFR slope significantly improved following SCMKT treatment compared with the pretreatment period (pretreatment vs. posttreatment, −4.9 ± 7.3 vs. 5.4 ± 5.4 mL/min/1.73 m²/year; P = 0.002). In contrast, there were no significant changes in systolic or diastolic blood pressure (132.9 ± 15.5 vs. 135.2 ± 13.4 mmHg; 70.2 ± 13.2 vs. 73.1 ± 7.5 mmHg, respectively). In addition, qualitative proteinuria did not show a marked change after SCMKT treatment. Sensitivity analyses excluding patients with changes in RAAS inhibitor therapy yielded consistent results.

One-year administration of SCMKT significantly improved the eGFR slope in patients with CKD. These findings suggest that SCMKT may improve the prognosis of CKD patients. Further prospective studies are warranted to determine the efficacy of SCMKT in slowing CKD progression.

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