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Am J Kidney Dis. 2013 Dec;62(6):1068-76. doi: 10.1053/j.ajkd.2013.05.005. Epub 2013 Jun 28.

Efficacy and safety of traditional chinese medicine (Shenqi particle) for patients with idiopathic membranous nephropathy: a multicenter randomized controlled clinical trial.

Author information

1
Department of Nephrology, Longhua Hospital Affiliated to the Shanghai University of Traditional Chinese Medicine, Shanghai, China. Electronic address: yipingchen01@126.com.

Abstract

BACKGROUND:

To compare the safety and efficacy of the traditional Chinese medicine Shenqi particle and standard therapy with prednisone and cyclophosphamide (control) in adult patients with idiopathic membranous nephropathy (IMN).

STUDY DESIGN:

Open-label, multicenter, parallel, randomized, controlled clinical trial.

SETTING & PARTICIPANTS:

From April 2008 to February 2011, a total of 190 patients with biopsy-proven IMN from 7 hospitals in China participated in the study. All patients had nephrotic syndrome with estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m(2).

INTERVENTION:

Shenqi particle (9.6 g 3 times per day) or prednisone (1 mg/kg/d tapering to 0.17 mg/kg/d) and cyclophosphamide (total dose of 9-12 g per square meter of body surface area) for 48 weeks.

OUTCOMES:

Primary outcomes included complete remission, defined as proteinuria (24-hour urine protein excretion) ≤0.3 g/d, or partial remission, defined as proteinuria with protein excretion >0.3-<3.5 g/d and a 50% reduction from its peak value at 48 weeks. Secondary outcomes included serum albumin level, eGFR, doubling of serum creatinine level, end-stage renal disease, and death.

RESULTS:

Baseline values for proteinuria and eGFR were 5.34 ± 2.74 g/d and 84.0 ± 27.4 mL/min/1.73 m(2) for the Shenqi particle group and 5.33 ± 2.47 g/d and 83.8 ± 24.9 mL/min/1.73 m(2) for the control group, respectively. 132 patients (63 Shenqi particle group, 69 control group) completed the study. Change in urinary protein excretion in the Shenqi particle group was -3.01 (95% CI, -3.68 to -2.34) g/d, and in the control group, -3.28 (95% CI, -3.98 to -2.58) g/d; the mean difference between groups was 0.27 (95% CI, -0.70 to 1.23) g/d (P = 0.6). Changes in eGFR were 12.3 (95% CI, 4.99 to 19.6) mL/min/1.73 m(2) in the Shenqi particle group and -2.8 (95% CI, -10.32 to 4.77) mL/min/1.73 m(2) in the control group; the mean difference between groups was 15.1 (95% CI, 4.56 to 25.55) mL/min/1.73 m(2) (P = 0.005). Severe adverse events occurred in only the control group (14.5%) and included lung infection, liver injury, and pneumonia.

LIMITATIONS:

High rate of loss to follow-up and lack of observation period prior to the study.

CONCLUSIONS:

Shenqi particle may be a promising alternative therapy for adults with IMN and nephrotic syndrome.

KEYWORDS:

Idiopathic membranous nephropathy; Shenqi particle; clinical trial; cyclophosphamide; prednisone; traditional Chinese medicine

PMID:
23810688
DOI:
10.1053/j.ajkd.2013.05.005
[Indexed for MEDLINE]

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