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. 2021 Nov 15;2021(11):CD004293. doi: 10.1002/14651858.CD004293.pub4

Chen 2013e.

Study characteristics
Methods
  • Study design: parallel, open‐label RCT

  • Study duration: recruitment was from April 2008 to February 2011

  • Duration of follow‐up: 48 weeks

Participants
  • Setting; multicentre (7 sites)

  • Country; China

  • Inclusion criteria: diagnosed with IMN by renal biopsy (stages I‐IV); aged 18 to 75 years; eGFR > 30 mL/min, 24‐hour urinary albumin ≥ 3.5 g

  • Baseline characteristics

    • Mean proteinuria ± SD (g/24 hours): treatment group (5.3 ± 2.7); control group (5.3 ± 2.4)

    • Mean serum albumin ± SD (g/L): treatment group (25.0 ± 8.0); control group (24.6 ± 6.8)

    • Mean eGFR ± SD (mL/min/1.73 m²): treatment group (84.0 ± 27.4); control group (83.8± 24.9)

    • Mean triglyceride ± SD (mmol/L): treatment group (3.20 ± 2.30); control group (2.73 ± 1.56)

    • Mean SCr ± SD (µmol/L): treatment group (82.0 ± 41.5); control group (77.1 ± 23.6)

    • Mean BUN ± SD (mmol/L): treatment group (5.25 ± 1.75); control group (5.79 ± 2.14)

    • Mean serum cholesterol ± SD (mmol/L): treatment group (7.67 ± 2.20); control group (8.09 ± 2.50)

  • Number: treatment group (95); control group (95)

  • Mean age ± SD (years); treatment group (49 ± 14); control group (53 ± 12)

  • Sex (M/F): treatment group (60/35); control group (65/30)

  • Exclusion criteria: other 19 types of membranous nephropathy; rapid loss of kidney function > 50% decline in eGFR on 3 months; secondary membranous nephropathy; HbA1c > 6.2mmol/L; treatment with steroids in last 6 months with immunosuppressive medication for > 4 weeks; presence of infection or malignant disease; uncontrolled hypertension, BP > 130/80 mm Hg; alanine transferase level >40 U/L and aspartate aminotransferase level >38 U/L; treated with ACEi or ARB within last 2 weeks

Interventions Treatment group
  • Shenqi particles (TCM): 9.6 g, 3 times/day


Control group
  • Prednisone (oral): 1 mg/day/kg, 12 weeks then tapered by 10 mg every 2 weeks to 30 mg/day, then tapered by 5 mg every 2 weeks to 20 mg/day and then 5 mg every 4 weeks to a maintenance dose of 10 mg/day

  • CPA (IV): 0.8 to 1 g/m² body surface area once every month for 6 months and then once every 3 months for another 6 months with a total dose 9 to 12 g/m²


Duration of treatment
  • 48 weeks

Outcomes
  • Complete or partial remission

    • Complete remission: reduction in proteinuria to protein excretion≤ 0.3 g/day

    • Partial remission: reduction to > 0.3 g and < 3.5 g/day and a 50% reduction from peak value

  • Serum albumin

  • GFR (using MDRD)

  • Doubling of SCr

  • Initiation of KRT or transplantation (i.e. ESKD)

  • Death

  • Severe adverse effects

Notes
  • Sample size, based on 20% difference in remission rate (80% to 60%)

  • Analysed per protocol and Intention to treat

  • Recruiting in December 2011

  • No patient had haemodialysis or transplantation while on the trial

  • Funded by National Science and Technology Support Project (2006BAI04A07‐2), the Xing Lin Team of the Shanghai University of Traditional Chinese Medicine, and The Ministry of Science and Technology Twelve Five Plan Major Science and Technology Special Projects “Major New Drug Development”–Establishment of Clinical Evaluation Platform for New Traditional Chinese Herbal Drugs (Malignant tumour and other diseases) (project number: 2011ZX09302‐006‐04).

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation as per random sequence. SAS program PROC PLAN
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes High risk High drop‐out rate (58/190); main reasons were a) took other medication, b) missed follow‐up visit
Selective reporting (reporting bias) Low risk Appropriate outcomes reported
Other bias Low risk Study appears free of other biases