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

Liu 2009b.

Study characteristics
Methods

  • Study design: parallel, open‐label RCT

  • Study duration: January 2006 to December 2007

  • Duration of follow‐up: 12 months
Participants

  • Setting: not reported

  • Country: China

  • Inclusion criteria: biopsy‐proven IMN with nephrotic syndrome

  • Baseline characteristics

    • Pathology stage: not reported

    • Mean proteinuria ± SD (g/24 hours): treatment group 1 (6.04 ± 2.52); treatment group 2 (5.66 ± 2.28)

    • Hypertension: treatment group 1 (10/43); treatment group 2 (11/41)

    • Mean serum albumin ± SD (g/L): treatment group 1 (24.1 ± 3.66); treatment group 2 (27.3 ± 4.96)

    • Mean SCr ± SD (mg/dL): treatment group 1 (0.79 ± 0.31); treatment group 2 (0.88 ± 0.38)

    • Baseline declining kidney function: 9/84 patients with an initial SCr of between 1.25 and 1.5 mg/dL (treatment group 1 (4); treatment group 2 (5)). No patients had SCr > 1.5 mg/dL

    • Use of ACEi or ARB before the end of the study/during follow‐up: treatment group 1 (15/14); treatment group 2 (14/12)

    • Previous immunosuppressive status: no differences in the number of patients that had been previously treated with steroids alone or in combination with cytotoxics. Previous treatment with steroids/steroids plus cytotoxics: treatment group 1 (13/4); treatment group 2 (14/3)

  • Number: treatment group 1 (43); treatment group 2 (41)

  • Mean age ± SD (years): treatment group 1 (40.5 ± 12.0); treatment group 2 (48.6 ± 10.3)

  • Sex (M/F): treatment group 1 (31/12); treatment group 2 (30/11)

  • Exclusion criteria: treated with steroids or immunosuppressive therapy within the 3‐month period before screening
Interventions Treatment group 1

  • Tripterygium wilfordii: 120 mg/day for 3 months. If the patients had complete remission, then gradually reduced to 60 mg/day for the remaining 9 months. If the patients did not reach complete remission, then continued the 120 mg dosage to a maximum of 6 months and then gradually reduced to 60 mg/day for the remission 6 months

  • Prednisone: 30 mg/day for 8 weeks, and gradually reduced by 5 mg every 2 weeks and then maintained at 10 mg every 2 days


Treatment group 2

  • Tripterygium wilfordii: 120 mg/day for 3 months. If the patients had complete remission, then gradually reduced to 60 mg/day for the remaining 9 months. If the patients did not reach complete remission, then continued the 120 mg dosage to a maximum of 6 months and then gradually reduced to 60 mg/day for the remission 6 months
Outcomes

  • Death

  • ESKD

  • 50% or 100% SCr increase

  • Partial or complete remission

  • Side effects leading to patient withdrawal or hospitalisation
Notes

  • Funding information: supported by Chinese grants (06G040, BK2007718, and 06Z025)

  • Published in Chinese
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk No sufficient detail about concealment of the random allocation sequence before or during enrolment of participants
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias)
All outcomes High risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Low risk Only 3/84 patients (all in treatment group 2) lost to 12‐month follow‐up
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were pre‐specified
Other bias Unclear risk Published in Chinese