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. 2012 Apr 18;2012(4):CD003964. doi: 10.1002/14651858.CD003964.pub3
Methods
  • Study design: parallel RCT

  • Losses to follow‐up/withdrawals: None

Participants
  • Setting: inpatients recruited from the paediatric department

  • Country: China

  • Ethnicity: Chinese

  • Nephrotic syndrome involving patients with new onset and relapse; not specifying primary or secondary types, diagnosed on "the National Diagnostic Criteria for Nephrotic Syndrome in Children"

  • Course of disease: new‐onset patients (5 days to 5 months); relapsing patients (2.5 months to 4 years)

  • Number: 60 children

  • Age range: 1 to 13 years

  • Gender (M/F): 48/12


Exclusion criteria: NS
Interventions Treatment group
  • Chinese medicinal herbs (oral)

    • "TIAOJINING"

    • Dose: 1.5 bag/time (< 5 years); 2 bags/time (5 to 9 years); 3 bags/time (> 9 years), 3 times/day (one bag = 15 g)

  • Baseline treatment including the standard steroid protocol for nephrotic children and other supportive therapies such as complements of calcium, potassium

  • Duration: 8 weeks


Control group
  • Baseline treatment including the standard steroid protocol for nephrotic children and other supportive therapies such as complements of calcium, potassium


Duration of follow‐up: NS
Outcomes
  • Infection

    • Diagnostic criteria: based on the authors' definition involving clinical symptoms, signs and general tests for blood, urine, stool and chest X‐ray

  • Adverse events

Notes
  • Spectrum of infections in order of incidence (episodes of infection)

    • Treatment group: URI (15); acute enteritis (2); purulent tonsillitis (1); bronchitis (1); pneumonia (1)

    • Control group: URI (31); acute enteritis (7); bronchitis (5); UTI (4); pneumonia (2); varicella (2); acute dysentery (1); skin infection (1)

  • Spectrum of microorganisms: NS

  • Source of funding: NS

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study did not provide the information on the method of random sequence generation, and only presented with the data as "all participants with nephrotic syndrome were randomly allocated to treatment and control groups".
Allocation concealment (selection bias) Unclear risk The study did not provide the information on allocation concealment.
Blinding (performance bias and detection bias) All outcomes Unclear risk The study did not provide the information on blinding.
Incomplete outcome data (attrition bias) All outcomes Low risk There were no missing data in this study.
Selective reporting (reporting bias) High risk Free of selective reporting bias was assessed as "No" due to some clinically important outcomes unstated, such as adverse events.
Other bias Unclear risk There was insufficient information to make judgement.