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. 2017 Oct 2;2017(10):CD011367. doi: 10.1002/14651858.CD011367.pub2

Wu 2014.

Methods Randomised controlled trial.
Conducted in general hospital in China.
80 children enrolled (control group = 27, experimental group 1 = 27, experimental group 2 = 26).
Allocation using random sampling table.
Dose of IVIG/placebo: 400 mg/kg/day for 3 consecutive days.
Outcome assessment during period of hospitalisation.
Participants Inclusion criteria
  • Aged 1‐6 years.

  • Diagnosis of hand, foot, and mouth (based on the Chinese Department of Ministry of Health published guidelines) complicated by encephalitis.


Exclusion criteria
  • Children with underlying immune problems and who were unconscious.

Interventions Control group: conventional comprehensive treatment including dehydration, reduction of intracranial pressure, nutritional support, anti‐infection treatment, keeping the skin clean, and general precautions to prevent infection.
Experimental group 1: intravenous injection of human blood gamma globulin*, 400 mg/kg a day for 3 consecutive days in addition to the comprehensive treatment.
Experimental group 2: spray of human interferon alfa‐2h, 1 or 2 sprays per time, 3 times/day on 3 consecutive days.
Outcomes Time for fever to subside.
Time to control convulsions.
Time to resolution of rashes.
Time for neuropathic symptoms to subside.
Mean stay in hospital.
Adverse events.
Notes Ethical approval obtained.
Informed consent obtained.
No information provided on funding.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random allocation using random sampling table.
Allocation concealment (selection bias) Unclear risk No information.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts and all participants included in outcome assessment.
Selective reporting (reporting bias) Unclear risk Study protocol not available in public domain.
Other bias Unclear risk Small sample size and no sample size calculation so unclear if sample size large enough to detect significant differences between study groups.
No information on funding provided.
Diagnostic criteria used for encephalitis not mentioned in paper.

CSF: cerebrospinal fluid; GCS: Glasgow Coma Score; IVIG: intravenous immunoglobulin; JEV: Japanese encephalitis virus.