| Methods |
Trial design: randomised, controlled, parallel study
Randomisation procedure: random number generated by New Drug Statistical Treatment statistical software
Blinding: no blinding |
| Participants |
Country: China
Setting: Hangzhou, Zhejiang province
61 children with type B influenza (32 cases in the therapy group, 29 cases in the control group)
Diagnostic criteria: (1) sudden fever; (2) accompanied by respiratory catarrh symptoms or alimentary tract symptoms such as abdominal pain, vomiting, diarrhea. Examination of stool sample and vomitus under microscope was negative; (3) may be accompanied with headache and myalgia; (4) physical examination found diffused congestion of pharyngeal cavity or hyperplasia of lymph follicle in the pharyngeal posterior wall; (5) over 5 people who had been in contact had similar symptoms; (6) WBC count of routine blood test was normal or decreased, neutrophil cell count was normal or lymphatic cell count was high
Baseline: gender, age, disease duration and severity of disease were similar in the 2 groups (P > 0.05)
Withdrawal: not reported |
| Interventions |
1. TCM group: E Shu You glucose injection containing 0.1g E Shu You and 12.5 G glucose per 250 ml injection (10 mg/kg/day intravenous injection 4 times a day)
2. Control group: ribavirin injection (10 to 15 mg/kg/day ) + vitamin C (50 mg/kg/d) + 10% glucose 500 ml: 10% normal saline 10 ml intravenous injection 4 times a day
Erythromycin capsule 30 mg to 50 mg orally 3 times a day was given to both groups. Ibuprofen was given temporarily to patients with high fever
Treatment duration was 3 to 5 days |
| Outcomes |
Recovery: temperature falls to normal within 72 hours, symptoms and physical signs had improved by more than 90%
Marked improvement: temperature falls to normal within 72 hours, symptoms and physical signs had improved by more than 70%
General improvement: temperature falls but not to normal within 72 hours, symptoms and physical signs had improved by more than 30%
No improvement: temperature does not fall or even increases within 72 hours, symptoms and physical signs improve by less than 30% |
| Notes |
Influenza virus B was isolated by CDC in Hangzhou city in this local epidemic |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Not used |
