Research Article

Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial

Table 2

Clinical outcomes for participants with severe HFMD.

Variable Conventional therapy group ( )Reduning injection combination therapy group ( )TCM formulas combination therapy group ( ) value of three groups’ comparison value of two groups’ comparison

Primary outcome
 Major complications, (%)5 (4.4)3 (2.5)3 (2.5)0.890
  Neurogenic pulmonary   edema 0 (0)1 (0.8)1 (0.8)0.626
  Cerebral edema2 (1.8)2 (1.6)1 (0.8)0.803
  Bacterial infection2 (1.8)0 (0)1 (0.8)0.335
  Circulatory failure1 (0.9)0 (0) 0 (0)0.343
Secondary outcome
 Time to fever clearance, h (95% CI) 20 (6.0–25.0) 18 (4.0–24.0)6 (4.0–16.0)0.0493 0.048 (TCM group relative to conventional group)
 Time to rash subsidence, days (95% CI)7 (6.0-7.0) 6 (6.0-7.0) 7 (6.0-7.0)0.667
 HFMD-related mortality0001.000
 Combined utilization of  intracranial pressure-lowering
 drugs
77%60.8%68%0.30
 Combined utilization of
 sedatives, %
24.8% 11.5% 18.30.0120.008 (Reduning group relative to conventional group)
 Adverse event, (%)0001.000