Abstract
Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7–10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0–25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0–24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0–16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD.
Highlights
Foot, and mouth disease (HFMD) is a common infectious disease in children that is usually caused by enterovirus 71 (EV71) or coxsackievirus type A 16 (CVA16), which account for more than 70% of cases [1,2,3,4]
We found that the Chinese herbal medicines in the form of Reduning injection and traditional Chinese medicine (TCM) enema show potential as a complementary therapy for severe HFMD
In conjunction with conventional therapy, Reduning injection significantly reduced the need for sedative administration, whereas the TCM formulas shortened the time to fever clearance in the treatment of severe HFMD
Summary
Foot, and mouth disease (HFMD) is a common infectious disease in children that is usually caused by enterovirus 71 (EV71) or coxsackievirus type A 16 (CVA16), which account for more than 70% of cases [1,2,3,4]. The illness is usually mild and self-limiting, with relief of symptoms within 7–10 days, but viruses can be detected in the stool for weeks after the symptoms dissipate [5] It is Evidence-Based Complementary and Alternative Medicine notable that, in certain cases, HFMD can progress into a severe condition with life-threatening complications, including aseptic meningitis and encephalitis, neurogenic pulmonary edema, pulmonary hemorrhage, and circulatory failure [10, 11]. The most common treatment is only to relieve symptoms by supportive therapy and the use of antivirals, antibiotics, and immunopotentiators [1, 5] Medications such as antivirals have not demonstrated convincing clinical efficacy, in treating severe HFMD [1, 2, 5], and there is no vaccine currently available.
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