Key result
Heat-clearing and detoxifying Chinese medicines plus conventional therapy significantly reduced the progression of mild HFMD to severe disease (OR 0.43; 95% CI 0.22-0.83; P=0.01).
Why the study?
Heat-clearing and detoxifying Chinese medicines combined with conventional therapy are commonly used for mild hand, foot, and mouth disease in China, but solid evidence on their efficacy and safety is lacking.
Does the addition of heat-clearing and detoxifying Chinese medicines to conventional therapy reduce the progression to severe disease in patients with mild hand, foot, and mouth disease?
Meta-Analysis (n=947)
randomized
Yes
Does the addition of heat-clearing and detoxifying Chinese medicines to conventional therapy reduce the progression to severe disease in patients with mild hand, foot, and mouth disease?
Odds Ratio: 0.43 (95% CI 0.22–0.83)
p-value: p=.01
Adding heat-clearing and detoxifying Chinese medicines to conventional therapy may reduce the progression of mild hand, foot, and mouth disease to severe disease and shorten the healing time of skin and oral lesions.
Supports adjunctive use in mild HFMD; extends low-certainty meta-analytic evidence for traditional Chinese medicines.
BACKGROUND: In China, heat-clearing and detoxifying Chinese medicines combined with conventional therapy are commonly applied to treat the mild hand, foot, and mouth disease (HFMD). However, there is lack of solid evidence on the efficacy and safety of such therapies. METHODS: We conducted a pooled analysis with individual patient data from 5 strictly randomized controlled clinical trials to assess the efficacy and safety of this combination therapy for mild HFMD. An intention-to-treat analysis was performed. A 2-stage meta-analysis method was adopted to analyze the pooled effect size. RESULTS: In total, 947 patients were included. Compared with conventional therapy, the combination therapy significantly reduced the progression rate of HFMD from mild to severe (odds ratio [OR] 0.43, 95% confidence interval [CI]: 0.22 to 0.83, P = .01). Meanwhile, the healing time of skin rash and oral ulcer in the combination therapy group was significantly shorter than that of conventional therapy. The overall hazard ratio (HR) of healing time of the skin rash or oral ulcer was 1.22 (95%CI: 1.04 to 1.43; P = .02). However, except Jinlianqingre effervescent tablets, the combination therapy cannot shorten the time to fever resolution (HR 1.12, 95%CI: 0.97 to 1.29, P = .14). Because of the heterogeneity, Jinlianqingre effervescent tablets were analyzed separately and the HRs of the time to fever resolution and the healing time of skin rash or oral ulcer were 3.88 (95%CI: 3.19 to 4.72; P < .0001) and 3.79 (95%CI: 2.81 to 5.11; P < .0001), respectively. There were 30 adverse events reported in total; 2 cases were related to Chinese medicines. CONCLUSION: In conclusion, the heat-clearing and detoxifying Chinese medicines on top of conventional therapy can effectively reduce the progressive rate of mild HFMD and improve healing of skin and oral mucosal lesions. More studies are needed for the time to fever resolution.
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Yan et al. (2020) conducted a meta-analysis in mild hand, foot, and mouth disease (HFMD) with fever (n=947). Heat-clearing and detoxifying Chinese medicines combined with conventional therapy vs. Conventional therapy was evaluated on progression rate of HFMD from mild to severe (OR 0.43, 95% CI 0.22-0.83, p=.01). Heat-clearing and detoxifying Chinese medicines plus conventional therapy significantly reduced the progression of mild HFMD to severe disease (OR 0.43; 95% CI 0.22-0.83; P=0.01).
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