Research Article: Evidence quality assessment of traditional Chinese medicine and integrated traditional Chinese and Western medicine for acute upper respiratory infection in children: an umbrella review of systematic reviews and meta-analyses
Abstract:
To systematically appraise the reporting completeness, methodological quality, risk of bias, and certainty of evidence for a prespecified outcome in systematic reviews and meta-analyses evaluating traditional Chinese medicine (TCM), either alone or in combination with conventional Western medicine, for acute upper respiratory tract infection (AURI) in children using an umbrella review approach.
PubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Database, and the Chinese Biomedical Literature Database (SinoMed) were systematically searched from database inception to February 5, 2026, without restrictions on publication year. Systematic reviews and meta-analyses evaluating TCM alone or TCM combined with conventional Western medicine for pediatric AURI were eligible for inclusion. Reporting completeness was assessed using the PRISMA 2020 statement, methodological quality using AMSTAR 2, and risk of bias using ROBIS. In addition, the certainty of evidence for the outcome of total effective rate was independently reassessed for each included systematic review using the GRADE framework.
A total of 41 systematic reviews and meta-analyses involving 57,590 children were included. The eligible reviews were published between 2010 and 2024; no systematic review or meta-analysis published between 2025 and February 5, 2026 met the prespecified eligibility criteria. Assessment against PRISMA 2020 identified varying degrees of underreporting, particularly with respect to protocol registration, complete search strategies, the influence of risk of bias on interpretation of findings, sensitivity analyses, and funding sources. According to AMSTAR 2, 37 reviews were rated as having moderate methodological quality, three as low quality, and one as critically low quality. ROBIS identified 38 reviews as being at high risk of bias. Across the 41 review-specific GRADE assessments of total effective rate, one was rated as moderate-certainty evidence, four as low-certainty evidence, and 36 as very-low-certainty evidence. These ratings apply exclusively to total effective rate, a non-standardized composite outcome, and should not be extrapolated to other outcomes such as time to fever resolution, duration of cough, or adverse events. Although most existing reviews suggested that TCM, either alone or combined with conventional Western medicine, may provide potential benefits in terms of total effective rate and selected short-term symptom outcomes, substantial clinical heterogeneity and methodological limitations were evident across the evidence base.
Existing systematic reviews suggest that TCM, either alone or in combination with conventional Western medicine, may offer potential clinical benefits for children with AURI. However, the overall evidence base is characterized by a high risk of bias, and the certainty of evidence for total effective rate—a non-standardized composite outcome—is predominantly low or very low. The available evidence is therefore insufficient to support strong clinical recommendations, and the findings should be interpreted cautiously. Future studies should prioritize standardized, clinically meaningful, patient-relevant outcomes and strengthen the rigorous evaluation of both efficacy and safety.
Introduction:
AURI is one of the most common infectious diseases in childhood and primarily affects the upper respiratory tract, including the nasal cavity, pharynx, and larynx ( 1 ). Because the immune system and respiratory defense mechanisms are not yet fully mature in children, they are particularly susceptible to viral and other respiratory pathogens. Common clinical manifestations include fever, nasal congestion, rhinorrhea, cough, sore throat, sputum production, and general malaise ( 2 ). AURI is characterized by a high…
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