Efficacy and safety of traditional Chinese medicine adjuvant therapy for severe pneumonia: evidence mapping of the randomized controlled trials, systematic reviews, and meta-analyses.

Severe pneumonia is a critical respiratory disease with high mortality. There is insufficient evidence on the efficacy and safety of traditional Chinese medicine (TCM) adjuvant therapy for severe pneumonia. This study aims to identify, describe, assess, and summarize the currently available high-quality design evidence on TCM adjuvant therapy for severe pneumonia to identify evidence gaps using the evidence mapping approach. Systematic searches were performed on English and Chinese online databases (PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, WanFang Data, CQVIP, and SinoMed) to identify papers from inception until August 2023 for inclusion into the review. Randomized controlled trials (RCTs), systematic reviews (SRs), and meta-analyses concerning TCM adjuvant therapy for severe pneumonia or its complications in adults were included. The risk of bias in RCTs was evaluated by using the ROB tool. The Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic Review (ROBIS) tool, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system were used to assess the methodological quality, risk of bias, and evidence quality of SRs or meta-analyses, respectively. Then, a bubble plot was designed to visually display information in four dimensions. A total of 354 RCTs and 17 SRs or meta-analyses met the inclusion criteria. The published RCTs had several flaws, such as unreasonable design, limited sample size, insufficient attention to non-drug therapy studies and syndrome differentiation, improper selection or use of outcome indicators, and failure to provide high-quality evidence. Sixteen SRs or meta-analyses of methodological quality scored "Critically Low" confidence. Twelve SRs or meta-analyses were rated as "High Risk." Most outcomes were rated as "Low" evidence quality. We found that TCM combined with conventional treatment could improve the clinical total effective rate and the TCM syndromes efficacy. The combined approach could also shorten mechanical ventilation time, infection control time, and length of hospital and ICU stay; significantly reduce temperature, respiratory rate, heart rate, white blood cell counts, levels of C-reactive protein, procalcitonin, blood inflammatory factors, bacteriological response, and D-dimer; decrease CPIS, APACHE II score, and PSI score; improve pulmonary imaging features, arterial blood gas indicators (including arterial oxygen pressure, arterial oxygen saturation, and oxygen index), and lung function (including forced vital capacity and forced expiratory volume in the first second) for severe pneumonia compared with conventional treatment only ( < 0.05). There was no significant difference in adverse reactions and incidence of adverse events ( > 0.05). In addition, compared with conventional treatment only, most SRs or meta-analyses concluded that TCM combined with conventional treatment was "Beneficial" or "Probably beneficial." TCM combined with conventional treatment had advantages in efficacy, clinical signs, laboratory results, and life quality outcomes of severe pneumonia, with no difference in safety outcomes compared with conventional treatment only. QingJin Huatan decoction is the most promising target, and Xuanbai Chengqi decoction has a "Probably beneficial" conclusion. XueBiJing injection and TanReQing injection are two commonly used Chinese herbal injections for treating severe pneumonia, and both are "Probably beneficial." However, there was a need for multicenter RCTs with large sample sizes and high methodological quality in the future. In addition, the methodological design and quality of SRs or meta-analyses should be improved to form high-quality, evidence-based medical evidence and provide evidence for the effectiveness and safety of TCM adjuvant therapy for severe pneumonia.