Dataset Information

Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial.

ABSTRACT:

Importance

Recurrent respiratory tract infection (RRTI) is common in children. Inappropriate RRTI treatment will lead to asthma and other diseases, thereby seriously affecting the growth and physical health of children. Immune function modulation can prevent and alleviate childhood RRTI. Yupingfeng (YPF), a patented traditional Chinese medicine (TCM), has immunomodulatory effects and is widely used in China to treat children with RRTI.

Objective

To evaluate the safety and efficacy of YPF monotherapy in treating children with RRTI.

Methods

This multicenter, randomized, double-blind, double-simulation, noninferiority clinical trial was conducted from January 2015 to August 2017, with an 8-week treatment period and 52-week follow-up after the drug withdrawal. Children aged 2-6 years with RRTI meeting the inclusion and exclusion criteria were enrolled in 13 hospitals in China and divided randomly into three groups (2:2:1 ratio) to receive YPF, pidotimod, or placebo. The primary outcome was the proportion of RRTI returning to normal standard level during the follow-up. The secondary outcomes were reduction in the number of RRTI recurrences, effect on clinical symptoms (in accord with TCM practice), effect per symptom, and safety. The trial was registered at the Chinese Clinical Trials Registry (www.chictr.org.cn) under the unique identifier ChiCTR-IPR-15006847.

Results

Three hundred and fifty-one children were enrolled and randomly assigned to 3 groups; 124, 125, and 61 children in the YPF, pidotimod, and placebo groups, respectively, had completed the trial. During the follow-up, the proportion of RRTI returning to normal standard level was 73.13%, 67.15%, and 38.81% with YPF, pidotimod, and placebo, respectively (P < 0.0001). The proportion of cases who returned to normal standard level in the YPF group was 34.32% higher than that in the placebo group. The safety profile did not significantly differ among the groups.

Interpretation

YPF granules were noninferior to the active control drug pidotimod oral solution for the treatment of RRTI in children, and were superior to placebo, with a high safety profile.

SUBMITTER: Xu B

PROVIDER: S-EPMC9218971 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundYupingfeng granules (YPFG) contribute to various chronic respiratory infections. Several clinical studies have evaluated its efficacy and safety in treating recurrent respiratory tract infections (RRTIs) in children. However, the evidence for its use has not been conclusively proven.ObjectiveThe aim of this study was to demonstrate the efficacy and safety of YPFG in the adjuvant treatment of RRTIs in children.MethodsWe searched PubMed, Embase, Web of Science, Cochrane Library, Clinical Trials, Chinese Clinical Trial Registry, Sinomad, China National Knowledge Infrastructure (CNKI), Wanfang Database, and Chinese Scientific Journals Database (VIP) for randomized controlled trials (RCTs) of YPFG adjuvant therapy for children with RRTIs as of September 1, 2022. We screened the literature for inclusion and exclusion criteria, assessed the quality of each included literature, and then extracted data from each study for this systematic review and meta-analysis.ResultsA total of 17 RCTs were included. Data analysis showed that the total clinical response rate in the YPFG group was significantly higher than that in the control group [risk ratio (RR) = 1.18, 95%CI (1.12, 1.24), I 2 = 39%, P < 0.00001]. Compared with the control group, three serum immunoglobulin levels were significantly increased in the YPFG group: IgA level [standardized mean difference (SMD) = 1.23, 95%CI (0.68, 1.78), I 2 = 95%, P < 0.0001]; IgM level [SMD = 0.85, 95%CI (0.35, 1.35), I 2 = 93%, P = 0.0009]; IgG level [SMD = 1.06, 95%CI (0.65, 1.47), I 2 = 91%, P < 0.00001]. The TNF-α level was significantly lower in the YPFG group [SMD = -1.03, 95%CI (-1.55, -0.51), I 2 = 84%, P = 0.0001] compared with the control group.ConclusionsIn summary, adjuvant YPFG therapy improves clinical efficacy and immunity in children with RRTIs. However, the effectiveness and safety of YPFG remain to be further verified.Systematic review registration[https://inplasy.com/inplasy-2022-3-0150/], identifier [INPLASY202230150].

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