Evidence map›Paper›PMID 40756995›Full record

ArticleFrontiers in pharmacology2025

Xiao'er Fengreqing oral liquid versus Xiao'er Yanbian granules for pediatric acute pharyngitis/tonsillitis (external wind heat syndrome): protocol and statistical analysis plan for a multi-center, randomized, double-blind, active drug-controlled trial.

Kai Liu, Lei Shi, Yi-Ke Song, Yu Du, Yi Yuan, Ze-Yang Shi, Jian-Ping Liu, Hui-Lan Liu, Zhao-Lan Liu

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kai Liu *Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Lei Shi *Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Yi-Ke Song *Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Yu DuBusiness Analytics, University of Colorado Denver, Denver, CO, United States.
Yi YuanCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Ze-Yang ShiCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Jian-Ping LiuCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Hui-Lan LiuThe Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China.
Zhao-Lan LiuCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To evaluate the effectiveness and safety of Xiao'er Fengreqing Oral Liquid (XFOL) for pediatric acute pharyngitis/tonsillitis (external wind heat syndrome) through a multi-center, randomized, double-blind, positive-controlled, non-inferiority clinical trial. Method: A total of 120 participants (60 per group) will be randomized to receive either XFOL or Xiao'er Yanbian Granules (positive control) for 5 days. The primary outcome is the throat pain resolution rate and overall effective rate at Day 5, assessed via the Wong-Baker Faces Pain Rating Scale (WBS). Secondary outcomes include time to symptom onset/resolution, fever resolution time, and traditional Chinese medicine (TCM) syndrome scores. Safety assessments will monitor adverse events, vital signs, and laboratory parameters. Statistical analyses will follow a pre-specified plan, employing non-inferiority testing, survival analysis for time-to-event endpoints, and generalized estimating equations for repeated measures. Missing data will be handled using the last observation carried forward (LOCF) method for effectiveness endpoints, while safety analyses will rely on observed cases. Conclusion: This trial will provide rigorous evidence on the non-inferiority and safety profile of Fengreqing Oral Liquid, supporting its integration into pediatric care for acute upper respiratory infections. Adherence to a predefined statistical analysis plan ensures transparency and minimizes bias, ultimately guiding evidence-based clinical practice for TCM interventions.

Indexed as

non-inferiority designpharyngitisrandomized controlled trialstatistical analysis plantonsillitistrial protocolXiao’er Fengreqing oral Liquid

Identifiers

PMID40756995
PMCPMC12314424

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.