Evidence map›Paper›PMID 30658660›Full record

ArticleTrials2019

Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial.

Qiulan Luo, Shiqing Zhou, Xiaoshan Li, Qubo Chen, Wenmin Lin, Liming Lu, Hua Li, Caifeng Chen, Wenyong Chen, Yunying Li

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 46% of its field
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, 5 citations in OpenAlex.

  1. Review
  2. Article
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

10 authors at 2 institutions in 1 country.

Qiulan LuoOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China.
Shiqing ZhouThe Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510120, China.
Xiaoshan LiOtorhinolaryngology Department, Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine (Nanhai District Hospital of Traditional Chinese Medicine of Foshan City), 16 Nanwu Road, Nanhai District, Foshan, 528200, China.
Qubo ChenBiological Resource Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Wenmin LinOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China.
Liming LuClinical Research Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Hua LiOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China.
Caifeng ChenOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China.
Wenyong ChenOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China.
Yunying LiOtorhinolaryngology Department, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, 510120, Guangdong Province, China. docliyunying@gzucm.edu.cn.ORCID http://orcid.org/0000-0002-0424-0154
Guangzhou University of Chinese Medicine · CNGuangdong Provincial Hospital of Traditional Chinese Medicine · CN

Funding

Special Scientific Research for Chinese Medicine of Guangdong Provincial Hospital of Chinese Medicine YN2015MS18
6 · The paper itself

Abstract

backgroundPeople with allergic rhinitis (AR) often seek help from Chinese medicine due to dissatisfaction with conventional treatments. Lung-spleen qi deficiency syndrome (LSQDS) is the most common type of AR, and the Chinese herbal medicine formula bi min fang (BMF) is commonly prescribed for AR patients with LSQDS. However, direct evidence supporting its efficacy and safety is not available, and its potential mechanism of action remains unclear. METHODS/

designThis paper presents a double-blind, double-dummy, randomized controlled trial. After a 2-week run-in period, 80 AR patients with LSQDS will be recruited and randomly allocated to the BMF group or the control group in a 1:1 ratio. The patients in the BMF group will receive BMF and the placebo for levocetirizine hydrochloride orally, while the control group participants will receive levocetirizine hydrochloride and the placebo for BMF orally. All participants will receive 4 weeks of treatment and 12 weeks of follow-up. The primary outcome is a change in the Total Nasal Symptom Score (TNSS). Secondary outcomes include changes in scores for the standard version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)), and visual analog scale (VAS); changes in serum levels of the cytokines interleukin-4, interferon-γ, transforming growth factor β-1, and interleukin-17; and changes in the gut microbiota composition in the stool. The TNSS, RQLQ(S), and VAS will be recorded at the beginning of, middle of and after the treatment period and at the end of each month in the 3-month follow-up period. Blood and stool samples will be collected at baseline and the end of the treatment. The aforementioned four cytokines will be detected in the serum using enzyme-linked immunosorbent assays, and the stool gut microbiota will be detected using 16S ribosomal ribonucleic acid sequencing. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide consolidated evidence of the effect of BMF on AR and the potential mechanism by which BMF acts. This study will be the first to explore the mechanism of action of Chinese herbal medicine on the gut microbiota in AR.

trial registrationChinese Clinical Trial Registry, ChiCTR-IPR-17010970 . Registered on 23 March 2017.

Indexed as

Administration, OralAdolescentAdultAgedAnti-Allergic AgentsChinaCytokinesDouble-Blind MethodDrug Administration ScheduleDrugs, Chinese HerbalFemaleGastrointestinal MicrobiomeHumansMaleMiddle AgedQuality of LifeAnti-Allergic AgentsCytokinesDrugs, Chinese HerbalAllergic rhinitisChinese herbal medicineCytokinesGut microbiotaRandomized controlled trial

Identifiers

PMID30658660
PMCPMC6339341
OpenAlexW2914107647

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.