Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial<sup>*</sup>

JIA Ming-yue; ZHANG Mei-yi; XIAO Si-yao; YU Yang; SHAO Xiang; HAN Chun-sheng; HAN Gui-ling

doi:10.1007/s11655-025-3948-0

Your Location：

Home >

Browse articles >

Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*

Clinical Experience | Updated：2025-10-23

- Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*
- Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*
- 中国结合医学杂志（英文版） 2025年31卷第11期页码：1029-1036
- Affiliations：
  
  1.Department of Pulmonary and Critical Care Medicine/Department of Integrated Traditional Chinese and Western Medicine for Pulmonary Diseases Part 1, National Center for Integrative Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital; National Center for Respiratory Medicine; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; National Clinical Research Center for Respiratory Diseases, Beijing (100029), China
  2.Graduate School of Beijing University of Chinese Medicine, Beijing (100029), China
- Author bio：
  
  Prof. HAN Gui-ling, E-mail: hjxdehan@163.com
- Funds：
  
  the National Natural Science Foundation of China(82104760);Chinese Association of Chinese Medicine Youth Realistic Project(2022-QNQSDEP-09);Funding Project for Clinical Research Business Expenses at Central High-Level Hospitals(2022-NHLHCRF-LX-01-0308);the Second Group of the Elite Plan Backbone Talent Project at China-Japan Friendship Hospital(ZRJY2023-GG05)
- DOI：10.1007/s11655-025-3948-0
  中图分类号：
- 录用：2025-07-18，
  
  网络出版：2025-09-09，
  
  纸质出版：2025-11
- Accepted：
Scan QR Code
Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*[J]. 中国结合医学杂志（英文版）, 2025,31(11):1029-1036.

JIA Ming-yue, ZHANG Mei-yi, XIAO Si-yao, et al. Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*[J]. Chinese journal of integrative medicine, 2025, 31(11): 1029-1036.
Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*[J]. 中国结合医学杂志（英文版）, 2025,31(11):1029-1036. DOI： 10.1007/s11655-025-3948-0.

JIA Ming-yue, ZHANG Mei-yi, XIAO Si-yao, et al. Lu'e Biyan Formula for Treatment of Allergic Rhinitis Patients with Fei (Lung)-Qi Deficiency-Coldness Syndrome: A Randomized, Double Blind, and Placebo-Controlled Trial^*[J]. Chinese journal of integrative medicine, 2025, 31(11): 1029-1036. DOI： 10.1007/s11655-025-3948-0.

摘要

Abstract

Objective:

To observe the clinical effect and safety of Lu'e Biyan Formula (LBF) combined with loratadine in the treatment of moderate to severe allergic rhinitis (AR) patients with Fei (Lung)-qi deficiency-coldness (FQDC) syndrome.

Methods:

From September 2023 to December 2024

moderate to severe AR patients with FQDC syndrome were recruited from the Outpatient Department of Integrated Traditional Chinese and Western Medicine for Pulmonary Diseases Part 1

China-Japan Friendship Hospital. Participants were randomly assigned to a test group and a control group by using a random number table at a ratio of 1:1. Both groups received oral loratadine tablets (10 mg

once daily) for 2 weeks. In addition

the test group received oral LBF (30 mL

twice daily)

and the control group received a placebo of LBF. Changes in the Total Nasal Symptom Score (TNSS)

Total Non-nasal Symptom Score (TNNSS)

Visual Analog Scale (VAS)

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

and Chinese medicine (CM) syndrome scores before and after treatment were compared between groups. Moreover

the total effective rates and disease recurrence rates were compared. Adverse events (AEs) during the study period were also recorded.

Results:

Totally 109 participants were recruited

and the full analysis set included 105 cases

54 in the test group and 51 in the control group. Compared with the pre-treatment values

the scores of sneezing

runny nose

nasal obstruction

nasal itching

TNSS

TNNSS

VAS

RQLQ

and CM syndrome were significantly reduced in both groups at 1 and 2 weeks post-treatment and 12 weeks post-drug withdrawal (

0.01). After treatment

the aforementioned scores in the test group were all markedly lower than those in the control group (

0.01). Moreover

the total effective rate in the test group was higher than that in the control group (98.15%

. 70.59%

0.01). After 12 weeks of drug withdrawal

there was no significant difference in the recurrence rate between groups (13.21%

. 22.22%

0.05). No obvious AEs were observed in either group following treatment.

Conclusions:

The combination of LBF with loratadine can effectively alleviate the symptoms of moderate to severe AR patients with FQDC syndrome

thereby improving their quality of life. This therapy demonstrated both precise effect and high safety. (Trial registration No. ITMCTR2025000589)

关键词

Keywords

references

浏览量

Downloads

CSCD

文章被引用时，请邮件提醒。

Submit

工具集

关联资源

Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial

Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, and Placebo-Controlled Trial

Efficacy and Safety of Zihua Wenfei Zhisou Granule in Treatment of Postinfectious Cough: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Trial

Efficacy and Safety of Ganyushu Granule in Treatment of Premenstrual Syndrome with Gan (Liver) Depression and Qi Stagnation Syndrome: A Randomized, Double-Blind, Multicenter, Phase-Ⅱ Clinical Trial

Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial