Exploring the efficacy and safety of Yu-Ping-Feng powder with variation against allergic rhinitis: a randomized, double-blind, placebo-controlled trial

Abstract

Background: Allergic rhinitis (AR) is a common allergic condition characterized by frequent sneezing, nasal congestion, nasal itching and rhinorrhea. Chinese medicine formula Yu-Ping-Feng Powder with Variation (YPV) is an empirical formula modified from an ancient Chinese medicine formula named Yu-Ping-Feng Powder, which is widely used for the treatment of allergic diseases such as AR and asthma.

Purpose: To evaluate the efficacy and safety of YPV on AR patients with the lung and spleen Qi deficiency type using a randomized, double-blind, placebo-controlled clinical trial (RCT).

Study design and methods: Between April 2022 and June 2023, a total of 58 participants were recruited and randomly allocated to receive either YPV (n = 29) or placebo (n = 29) for 8 consecutive weeks. The changes of the Total Nasal Symptom Score (TNSS), and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or the Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ) scores at week 8 were used as the primary outcomes. The secondary outcomes included (1) the change of TNSS at weeks 4, 12 and 16; (2) the RQLQ or the PADQLQ scores at weeks 4, 12 and 16; (3) the change of frequency of AR episodes and their severity Visual Analog Scale (VAS) at weeks 4, 8, 12 and 16; (4) the changes of the gut microbiota composition in stool samples at week 8; and (5) adverse events related to the study treatment.

Results: YPV treatment could significantly improve the RQLQ score in AR patients at weeks 4, 8, 12, and 16 (p = 0.05, p = 0.04, p = 0.04 and p = 0.03, respectively), when compared with the placebo treatment. However, it did not improve the TNSS score at week 8 in AR patients when compared with the placebo group. In addition, YPV treatment could reduce the VAS score in AR patients at weeks 12 and 16 when compared with the placebo group, although the reductions were not statistically significant (p = 0.06 and p = 0.08, respectively). Importantly, no overt adverse effects were observed in both YPV and placebo groups.

Conclusion: YPV was well-tolerated and could effectively ameliorate multiple symptoms of AR and improve the quality of life of AR patients after 8-week treatment. Trial registration ClinicalTrials.gov, NCT04976023. Registered 26 July 2021, https://clinicaltrials.gov/study/NCT04976023?cond=The%20Effects%20of%20Using%20Yupingfeng%20Powder%20with%20Variation%20for%20the%20Treatment%20of%20Allergic%20Rhinitis&rank=2.

Keywords: Allergic rhinitis; RCT; Yu-Ping-Feng powder with variation (YPV).

Fig. 1

Total ion chromatogram of YPF granule. A Positive ion model and B negative ion model. The black numbers indicated the 10 identified compounds: (1) Citric acid, (2) Adenosine, (3) Magnolin, (4) α-Lactose, (5) Turanos, (6) L-arginine, (7) Soyasaponin Bb, (8) Amlaic acid, (9) Pinoresinol dimethyl ether and (10) Manninotriose

Fig. 2

Clinical trial flow chart

Fig. 3

Effects of the YPV on the changes of primary and secondary outcomes from baseline during the study period. A TNSS score; B VAS score; C RQLQ score. Data were expressed as mean (SD). *p < 0.05 compared with the placebo group

Fig. 4

Effects of the YPV on gut dysbiosis in AR patients. A Effects of the YPV on α-diversity in AR patients, including ACE, chao1, Faith’s PD, observed features, Shannon’s entropy, and Simpson index; B PCoA of microbial community structure; C Gut microbiota composition at the phylum level; D Firmicutes/Bacteroidota ratio; E The relative abundance of gut microbiota composition between two groups at the phylum level; F Gut microbiota composition at the genus level; G Gut microbiota composition at the species level