Efficacy and Safety of Yiqi Wenyang Sanhan Formula Combined With Acupoint Application in Patients With Combined Allergic Rhinitis and Asthma Syndrome During Remission and Yang-Deficiency Syndrome

Summary

Allergic rhinitis-asthma syndrome is a clinical comorbid condition involving both upper and lower airway allergic inflammation, reflecting the concept of "one airway, one inflammatory response." Epidemiological studies have demonstrated a strong coexistence between allergic rhinitis and asthma: allergic rhinitis is present in a substantial proportion of patients with asthma, while some patients with allergic rhinitis may further develop concomitant asthma. Clinically, the disease is characterized by recurrent and fluctuating episodes, which are often associated with seasonal or persistent allergen exposure. In terms of symptomatology, upper airway manifestations mainly include nasal itching, paroxysmal sneezing, watery rhinorrhea, and nasal obstruction, whereas lower airway manifestations are primarily recurrent wheezing, shortness of breath, chest tightness, and cough. When these two conditions coexist, they not only increase the overall symptom burden but also further impair patients' quality of life and complicate disease control.

During the remission stage, patients may exhibit alleviation of nasal and lower airway symptoms and may even enter a relatively "asymptomatic" state; however, this does not necessarily indicate complete resolution of airway inflammation. The Global Initiative for Asthma has emphasized that even in patients with only intermittent or infrequent symptoms, persistent airway inflammation may still be present. Therefore, the central goal of management during remission is not merely to wait for recurrence, but to reduce the risks of acute exacerbation and disease progression through standardized long-term intervention. Specifically, inhaled corticosteroid (ICS)-containing regimens should be maintained as the cornerstone of asthma control during remission, and sole reliance on short-acting β2-agonists should be avoided. Meanwhile, in patients with concomitant allergic rhinitis, nasal management should be carried out simultaneously, with intranasal corticosteroids particularly recommended. In addition, attention should be paid to allergen exposure control, correct use of inhalation devices, treatment adherence, and the assessment of comorbidities. Existing systematic reviews also suggest that conventional treatment for rhinitis may improve quality of life in patients with this comorbidity to a certain extent and may have favorable effects on some objective asthma outcomes, although its impact on overall asthma control remains somewhat heterogeneous.

Precisely because patients with allergic rhinitis-asthma syndrome remain at risk of persistent inflammation, constitutional imbalance, and recurrent attacks during remission, traditional Chinese medicine (TCM) has considerable potential for intervention at this stage. TCM emphasizes the principle of "treating disease before its onset," namely, preventing illness before it arises and preventing progression once it has occurred. Its strengths lie not only in symptom control during the active phase, but also in the regulation of the overall bodily state, constitution-based differentiation, and the proactive management of recurrence risk during remission. The International Clinical Practice Guideline for Allergic Rhinitis in TCM, issued by the World Federation of Chinese Medicine Societies in 2024, has incorporated standardized frameworks for internal therapies, external therapies, constitution identification and regulation strategies, as well as preventive and nursing measures, highlighting the unique role of TCM in the long-term management of allergic airway diseases. At the same time, existing systematic reviews and narrative reviews suggest that interventions such as acupuncture, acupoint application, and Chinese herbal medicine may have certain potential in improving rhinitis symptoms, enhancing quality of life, and reducing recurrence rates in some patients; however, the overall quality of evidence and the consistency of findings still require further improvement.

Based on the above considerations, the present study shifts the focus forward to the remission stage of allergic rhinitis-asthma syndrome, targeting this critical period in which symptoms may be temporarily alleviated but inflammation persists, and clinical stability coexists with an ongoing risk of recurrence. By using the Yiqi Wenyang Sanhan Formula combined with acupoint application therapy, this study attempts to explore the clinical value and practical significance of TCM intervention in the long-term management of this condition. Unlike research approaches that focus exclusively on the control of acute exacerbations, the present study places greater emphasis on the systematic evaluation of recurrence prevention, interruption of disease progression, and optimization of the overall patient condition, with the aim of providing evidence for whole-course management strategies more consistent with the characteristics of chronic allergic airway diseases.

Conditions

• Allergic Rhinitis With Asthma

Interventions

DRUG

Yiqi Wenyang Sanhan Formula Combined with Acupoint Application

The treatment group received the Yiqi Wenyang Sanhan Formula (the detailed composition is provided in Table 1; 200 mL per sachet), which was prepared by the Department of Traditional Chinese Medicine Preparations, Beijing Daxing District Hospital of Integrated Traditional Chinese and Western Medicine. The regimen consisted of oral administration twice daily, once in the morning and once in the evening after meals, for 4 consecutive weeks. For acupoint application therapy, the herbal materials were ground into a fine powder and mixed with ginger juice to form a paste, which was then applied to the following acupoints (Figure 2): Tiantu (RN22), Gaohuang (BL43), Feishu (BL13), Shenshu (BL23), and Guanyuan (RN4). Acupoint application was initiated 1 month before the anticipated onset of each patient's disease cycle and was used in combination with the herbal formula. The patches were applied once every other day, with each application lasting 4-6 h.

DRUG

placebo of Yiqi Wenyang Sanhan Formula combined with acupoint application

The control group received a placebo matched to the Yiqi Wenyang Sanhan Formula in appearance and primary color, which was prepared by the Preparation Room of Beijing Daxing District Hospital of Integrated Traditional Chinese and Western Medicine. The placebo was administered in the same manner as in the treatment group, i.e., orally twice daily, once in the morning and once in the evening after meals, for 4 consecutive weeks. The herbal formula was initiated 1 month before the anticipated onset of each patient's disease cycle, with the aim of achieving preventive and therapeutic effects during the remission stage. The control group received a placebo patch matched to the acupoint patch in appearance and primary color. Acupoint application was initiated 1 month before the anticipated onset of each patient's disease cycle and was used in combination with the herbal formula. The patches were applied once every other day, with each application lasting 4-6 h.

Sponsors & Collaborators

• Beijing Daxing District Hospital of Integrated Chinese and Western Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-31

Completion

2027-12-31