Baseline analysis
In this study, an Intention to Treat (ITT) analysis was conducted to assess whether there were statistical differences between the two groups in terms of demographic characteristics (gender, age, height, weight), vital signs (systolic blood pressure, diastolic blood pressure, respiration, heart rate), and disease severity (blood routine, liver and kidney function, coagulation analysis, medical history comparison).
Demographic characteristics
The gender distribution between the two groups was tested using the chi-square test, as shown in Table 2. The results indicate no statistically significant difference in gender between the groups. The normality of age, weight, and height was assessed using the Kolmogorov-Smirnov method. At the test level of α = 0.05, the age and weight data followed a normal distribution, whereas the height data did not. For age and weight, a two-sample t-test was conducted, with homogeneity of variance tested (age: F = 0.067; weight: F = 1.102, P = 0.296). Since the variances for age and weight were homogeneous, the results suggest no statistically significant difference between the catgut embedding group and the sham catgut embedding group at α = 0.05. As height data came from a non-normal distribution, the rank sum test of two independent samples was applied, and the results showed no significant difference in height between the two groups.
Comparison of vital signs between groups
The normality of systolic blood pressure, diastolic blood pressure, respiration, and heart rate was tested using the Kolmogorov-Smirnov method. At α = 0.05, only systolic blood pressure was normally distributed, so a t-test was performed on systolic blood pressure, while the rank sum test of two independent samples was used for the remaining three vital signs. Mann-Whitney U statistics and P values were calculated. The results showed no significant differences in vital signs between the two groups, as detailed in Table 3.
Comparison of disease data between groups
Blood routine, liver and kidney function, and coagulation analysis: The normality of white blood cells, eosinophils, prothrombin time (PT), and activated partial thromboplastin time (APTT) was tested using the Kolmogorov-Smirnov method. At α = 0.05, only PT and APTT followed a normal distribution. For these two variables, a t-test was applied, while the rank sum test was used for the remaining two variables. Mann-Whitney U statistics and P values were calculated. The results showed no significant differences in white blood cells, eosinophils, PT, or APTT between the two groups, as shown in Table 4.
Liver and kidney function: The normality of aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine (Crea) was assessed using the Kolmogorov-Smirnov method. At α = 0.05, only AST and ALT followed a normal distribution. ALT was analyzed using a t-test, while AST data were not homogeneous, requiring a separate t-test. For BUN and Crea, the rank sum test of two independent samples was applied. Mann-Whitney U statistics and P values were calculated. The results showed no significant differences in liver and kidney function between the two groups, as shown in Table 5.
Medical history (persistent vs. intermittent)
Patients were classified into persistent or intermittent allergic rhinitis based on disease duration and frequency of onset. A chi-square test was used to examine the frequency distribution of allergic rhinitis types between the two groups. The chi-square test results indicated no significant difference in allergic rhinitis types between the groups (χ² = 0.897, P = 0.344). The distribution of patient types in both groups is shown in Figure 5.
VAS and RQLQ scale results
The Visual Analogue Scale (VAS) is a symptom severity rating scale that includes key symptoms such as nasal congestion, itchy nose, sneezing, and runny nose. Patients rate the severity of these symptoms on a 10 cm scale (marked from 1 to 10) based on their subjective feelings, with higher scores indicating more severe symptoms29. The rhinoconjunctivitis quality of life questionnaire (RQLQ) evaluates 7 dimensions: daily activities, sleep, non-nasal eye symptoms, practical problems, nasal symptoms, ocular symptoms, and emotions. It consists of 28 questions, with scores ranging from 0 to 6 for each question, and a total score range of 0 to 168. A higher score indicates a greater impact on the patient's quality of life30.
Comparison of pre-treatment VAS and RQLQ scores between groups
The normality of the VAS scores for symptoms in both groups was assessed using the Kolmogorov-Smirnov method. At α = 0.05, neither group showed normal distribution, so the Wilcoxon rank sum test was applied. For the RQLQ, normality was confirmed, and a two-sample t-test was used. The results, shown in Table 6, indicated no significant differences in pre-treatment total VAS scores, VAS scores for individual symptoms, or RQLQ scores between the two groups of AR patients.
Within-group comparison before and after treatment
Paired t-tests were performed to compare the VAS and RQLQ scores within each group before and after treatment. Normality tests for each difference pair were conducted, and at α = 0.05, all differences followed a normal distribution. Statistically significant differences were found in the VAS scores between the control group before and after treatment, as well as between the groups at 4 and 8 weeks after treatment. The results are shown in Table 7 and Table 8.
Intergroup comparison at 4 and 8 weeks post-treatment
The VAS and RQLQ scores at 4 and 8 weeks post-treatment were tested for normality using the Kolmogorov-Smirnov method. At α = 0.05, the data from both groups followed a normal distribution, so a two-sample t-test was applied. The results are presented in Table 9.
VAS score items: At both 4 and 8 weeks post-treatment, there were no statistically significant differences between groups A and B for VAS score items. However, at 8 weeks post-treatment, the differences were statistically significant.
RQLQ score items: At both 4 and 8 weeks post-treatment, significant differences were observed between groups A and B for the RQLQ score items.
Laboratory test results
Serum-specific immunoglobulin E (sIgE) is a key diagnostic marker for allergic rhinitis, as highlighted by the ARIA31 and Chinese guidelines for the diagnosis and treatment of allergic rhinitis1. In this study, sIgE levels were measured using enzyme-linked immunosorbent assay (ELISA), which directly reflects the presence of antibodies against antigens in the serum of subjects before and after treatment. In addition to sIgE, key cytokines such as IL-4, IL-10, and IL-12 were also assessed. IL-4 and IL-10 are Th2 cytokines, while IL-12 is primarily produced by antigen-presenting cells. During the allergen sensitization phase, Th0 cells, which are the precursors to Th cells, differentiate into Th2 cells under the influence of IL-10, secreted by antigen-presenting cells. Regulatory T cells (Tregs), which play an important role in maintaining immune response and tolerance, also secrete IL-10 and TGF-β32. Th2 cells secrete IL-4, which promotes IgE synthesis by B cells. Successful treatment of allergic rhinitis typically results in a decrease in IL-4 and IL-12 levels, while IL-10 levels may increase, promoting immune regulation and tolerance33. Therefore, measuring these cytokines provides insight into whether acupoint catgut embedding therapy is effective in alleviating symptoms by modulating inflammatory factors.
Comparison of laboratory markers before and after treatment
For each group, sIgE, IL-4, IL-10, and IL-12 levels were analyzed before and after treatment using paired t-tests. Normality tests were conducted on the pairwise differences before the statistical tests. At α = 0.05, all differences followed a normal distribution. The results indicated that there were statistically significant changes in sIgE levels between pre-treatment and post-treatment in both groups (A and B). However, for the other cytokine markers (IL-4, IL-10, IL-12), no significant differences were observed before and after treatment. These results are summarized in Table 10.
Between-group comparison at each time point
The normality of laboratory test values for both groups was evaluated using the Kolmogorov-Smirnov method before and 8 weeks after the end of treatment. At α = 0.05, the data for each pair of differences followed a normal distribution, and a two-sample t-test was applied. Statistically significant differences were observed in sIgE levels between groups A and B before and after treatment. However, for the other cytokine indicators (IL-4, IL-10, IL-12), no significant differences were found between the groups at either pre-treatment or post-treatment time points. These results are shown in Table 11.
Adverse reaction events
The adverse events experienced by patients in both groups were recorded and summarized in Table 12. The results indicated that no serious adverse events were reported in either group during the study period. All observed adverse reactions were mild and were successfully managed with appropriate interventions. This suggests that both acupoint catgut embedding therapy and the sham treatment were well-tolerated by the participants, with no significant safety concerns arising throughout the course of the trial.
Figure 1: Experimental flow chart. Illustrates the sequence of events in the experimental procedure. Please click here to view a larger version of this figure.
Figure 2: Operation flow chart. Depicts the step-by-step procedure followed during the operation. Please click here to view a larger version of this figure.
Figure 3: Wire materials required for this test. (A) Alcohol. (B) Tray, dry cotton balls, and gauze. (C) Cotton balls with iodophor. (D) Sterile gloves. (E) Threads for burying the needles (used in this experiment – PDO lines). (F) Tweezers. (G) Needles for burying the threads. (H) Scissors. (G) Acupuncture needle. The items shown are those in the disposable change kit, excluding alcohol, buried needles, and PDO threads. The packaging of the disposable kit has been removed for demonstration purposes. Please click here to view a larger version of this figure.
Figure 4: Schematic diagram of acupoints. (A-1) Specific location of the Hegu (LI4); (A-2) Method for acquiring Hegu (LI4); (A-3) Hegu (LI4) embedded needle manipulation. (B-1) Specific location of the Quchi (LI11); (B-2) Method for acquiring Quchi (LI11); (B-3) Quchi (LI11) embedded needle manipulation. (C-1) Specific location of the Yingxiang (LI20); (C-2) Yingxiang (LI20) embedded needle manipulation. (D-1) Specific location of the Zusanli (ST36); (D-2) Zusanli (ST36) embedded needle manipulation. Please click here to view a larger version of this figure.
Figure 5: Frequency distribution of allergic rhinitis classification. The frequency distribution of patients based on persistent or intermittent allergic rhinitis classification. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). Chi-square test results showed no significant difference in the distribution of allergic rhinitis types between the two groups (x² = 0.897, p = 0.344). Please click here to view a larger version of this figure.
Table 1: Specific locations and points of buried acupuncture points. 1 inch ≈ 3 cm. Please click here to download this Table.
Table 2: Demographic characteristics of the two groups of subjects. Data are expressed as Mean ± SD. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). Please click here to download this Table.
Table 3: Vital signs of the two groups of subjects. Data are expressed as Mean ± SD. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). Please click here to download this Table.
Table 4: Blood routine and coagulation analysis of the two groups of subjects. Data are expressed as Mean ± SD. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). PT: Prothrombin Time; APTT: Activated Partial Thromboplastin Time. Please click here to download this Table.
Table 5: Liver and kidney function of the two groups of subjects. Data are expressed as Mean ± SD. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). AST: Aspartate Aminotransferase; ALT: Alanine Aminotransferase; BUN: Blood Urea Nitrogen; Crea: Creatinine. Please click here to download this Table.
Table 6: Comparison of VAS and RQLQ scale scores before treatment. Differences were statistically significant if p < 0.05. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). Please click here to download this Table.
Table 7: VAS and RQLQ scale scores before and after treatment. Data are expressed as Mean ± SD. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). "4w post-treatment" represents 4 weeks after the end of treatment; "8w post-treatment" represents 8 weeks after the end of treatment. Please click here to download this Table.
Table 8: Statistical results of within-group pre-post control of VAS and RQLQ scores. Differences were statistically significant if p < 0.05. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). "4w post-treatment" represents 4 weeks after the end of treatment; "8w post-treatment" represents 8 weeks after the end of treatment. Please click here to download this Table.
Table 9: Between-group comparison of VAS and RQLQ scores at 4 and 8 weeks post-treatment. Differences were statistically significant if p < 0.05. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). "4w post-treatment" represents 4 weeks after the end of treatment; "8w post-treatment" represents 8 weeks after the end of treatment. Please click here to download this Table.
Table 10: Pre- and post-treatment comparison of laboratory test indices (ng/L). Differences were statistically significant if p < 0.05. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). "8w post-treatment" represents 8 weeks after the end of treatment. Please click here to download this Table.
Table 11: Between-group comparison of laboratory test indices before and 8 weeks after treatment. Differences were statistically significant if p < 0.05. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). "8w post-treatment" represents 8 weeks after the end of treatment. Please click here to download this Table.
Table 12: Incidence of adverse events in each group. Group A: Acupoint catgut embedding treatment group (N = 64); Group B: Sham catgut embedding treatment group (N = 64). Please click here to download this Table.
