Acupoint Catgut Embedding Therapy in Traditional Chinese Medicine for Managing Allergic Rhinitis

Summary

This protocol details the procedure for acupoint burrowing and demonstrates its effectiveness in treating allergic rhinitis.

Abstract

Acupuncture Point Embedding Therapy is a comprehensive treatment method that combines modern biomaterials with acupuncture techniques. Acupoint catgut embedding (ACE) not only avoids the adverse reactions associated with Western medicine but also incorporates the benefits of traditional acupuncture, extending the duration of its therapeutic effects. Allergic rhinitis (AR) is a condition known for its challenging treatment and tendency to persist. This randomized controlled trial included 128 AR patients to evaluate the effectiveness of ACE for AR management. Data were collected at baseline, four weeks after treatment, and eight weeks after treatment. Baseline analysis was performed, and the visual analog scale (VAS) was used as a clinical observation index for this method. The rhinoconjunctivitis quality of life questionnaire (RQLQ) served as a quality of life index. Specific IgE (sIgE), IL-4, IL-10, and IL-12 were used as laboratory observation indices. The results of the experiment validate the clinical effectiveness of ACE in treating AR. Although this technique is efficient and commonly used in clinics, its invasive nature poses risks of hospital-acquired infections. Based on this experiment, this protocol refines traditional techniques, providing detailed instructions on patient preparation, operation techniques, and postoperative care to ensure the safe and effective administration of therapy. By standardizing this therapy, ACE is anticipated to become an important non-drug treatment option for alleviating symptoms in AR patients, thereby significantly enhancing their quality of life.

Introduction

Allergic rhinitis (AR) is an allergic condition mediated by specific immunoglobulin E (sIgE) and involving multiple immune cells^1,2. In recent years, the average prevalence of allergic rhinitis has continued to rise³, and untreated AR can lead to complications such as asthma, sinusitis, otitis media, and snoring. Its persistent adverse effects can negatively impact daily activities, including work and study^4,5,6. Western medical treatments primarily include nasal glucocorticoids and oral antihistamines⁷. However, nasal glucocorticoids are associated with side effects like nasal bleeding, nasal septum perforation, and potential developmental impacts in children, as well as risks of glaucoma^8,9,10. Studies indicate that, despite improvements in antihistamines, side effects such as sedation and cardiovascular issues in children cannot be fully eliminated^11,12,13.

The efficacy of traditional acupuncture, a well-regarded external therapy in traditional Chinese medicine, has been supported by international research for many years^14,15. However, traditional acupuncture treatment has two limitations that may affect its effectiveness. First, it relies on acupuncture needles to produce a therapeutic effect through short-term, localized stimulation of acupoints. Second, it involves an intermittent stimulation approach, typically requiring treatment sessions daily or every other day. These factors can limit its accessibility for some patients who may be unable to receive regular treatments due to needle aversion or scheduling difficulties, ultimately impacting the treatment's overall effectiveness.

Acupoint catgut embedding (ACE) is an advanced acupuncture technique developed from traditional acupuncture. It not only provides extended acupuncture treatment and disease prevention^16,17but also demonstrates significant long-term effectiveness in managing chronic diseases^18,19. ACE improves the conventional acupuncture approach by embedding materials that generate sustained, mild, and therapeutic stimulation at the acupoint. The decomposition and absorption of the embedded thread in the tissue create a prolonged acupuncture effect, with stimulation lasting 2-4 weeks^20,21. This method addresses the limitations of short stimulation duration, non-persistent therapeutic effects, and the challenge of maintaining treatment consistency in traditional acupuncture. Furthermore, patients are not required to visit the clinic daily, which greatly enhances compliance²².

With advancements in biomedical embedding materials and improvements in embedding needles, new breakthroughs have emerged in traditional acupuncture. By controlling the composition, degradation rate, and minimally invasive techniques of embedding materials, ACE positively impacts acupuncture treatment by increasing the stimulation intensity, extending its duration, and reducing the discomfort and inconvenience associated with frequent acupuncture sessions.

Thus, three key considerations are essential in the treatment of AR: the inherent benefits of acupuncture, the strengths of acupoint catgut embedding therapy in enhancing and sustaining these benefits, and the unavoidable side effects associated with medications. We believe that ACE offers an effective alternative for treating AR, particularly for patients who require careful management of potential adverse drug reactions. For these patients, acupoint catgut embedding therapy represents an ideal therapeutic option.

In response, our research team designed a randomized, controlled clinical experiment to verify this hypothesis. Using clinical trial design, baseline characteristic analysis, VAS and RQLQ scales, and laboratory examination results, we demonstrate the clinical efficacy of acupoint catgut embedding therapy for AR treatment. This article details the specific clinical procedures for ACE, including patient eligibility assessment, medical device usage, acupoint treatment, post-treatment care, and emergency response protocols, to provide a standardized operational reference for the clinical application of acupoint catgut embedding therapy.

Research design

Research methods
This study employed a randomized, double-blind, controlled design. Cases were rigorously screened based on diagnostic, inclusion, and exclusion criteria. Random data for two groups were generated using the RAND function in Excel. Group A included patients receiving acupoint catgut embedding, while Group B consisted of patients receiving sham catgut embedding. Upon confirming patient enrollment, random numbers were assigned according to the enrollment order.

Randomization method
A computer-based randomization technique was used with Excel's RAND function to generate a randomized treatment allocation for the subjects. The random allocation scheme and coding table were sealed in opaque envelopes, opened sequentially according to the subjects' registration order. Researchers responsible for the random allocation coding did not participate in subject registration. The blinding procedure was maintained in line with blinding requirements and protocols, and any damage to the opaque envelopes was documented with a reasonable explanation.

Implementation of blinding and control
The control group underwent sham embedding using the same acupoints, needles, and techniques as the treatment group. Preparations for acupoint embedding were carefully arranged before subjects received treatment, with minimal communication between the acupoint embedding operator and the patient regarding the specifics of the embedding procedure. Subjects were treated in isolation to prevent inter-patient communication that could interfere with blinding. During the trial, investigators, operators, and statisticians were assigned separate roles, and a third-party evaluator, blinded to the subgroup assignments, assessed study efficacy and adverse events.

Protocol

This randomized controlled trial involved patients from the Department of Otorhinolaryngology at the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine. The study protocol received approval from the Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (registration number: ChiCTR-TRC-12002191). Patients were informed about the study's purpose and procedures, and consent was obtained for the use of images and videos during the experiment.

Before the procedure, a patient assessment was conducted. Patients with possible coagulation dysfunction were examined for coagulation function. Inclusion criteria were established based on AR guidelines¹, which included patients aged 18-70 years with at least one positive skin allergen prick test. Exclusion criteria included any of the following: pregnancy, lactation, menstruation, undergoing immunotherapy, allergies to heterologous proteins (e.g., eggs), or to polydioxanone. Suspension or exclusion criteria included: the occurrence of severe complications during the study, voluntary withdrawal, incomplete examination or treatment records, use of other medications or treatments outside the study, and interruptions in treatment for various reasons.

For the experimental flow chart, see Figure 1. Details of the reagents, equipment, and software used in this study are provided in the Table of Materials.

1. Preoperative preparation

NOTE: All subjects in this trial were operated on using acupoint burrowing by physicians who had obtained the qualification certificate of Traditional Chinese Medicine (TCM) practitioners or had been qualified as attending physicians for more than 3 years. The acupoint burrowing operators underwent uniform training before the trial and followed the standard operating procedures outlined below. The operation process is shown in Figure 2.

1. Check all medical equipment and materials required for treatment. Ensure the following items are available: disposable sterile dressing change kit (including gloves, suture removal scissors, tweezers, dry cotton balls, 0.5% povidone-iodine cotton balls, gauze, disposable plastic tray, and blue padded sheet), 7 G hypodermic needles, 4 G PDO thread, alcohol, and sterile dressings (band-aids) (Figure 3).
   NOTE: Select embedded thread needles from 7 G²³, 8 G²⁴, and 9 G²⁵, and match them with the corresponding thread specifications. Choose different lines based on the condition being treated. In this experiment, PDO thread was selected²⁶.
2. Have the medical assistant wear sterile gloves after hand disinfection and open the dressing package. The doctor performing the operation must disinfect their hands first and then open the inner packaging.
   1. Spread the surgical items needed for disinfection on a blue mat. After completing the preoperative preparation, the surgeon must clean their hands and arms again and wear disposable sterile gloves.
3. Place the PDO thread in a tray and pour alcohol over it for 10 min. This step disinfects the thread, ensuring it is completely sterile (the alcohol should cover the needle and thread).
4. Position the patient in a supine position. Instruct the patient to keep their hands flat on the abdomen, ensuring that their hands do not cross.
   1. Accurately verify and confirm the patient's information: name, bed number, and identity documents. Explain the treatment process and mechanism of acupoint catgut embedding in detail to ensure the patient understands its safety, alleviates any tension or fear, and reduces the chance of needle sticking.

2. Surgical procedure

1. Refer to Table 1 and Figure 4 for specific locations. Hold a 0.5% iodophor cotton ball with tweezers and disinfect the left Yingxiang (LI20) and its surrounding area. Insert the wire into the needle end of the embedding needle. Ensure aseptic operation when selecting which point to bury and disinfect.
   NOTE: Use sterile cotton swabs to detect acupoints when locating them. Sensitive points are specific acupoints.
2. Hold the needle in the right hand, gripping the needle handle with the thumb, index finger, and middle finger. The ring finger must stabilize the needle body to prevent it from shaking.
   1. With the left hand, create a gap between the cheek and nose using the index finger and thumb to allow for easier needle insertion, while the ring and pinky fingers pinch a dry cotton ball. Hold the needle in the right hand to quickly pierce the skin with the needle tip.
3. Observe the patient's reaction when the needle pierces the skin. If the patient experiences muscle soreness, numbness, or a sensation similar to an electric shock, it indicates the feeling of obtaining qi (deqi)^{23,24,25,26,27,28}. Slowly push the end of the needle body with the thumb to embed the thread in the acupoint, then withdraw the needle slowly.
   NOTE: If the patient does not respond after reaching the appropriate needle depth, perform the needle manipulation techniques-lifting, thrusting, and twirling-to assist the patient in achieving the feeling of deqi.
4. After removing the needle, press the needle hole with a dry cotton ball to prevent bleeding. Bury the right Yingxiang (LI20) in the same manner.
5. Sterilize the entire needle with an alcohol cotton ball, load the thread into the acupoint embedding needle (as in step 2.1), locate the left Hegu (LI14), and disinfect the acupoint and surrounding area using a circular motion.
   1. Perform the same steps as described in 2.2 to insert the needle, obtain qi as per step 2.3, and remove the needle as per step 2.4. Repeat the steps for burying both Quchi (LI11) and Zusanli (ST36).

3. Post-treatment care

1. After removing the needle, instruct the patient to rest in the supine position for at least 15 min to avoid any accidents.
2. For 3 days after embedding, keep the acupoints dry. Avoid using cosmetics, facial cleansers, shower gel, or similar products. Ensure the acupuncture site remains dry and clean to prevent infection. Provide the contact details of the attending physician for consultation if needed, and refer the patient to outpatient care if necessary.
3. Inform the patient about the course of treatment and instruct them to follow the treatment schedule.
   1. For acute patients, bury the threads every 3-5 days; for subacute patients, every 7-10 days; and for chronic patients, every 15-30 days.
      NOTE: Based on this treatment protocol, AR, as a chronic recurrent disease, is considered both a long-term and persistent condition in clinical practice. Therefore, select the number of days between treatments according to the embedding frequency typically used for chronic diseases. The PDO thread usually absorbs in 14-21 days. In this study, each subject underwent two acupoint catgut embeddings, with the duration of each embedding being 2 weeks.

4. Adverse event prevention and countermeasures

1. Precautions
   1. Communicate in detail with patients and their families before starting the study. Ensure the patient understands the purpose of the treatment, the specific procedure, and the necessary precautions, and obtain the patient's active cooperation.
   2. Perform the operation strictly following aseptic principles to prevent the possibility of intraoperative infection.
   3. Record all adverse reactions during treatment in detail (including bleeding, allergies, infections, severe pain, etc.).
2. Response measures
   1. Pain and discomfort: This may occur due to continuous stimulation from acupoint embedding during and after the procedure. After 24 h, instruct the patient to apply a hot compress.
   2. Bleeding and hematoma: A few drops of blood are normal. Apply a adhesive bandage to compress and stop bleeding. If hematoma occurs, use symptomatic hot or cold compresses.
      NOTE: The key to preventing and reducing bleeding is to handle the operation gently, minimizing damage to normal tissue and avoiding blood vessels. This will naturally prevent bleeding and hematoma.
   3. Fever: Monitor the body temperatures of the patients.
      ​NOTE: A few patients may develop a mild fever after thread embedding, typically below 38 °C, without upper respiratory tract infection or viral cold symptoms. This usually lasts for about 3 days, with the body temperature gradually decreasing until it returns to normal. This is a normal reaction as the body absorbs heat from the thread, known as "heat absorption."
   4. Infection: While the chance of infection from acupoint embedding is very low, take it seriously if it occurs. Consult an infection specialist if you lack experience in treating infections.

5. Data analysis

1. Perform statistical analyses using SPSS. Use the Chi-Square Test for categorical data, and apply the Independent Sample Test, Kruskal-Wallis H Test, or Wilcoxon two-sample rank-sum test for continuous data.
2. Consider differences statistically significant if p < 0.05.

Results

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

Discussion

Allergic rhinitis (AR) is one of the most common allergic diseases, and there are many challenges in current treatment, such as the short duration of drug effects, relapse after discontinuation, the high cost of immunotherapy, and the risk of serious adverse effects from surgery. Its inability to completely cure the condition has a significant impact on patients' lives^34,35. In acupuncture treatment, buried threads at acupoints play an important role in impro...

Materials

Name	Company	Catalog Number	Comments
7 G buried needle set	Taizhou Luoan Medical Co.	20240103	none
Embedded Thread Body No. 4-0	Hangzhou Aipu Medical Equipment Co.	20231227	none
Ethanol	Sichuan Yinjieshi yil Technology Co.	231206	none
HYA-15 disposable dressing change kit	Zhende Medical Supplies Co.	202308021B	Includes: gloves, suture removal scissors, tweezers, dry cotton balls, povidone-iodine cotton balls, gauze, plastic tray, pad sheet
IBM SPSS Statistics	IBM	R26.0.0.0	For analysing data.
Image Editor	Mac OS X	C02GM7ZGQ6L7	Used in pictures for black and white masking.
MEITU app	China Xiamen Meitu Network Technology Co., Ltd.	10.16.0	This is a beautiful drawing tool software with powerful algorithms. In this study, I used this software to stitch small graphs, such as Figure 3 and Figure 4. This software can freely stitch pictures without damaging the image quality.
XingTu app	Shenzhen FaceMeng Technology Co.	version number?9.7.2	This is a very professional retouching software developed in China.Used in pictures for writing and outlining text and lines.