The Clinical Effect of Combined Needle-Embedding Therapy for Patients with Lifestyle-Related Dry Eye Disease

Summary

This study explores a novel combined treatment of needle-embedding therapy and conventional care, demonstrating improved symptoms, recovery, and quality of life for dry eye disease (DED). It also outlines the procedure and highlights its feasibility and effectiveness for lifestyle-related DED.

Abstract

Dry eye disease (DED) is a multifactorial, chronic ocular surface disorder with a rising global prevalence. It has become an important public health concern that requires appropriate management and prevention. However, standardized and effective treatments for DED remain limited. This study introduces a combined approach using needle-embedding therapy and conventional nursing care as a novel intervention for patients with DED. Patients received traditional treatments, including warm compresses, eyelid massage, and artificial tear therapy, followed by the insertion of disposable sterile thumbtack needles into six predefined acupoints. Each needle was left in place for 24 h before removal. Tear meniscus height and tear film breakup time were recorded in real time during treatment.

This article describes the standard operating procedure and clinical outcomes of the combined needle-embedding therapy in patients with lifestyle-related DED, aiming to evaluate its feasibility and therapeutic efficacy. According to the statistical results, this combined therapy alleviated DED symptoms, promoted ocular surface recovery, and enhanced patient comfort and quality of life.

Introduction

Dry eye disease (DED) is a multifactorial, chronic ocular surface disorder resulting from imbalances in the ocular surface microenvironment and instability of the tear film, caused by abnormalities in the quality, quantity, or dynamics of the tear fluid¹. It is often accompanied by ocular surface inflammation, tissue injury, and neural dysfunction, leading to ocular discomfort and visual disturbance². According to epidemiological studies, the global prevalence of DED ranges from 5% to 35%³, and the prevalence in China ranges from 21% to 30%⁴, affecting individuals across all age groups.

The Chinese Expert Consensus on Dry Eye Disease⁵ defines lifestyle-related DED as dry eye symptoms induced by long-term unhealthy lifestyle behaviors. These may include excessive use of electronic devices or contact lenses, inadequate sleep, improper eye makeup practices, prolonged indoor stays, increased exposure to particulate matter, and poor nutritional intake^6,7,8,9. Given the growing burden of DED as a public health concern, Chinese scholars have proposed that it should be managed and prevented as a chronic disease¹⁰.

The 'Ophthalmology of Traditional Chinese Medicine (TCM)'¹¹ classifies DED under the categories of "nearing depletion of divine water," "eye dryness," and "blurred vision," describing primary manifestations such as ocular dryness, discomfort, and blurred vision. The basic pathogenesis is attributed to internal yin deficiency, yang excess, and depletion of body fluids, resulting in insufficient nourishment of the eyes. Additionally, an irregular diet, smoking, alcohol consumption, and a preference for spicy foods may contribute. Incomplete treatment of epidemic red eye or acute wind-heat invasion may also leave residual pathogenic factors in the spleen and lung meridians.

Therefore, both internal and external treatments can be used to nourish yin, moisten dryness, soothe the liver, relieve depression, invigorate qi, and raise yang¹². External therapies such as acupuncture, warm compress therapy, and herbal iontophoresis are widely applied.

In contrast, Western medicine provides various treatments for DED, including artificial tear therapy, anti-inflammatory medications, eyelid hygiene, intense pulsed light (IPL) therapy, and surgical interventions¹³. However, numerous side effects have been reported^14,15,16,17. Consequently, an effective complementary therapy for DED is urgently needed, as clinicians and patients alike seek safer, more effective, and economical treatments^18,19.

Acupuncture, a key component of TCM, is practiced in more than 180 countries and regions and has demonstrated significant efficacy in treating various diseases, including DED^20,21,22. Clinical studies have shown that acupuncture can improve intermediate outcomes in DED^23,24; therefore, integrating Chinese and Western therapies may further enhance clinical efficacy in DED treatment²⁵.

Compared with traditional acupuncture, needle-embedding therapy provides sustained acupoint stimulation, thereby enhancing therapeutic efficacy and improving patient compliance. However, clinical evidence on the combined application of this therapy remains limited. This study developed individualized treatment regimens and compared changes in dry eye symptoms, clinical signs, and quality of life before and after intervention using intradermal needling and conventional nursing therapy, aiming to provide evidence for the clinical application of combined needle-embedding and conventional nursing therapy in lifestyle-related DED.

Protocol

This study was approved by the Ethics Board of the First Affiliated Hospital of Chongqing Medical University. The studies were conducted in accordance with the local legislation and institutional requirements. Written consent was obtained from the patients for this study.

1 . Perform conventional dry eye treatment

1. Apply a warm compress to patients with dry eye for 15 min, twice daily. Prepare clean cotton towels, cotton swabs, and a container of hot water.
   NOTE: The temperature of a warm compress is 40 to 42 °C. Mild skin redness after the warm compress is normal. If pain or excessive redness occurs, discontinue the procedure immediately.
2. Perform eyelid massage for 5 min to enhance ocular blood circulation, twice daily. Instruct patients to gently close their eyes and use the index finger or a cotton swab to apply gentle pressure from the inner canthus to the outer canthus, moving from the base of the eyelashes toward the eyelid margin. Repeat five to ten times.
3. Clean the eyelid margins twice daily. Soak a cotton swab in warm water or sterile saline, and gently remove scales and secretions from the eyelid margin, particularly at the base of the eyelashes, moving from the inner to the outer canthus, until the eyelid margin is clean.
4. Administer artificial tear therapy and provide patient instruction on proper use. For mild DED, instill 0.1% sodium hyaluronate four times daily. For moderate to severe DED, use artificial tears as needed based on symptom severity.
5. Continue all treatments for 12 weeks.
   NOTE: Patients were assessed after 4 and 8 weeks of treatment with the following measures: OSDI, corneal fluorescein staining, subjective symptom scores, TMH, and BUT. For patients with normalized results, the regimen of artificial tears, warm compresses, eyelid massage, and lid hygiene would be tapered to once weekly, and needle therapy was ceased. Patients in the needle-embedding therapy group were screened for allergy history before treatment. They would be monitored for 30 min after injection, while being able to leave only if there were no periorbital adverse reactions observed, including redness, swelling, bleeding, or pruritus. They should continue self-observation while preventing external forces from the stickers.

2. Provide individualized treatment

NOTE: Needle-embedding therapy is primarily indicated for patients with mild-to-moderate dry eye syndrome, particularly those who are unresponsive to pharmacological treatments, intolerant of their side effects, or prefer non-pharmacological therapeutic options.

1. For intradermal acupuncture, select three pairs of periocular acupoints, alternating bilaterally per session. These include Jingming (BL1), Cuanzhu (BL2), Taiyang (EX-HN5), Tongziliao (GB1), Sibai (ST2), and Chengqi (ST1). Before each session, disinfect a 1 cm area around each acupoint with a 75% alcohol swab.
   NOTE: Jingming (BL1) is located in the depression slightly above the inner canthus. Cuanzhu (BL2) is located at the medial end of the eyebrow in a small depression. Tongziliao (GB1) is approximately 0.5" lateral to the outer canthus, in the depression at the lateral margin of the orbital bone (1" defined as the width of the patient's interphalangeal joint of the thumb). Taiyang (EX-HN5) is located in the temporal region, in the depression approximately one horizontal finger posterior to the midpoint between the lateral canthus and eyebrow. Chengqi (ST1) is directly below the pupil, between the eyeball and the infraorbital margin. Sibai (ST2)is directly below the pupil, in the middle of the infraorbital foramen. Insertion may cause a brief, mild swelling or distending sensation, indicating acupoint penetration. After needle removal, circular adhesive marks may remain temporarily on the skin. Refer to Figure 1, Figure 2, and Figure 3 for the acupuncture points.
2. Insert a disposable sterile thumbtack needle (0.18 mm × 1.0 mm) completely into each of the six acupoints until the adhesive plaster is securely attached to the skin.
3. Retain the thumbtack needles for 24 h before removal.
   NOTE: During intradermal acupuncture (IA) treatment, monitor for adverse reactions such as headache, nausea, vomiting, visual disturbances from nerve irritation, local infection, or skin inflammation. If such symptoms occur, provide comfort care, apply an ice compress, or remove the intradermal needles as clinically indicated.
4. Return all removed intradermal needles to the medical staff for compliance assessment. Continue treatment for 12 weeks, with sessions conducted twice weekly.
   NOTE: If redness, itching, or generalized reactions occur beyond the needle site, immediately remove the needle and consult a physician. This therapy is contraindicated for patients with metal allergies (e.g., nickel or chromium sensitivity) due to stainless steel components.
5. Document treatment dates, duration, and any complications such as pain, local irritation, redness, or blurred vision. Record daily activities, including screen time, sleep duration, and frequency of artificial tear use.
6. After treatment, gently pinch and lift both sides of the adhesive tape to remove the needle. Circular adhesive marks may appear temporarily on the skin after removal.

3. Collect the treatment results

1. Collect the results before treatment and at the end of the 12-week treatment, including OSDI scores, corneal fluorescein staining scores, total subject symptom scores, and the results of tear meniscus height (TMH), tear film breakup time (BUT), and Schirmer I test²⁶.
   ​NOTE: Normal value for SchirmerⅠtest is 10-15 mm/5 min.
2. Moisten the orange-red fluorescein sodium tip of the test strip with one to two drops of sterile saline. Lightly touch the moistened portion to the subject's inferior conjunctival sac. Instruct the subject to gently close the eyes and move them in all directions. Immediately observe corneal staining under cobalt blue illumination using a slit-lamp microscope.
   1. Use the twelve-point method to calculate corneal fluorescein staining scores. Divide the cornea into four quadrants and assign each a score of 0-3 points: 0 = no staining, 1 = 1-30 punctate stained dots, 2 = >30 scattered stained dots, and 3 = coalescent staining, filaments, or ulceration.
3. Administer a standardized questionnaire of twelve items assessing ocular symptoms, activity limitations, and patient concern about eye condition. Evaluate ocular comfort and health based on participant responses. Calculate the total score using the formula:
   Total score = (sum of all item scores × 100) / (number of items answered × 4).
   Normal: 0-12 points; mild DED: 13-22 points; moderate DED: 23-32 points; severe DED: ≥33 points.
4. Evaluate symptoms including dryness, itching, redness, foreign body sensation, visual fatigue, and photophobia according to the "Clinical Guiding Principles for New Traditional Chinese Medicine Drugs"²⁷.
   1. Record the score for the more symptomatic eye. Score each questionnaire from 0 to 4 based on severity. Score subjective symptoms on a four-point scale: 0 = no symptoms, 1 = mild (occasional), 2 = moderate (frequent), and 3 = severe (persistent). Calculate the total score (0-18 points) to represent overall symptom severity
5. Measure tear meniscus height and tear film breakup time noninvasively in real time.

4. Evaluate treatment effects

1. Use IBM SPSS Statistics software (version 26.0; IBM Corp.) to analyze the collected data.
2. Apply an independent-samples Student's t-test to compare values before and after treatment. A p-value < 0.05 is considered statistically significant.

Results

A total of 220 eyes from 110 patients with dry eye disease (DED) were included in this study, consisting of 18 males and 92 females. _All participants met the diagnostic criteria defined in the "Chinese Expert Consensus on Dry Eye Disease (2020)"²⁸. The mean participant age was 39 years (range: 2-24 months disease duration), and no participant withdrew from the study. Baseline characteristics, including sex, age, and disease duration, did not differ significantly between the two treatment groups (...

Discussion

Traditional Chinese medicine (TCM) needle-embedding therapy is a micro-invasive treatment designed to enhance periocular blood circulation and stimulate ocular surface homeostasis. The results of this study demonstrated that combined acupuncture therapy effectively alleviated both subjective symptoms and objective clinical indicators of lifestyle-related dry eye disease (DED), given that the OSDI Scores decreased by 71.22% after treatment, while improving patient comfort and quality of life.

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Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
0.1% sodium hyaluronate	URSAPHARM Arzneimittel GmbH		Instill it into eyes to moisturize the ocular surface and alleviate dry eye symptom.
fluorescein sodium ophthalmic strips	Liaoning Meizilin Pharmaceutical Co., Ltd		Soak the orange-red fluorescein sodium portion of the test strip with 1-2 drops of physiological saline, gently touch the soaked portion with the subconjunctiva of the subject, gently close the eyes and rotate the eyeball, and immediately observe whether the cornea is stained under blue light conditions of a slit lamp microscope.
IBM SPSS Statistics 26.0	statistics	Version 26.0	SPSS  is used for statistical analyses on the clinical data between different groups.
OCULUS Keratoaraph 5M	OCULUS Optikger?ste GmbH	TP00021372210	Use it to measure TMH/BUT of the dry eye patients.
Seirin PyonexNeedles	Sichuan Weigao Science& Technology Co Ltd	20162201259	Insert it completely into these 6 selected acupoints to provide the acupuncture therpy.