Guo Meng-hu, Cui En-cao, Li Xin-yuan, Zong Lei

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China

Diverse Needling Methods for Dry Eye Syndrome: A Randomized Controlled Study

Guo Meng-hu, Cui En-cao, Li Xin-yuan, Zong Lei

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China

Objective: To explore a proper acupuncture treatment protocol for dry eye syndrome (DES), by comparing the therapeutic effects between ordinary acupuncture and electroacupuncture (EA).

Methods: Forty-seven eligible subjects with DES were randomized into an acupuncture group (n=23) and an EA group (n=24). With the same acupoint formula, the acupuncture group was treated with ordinary acupuncture, and the EA group was treated with ordinary acupuncture plus electrical stimulation. After a treatment course, eye symptom score, Schirmer I test (SIT), Break-up Time (BUT) of tear film, Corneal Fluorescein Staining (CFS), and Visual Analogue Scale (VAS) were adopted in evaluation and comparison of the two groups.

Results: The total effective rate was 79.2% in the EA group versus 56.5% in the acupuncture group, and the difference was statistically significant (P＜0.05). After treatment, both groups had marked improvements in eye symptom score, SIT, BUT, CFS, and VAS values (P＜0.001); the EA group was better than acupuncture group in improving eye symptom score and SIT value (both P＜0.05); the differences were insignificant in comparing VAS, BUT and CFS results between the two groups (P＞0.05).

Conclusion: Both EA and ordinary acupuncture are effective in treating DES, but EA is better than ordinary acupuncture in improving eye symptom and SIT score.

Acupuncture Therapy; Electroacupuncture; Dry Eye Syndromes; Randomized Controlled Trial

Dry eye syndrome (DES) is a kind of disease caused by abnormal quantity or quality of tears resulting in tear film instability and damage to ocular surface, and subsequently leading to ocular discomfort[1]. As one of the commonly encountered ophthalmological diseases, it affects 14.6% of the Americans according to a survey[2]. There are varied clinical manifestations in DES patients, usually represented by dry and itchy feeling in the eyes, a sensation of having a foreign body in the eyes, light sensitivity, and asthenopia[3]. In severe cases, damage to corneal surface, filamentary keratitis, and keratohelcosis may develop, and finally lead to corneal opacity and visual loss, greatly affecting one’s daily life and work.

This study adopted a randomized-controlled trial to observe the effects of diverse needling methods on DES, by comparing the changes of eye symptom score, Schirmer I Test (SIT), Break-up Time (BUT) of tear film, Corneal Fluorescein Staining (CFS), and Visual Analogue Scale (VAS) results between ordinary needling and electroacupuncture (EA), and to explore an appropriate acupuncture treatment protocol for DES.

1 Clinical Materials

1.1 Diagnostic criteria

It was referred to the diagnostic criteria of DES by Prof. Liu Zu-guo and also the Criteria of Diagnosis and Therapeutic Effects of Diseases and Syndromes in Traditional Chinese Medicine[4].

DES can be diagnosed when it meets the first 3 of the following 4 items; the diagnosis can be reconfirmed when the 4th item is also met. ① With one or over one of the following subjective symptoms: Dryness of eyes; sensation of having a foreign body in the eyes; burning sensation; light sensitivity; visual fatigue; blurred vision; and red eyes. ② BUT≤10 s. ③ SIT≤10 mm/5 min. ④ CFS is positive.

1.2 Inclusion criteria

Subjects who conform to the above diagnostic criteria of DES; subjects aged 20-70 years old; other involved medication treatment should have been ceased over 2 weeks; subjects who have signed informed consent form.

1.3 Exclusion criteria

Other ophthalmological diseases, including obstruction of lacrimal passage, conjunctival or corneal diseases, severe trachoma, and conjunctival or corneal scarring; subjects who had an eye surgery within the last 6 months; for cases who also have dry mouth, dry skin and joint aches, Sjogren’s syndrome should be considered; subjects who are accompanied by severe diseases involving cardiovascular and cerebrovascular systems, liver, kidney, and hematopoietic system, as well as psychopathies; a confirmed or suspicious history of drug abuse; women in pregnancy or lactation period; subjects who have other severe diseases or who are inadvisable to receive acupuncture treatment; DES patients who are receiving other therapies.

Subjects who conform to one of the above criteria have to be excluded.

1.4 General data

All of the 47 eligible subjects were the outpatients of Acupuncture Department and Ophthalmology Department, Yueyang Hospital of Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine. Taking 200 as the random seed, 50 random numbers were generated by using STATA 10.0 software and sequenced from small one to big one. The former 25 numbers were classified into group A, and the latter 25 into group B; group A was defined as acupuncture group, and group B as EA group. The 50 random numbers were put into envelopes and opened according to the visiting sequence of patients. The patients were enrolled into the corresponding group according to the random number obtained. There were no significant differences between the two groups in comparing gender, age, disease duration, eye symptom score, SIT, BUT, CFS, and VAS results (P＞0.05), hence they were comparable (table 1).

The clinical managements of the two groups are shown in Fig.1.

Table 1. Comparison of general data ()

Table 1. Comparison of general data ()

Acupuncture 23320 52±12 1.6±1.4 EA 24420 52±11 1.7±1.2

Fig.1 Clinical management flow chart

2 Treatment Methods

2.1 Acupuncture group

Major acupoints: Shangjingming [Extra, locates at upper Jingming (BL 1)], Xiajingming [Extra, locates at lower Jingming (BL 1)], Tongziliao (GB 1), Cuanzhu (BL 2), Fengchi (GB 20), and Hegu (LI 4).

Adjunct acupoints: Sanyinjiao (SP 6), Taixi (KI 3), and Taichong (LR 3).

Operation: The above acupoints were selected bilaterally. Fengchi (GB 20) was needled with filiform needles of 0.25 mm in diameter and 40 mm in length, directed to the homolateral inner canthus, with repeated lifting and thrusting manipulations till needling sensation radiating to forehead or eyes. The rest acupoints were treated with filiform needles of 0.25 mm in diameter and 25 mm in length. For Shangjingming (Extra) and Xiajingming (Extra), needles were inserted perpendicularly and slowly till eyeballs had sour and swollen feelings and the needles were not manipulated but held by the needle handle for 1 min to maintain theneedling sensation. Tongziliao (GB 1) was at first perpendicularly inserted by depth of 0.8 cun. When sour and swollen sensations were produced by mild rotating, lifting and thrusting, the needle was manipulated for 0.5 min and then horizontally inserted towards ear apex by depth of 0.7-0.8 cun, and was retained after needling sensation was achieved. Cuanzhu (BL 2) was inserted towards Jingming (BL 1) by depth of 0.7-0.8 cun. Needling sensation was the only requirement when the other acupoints were needled. The needles were retained for 20 min.

2.2 EA group

In the EA group, acupoint selection and acupuncture operation were the same as those in the acupuncture group. After needling sensation was obtained, Tongziliao (GB 1) and Cuanzhu (BL 2) were connected together to G6805-2 EA apparatus, with continuous wave and frequency of 1.5 Hz, and intensity within the patients’ endurance. The needles were retained for 20 min.

For both groups, the treatment was given three times a week, and therapeutic effect was observed after 12 sessions.

3 Therapeutic Results

3.1 Observation indexes

3.1.1 Eye symptom score

Referred to the Guiding Principles for Clinical Study of New Chinese Medicines, the commonest 5 symptoms of DES were scored, and the total sum of the component scores was the general symptom score. The 5 symptoms were dryness of eyes, visual fatigue, sensation of having a foreign body in the eyes, red eyes, and light sensitivity. Dryness of eyes was scored at 0, 2, 4, and 6, respectively representing absence of symptom, mild, moderate and severe degrees, and the other four symptoms were similarly scored at 0, 1, 2, and 3. The two eyes were scored separately.

3.1.2 SIT

One side of filter paper strip was folded at 5 mm and placed inside lower eyelid by external 1/3 (conjunctival sac). The eyes were closed for 5 min. Moisture length was then measured from the folding line. SIT ＜10 mm represents a decreased tear secretion.

3.1.3 BUT

BUT is to test the time required for the first dry spot to appear on the fluorenscein-stained tear film. BUT＞10 s represents normal.

3.1.4 CFS

CFS reflects deficit of corneal epithelium, and ＜1 is defined as normal.

3.1.5 VAS

A 10 cm long rope was given to the subjects, with its left end marked 0 representing absence of discomfort, and its right end marked 10 representing extreme discomfort. The subjects were asked to mark on the rope to record the severity of eye discomfort. The marked spot was then measured and scored. The above examinations were conducted by professions of the Ophthalmology Department.

3.2 Criteria of therapeutic effects

The criteria of therapeutic effects were made according to the Guiding Principles for Clinical Study of New Chinese Medicines.

Therapeutic effect index = (Pre-treatment symptom score－Post-treatment symptom score)/Pre-treatment symptom score × 100%.

Markedly effective: After treatment, symptoms are obviously improved and therapeutic effect index ＞70%; BUT and SIT are normal, and CFS=0.

Effective: After treatment, symptoms are improved and therapeutic effect index ranges 30%-70%; BUT, SIT, and CFS are improved.

Failure: Therapeutic effect index ＜30%, and none of the dry eye examinations shows improvement.

3.3 Statistical methods

The SPSS 13.0 version software was adopted for statistical analyses. When it’s not a normal distribution, the data were expressed by medians. Self comparisons were performed by using paired rank sum test, and comparisons between groups were performed by using independent samples test. When it’s a normal distribution, the data were expressed by (). The post-treatment inter-group comparisons were performed by independent sample t-test. Numeration data were analyzed by Chi-square test.

3.4 Treatment results

3.4.1 Comparison of therapeutic effects between the two groups

There were totally 46 eyes in acupuncture group, and its total effective rate was 56.5%; there were 48 eyes in the EA group, and the total effective rate was 79.2%. The Chi-square test showed that the total effective rate of EA group was significantly superior to that of acupuncture group (P＜0.05), (table 2).

Table 2. Comparison of therapeutic effects (amount of eye)

3.4.2 Comparison of observation indexes before and after treatments

After a 1-month treatment, both groups achieved significant improvements in each index (P＜0.01). The EA group was better than acupuncture group in improving eye symptom score and SIT value (P＜0.05); but there were no statistical differences between the two groups in improvements of VAS, BUT, and CFS results (P＞0.05), (table 3).

Table 3. Comparison of indexes before and after treatments ()

Table 3. Comparison of indexes before and after treatments ()

Note: Inner-group comparison with the pre-treatment result, 1) P＜0.01; compared with the post-treatment result of the acupuncture group, 2) P＜0.01, 3) P＜0.05

Indexes Acupuncture group (n=23) EA group (n=24) Pre-treatment Post-treatment Pre-treatment Post-treatment Eye symptom score 10.9±3.1 6.4±3.21)11.2±2.7 4.0±2.61)2)VAS 6.9±1.6 4.6±2.41)6.9±1.2 3.9±1.61)SIT 4.1±2.9 6.2±3.51)4.9±3.7 8.2±4.71)3)BUT 4.2±1.7 6.1±2.41)4.3±2.1 7.0±3.11)CFS 0 (2.25) 0 (0)1)0 (0) 0 (0)1)

4 Discussion

DES equals “Bai Se Zheng (xerosis conjunctivitis)” in ophthalmology of traditional Chinese medicine (TCM). In TCM, it’s thought to be closely related to the lung, liver, and kidney, and its major pathogenesis should be deficiency of yin and body fluid that can’t ascend to moisturize eyes[5-6].

In this study, periocular acupoints including Shangjingming (Extra), Xiajingming (Extra), Tongziliao (GB 1), and Cuanzhu (BL 2), as well as Fengchi (GB 20) on the neck were selected as the major acupoints, for activating the circulation of qi and blood in the eyes, head, and face. Shangjingming (Extra) and Xiajingming (Extra) are respectively located nearby the superior and lower lacrimal canaliculus; Tongziliao (GB 1) acts to disperse the accumulated heat in Shaoyang, and locates nearby lacrimal gland; Cuanzhu (BL 2) is needled with the direction towards Jingming (BL 1). These four acupoints work together to improve lacrimal secretion and tear metabolism. Fengchi (GB 20) regulates qi activities in the head and face, and also strengthens the action of periocular acupoints, is good at treating the head and face diseases. Hegu (LI 4) is the Yuan-Primary acupoint of the Large Intestine Meridian, which is in control of diseases related to body fluid, and let alone facial and oral diseases can all be treated by using Hegu (LI 4). Therefore, this acupoint is punctured to activate qi activities of head and face, and to help the transportation and distribution of body fluid. Sanyinjiao (SP 6) is a crucial acupoint of the Spleen Meridian; Taixi (KI 3) is the Yuan-Primary acupoint of the Kidney Meridian; Taichong (LR 3) is the Yuan-Primary acupoint of the Liver Meridian. When they are used together, it can tonify the yin of liver and kidney, and produce fluid to moisturize the dryness.

After treatment, both groups had obvious improvements in eye symptom score, SIT, BUT, CFS, and VAS scores. It reveals that acupuncture has an accurate effect in treating DES. The EA group is superior to acupuncture group in comparing the total effective rate, and in improving eye symptom score and SIT. It suggests that electrical stimulation somehow further enhances the therapeutic effect of acupuncture in treating DES.

Researchers have found that it’s effective to treat DES by using acupuncture alone or by using multiple acupuncture methods together[7-9]. However, there is lack of researches on whether there are differences among different acupuncture methods. DES has complicated etiology and pathogenesis, and for DES caused by different reasons, the acupuncture method also varies. Due to the rather short needle-retaining time and difficulty performing needling manipulations for the thin subcutaneous tissue around eyes, this study adopted EA to strengthen the stimulation to topical acupoints to further enhance therapeutic effect, and compared it with ordinary acupuncture treatment. In the EA group, the two electrodes were connected to Tongziliao (GB 1) and Cuanzhu (BL 2), between which there locates lacrimal gland, where is exactly in the electrical stimulation spectrum. For the results we surmise that EA amplifies the needling stimulation to periocular areas, and further enhances the secretion of lacrimal gland and the production of tear. Therefore, EA has better therapeutic effect in treating aqueousdeficient DES compared to ordinary acupuncture. Over-evaporated DES is mainly caused by abnormal function of lipid layer of tear film. BUT reflects the quality of lipid layer, which is secreted by meibomian gland and influenced by sex hormones[10]. The present study result shows an insignificant difference betweenthe two groups in BUT after treatment, which may be because of the small sample size or different mechanisms and effects of multiple acupuncture methods on regulating tear film.

Eye symptom score is based on the major symptoms of DES patients, while VAS is based on the subjective feeling of the patients. In this study, the EA group is better than the acupuncture group in improving eye symptom score, but in comparing the improvement of VAS score, there was no significant difference. DES patients usually have complicated and diverse clinical symptoms. It’s common to see that some symptoms are gone or reduced while some other symptoms still exist and go on bringing discomfort to patients after several treatment sessions. This is possibly the reason inducing the inconformity between the improvements of eye symptom score and VAS score. The relativity and difference between the two items still expect further studies.

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[10] Shi L, Wang YL. Research progress of the effects of sex hormone on the structure and function of tear film. Liaoning Zhongyiyao Daxue Xuebao, 2010, 12(2): 108-110.

Translator: Hong Jue

R246.82

A

Date: January 25, 2013

Author: Guo Meng-hu, M.M.

Zong Lei, chief physician, supervisor of master degree candidate. E-mail: lzong65@163.com