THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 16, Number 12, 2010, pp.

12911294 Mary Ann Liebert, Inc. DOI: 10.1089/acm.2009.0537

Acupuncture Reduces Symptoms of Dry Eye Syndrome: A Preliminary Observational Study

1 Ju-Hyun Jeon, OMD, PhD, Mi-Suk Shin, RN,2 Myeong Soo Lee, PhD,2 So-Young Jeong, BS,2 1 Kyung Won Kang, MS,2 Young-Il Kim, OMD, PhD, and Sun-Mi Choi, OMD, PhD2

Abstract

Objective: The aim of this study was to evaluate the effect of acupuncture treatment on dry eye syndrome. Design: This was a prospective observational study. Setting: The study was conducted at a clinical evaluation center for acupuncture and moxibustion of the Korean Institute of Oriental Medicine, Republic of Korea. Subjects: The subjects were patients with dry eye disease (N 36), dened by Schirmer test scores of <10 mm/ 5 min and tear lm break-up times (BUTs) of <10 seconds. Treatments: Participants were treated with acupuncture three times per week for 4 weeks. Measure of effectiveness: Schirmer test scores, BUTs, symptom scores, ocular surface disease index (OSDI) scores and dry eye symptom questionnaires were compared before and after treatment to evaluate the efcacy of acupuncture treatment. Results: After treatment, symptom scores, OSDI scores and the number of dry eye symptoms were all signicantly lower ( p < 0.0001). Although tear wettings were signicantly higher (left: p < 0.0001, right: p 0.0012), there were no signicant differences in BUTs. Conclusions: This study suggests that acupuncture treatment can effectively relieve the symptoms of dry eye and increase watery secretion.
Introduction ry eye syndrome is a tear lm disorder that occurs due to a deciency of tears or excessive evaporation.1 Dry eye syndrome causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort.1 The most common cause of this syndrome is damage to the lacrimal gland, which is involved in aqueous secretion.2 Early interventions for dry eye syndrome were palliative, attempting to replace water lost from the tear lm.3 Current therapies are directed at underlying inammation, an important component of dry eye syndrome, and at the resulting changes to the ocular surface.3 Patients with eye diseases often turn toward complementary and alternative medicine (CAM).4,5 There is a wide range of CAM used for treating dry eye, including dietary supplements, herbal medicine, and acupuncture. Acupuncture is considered to be effective for various conditions.6 It is also thought to be effective at modulating the autonomic nervous system and immune system.79 Based on this information, it is reasonable to assume that acupuncture might be able to regulate lacrimal gland function and thereby relieve dry eye
1 2

symptoms. As there are few reports on this hypothesis,10,11 this observational study investigated whether acupuncture is effective at treating symptoms of dry eye syndrome. Patients and Methods Participants Fifty (50) subjects were recruited from an Internet homepage, a newspaper insert, and a poster billing. Subjects were included if they were 1970 years of age and had dry eye symptoms, Schirmer test scores of <10 mm/5 min, and tear lm break-up times (BUTs) of <10 seconds. All subjects were required to provide written informed consent before any study-specic procedures were performed. We excluded subjects with previous anterior segment inammation or trauma (surgical or other trauma), active blepharitis, previous facial palsy, allergy, punctal occlusion, or punctal plug insertion. Contact lens users were also excluded. Patients were excluded if they used systemic medications such as sleeping tablets, tranquilizers, antidepressants, monoamine oxidase inhibitors, dopaminergics, neuroleptics, benzodiazepines, antiserotoninergics, b-blockers, or antiemetic

Acupuncture, Moxibustion, and Meridian Research Center, Korea Institute of Oriental Medicine, Daejeon, South Korea. Division of Standard Research, Korea Institute of Oriental Medicine, Daejeon, South Korea.

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1292 agents. We also excluded women who were receiving hormone replacement therapy, were pregnant or lactating, and those for whom pregnancy was possible. This clinical study received formal approval from the Ethics Committee and was conducted in conformance with the provisions of the Declaration of Helsinki (1995). The recording of adverse events was a means of assessing the safety of acupuncture treatment. Procedures Participants were scheduled for acupuncture treatment 3 times a week for 4 weeks (12 times total). Dry eye symptoms and questionnaires were evaluated pretreatment and after each of the 12 acupuncture treatments (total 13 times). Ocular surface disease index (OSDI) was measured baseline and after the 3rd, 6th, 9th, and 12th sessions (total 5 times). BUT and Schirmer tests were also performed pretreatment and after 12 acupuncture treatments (total 2 times). Acupuncture treatment Acupuncture treatments were performed by 3 Korean doctors who had received postgraduate training in acupuncture and had more than 3 years of clinical experience. Disposable stainless steel needles (0.2030 mm, Haeng Lim 1.44 (0.56) <0.0001 31.1 (19.5) <.0001 4.0 (1.7) <0.0001 1.46 (0.63) <0.0001 1.66 (0.7) 0.0004 34.8 (18.1) <.0001 4.2 (1.4) <0.0001 1.50 (0.63) <0.0001 2.22 (0.71) 48.6 (16.6) p-value Number of dry eye symptoms p-value Symptom score p-value OSDI 6.9 (1.8) 4.3 (2.4) <0.0001 2.03 (0.93) 0.311 4.2 (1.7) <0.0001 1.81 (0.74) 0.007 1.97 (0.82) 0.088 38.7 (20.2) 0.004 5.0 (1.9) <0.0001 4.3 (1.7) <0.0001 1.91 (0.78) 0.031 4.0 (1.9) <0.0001 1.63 (0.72) 0.001 1.69 (0.78) 0.0004 35.0 (17.2) <.0001 4.3 (1.3) <0.0001 1.60 (0.68) <0.0001 4.2 (1.3) <0.0001 3.7 (1.7) <0.0001 1.52 (0.72) <0.0001 3.8 (1.5) <0.0001 3.7 (1.5) <0.0001 Visit 13

JEON ET AL.

Visit 10

Visit 11

Visit 12

FIG. 1. Treated acupuncture points. (A) LU3; (B) Extra acupuncture point (Duomingxue); (C) Auricular acupuncture point Eye 2; (D) Korean hand acupuncture point E2.

Variable

Values are represented as mean (standard deviation). Wilcoxon signed-rank test was used to test signicance between baseline and each visit. OSDI, ocular surface disease index.

Table 1. Mean (Standard Deviation) of Variables at Each Measurement Point

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Visit 9

ACUPUNCTURE FOR DRY EYE SYNDROME Seo Won Co., Korea) were inserted into acupuncture points (auricular acupuncture point eye 2 and Korean hand acupuncture point E2 to a depth of 0.1 cun and LU3 and extra acupuncture point to a depth of 0.5 cun). The sparrow pecking technique (alternate pushing and pulling of the needle) was not applied. The needles were left in place for 30 minutes. Acupuncture points We select the LU3 (Fig. 1A) according to Traditional Chinese Medicine. The other treatment point selections were based on microacupuncture rules and the chief virtue of each acupuncture point. The extra acupuncture point, Duomingxue, is located in the middle point of Acromion and LU5 (Fig. 1B).12 Auricular acupuncture point Eye 2 is located below the intertragic notch (posterior of the notch) (Fig. 1C). Points were selected according to the method of the school of Noiger.13 Korean hand acupuncture point E2 is located on the palm of the middle nger, in the distal phalanx, at the intersection of the Radial and Ulnar vertical line. The point was selected according to the Yoo Tae Woos Koryo hand therapy method (Fig. 1D).14 Outcome measures Primary outcomes. Symptom scores and OSDI were the primary outcomes used to evaluate the efcacy of the acupuncture treatment.15 Symptom scores were evaluated using a scoring system of 04, where 0 indicates an absence of symptoms and 4 indicates very severe symptoms. Participants scored 10 symptoms associated with dry eye syndrome, including burning sensation, stinging sensation, itching sensation, foreign body sensation, dryness, soreness, lid heaviness, photophobia, injection, and tearing. Total scores, obtained by adding the scores of each symptom, were used for the evaluation of ocular discomfort. OSDIs were used to quantify the specic impact of acupuncture on dry eye syndrome. This disease-specic questionnaire included three subscales: ocular discomfort, function, and environmental triggers. Questionnaires were lled out and collected once a week throughout the study. Possible responses referred to the frequency of the disturbance: none of the time, some of the time, half of the time, most of the time, or all of the time. Subscale scores were

1293 computed for OSDI-symptoms, OSDI-function and OSDItriggers, as well as an overall averaged score. OSDI subscale scores ranged from 0 to 100, with higher scores indicating more problems or symptoms. Secondary outcomes. The secondary outcome measures were the number of dry eye symptoms, Schirmer test score, and BUT score. The number of dry eye symptoms was evaluated by counting 10 dry eye symptoms (burning sensation, stinging sensation, itching sensation, foreign body sensation, dryness, soreness, lid heaviness, photophobia, injection, and tearing). The total number of symptoms was used to evaluate the level of ocular discomfort. Schirmer tests were performed by placing a Schirmer tear strip (Eagle Vision, USA) over the lower lid margin at the junction of the middle and lateral third of the tear lm for 5 minutes. Patients were given anesthesia (0.5% proparacaine (Alcaine)) prior to testing. Schirmer test scores were obtained by measuring the lengths (millimeters) of the wet portions of the strips and recorded. BUTs were calculated as the number of seconds between the last complete blink and the rst disturbance of the precorneal tear lm after touching the inferior temporal bulbar conjunctiva with a uorescein sodium strip that was dampened with a preservative-free saline solution. The mean value of a total of three measurements was recorded. Statistical analysis The statistical analysis was performed using SAS 9.1. To compare therapeutic effects between preacupuncture and postacupuncture, a paired t-test and Wilcoxons signed rank test were used. The same analysis was used to compare between baseline (pretreatment) and each visit. The results are presented as mean values and standard deviation. Probability ( p) values < 0.05 were considered signicant in all statistical testing. Effect size was calculated with Cohens d. Results A total of 50 patients volunteered for the study, and 12 did not t the inclusion criteria. Only 2 of the remaining 38 patients were excluded because they took medicine on the rst treatment day. Two (2) participants withdrew their consent

Table 2. Outcome Measures After 12 Sessions of Acupuncture for Dry Eye Syndrome Outcome measures Symptom score OSDI Number of dry eye symptoms Schirmer test Left Right BUT Left Right Pretreatment 2.22 (0.71) 48.6 (16.6) 6.9 (1.8) 5.3 (1.9) 5.3 (1.9) 5.4 (1.7) 4.9 (1.7) Post-treatment 1.44 (0.56) 31.1 (19.5) 4.0 (1.7) 7.4 (3.2) 7.4 (3.4) 5.3 (2.2) 4.8 (2.3) Effect size (95% CI) 1.21 (0.67, 1.74) 1.64 (1.07, 2.21) 0.95 (0.43, 1.46) 0.80 (0.29, 1.31) 1.13 (0.60, 1.66) 0.05 (0.44, 0.54) 0.05 (0.44, 0.54) p <0.0001 <0.00001 0.0003 0.002 <0.0001 0.82 0.84

Values are represented as mean (standard deviation). The Wilcoxon signed-rank test was used to test signicance between pretreatment and post-treatment. CI, condence interval; OSDI, ocular surface disease index; BUT, tear lm break-up time.

1294 for the trial, and 2 were excluded because they took steroids or other medications during the treatment period. The remaining 32 patients completed the study. The mean age and duration of disease were 47.4 (range 2262) years and 5.6 years (range 2 months20 years), respectively. The changes in the symptom scores, OSDI, and number of symptoms are shown in Table 1. All of the outcome measures were improved by the acupuncture sessions. Table 2 lists outcome measures before and after treatment. These measures indicate that there were signicant improvements in dry eye symptoms, OSDIs, the number of dry eye symptoms, and Schirmer test scores. However, there were no signicant changes in BUTs. The most affected variable was OSDI (effect size 1.64). None of the participants reported any adverse events. Discussion Our pilot study suggests that 12 sessions of acupuncture treatment signicantly improved subjective outcome measures of dry eye syndrome, including total symptom score, number of symptoms and OSDI, as well as the objective outcome measure of the Schirmer test. This nding is consistent with results of previous studies. Tseng et al.11 reported that 16 sessions of acupuncture treatment improved symptoms of dry eye syndrome. Another study also reported benecial effects of 10 sessions of acupuncture treatment on dry sensations in the eye.10 Assuming that acupuncture is a potentially useful treatment option for dry eye syndrome, its mechanism of action may be of interest. The results presented here suggest that acupuncture can inuence lacrimal glandular function in the synthesis and secretion of aqueous secretions.16 Others have postulated that acupuncture may reduce tension and alleviate pain intensity or increase pain threshold.17 However, none of these theories have been addressed. The results from this uncontrolled pilot study provide a foundation for the exploration of acupuncture as a nonpharmacological therapy for improving symptoms of dry eye syndrome. However, we cannot completely discount the possibility that a placebo effect during the intervention caused improvements in symptoms related to dry eye syndrome. Other limitations of this pilot study include the small sample size and the absence of a control treatment and appropriate follow-up of possible recurrences. Further studies that include a randomized design, larger sample sizes, and more detailed data on the subjects are needed to convincingly show the effects of acupuncture in patients with dry eye syndrome. Disclosure Statement No competing nancial interests exist. References
1. Lemp MA. Report of the national eye institute/industry workshop on clinical trials in dry eyes. CLAO J 1995;21:221 232.

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2. Yokoi N, Mossa F, Tiffany JM, Bron AJ. Assessment of meibomian gland function in dry eye using meibometry. Arch Ophthalmol 1999;117:723729. 3. Perry HD, Donnenfeld ED. Medications for dry eye syndrome: A drug-therapy review. Manag Care 2003;12:2632. 4. Rhee DJ, Spaeth GL, Myers JS, et al. Prevalence of the use of complementary and alternative medicine for glaucoma. Ophthalmology 2002;109:438443. 5. Smith JR, Spurrier NJ, Martin JT, Rosenbaum JT. Prevalent use of complementary and alternative medicine by patients with inammatory eye disease. Ocul Immunol Inamm 2004;12:203214. 6. Ernst E. Acupuncture: A critical analysis. J Intern Med 2006; 259:125137. 7. Backer M, Grossman P, Schneider J, et al. Acupuncture in migraine: Investigation of autonomic effects. Clin J Pain 2008;24:106115. 8. Kavoussi B, Ross BE. The neuroimmune basis of antiinammatory acupuncture. Integr Cancer Ther 2007;6:251 257. 9. Uchida S, Hotta H. Acupuncture affects regional blood ow in various organs. Evid Based Complement Alternat Med 2008;5:145151. 10. Nepp J, Wedrich A, Akramian J, et al. Dry eye treatment with acupuncture: A prospective, randomized, doublemasked study. Adv Exp Med Biol 1998;438:10111016. 11. Tseng KL, Liu HJ, Tso KY, et al. A clinical study of acupuncture and ssp (silver spike point) electro-therapy for dry eye syndrome. Am J Chin Med 2006;34:197206. 12. Chan L. Introduction to Medicine [in Chinese]. Beijing: China Press of Traditional Chinese Medicine, 1995. 13. Hecker H-U, Steveling A, Peuker E, et al. Color Atlas of Acupuncture, Body Points, Ear Points, Trigger Points. New York: Thieme, 2001. 14. Woo YT. Koryo Hand Therapy. Seoul: YinyangMaekjin Publishing, 2004. 15. Pugfelder SC, Tseng SC, Sanabria O, et al. Evaluation of subjective assessments and objective diagnostic tests for diagnosing tear-lm disorders known to cause ocular irritation. Cornea 1998;17:3856. 16. Gong L, Sun X. Treatment of intractable dry eyes: Tear secretion increase and morphological changes of the lacrimal gland of rabbit after acupuncture. Acupuncture Electro-Ther Res 2007;32:223233. 17. Nepp J, Tsubota K, Goto E, et al. The effect of acupuncture on the temperature of the ocular surface in conjunctivitis sicca measured by non-contact thermography: Preliminary results. Adv Exp Med Biol 2002;506A:723726.

Address correspondence to: Sun-Mi Choi, OMD, PhD Acupuncture, Moxibustion & Meridian Research Center Korea Institute of Oriental Medicine Daejon, 305811 South Korea E-mail: smchoi@kiom.re.kr

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