Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops)

Tae-Hun Kim, Jung Won Kang, Kun Hyung Kim, Kyung-Won Kang, Mi-Suk Shin, So-Young Jung, Ae-Ran Kim, Hee-Jung Jung, Jin-Bong Choi, Kwon Eui Hong, Seung-Deok Lee, Sun-Mi Choi, Tae-Hun Kim, Jung Won Kang, Kun Hyung Kim, Kyung-Won Kang, Mi-Suk Shin, So-Young Jung, Ae-Ran Kim, Hee-Jung Jung, Jin-Bong Choi, Kwon Eui Hong, Seung-Deok Lee, Sun-Mi Choi

Abstract

Purpose: To evaluate the effects of acupuncture compared to a control group using artificial tears.

Setting & design: multicenter randomised controlled trial (three local research hospitals of South Korea).

Study population: 150 patients with moderate to severe dry eye.

Intervention: Participants were randomly allocated into four weeks of acupuncture treatment (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) or to the artificial tears group (sodium carboxymethylcellulose).

Main outcome measure(s): The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer Ι test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2).

Results: There was no statistically significant difference between two groups for the improvement of dry eye symptoms as measured by OSDI (MD -16.11, 95% CI [-20.91, -11.32] with acupuncture and -15.37, 95% CI [-19.57, -11.16] with artificial tears; P = 0.419), VAS (acupuncture: -23.84 [-29.59, -18.09]; artificial tears: -22.2 [-27.24, -17.16], P = 0.530) or quality of life (acupuncture: -1.32 [-1.65, -0.99]; artificial tears: -0.96 [-1.32, -0.6], P = 0.42) immediately after treatment. However, compared with artificial tears group, the OSDI (acupuncture: -16.15 [-21.38, -10.92]; artificial tears: -10.76 [-15.25, -6.27], P = 0.030) and VAS (acupuncture: -23.88 [-30.9, -16.86]; artificial tears: -14.71 [-20.86, -8.55], P = 0.018) were significantly improved in the acupuncture group at 8 weeks after the end of acupuncture treatment. TFBUT measurements increased significantly in the acupuncture group after treatment.

Conclusions: Acupuncture may have benefits on the mid-term outcomes related to dry eye syndrome compared with artificial tears.

Trial registration: ClinicalTrials.gov NCT01105221.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Study flow chart.
Figure 1. Study flow chart.
Figure 2. Ocular surface disease index (OSDI).
Figure 2. Ocular surface disease index (OSDI).
Figure 3. Visual analogue scale (VAS) for…
Figure 3. Visual analogue scale (VAS) for self-assessment of ocular discomfort.
Figure 4. Tear film break-up time (TFBUT).
Figure 4. Tear film break-up time (TFBUT).
Figure 5. Schirmer Ι test.
Figure 5. Schirmer Ι test.

References

    1. Lemp MA, Baudouin C, Baum J, Dogru M, Foulks GN, et al. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:75–92.
    1. Epidemiology Subcommittee of the International Dry Eye WorkShop. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:93–107.
    1. Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011;30:379–387.
    1. Pflugfelder SC. Prevalence, burden, and pharmacoeconomics of dry eye disease. Am J Manag Care. 2008;14:S102–106.
    1. Lemp MA. Management of dry eye disease. Am J Manag Care. 2008;14:S88–101.
    1. NIH Consensus Conference. Acupuncture. JAMA. 1998;280:1518–1524.
    1. Law SK, Li T. Cochrane Database Syst Rev; 2007. Acupuncture for glaucoma.CD006030
    1. Lam DS, Zhao J, Chen LJ, Wang Y, Zheng C, et al. Ophthalmology; 2011. Adjunctive Effect of Acupuncture to Refractive Correction on Anisometropic Amblyopia One-Year Results of a Randomized Crossover Trial.
    1. Lee MS, Shin BC, Choi TY, Ernst E. Acupuncture for treating dry eye: a systematic review. Acta Ophthalmol. 2011;89:101–106.
    1. Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, et al. Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol. Trials. 2010;11:107.
    1. Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, et al. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009;10:112.
    1. Behrens A, Doyle JJ, Stern L, Chuck RS, McDonnell PJ, et al. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006;25:900–907.
    1. Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, et al. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010;88:e328–333.
    1. Hardten DR, Brown MJ, Pham-Vang S. Evaluation of an isotonic tear in combination with topical cyclosporine for the treatment of ocular surface disease. Curr Med Res Opin. 2007;23:2083–2091.
    1. Kwon D-H, Kim Y-S, Choi D-Y. Book research into acupuncture treatment for dry eye. The Journal of Korean Acupuncture & Moxibustion society. 2009;27:10–24.
    1. So DW. Acupuncture outcomes, expectations, patient-provider relationship, and the placebo effect: implications for health promotion. American Journal Of Public Health. 2002;92:1662–1667.
    1. WHO Reginoal Office for the Western Pacific. Manila: World Health Organization; 2008. WHO Standard Acupuncture Point Locations in the Western Pacific Region.
    1. Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118:615–621.
    1. Miller KL, Walt JG, Mink DR, Satram-Hoang S, Wilson SE, et al. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010;128:94–101.
    1. Her J, Yu S, Seo S. Clinical Effects of Various Antiinflammatory Therapies in Dry Eye Syndrome. J Korean Opthalmol Soc. 2006;47:1901–1910.
    1. Paterson C. Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. Br Med J. 1996;312:1016–1020.
    1. Yuan J, Purepong N, Hunter RF, Kerr DP, Park J, et al. Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial. Complement Ther Med. 2009;17:131–140.
    1. Bron AJ, Abelson MB, Ousler G, Pearce E, Tomlinson A, et al. Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop. Ocul Surf. 2007;5:108–152.
    1. Foulks GN, Bron AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf. 2003;1:107–126.
    1. Anonymous WHO toxicity grading scale for determining the severity of adverse events. Available: . Accessed: 13 May 2011.
    1. Linde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, et al. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain. 2007;128:264–271.
    1. Jeon JH, Shin MS, Lee MS, Jeong SY, Kang KW, et al. Acupuncture reduces symptoms of dry eye syndrome: a preliminary observational study. J Altern Complement Med. 2010;16:1291–1294.
    1. Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, et al. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med. 2011;365:119–126.
    1. He HQ, Wang ZL, Hu HL, Liu R. Effect of acupuncture on lacerimal film of xeroma patients. J Nanjing TCM University. 2004;20:158–159.
    1. Pang YJ, Jia GQ, Feng JL. The effect of acupuncture on the tear production in patients with Sjogren’s syndrome. J Tradit Chin Opahthalmol. 2003;13:18–20.
    1. Wang ZL, He HQ, Huang D, Shi CG. Effect of integral syndrome differentiation acupuncture on the tear film stability in the patient of xerophthalmia. Zhongguo Zhen Jiu. 2005;25:460–463.
    1. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009;15:213–216.
    1. Witt CM. Clinical research on acupuncture - Concepts and guidance on efficacy and effectiveness research. Chin J Integr Med. 2011;17:166–172.
    1. Witt CM, Brinkhaus B. Efficacy, effectiveness and cost-effectiveness of acupuncture for allergic for allergic rhinitis - An overview about previous and ongoing studies. Auton Neurosci. 2010;157:42–45.
    1. Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009;360:1925–1927.
    1. Anonymous Management and therapy of dry eye disease: report of the Management and Therapy Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5:163–178.
    1. Kim WJ, Kim HS, Kim MS. Current Trends in the Recognition and Treatment of Dry Eye: A Survey of Ophthalmologists. J Korean Ophthalmol Soc. 2007;48:1614–1622.
    1. Berman BM, Langevin HM, Witt CM, Dubner R. Acupuncture for chronic low back pain. N Engl J Med. 2010;363:454–461.
    1. Lemp MA, Bron AJ, Baudouin C, Benitez Del Castillo JM, Geffen D, et al. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol 151: 792–798. 2011;e791
    1. Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, et al. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010;51:6125–6130.
    1. Oke SL, Tracey KJ. The inflammatory reflex and the role of complementary and alternative medical therapies. Ann N Y Acad Sci. 2009;1172:172–180.
    1. Nepp J, Jandrasits K, Schauersberger J, Schild G, Wedrich A, et al. Is acupuncture an useful tool for pain-treatment in ophthalmology? Acupunct Electrother Res. 2002;27:171–182.
    1. Detsky AS, Naylor CD, O’Rourke K, McGeer AJ, L’Abbe KA. Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol. 1992;45:255–265.
    1. Egger M, Juni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess. 2003;7:1–76.
    1. Altman DG. Statistics and ethics in medical research: III How large a sample? Br Med J. 1980;281:1336–1338.
    1. White A, Cummings TM, Filshie J. An introduction to Western medical acupuncture. Edinburgh: Churchill Livingstone/Elsevier. 2008;xviii:240.
    1. Park JE, Lee MS, Choi JY, Kim BY, Choi SM. Adverse events associated with acupuncture: a prospective survey. J Altern Complement Med. 2010;16:959–963.
    1. Zhao L, Zhang FW, Li Y, Wu X, Zheng H, et al. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011;12:87.
    1. Witt CM, Pach D, Reinhold T, Wruck K, Brinkhaus B, et al. Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain. Eur J Pain. 2011;15:193–197.

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