Abstract
PurposeTo evaluate the effects of acupuncture compared to a control group using artificial tears.Methods 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).ResultsThere 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.ConclusionsAcupuncture may have benefits on the mid-term outcomes related to dry eye syndrome compared with artificial tears.Trial registrationClinicalTrials.gov NCT01105221.
Highlights
Dry eye syndrome is a common ophthalmologic disorder causing ocular discomfort in daily life
An increased knowledge of dry eye pathology has changed the definition of dry eye syndrome from describing a trivial ocular disorder related to secretion deficiency or excess tear evaporation to detailing a multi-factorial disease, which may involve chronic inflammation or tear film instability [1]
The incidence is increasing, which may be related to changes in life style and working environments, increased average life expectancies and usage of medical interventions that can cause dry eye syndrome, including laser-assisted in situ keratomileusis (LASIK) surgery, radiation therapy, contact lenses and medications such as antihistamines or diuretics [1]
Summary
The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Checklist S1 and Protocol S1. The secondary outcomes were the differences in 100 mm VAS for the ocular discomfort, quality of life questionnaire using the Measure Yourself Medical Outcome Profile-2 (MYMOP-2), TFBUT, Schirmer I test (with anaesthesia) score and adverse event rate of acupuncture treatment and artificial tears usage. Both eyes were assessed for the evaluation of TFBUT and Schirmer I test, respectively. ANCOVA (Analysis of Covariance) were used for continuous outcomes such as OSDI score, TFBUT, Schirmer test result, QOL and VAS for self-assessment of ocular discomfort, adjusted for baseline values and research centres as covariates.
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