Acupuncture for the Treatment of Dry Eye: A Multicenter Randomised Controlled Trial with Active Comparison Intervention (Artificial Teardrops)
نویسندگان
چکیده
PURPOSE To 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). 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.
منابع مشابه
Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
BACKGROUND Previous studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye. However, firm conclusions could not be drawn from these studies because the quality of the trials was too low to establish concrete evidence. Therefore, this study was designed both to avoid the flaws of the existing trials and to assess the effectiveness, cost-effectiveness...
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