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.

The aim of this study was to determine whether pharmacopuncture is a clinically effective and safe method for the treatment of knee osteoarthritis. Patients were recruited between August 2008 and December 2008 at the Ilsan Hospital associated with Dongguk University. Patients were randomly assigned to one of the two groups. The experimental group (n = 30) received pharmacopuncture using root bark of Ulmus davidiana Planch (UDP) twice a week for 6 weeks; the control group (n = 30) received normal saline injections. Fifty-three patients completed the trial. After the seventh treatment, we found that UDP pharmacopuncture was more effective in pain improvement using a Visual Analog Scale than was normal saline injection. However, the two interventions were not significantly different as measured by the Western Ontario and McMaster Universities pain score and total pain scores, 36-Item Short Form Health Survey, and Korean Health Assessment Questionnaire. No subject showed any serious adverse effects. The effects of pharmacopuncture treatment were a combination of placebo, needle stimulation, mechanical effect of the solution, and a chemical effect of UDP. However, normal saline used as the control intervention displayed the first three effects, and thus its effect was not inert. This may have influenced the results of the trial, which was statistically insignificant between the two groups, except following the seventh treatment session.

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BackgroundPrevious 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 and qualitative characteristics of acupuncture treatment for dry eye.Methods/designOne hundred fifty participants with dry eye will be recruited into three independent hospitals from different areas: Korea Institute of Oriental Medicine, DongGuk University Ilsan Oriental Hospital and Dongshin University Gwangju Oriental Hospital. The number of participants required was calculated from the data of a previous, relevant study. These patients will be randomly allocated into acupuncture treatment or artificial tear groups. Either 17 acupuncture points (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) will be used 3 times a week or disposable artificial tear drops (Refresh Plus®, ALLERGAN) will be provided for use at least once a day for 4 weeks. The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer I 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) will be assessed for approximately 3-months for each study participant. In addition, qualitative study and cost-effectiveness of acupuncture treatment will be conducted.Trial registrationClinicalTrials.gov (Identifier: NCT01105221).

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