This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks. According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20\*30mm (Dongbang Co., korea) acupuncture needle. All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.
Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks. Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20\*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.
Clinical Research Center, Korea institute of oriental medicine
Daejeon, Chongchungdo, South Korea
Ocular Surface Disease Index : OSDI
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.
Time frame: Visit 11 (after 3 weeks from baseline)
Visual Analogue Scale of Self Symptoms
Time frame: every visit
Schirmer 1 Test
Time frame: visit 1,10
Tear Film Break-up Time : BUT
Time frame: Visit 1, 10
Medication Quantification Scale (MQS)
Time frame: every visit
General Assessment
Time frame: visit 11
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