Dry Eye Syndromes
Conditions
Keywords
Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time
Brief summary
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.
Interventions
DEVICEStandardized Acupuncture
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.
DEVICENon-acupuncture point shallow penetration acupuncture
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.
Sponsors
Korea Institute of Oriental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below: 1. Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing 2. Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test
Exclusion criteria
* Those who have defects of eyelid or eyelashes * Those who have acute infection of eyelid, eyeball or accessories of eye * Those who have Stevens-Johnson syndromes or Pemphigoids * Those who have Vitamin A deficiency * Those who have any defects of eye or accessories of eye by external injuries * Those who have undergone any surgical operation for eye during last 3 months * Those who are using contact lens * Those who have any difficulties about eye opening or eye closing due to facial palsy * Those who have undergone punctual occlusion surgery * Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops) * Those who have systemic immune therapy * Those who are pregnant or have any plan for pregnancy * Those who are not appropriate to this study by investigators decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index : OSDI | Visit 11 (after 3 weeks from baseline) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale of Self Symptoms | every visit |
| Schirmer 1 Test | visit 1,10 |
| Tear Film Break-up Time : BUT | Visit 1, 10 |
| Medication Quantification Scale (MQS) | every visit |
| General Assessment | visit 11 |
Countries
South Korea
Participant flow
Recruitment details
Recruitment period was from 15 September 2009 to 27 October 2009. Through the advertisements in regional newspapers or university websites, patients were recruited at the clinical research center of the Korea Institute of Oriental Medicine (KIOM) in Daejeon University hospital, Daejeon, Korea.
Pre-assignment details
49 participants were tested for eligibility. 6 were excluded because of the insufficient pre-allocation test, denied informed consent and other reasons. After 1 week run-in period, 1 participant was excluded for withdrawal of informed consent. After all, 42 participants were included in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Standardized Acupuncture Group Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after de qi manipulation for the verum acupuncture group. | 21 |
| Non-acupoint Shallow Penetration Group 17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | infection of influenza A(H1N1) | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Non-acupoint Shallow Penetration Group | Standardized Acupuncture Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age Continuous | 42.76 years STANDARD_DEVIATION 9.59 | 40.52 years STANDARD_DEVIATION 11.8 | 41.64 years STANDARD_DEVIATION 10.68 |
| Region of Enrollment Korea, Republic of | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
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)
Population: Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p\<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standardized Acupuncture Group | Ocular Surface Disease Index : OSDI | -17.61 Scores on the OSDI score | Standard Deviation 15.61 |
| Non-acupoint Shallow Penetration Group | Ocular Surface Disease Index : OSDI | -17.20 Scores on the OSDI score | Standard Deviation 18.81 |
Secondary
General Assessment
Time frame: visit 11
Secondary
Medication Quantification Scale (MQS)
Time frame: every visit
Secondary
Schirmer 1 Test
Time frame: visit 1,10
Secondary
Tear Film Break-up Time : BUT
Time frame: Visit 1, 10
Secondary
Visual Analogue Scale of Self Symptoms
Time frame: every visit