title: Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol.
abstract: 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 and qualitative characteristics of acupuncture treatment for dry eye.
  
  
  METHODS
  One 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.
  
  
  BACKGROUND
  ClinicalTrials.gov (Identifier: NCT01105221).
authors.affiliation: Acupuncture, Moxibustion and Meridian Research Centre, Korea Institute of Oriental Medicine, Daejeon, South Korea.
authors.forename: Tae-Hun
authors.initials: TH
authors.lastname: Kim
authors.forename: Jung Won
authors.initials: JW
authors.lastname: Kang
authors.forename: Kun Hyung
authors.initials: KH
authors.lastname: Kim
authors.forename: Kyung-Won
authors.initials: KW
authors.lastname: Kang
authors.forename: Mi-Suk
authors.initials: MS
authors.lastname: Shin
authors.forename: So-Young
authors.initials: SY
authors.lastname: Jung
authors.forename: Ae-Ran
authors.initials: AR
authors.lastname: Kim
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Jung
authors.forename: Seung-Deok
authors.initials: SD
authors.lastname: Lee
authors.forename: Jin-Bong
authors.initials: JB
authors.lastname: Choi
authors.forename: Sun-Mi
authors.initials: SM
authors.lastname: Choi
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D015352:Dry Eye Syndromes / Q000523:psychology / Q000628:therapy*; D006801:Humans; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D009883:Ophthalmic Solutions