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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...

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Autores principales: Kim, Tae-Hun, Kang, Jung Won, Kim, Kun Hyung, Kang, Kyung-Won, Shin, Mi-Suk, Jung, So-Young, Kim, Ae-Ran, Jung, Hee-Jung, Lee, Seung-Deok, Choi, Jin-Bong, Choi, Sun-Mi
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998498/
https://www.ncbi.nlm.nih.gov/pubmed/21078194
http://dx.doi.org/10.1186/1745-6215-11-107
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author Kim, Tae-Hun
Kang, Jung Won
Kim, Kun Hyung
Kang, Kyung-Won
Shin, Mi-Suk
Jung, So-Young
Kim, Ae-Ran
Jung, Hee-Jung
Lee, Seung-Deok
Choi, Jin-Bong
Choi, Sun-Mi
author_facet Kim, Tae-Hun
Kang, Jung Won
Kim, Kun Hyung
Kang, Kyung-Won
Shin, Mi-Suk
Jung, So-Young
Kim, Ae-Ran
Jung, Hee-Jung
Lee, Seung-Deok
Choi, Jin-Bong
Choi, Sun-Mi
author_sort Kim, Tae-Hun
collection PubMed
description 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/DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01105221).
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spelling pubmed-29984982011-01-05 Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol Kim, Tae-Hun Kang, Jung Won Kim, Kun Hyung Kang, Kyung-Won Shin, Mi-Suk Jung, So-Young Kim, Ae-Ran Jung, Hee-Jung Lee, Seung-Deok Choi, Jin-Bong Choi, Sun-Mi Trials Study 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 and qualitative characteristics of acupuncture treatment for dry eye. METHODS/DESIGN: 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. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01105221). BioMed Central 2010-11-16 /pmc/articles/PMC2998498/ /pubmed/21078194 http://dx.doi.org/10.1186/1745-6215-11-107 Text en Copyright ©2010 Kim et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Kim, Tae-Hun
Kang, Jung Won
Kim, Kun Hyung
Kang, Kyung-Won
Shin, Mi-Suk
Jung, So-Young
Kim, Ae-Ran
Jung, Hee-Jung
Lee, Seung-Deok
Choi, Jin-Bong
Choi, Sun-Mi
Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title_full Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title_fullStr Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title_full_unstemmed Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title_short Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
title_sort acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998498/
https://www.ncbi.nlm.nih.gov/pubmed/21078194
http://dx.doi.org/10.1186/1745-6215-11-107
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