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Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial

BACKGROUND: Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acup...

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Autores principales: Wang, Yan, Gao, Yun-xian, Sun, Qi, Bu, Qian, Shi, Jing, Zhang, Ya-ni, Xu, Qin, Ji, Yan, Tong, Min, Jiang, Guang-li
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4289244/
https://www.ncbi.nlm.nih.gov/pubmed/25476698
http://dx.doi.org/10.1186/1745-6215-15-477
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author Wang, Yan
Gao, Yun-xian
Sun, Qi
Bu, Qian
Shi, Jing
Zhang, Ya-ni
Xu, Qin
Ji, Yan
Tong, Min
Jiang, Guang-li
author_facet Wang, Yan
Gao, Yun-xian
Sun, Qi
Bu, Qian
Shi, Jing
Zhang, Ya-ni
Xu, Qin
Ji, Yan
Tong, Min
Jiang, Guang-li
author_sort Wang, Yan
collection PubMed
description BACKGROUND: Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months. METHODS/DESIGN: A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A total of 100 teenagers, between seven and 12 years of age, with mild-to-moderate myopia and spherical lenses <-6.00 D and cylindrical lenses <-1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine, a grade III level A teaching hospital in Urumqi, Xinjiang, China (Xinjiang Medical University Affiliated Hospital of Traditional Medicine). The subjects will be randomly assigned to two different groups (control and acupuncture groups), each group containing 50 subjects. The subjects in both groups wear single-vision corrective lenses. In the acupuncture group, acupuncture will be performed daily for nine consecutive days on five points (bilateral Cuanzhu, Tongziliao, Sibai, Muchuang, and Hegu), followed by no treatment for one day. Six cycles of treatment will be undertaken continuously for a total of 60 days. Following 60 days of treatment, a follow-up period of six months will be included. The primary outcome will be diopter determination. The secondary outcomes will include distance visual acuity, axial length, lens thickness, ciliary body thickness, and subjective symptoms of the eyes and entire body. The main time points for the evaluation of clinical efficacy will be the first, third, and sixth months after treatment. DISCUSSION: This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia, as well as information on the safety of acupuncture. TRIAL REGISTRATION: Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003448; registration date: 7 August 2013).
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spelling pubmed-42892442015-01-11 Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial Wang, Yan Gao, Yun-xian Sun, Qi Bu, Qian Shi, Jing Zhang, Ya-ni Xu, Qin Ji, Yan Tong, Min Jiang, Guang-li Trials Study Protocol BACKGROUND: Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months. METHODS/DESIGN: A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A total of 100 teenagers, between seven and 12 years of age, with mild-to-moderate myopia and spherical lenses <-6.00 D and cylindrical lenses <-1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine, a grade III level A teaching hospital in Urumqi, Xinjiang, China (Xinjiang Medical University Affiliated Hospital of Traditional Medicine). The subjects will be randomly assigned to two different groups (control and acupuncture groups), each group containing 50 subjects. The subjects in both groups wear single-vision corrective lenses. In the acupuncture group, acupuncture will be performed daily for nine consecutive days on five points (bilateral Cuanzhu, Tongziliao, Sibai, Muchuang, and Hegu), followed by no treatment for one day. Six cycles of treatment will be undertaken continuously for a total of 60 days. Following 60 days of treatment, a follow-up period of six months will be included. The primary outcome will be diopter determination. The secondary outcomes will include distance visual acuity, axial length, lens thickness, ciliary body thickness, and subjective symptoms of the eyes and entire body. The main time points for the evaluation of clinical efficacy will be the first, third, and sixth months after treatment. DISCUSSION: This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia, as well as information on the safety of acupuncture. TRIAL REGISTRATION: Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003448; registration date: 7 August 2013). BioMed Central 2014-12-05 /pmc/articles/PMC4289244/ /pubmed/25476698 http://dx.doi.org/10.1186/1745-6215-15-477 Text en © Wang et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Wang, Yan
Gao, Yun-xian
Sun, Qi
Bu, Qian
Shi, Jing
Zhang, Ya-ni
Xu, Qin
Ji, Yan
Tong, Min
Jiang, Guang-li
Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title_full Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title_fullStr Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title_full_unstemmed Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title_short Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
title_sort acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4289244/
https://www.ncbi.nlm.nih.gov/pubmed/25476698
http://dx.doi.org/10.1186/1745-6215-15-477
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