受試者同意書版本:
生效日期:
計畫名稱：耳穴貼壓對青光眼病人眼壓的控制效果評估
醫院名稱：南投醫院 電話：049-2231150
計畫主持人：何建賢 職稱：眼科 主任 電話：0932569128
緊急聯絡人：何建賢 職稱：眼科 主任 電話：0932569128
計畫主持人簽名： 日期：
受試者姓名： 性別： 年齡： 病歷號碼：
通訊地址： 電話：
法定代理人姓名： 性別： 年齡：
通訊地址： 電話：
（醫療法第五十七條規定：受試者為無行為能力或限制行為能力人，應得其法定代理 人之同意）
一、試驗目的及方法： 預期效果，在這種前題下，使用替代輔助療法 (alternative and complementary/CA M therapy) 治療青光眼有很多人呈現高度關切的興趣。
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行追蹤。
二、預期醫療效能：
國外在動物實驗研究上，利用針灸刺激狗的LI-4(合谷), LIV-3(太衝), GB-37(光明 )可有效降低眼壓；日本方面也曾在青光眼病患身上利用針灸刺激肝、腎俞、攢竹、
四白、太陽等穴，發現可以有意義降低眼壓並有改善視力的效果。故我們推估以耳穴 貼壓青光眼患者的適當穴位將有降低眼壓及改善視力的效果。
三、可能產生之併發症、副作用、危險及其處理方法：
局部貼布過敏，如有過敏現象發生，請立即移除耳珠貼布並與計畫主持人連絡。
四、試驗可能造成的不適：
局部貼布過敏
五、其他可能之治療方法及說明：
本試驗為輔助療法，以不干擾國際上已確定有效之正規治療 為主；所以病人是除了接受正規治療外，多接受一項耳穴貼療，
以調理病患本身循環及眼部狀況。
六、試驗經費來源及所有參與試驗之機構：
本試驗無特殊贊助經費來源，由南投醫院眼科、中國醫藥大學中西醫結合研究所 共同執行
七、受試者應注意事項：
受試者應配合標準作業流程，於第一、第二、第三、第四、第八週回門診回診並 接受眼壓及視力測量。
八、本試驗受試者之權益將受到下列保護：
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附件三 臨床計畫主持人證書
附件四 論文接受函
(預計 2010 年 10 月刊登發表) --- Original Message ---
From: <[email protected]>
To: <[email protected]>
Cc: <[email protected]>; <[email protected]>
Sent: Wednesday, March 17, 2010 1:19 AM
Subject: Journal of Alternative and Complementary Medicine - Decision on Manuscript ID JACM-2010-0020.R2
16-Mar-2010
Dear Prof. Chen:
We are pleased to accept your manuscript entitled "Intraocular Pressure-Lowering Effect of Auricular Acupressure in Patients with Glaucoma: A Prospective Single-Blinded Randomized Controlled Trial" for publication in Journal of Alternative and Complementary Medicine. Your paper is tentatively scheduled for publication in our October 2010 issue.
You will receive page proofs electronically from Jason Schappert ([email protected]) and may receive additional correspondence related to production from Ms. Billie Spaight ([email protected]). Please add these to your address book so correspondence from them is not caught in your spam filter.
All authors will get a follow-up email with instructions on how tocomplete our online Copyright Agreement form. FAILURE BY ALL AUTHORS TO SUBMIT THIS FORM MAY RESULT IN A DELAY OF
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PUBLICATION.
The corresponding author is responsible for communicating with coauthors to make sure they have completed the online copyright form. Authors not permitted to release copyright must still return the form acknowledging the statement of the reason for not releasing the copyright. The corresponding author will receive notification when all copyright forms have been submitted.
Authors who would like their papers to be made free online immediately after publication can sign up for Liebert Open Option for a one-time fee. If the paper has NIH funding, it will also be uploaded onto PubMedCentral on behalf of the author. Please contact Karen Ballen at [email protected] or at (914) 740-2194 for more information.
Thank you for your contribution. On behalf of the Editors of Journal of Alternative and Complementary Medicine, we look forward to your continued contributions to the Journal.
Sincerely, Barbara Perrin
Journal of Alternative and Complementary Medicine Editorial Office [email protected]
Abstract
Background: The objective of the study was to evaluate the effect of auricular acupressure in controlling the intraocular pressure (IOP) in glaucoma patients.
Methods: Thirty-three patients were recruited through advertisement at the clinic for glaucoma. These patients were divided into the auricular acupressure group (16 patients, 28 glaucoma eyes) and the sham group (17 patients, 32 glaucoma eyes). Patients in the acupressure group received auricular acupoint (kidney, liver, and eye) stimulator tapping and regular massage twice a day for 4 weeks.
Patients in the sham group received tapping at sham auricular acupoints (wrist, shoulder, and jaw) without massage stimulation. The IOP and visual acuity (VA) were assessed before and after the treatment in the first 4 weeks and followed up, up to 8 weeks.
Results: After the treatment and at the 8-week follow-up, IOP and VA improved significantly in the acupressure group when compared with pre-treatment (P<0.05). The most significant IOP-lowering effect was seen at about 3 to 4 weeks after auricular acupressure. IOP returned to the initial level after acupressure had been discontinued for 4 weeks. Significant improvement of the uncorrected VA (UCVA) was noted at about 2 to 4 weeks in the acupressure group. UCVA improvement was also noted in the sham group. The difference was only significant in week 3. Improvement of the best-corrected VA was noted in both groups, but was only significant at the acupressure group in week 2.
Conclusions: Our data suggest that auricular acupressure can be used as a complementary treatment to ameliorate IOP and VA for patients with glaucoma.
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Keywords：auricular acupressure, complementary and alternative medicine, glaucoma, intraocular pressure, visual acuity