Response to Re: A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients.
Response to Re: A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients.
复制标题
对 Re 的反应：改善视网膜色素变性患者视觉功能的针灸方案的初步研究。
DOI：
10.1111/cxo.12243
复制
发表时间：
2015
影响因子：
1.9
通讯作者：
Dagnelie,Gislin
中科院分区：
文献类型：
--
作者：
Bittner,AvaK;Rosenfarb,Andy;Gould,Jeff;Dagnelie,Gislin
EDITOR: We are grateful for Mr. Curtis’ comments, which gives us an opportunity to provide further clarifications. In reading our previous report, one should bear in mind that clinical trials are conducted in a series of steps called phases. In phase I, such as our pilot study of electro-acupuncture for retinitis pigmentosa, 1 researchers test a new intervention in a small group to evaluate safety and determine estimates of effect size. Previous phase I trials for orphan retinal diseases, such as retinitis pigmentosa, have included very small samples without a placebo control. 2, 3 If phase I trials demonstrate safety and support study hypotheses, then later phase trials will include larger numbers of subjects and a control group. In his letter, Curtis raises the concern that the subjects with retinitis pigmentosa in our phase 1 trial may have experienced placebo effects, as they were actively seeking an intervention to help with their otherwise untreatable visual loss. He also suggests that heat lamps applied to the stomach, as in our pilot study, may enhance placebo effects but gives no reference or scientific support for this statement. The occurrence of placebo effects following acupuncture is indeed a possibility and an unavoidable factor in any clinical trial. This is precisely why we reported previously the need for future controlled trials, have now identified an appropriate sham intervention and are currently conducting an NIH-funded placebocontrolled trial of electro-acupuncture for retinitis pigmentosa (clinicaltrials. gov: NCT02086890).Curtis claims there are learning effects for visual field and scotopic tests but references a study of frequency doubling perimetry in people without ocular disease and without previous experience with visual field testing. Previously, we addressed this issue by referencing studies indicating no learning effects for these tests in a retinitis pigmentosa population with previous visual field experience. 1 It was important to use a ‘large’test battery (n= 4) in our initial exploratory study, as we did not know which of the many aspects of visual loss in retinitis pigmentosa might be affected by acupuncture. Curtis commented that it is possible to obtain significant positives by chance when using a large number of tests in a small sample. For this reason, we did not apply any statistical tests to detect significance in our data. Instead, we determined the proportion of patients with improvements outside the 95 per cent confidence interval reported previously for testretest variability in retinitis pigmentosa. 1 Exceeding this interval is highly suggestive that the change is not likely due to chance or usual variability.
