针刺师盲法的效果：不同直径的双盲针灸针。
Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles.
出版信息
Altern Ther Health Med. 2021 Sep;27(5):62-66.
CONTEXT
It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16 mm diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them.
OBJECTIVE
The study intended to compare the effects on an acupuncturist's blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters.
DESIGN
We conducted a double-blind randomized trial.
SETTING
The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan.
PARTICIPANTS
The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy.
METHODS
The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student's dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions.
PRIMARY OUTCOME MEASURES
After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter.
RESULTS
Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist's confidence (P = .16). In 99% of the tests, the cue that contributed to the acupuncturist's guess was the feeling of the needle insertion.
CONCLUSION
These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn't significantly affect the acupuncturist's blinding.
背景
在针灸的对照临床试验中，很难采用双盲设计进行实验。为了解决这个盲法问题，我们设计了带有填充料的双盲针（DBN），以模拟常规针灸针插入时的阻力感。过去使用 0.16 毫米直径的 DBN 进行的研究结果发现，针灸师在插入过程中感觉到的阻力成功地使他们失去了知觉。
目的
本研究旨在比较使用直径为 0.14、0.16、0.18 和 0.20 毫米的穿透性 DBN 对针灸师的盲法效果。
设计
我们进行了一项双盲随机试验。
地点
试验在日本东京的日本针灸、艾灸和物理疗法学校进行。
参与者
参与者是一名有执照的针灸师，他在 20 名熟悉针灸的健康学生身上进行了 320 次针刺，这些学生都曾在日本针灸、艾灸和物理疗法学校接受过治疗。
方法
针灸师被告知她将进行穿透性或非穿透性针刺，但只使用穿透性针刺。她使用交替旋转技术将四种尺寸的针刺入每个学生的两个前臂背侧。在另一天，至少在两次治疗之间间隔一天，再次重复该过程。
主要结果测量指标
在针灸师拔出每根针后，我们询问她：（1）插入的针的类型，（2）她对猜测的信心程度，以及（3）有助于她猜测的线索。采用卡方检验确定每种针直径的正确或错误识别针的比例是否符合 0.5 的预期概率。
结果
在 320 次针刺中，针灸师正确识别了 0.14 毫米的 54%、0.16 毫米的 45%、0.18 毫米的 46%和 0.20 毫米的 50%。正确和错误识别的针的比例与 0.5 的概率相拟合，针灸师的信心无显著差异（P=0.16）。在 99%的测试中，有助于针灸师猜测的线索是针刺的感觉。
结论
这些发现表明，从 0.14 到 0.20 毫米的 DBN 直径差异并没有显著影响针灸师的盲法效果。
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