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Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

Blind Procedures

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...

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A placebo acupuncture needle with potential for double blinding - a validation study.

Nobuari Takakura¹, Hiroyoshi Yajima

¹Hanada College Japanese School of Acupuncture, Moxibustion and Physiotherapy, Tokyo, Japan. takakura@hanada.ac.jp

Acupuncture in Medicine : Journal of the British Medical Acupuncture Society

|December 23, 2008

Summary

The non-penetrating placebo needle effectively masked informed subjects, indicating its utility in acupuncture research. This method enhances the reliability of double-blind studies by maintaining patient and practitioner blindness.

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Area of Science:

Acupuncture Research
Clinical Trial Methodology
Placebo Controls

Background:

Non-penetrating placebo needles are known to mask patients unaware of potential placebo use.
This study investigated the efficacy of these needles in masking subjects fully informed about potential placebo administration.

Purpose of the Study:

To evaluate the effectiveness of non-penetrating placebo needles in masking informed participants in acupuncture studies.
To assess the impact of needle type (penetrating vs. non-penetrating) on perceived pain and de qi sensations.

Main Methods:

114 informed volunteers received random combinations of penetrating and non-penetrating needles at TE5 points.
Participants reported their identification of each needle type and rated pain and de qi sensations using a visual analogue scale (VAS).
Statistical analysis included chi-squared tests and Mann-Whitney U tests.

Main Results:

Subjects incorrectly identified 64 of 114 non-penetrating needles and 36 of 114 penetrating needles.
There were no significant differences in reported skin penetration pain or de qi sensations between penetrating and non-penetrating needles.
The non-penetrating needle demonstrated effectiveness in masking informed subjects.

Conclusions:

The non-penetrating placebo needle is effective in masking fully informed subjects in acupuncture research.
Its combination with a matched penetrating needle holds potential for robust double-blind (patient and practitioner) studies.
This finding supports the use of placebo needles to enhance the validity of acupuncture clinical trials.