First Evidence of Double-Blind Trial

What is Blinding in Clinical Trial?

It is also called masking. It refers to the process of withholding the treatment allocation information from the people involved in clinical trials.

There are numerous participants in a clinical trial. It includes patients/subjects, researchers, physicians, technicians, etc. Blinding is done to one or more groups.

It is an essential methodological feature of clinical trials for validating a new treatment option. However, it cannot be implemented in all types of clinical trials.

Types of Blinding Trials

Generally, single, double, and triple-blind trials are done.

Single Blind Trial: Here the participant patients or subjects are masked or blinded. It means they can’t know which treatment they are receiving.

Double-Blind Trial: Both the subjects and the researchers are blinded.

Triple-Blind Trial: Subjects, researchers, and also data-analysts are blinded.

First Evidence of Blinding Trial in Clinical Trial History

Popularity of Homeopathy

At the beginning of the 19th century, homeopathy was honored as an excellent treatment process in Germany. ?Even the royal family members in the Kingdom of Bavaria used to rely on it. But there were also many critiques of homeopathy. They made a serious complaint stating that it has no scientific foundation. They expressed their doubts regarding the effectiveness of homeopathic medicines. According to them, patients cured by homeopathy were cured by either natural healing power or power of belief.

An Assessment was Needed

Then an objective assessment done by impartial experts became necessary. So a public invitation was printed and distributed to welcome interested people to participate in the experiment. More than 120 people showed interest.

Assessment Procedure

100 persons were selected. Accordingly, 100 vials were made ready in two lots. One contained only distilled water. The other lot contained homeopathic medicine (a grain of salt was dissolved in 100 drops of distilled snow water and the resulting solution was diluted 29 times at a ratio of 1 to 100).

Vials were distributed among 100 persons randomly. A secret list was prepared where the distribution information was recorded. ?

Reporting

Three weeks later, the participants came to report about their well-being. The secret list was opened to acknowledge who received distilled water and who received homeopathic medicines.

Only eight people in total said they experienced something unusual. 5 of them received medicine and the rest received distilled water.

Conclusion

So it was concluded that the effects of homeopathic medicines are the fruit of imagination, self-deception, and preconceived opinion.

Conclusion Biased or Authentic?

Actually, there were many people against homeopathy. They also participated in the trial. So they might have a tendency to prove themselves.

It's true that they didn’t know whether they were taking distilled water or homeopathic medicine. If they experienced something unusual, most probably they didn’t want to reveal it. Because it might support the effectiveness of the homeopathy medicine.

So there was a chance that the purpose of double-blind study was not served properly in this first study.

Links:

1.????? https://pmc.ncbi.nlm.nih.gov/articles/PMC1676327/

2.????? https://www.verywellmind.com/what-is-a-double-blind-study-2795103