Patulin Trial: First Randomized Controlled Trial in the History of Clinical Trial

What is a Large-scale, Double-blind, Comparative Clinical Trial?

The key points to be understood about this trial are:

·?????? Large Scale: This means that the investigation must be done on many subjects in several widely separated places. It must continue for a long time to get precise results.

·?????? Double-Blind: Both the researchers and the subjects are kept unaware of which treatment is being provided to whom. It minimizes the bias in data collection.

·?????? Comparative: The study compares the effect of a new treatment with a standard treatment or placebo.

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Patulin Trial: First Large-scale, Double-blind, Comparative Clinical Trial in the General Population

Discovery of Patulin:

The trials on Patulin started in a very surprising way. In 1941, Harold Reistrick, a professor of Biochemistry at the University of London isolated patulin from several fungal species belonging to the genera Penicillium and Aspergillus. It is a very beautiful crystalline product.

Study on Patulin:

He studied various properties of it for 2 years.

At the beginning of 1943, he became curious to know if it had anti-cancerous properties. He handed over some samples of patulin to Dr. W. E. Guy, the Director of the Imperial Cancer Research Fund Laboratories.

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Search for Cold-Curing Properties of Patulin:

By that time, when Guy received patulin in his laboratory, he was suffering from a severe cough and cold. He was very sick and became very desperate for treatment. All the available treatments failed to cure him from this cold. So he decided to try this new substance patulin, by chance, on him. He made a solution of patulin and douched it into his nasal passage. It became unblocked within an hour. He repeated it two times that same day and the next day morning. His cold was cured and he joined his work.

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Clinical Trials on Patulin’s Effectiveness to Cure Cold:

He felt very enthusiastic about studying the effectiveness of patulin in treating colds. He created an opportunity for a randomized, control trial.

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First Trial:

It was done in early 1943 by Commander W A Hopkins, a surgeon commander in the Royal Navy of the United Kingdom. There were 95 and 85 patients in the patulin and placebo group respectively. 55 of the patients from the patulin group recovered during the trial. On the other hand, only 8 patients from the placebo group recovered from the cold. The result indicated the effectiveness of patulin.

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Few More Trials:

After this, a few more trials were conducted in the Navy. But all showed disappointing results. These results showed that cold lasted for a longer time in the patulin-receiving patients.

In October 1943, the manufacturer of patulin, the Therapeutic Research Corporation approached the Medical Research Council for a larger trial.

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A Big Randomized Controlled Trial on Patulin

The common cold was a personal and national burden in the country, and Patulin showed a ray of hope in its first randomized control trial. So all the physicians, researchers, and research funders wanted a much bigger trial on patulin.

Thus, from January to April 1944, a trial on a larger population was conducted at 14 different locations within London. Each patient was assessed by a medical officer to confirm their severe cold. Totally 1449 patients participated. 668 were treated with patulin and 680 were in the control group.

They were given their own bottle of medicine and the required instruction. Their progress were recorded after 1,2, and 7 days. A total of 101 patients didn’t retirn for report.

The result showed that control group patients recovered faster than the patulin group. Thus a conclusion was drawn that patulin cannot be used as a remedy for the common cold.

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