…But why?

According to the annals of history, 20^th May 1747 is the day that British ship’s Doctor James Lind began the world’s first randomized clinical trial, a study which pointed the way towards preventing scurvy and effectively cured 2 men of the disease in the process.

What is scurvy?

Initially, anyone who contracted scurvy would display cold-like symptoms – extreme fatigue, pallour, and often a sense of listlessness or depression. As it progressed, the disease caused fever and rashes, a swollen tongue, and for the gums to become ‘spongy’, resulting in tooth loss. Eventually, untreated scurvy became fatal, causing heavy bleeding.

Although rarely seen today, scurvy was extremely common in sailors when Lind conducted his study. The disease had a long history, having been recorded by Hippocrates as well as the ancient Egyptians. In 1740, 1900 men had set out to circumnavigate the world and 1400 had died along the way, mostly from scurvy. At the height of global exploration, scurvy was a massive hindrance to naval travel. Finding a way to treat this scourge of the seas would allow longer and more lucrative voyages – so something had to be done!

Lind’s Experiment

When 12 men on board the HMS Salisbury contracted scurvy, Dr James Lind separated them into 6 groups of two, prescribing each group with a different potential treatment. Now, keeping in mind that they were in the middle of the ocean, Lind’s treatment options were limited! He gave the respective groups:

• Cider
• Vinegar
• Seawater (yummy!)
• A paste of garlic, horseradish and mustard
• Diluted sulphuric acid
• Citrus fruits

Of all of these would-be medicines, citrus fruits were the hardest to come by, and the ‘citrus’ sailors ran out of supplies after just 6 days. Fortunately, they were both well on their way to a complete recovery by this point!

How big a difference did Lind’s Clinical Trial make?

You might be surprised to learn that Dr Lind’s research did NOT represent a turning point in the treatment of scurvy!

Although he noted the benefits of citrus, James Lind did not challenge the medical establishment, who believed that scurvy was caused by food decomposing in sailors’ stomachs. As citrus fruits were rare and expensive, Doctors and Captains alike were unwilling to give them to crews routinely.

Cases of scurvy decreased as citrus and other vitamin c-rich foods became more commonplace, but the disease remained an issue until the Mid-20^th Century – some 200 years after Lind’s research took place.

So why is Lind’s experiment still celebrated on International Clinical Trials Day?

Well, perhaps we are celebrating the process, rather than the outcome? Lind’s study was a beautifully simple and efficient way of comparing different treatments. By ‘randomizing’ his patients and pursuing different treatment options, Lind created a model which we still use at Covance today to answer questions like:

• Does this treatment perform better than existing products?
• Does it work better than a placebo?
• Is it more effective when taken on a full or empty stomach?
• Does introducing a second drug make this treatment more or less effective?

Fortunately, although clinical trials still resemble Lind’s experiment, we now have cutting-edge technology to monitor and record a huge range of  the body’s responses, and an office full of boffins who spend months or even years analysing the results – so unlike Dr Lind, we won’t be overlooking any miracle cures!

If you’d like to get involved with shaping the future of medicine, we’re currently recruiting healthy men and women aged 18-55 to take part in studies at our Leeds clinic. Apply now to participate in one of our paid clinical trials. You won’t have to drink any seawater. We promise!

This post was written for International Clinical Trials Day 2016 by Ruth Smethurst. All views expressed are her own, and do not represent Covance.