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Clinical Study Types - for Librarians

Earliest Clinical Trial

Clinical trialshave been conducted for a very, very long time.  The excerpts below are from this very interesting article: Evolution of Clinical Research: A History Before and Beyond James Lind  by Dr Arun Bhatt 

Nebuchadnezzar, 500 BC (approx)

The world's first clinical trial is recorded in the “Book of Daniel” in The Bible. This experiment resembling a clinical trial was not conducted by a medical, but by King Nebuchadnezzar a resourceful military leader. During his rule in Babylon, Nebuchadnezzar ordered his people to eat only meat and drink only wine, a diet he believed would keep them in sound physical condition. But several young men of royal blood, who preferred to eat vegetables, objected. The king allowed these rebels to follow a diet of legumes and water — but only for 10 days. When Nebuchadnezzar's experiment ended, the vegetarians appeared better nourished than the meat-eaters, so the king permitted the legume lovers to continue their diet. This probably was the one of the first times in evolution of human species that an open uncontrolled human experiment guided a decision about public health.

James Lind, 1700's

James Lind is considered the first physician to have conducted a controlled clinical trial of the modern era.1–4 Dr Lind (1716-94), whilst working as a surgeon on a ship, was appalled by the high mortality of scurvy amongst the sailors. He planned a comparative trial of the most promising cure for scurvy.1–4 His vivid description of the trial covers the essential elements of a controlled trial.

Lind describes“”On the 20th of May 1747, I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of the knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all, viz. water gruel sweetened with sugar in the morning; fresh mutton-broth often times for dinner; at other times light puddings, boiled biscuit with sugar, etc., and for supper, barley and raisins, rice and currants, sago and wine or the like. Two were ordered each a quart of cyder a day. Two others took twenty-five drops of elixir vitriol three times a day … Two others took two spoonfuls of vinegar three times a day … Two of the worst patients were put on a course of sea-water … Two others had each two oranges and one lemon given them every day … The two remaining patients, took … an electary recommended by a hospital surgeon … The consequence was, that the most sudden and visible good effects were perceived from the use of oranges and lemons; one of those who had taken them, being at the end of six days fit for duty … The other was the best recovered of any in his condition; and … was appointed to attend the rest of the sick. Next to the oranges, I thought the cyder had the best effects …” (Dr James Lind's “Treatise on Scurvy” published in Edinburgh in 1753)

Although the results were clear, Lind hesitated to recommend the use of oranges and lemons because they were too expensive.3 It was nearly 50 years before the British Navy eventually made lemon juice a compulsory part of the seafarer's diet, and this was soon replaced by lime juice because it was cheaper.

Lind's Treatise of 1953, was written while he was resident in Edinburgh and a Fellow of the Royal College of Physicians, contains not only his well known description of a controlled trial showing that oranges and lemons were dramatically better than the other treatments for the disease, but also a systematic review of previous literature on scurvy.5

 

Resources

Bhatt, A. (2010). Evolution of clinical research: a history before and beyond james lind. Perspectives in Clinical Research, 1(1), 6-10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/

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