When looking through the evolution of clinical research over the decades, Dr. James Lind’s contribution has always borsegabsoutlet kleankanteenkinder relaxdaysstore capsvondutch tatacalzature giga-sport 24hbottle borsalamilanesa guardianialberto donkeyluckycat loevenichmutze guardianialberto marellaabiti fracominasaldi saldigeoxeen considered as a major turning point. He has marked a significant milestone by conducting the world’s first ever documented controlled clinical trial on scurvy patients.[1]
Scurvy is a state of dietary deficiency of vitamin C (ascorbic acid). The human body cannot produce it’s own vitamin C and the body’s pool of vitamin C can be depleted in 1-3 months in the absence of a dietary source.[2]Even though it is rarer now, scurvy is probably the nutritional deficiency disease that has caused the most suffering in recorded history.
Since the late 16th century, when European countries embarked on long intercontinental sea voyages, scurvy has been a nightmare disease for the sailors. Sailors were especially affected because they were away on sea for months and had no fresh food. They presented with lack of enthusiasm, weakness, easy bruising, tiny or large skin haemorrhage, bleeding gums, swollen legs and ultimately died if untreated.[3]
As this went on for decades, even though no one knew what was causing the disease, with experience, lay people knew that this deadly disease could be cured and prevented by oranges and lemons. However, most Physicians ignored this lay therapy in favour of ancient theories and polypharmacy.[4]
While working as a surgeon on a ship,appalled by the high mortality of this disease, James Lind planned a trial in search of the most promising cure.On 20th of May 1747, he selected 12 patients with scurvy on board. The patients selected in general were of similar disease state as much as possible, with putrid gums, lack of energy, weakness of the knees & so on.[3] They were separated from others and kept in one place& were given one common diet. This depicts James Lind’s understanding of the need to safeguard against selection bias and shows how he has tried to maintain clinical conditions, environment and basic diet constant.
Six treatment strategies; a quart of cider a day,25 drops of elixir of vitriol (a mixture of sulphuric and alcohol) 3 times a day, two spoonfuls of vinegar 3 times a day, a course of sea water, 2 oranges and one lemon a day,an electuary (medicinal substance) recommended by a hospital surgeon were considered for the trial. Two of the patients were assigned to each treatment strategy. The most sudden and visible positive effects were seen with orange and lemon & one person was fit for duty at the end of 6 days of treatment. [3]
This is considered the first documented controlled clinical trial of the modern era. James Lind has written his experiences in “a treatise of the scurvy”,published in Edinburgh in 1753 which also contains a systematic review of previous literature on scurvy.[3]Throughout the centuries, clinical trials have come a long way while facing many challenges; scientific, ethical and regulatory. By discovering new treatments as well as new ways to detect, diagnose and prevent diseases, clinical trials have provided and will continue to provide the scientific basis for evidence based medicine.
REFERENCES
- Bhatt A. Evolution of clinical research: A history before and beyond James Lind. PerspectClin Res. 2010;1:6–10.
- Scurvy: Practice Essentials, Pathophysiology, Etiology [Internet]. Emedicine.medscape.com. 2021 [cited 5 July 2021]. Available from: https://emedicine.medscape.com/article/125350-overview
- Milne I. Who was James Lind, and what exactly did he achieve. J R Soc Med. 2012;105(12):503-508. doi:10.1258/jrsm.2012.12k090
- Baron J. Evolution of clinical research: A history before and beyond James Lind. Perspectives in Clinical Research. 2012;3(4):149.
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