From collagen to Covid: Why clinical trials are important

Phase-Plastic-Surgery-Blog-Clinical Trials

I just finished doing a peer review on a clinical study about breast implants, and I always find this activity enlightening. Clinical research requires this sort of independent double-check (the reviewers’ and the author’s identity are blinded to each other to eliminate bias). So many issues need good clinical trials now, from best practices to optimize breast implant safety to the scramble for answers during the COVID-19 pandemic. In fast-developing or controversial situations, there’s often a temptation to shortcut the tried and true methods that lead to informed decision making. Whether from the

rush to hype a new procedure or respond to an epidemic, reliable solutions come from clinical studies with measurable results. That’s why I support the process and why I have participated in many clinical studies and done dozens of peer reviews. We have investigated noninvasive ultrasound for localized fat reduction, decreasing pain scores with Exparel, the Galaflex internal bra, molecular approaches to scar reduction, and more. The opportunity for innovative problem solving is one of the things that drew me to the specialty of plastic surgery, but new ideas still have to be proven.

The origin of clinical trials: scurvy and the "fair test"

Clinical trials aren’t a new idea, but lately there seems to be a trend to downplay their importance. The first documented randomized clinical trial dates as far back as 1747, aboard the HMS Salisbury of Britain’s Royal Navy. Scurvy was rampant, having killed more British seamen than the wars with the French and Spanish. Surgeon mate James Lind, acting on a hunch that scurvy could be cured through the introduction of acids, recruited 12 men for his “fair test.” Sailors were allocated to one of six different daily treatments for a period of two weeks. Among the treatments were cider; vinegar before meals; half a pint of sea water; two oranges and a lemon; and a medicinal paste made up of garlic, mustard seed, and dried radish. Those given citrus fruits experienced “the most sudden and good visible effects,” according to Lind’s report on the trial, and British sailors have known as “limeys” ever since.

Why we still need clinical trials

Though it would be almost another two hundred years before Vitamin C was isolated, the basics of clinical trial design were demonstrated by Lind’s experiment. Thousands of clinical studies on Vitamin C have been published since then, and interestingly it still seems misunderstood. Does it help prevent colds? Probably not. Ditto for cancer and heart disease. It is a strong antioxidant? Yes, but it is also a pro-oxidant in some situations.[i] One thing is certain though: it remains effective for prevention of scurvy, a disorder of collagen production, which requires vitamin C as an enzyme cofactor. And since collagen is so important for healthy skin and good healing, it is still a big topic in plastic surgery and aesthetic medicine.

We will always need clinical trials, whether you are trying to build better collagen, improve breast augmentation techniques, or find a cure for Covid. They may not always give definitive results, or the results you want, but the whole point of doing them is to find out what works and what doesn’t.

[i] Kaźmierczak-Barańska J, Boguszewska K, Adamus-Grabicka A, Karwowski BT. Two Faces of Vitamin C-Antioxidative and Pro-Oxidative Agent. Nutrients. 2020;12(5):E1501. Published 2020 May 21.

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